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  • TCVN TIU CHUN QUC GIA * NATIONAL STANDARD

    TCVN ISO 9001 : 2008 Xut bn ln 3 Third edition

    H THNG QUN L CHT LNG CC YU CU

    QUALITY MANAGEMENT SYSTEMS REQUIREMENTS

    H NI 2008

  • TCVN ISO 9001 : 2008

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  • TCVN ISO 9001 : 2008

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    Mc lc 0 Li gii thiu .....................................................................................................................

    1 Phm vi p dng ...............................................................................................................

    1.1 Khi qut ...................................................................................................

    1.2 p dng .....................................................................................................

    2 Ti liu vin dn ................................................................................................................

    3 Thut ng v nh ngha ...................................................................................................

    4 H thng qun l cht lng .............................................................................................

    4.1 Yu cu chung...........................................................................................................

    4.2 Yu cu v h thng ti liu........................................................................

    5 Trch nhim ca lnh o.................................................................................................

    5.1 Cam kt ca lnh o .................................................................................

    5.2 Hng vo khch hng ..............................................................................

    5.3 Chnh sch cht lng ...............................................................................

    5.4 Hoch nh ................................................................................................

    5.5 Trch nhim quyn hn v trao i thng tin ..............................................

    5.6 Xem xt ca lnh o .................................................................................

    6 Qun l ngun lc .............................................................................................................

    6.1 Cung cp ngun lc ...................................................................................

    6.2 Ngun nhn lc..........................................................................................

    6.3 C s h tng ............................................................................................

    6.4 Mi trng lm vic....................................................................................

    7 To sn phm ...................................................................................................................

    7.1 Hoch nh vic to sn phm ...................................................................

    7.2 Cc qu trnh lin quan n khch hng......................................................

    7.3 Thit k v pht trin ..................................................................................

    7.4 Mua hng ...................................................................................................

    7.5 Sn xut v cung cp dch v......................................................................

    7.6 Kim sot thit b theo di v o lng ......................................................

    8 o lng, phn tch v ci tin .........................................................................................

    8.1 Khi qut ...................................................................................................

    8.2 Theo di v o lng .................................................................................

    8.3 Kim sot sn phm khng ph hp............................................................

    8.4 Phn tch d liu ........................................................................................

    8.5 Ci tin ......................................................................................................

    Ph lc A (tham kho) S tng ng gia TCVN ISO 9001 : 2008 v TCVN ISO 14001: 2005... Ph lc B (tham kho) Nhng thay i ca ISO 9001 : 2008 so vi ISO 9001 : 2000......... Th mc ti liu tham kho .............................................................................................

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    62 Contents 0 Introduction ................................................................................................................

    Trang 6

  • TCVN ISO 9001 : 2008

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    1 Scope ........................................................................................................................

    1.1 General .............................................................................................................

    1.2 Application .........................................................................................................

    2 Normative reference ..................................................................................................

    3 Terms and definitions ................................................................................................

    4 Quality management system .....................................................................................

    4.1 General requirements ........................................................................................

    4.2 Documentation requirements ............................................................................

    5 Management responsibility ........................................................................................

    5.1 Management commitment .................................................................................

    5.2 Customer focus .................................................................................................

    5.3 Quality policy .....................................................................................................

    5.4 Planning ............................................................................................................

    5.5 Responsibility, authority and communication .....................................................

    5.6 Management review ..........................................................................................

    6 Resource management .............................................................................................

    6.1 Provision of resources .......................................................................................

    6.2 Human resources ..............................................................................................

    6.3 Infrastructure .....................................................................................................

    6.4 Work environment .............................................................................................

    7 Product realization ....................................................................................................

    7.1 Planning of product realization ..........................................................................

    7.2 Customer-related processes .............................................................................

    7.3 Design and development ...................................................................................

    7.4 Purchasing ........................................................................................................

    7.5 Production and service provision .......................................................................

    7.6 Control of monitoring and measuring equipment ...............................................

    8 Measurement, analysis and improvement .................................................................

    8.1 General .............................................................................................................

    8.2 Monitoring and measurement ............................................................................

    8.3 Control of nonconforming product .....................................................................

    8.4 Analysis of data .................................................................................................

    8.5 Improvement .....................................................................................................

    Annex A Correspondence between ISO 9001 : 2008 and ISO 14001 : 2004................ Annex B Changes between ISO 9001 : 2008 and ISO 9001 : 2000. ............................. Bibliography ..................................................................................................................

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  • TCVN ISO 9001 : 2008

    5

    Li ni u

    TCVN ISO 9001 : 2008 thay th cho TCVN ISO 9001 : 2000

    (ISO 9001 : 2000);

    TCVN ISO 9001 : 2008 hon ton tng ng vi ISO 9001 :

    2008;

    TCVN ISO 9001 : 2008 do Ban k thut Tiu chun Quc gia

    TCVN/TC 176 Qun l cht lng v m bo cht lng bin

    son, Tng cc Tiu chun o lng Cht lng ngh, B

    Khoa hc v Cng ngh cng b.

  • TCVN ISO 9001 : 2008

    6

    Li gii thiu

    0.1 Khi qut

    Chp nhn mt h thng qun l cht lng

    nn l mt quyt nh chin lc ca t chc.

    Vic thit k v p dng h thng qun l cht

    lng ca t chc ph thuc vo

    a) mi trng ca t chc, cc thay i v

    nhng ri ro trong mi trng ,

    b) cc nhu cu khc nhau,

    c) cc mc tiu ring bit,

    d) cc sn phm cung cp,

    e) cc qu trnh c s dng,

    f) quy m v c cu ca t chc.

    Mc ch ca tiu chun ny khng nhm dn

    n s ng nht v cu trc ca cc h thng

    qun l cht lng hoc s ng nht ca h

    thng ti liu.

    Cc yu cu ca h thng qun l cht lng

    quy nh trong tiu chun ny b sung cho cc

    yu cu i vi sn phm. Thng tin "Ch

    thch" l hng dn hiu ng hoc lm r

    cc yu cu cn ch thch.

    Tiu chun ny c th c s dng cho ni b

    v t chc bn ngoi, k c cc t chc chng

    nhn, nh gi kh nng p ng cc yu

    cu ca khch hng, cc yu cu lut nh v

    ch nh p dng cho sn phm cng nh cc

    yu cu ring ca t chc.

    Cc nguyn tc qun l cht lng nu trong TCVN

    ISO 9000 v TCVN ISO 9004 c xem xt khi

    xy dng tiu chun ny.

    0.2 Cch tip cn theo qu trnh

    Introduction

    0.1 General

    The adoption of a quality management system

    should be a strategic decision of an

    organization. The design and implementation of an

    organization's quality management system is

    influenced by

    a) its organizational environment, changes in

    that environment, and the risks associated with

    that environment,

    b) its varying needs,

    c) its particular objectives,

    d) the products it provides,

    e) the processes it employs,

    f) its size and organizational structure.

    It is not the intent of this International Standard

    to imply uniformity in the structure of quality

    management systems or uniformity of

    documentation.

    The quality management system requirements

    specified in this International Standard are

    complementary to requirements for products.

    Information marked "NOTE" is for guidance in

    understanding or clarifying the associated

    requirement.

    This International Standard can be used by

    internal and external parties, including

    certification bodies, to assess the organization's

    ability to meet customer, statutory and regulatory

    requirements applicable to the product, and the

    organization's own requirements.

    The quality management principles stated in ISO

    9000 and ISO 9004 have been taken into

    consideration during the development of this

    International Standard.

    0.2 Process approach

    This International Standard promotes the adoption

  • TCVN ISO 9001 : 2008

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    Tiu chun ny khuyn khch vic chp nhn cch

    tip cn theo qu trnh khi xy dng, thc hin v

    ci tin hiu lc ca h thng qun l cht lng,

    nng cao s tha mn ca khch hng thng qua

    vic p ng yu cu ca h.

    vn hnh mt cch c hiu lc, t chc phi xc

    nh v qun l nhiu hot ng c lin h mt thit

    vi nhau. Hot ng hoc t hp cc hot ng tip

    nhn cc u vo v chuyn thnh cc u ra c

    th c coi nh mt qu trnh. Thng thng u

    ra ca qu trnh ny s l u vo ca qu trnh tip

    theo.

    Vic p dng mt h thng cc qu trnh trong

    t chc, cng vi s nhn bit v mi tng

    tc gia cc qu trnh ny, cng nh s qun

    l chng to thnh u ra mong mun, c

    th c coi nh "cch tip cn theo qu

    trnh".

    u th ca cch tip cn theo qu trnh l vic kim

    sot lin tc s kt ni cc qu trnh ring l trong

    h thng cc qu trnh, cng nh s kt hp v

    tng tc gia cc qu trnh .

    Khi c s dng trong h thng qun l cht

    lng, cch tip cn trn nhn mnh tm quan

    trng ca:

    a) vic hiu v p ng cc yu cu,

    b) nhu cu xem xt qu trnh v mt gi tr gia

    tng,

    c) c c kt qu v vic thc hin v hiu

    lc ca qu trnh, v

    d) ci tin lin tc qu trnh trn c s o

    lng khch quan.

    M hnh h thng qun l cht lng da trn

    qu trnh nu Hnh 1 minh ha s kt ni ca

    qu trnh c trnh by trong cc iu t 4 n

    8. M hnh ny th hin rng khch hng ng

    mt vai tr quan trng trong vic xc nh cc yu

    cu c xem nh u vo. Vic theo di s

    tho mn ca khch hng i hi c s nh gi

    of a process approach when developing,

    implementing and improving the effectiveness of a

    quality management system, to enhance customer

    satisfaction by meeting customer requirements.

    For an organization to function effectively, it has to

    determine and manage numerous linked activities.

    An activity or set of activities using resources, and

    managed in order to enable the transformation of

    inputs into outputs, can be considered as a process.

    Often the output from one process directly forms the

    input to the next.

    The application of a system of processes within an

    organization, together with the identification and

    interactions of these processes, and their

    management to produce the desired outcome, can

    be referred to as the "process approach".

    An advantage of the process approach is the

    ongoing control that it provides over the linkage

    between the individual processes within the system

    of processes, as well as over their combination and

    interaction.

    When used within a quality management system,

    such an approach emphasizes the importance of

    a) understanding and meeting requirements,

    b) the need to consider processes in terms of added

    value,

    c) obtaining results of process performance and

    effectiveness, and

    d) continual improvement of processes based on

    objective measurement.

    The model of "a process-based quality

    management system shown in Figure 1

    illustrates the process linkages presented in clauses 4 to 8. This illustration shows that

    customers play a significant role in defining

    requirements as inputs. Monitoring of customer

    satisfaction requires the evaluation of information

    relating to customer perception as to whether the

  • TCVN ISO 9001 : 2008

    8

  • TCVN ISO 9001 : 2008

    9

    Figure 1 Model of a process-based quality management system

    Ci tin lin tc h thng qun l cht lng

    Trch nhim ca lnh o

    o lng, phn tch v ci tin

    Qun l ngun lc

    Khch hng

    Yu cu

    Khch hng S tha mn

    Sn phm To sn phm

    u vo u ra

    Hot ng gia tng gi tr Dng thng tin

    Ch gii

    Hnh 1 M hnh h thng qun l cht lng da trn qu trnh

  • TCVN ISO 9001 : 2008

    10

    0.3 Mi quan h vi ISO 9004

    TCVN ISO 9001 v TCVN ISO 9004 l cc tiu

    chun v h thng qun l cht lng, c thit

    k s dng ng thi, nhng cng c th c

    s dng mt cch c lp.

    TCVN ISO 9001 quy nh cc yu cu i vi h

    thng qun l cht lng, c th c s dng

    trong ni b t chc cho vic chng nhn hoc

    cho cc mc ch hp ng. Tiu chun ny tp

    trung vo hiu lc ca h thng qun l cht

    lng trong vic tha mn yu cu khch hng.

    Vo thi im cng b tiu chun ny, ISO 9004

    ang c sot xt. Bn tiu chun ISO 9004

    c sot xt s a ra hng dn cho lnh o

    t c nhng thnh cng bn vng cho mi

    t chc trong mt mi trng phc tp vi nhng

    i hi kht khe v lin tc thay i. ISO 9004

    quan tm n qun l cht lng rng hn so vi

    TCVN ISO 9001; tiu chun ny hng vo nhu

    cu v mong i ca tt c cc bn quan tm

    cng nh vic tha mn ca h thng qua vic

    ci tin lin tc v c h thng cc hot ng ca

    t chc. Tuy nhin, tiu chun ny khng dng

    chng nhn, quy nh bt buc hoc k kt

    hp ng.

    0.3 Relationship with ISO 9004

    ISO 9001 and ISO 9004 are quality management

    system standards which have been designed to

    complement each other, but can also be used

    independently.

    ISO 9001 specifies requirements for a quality

    management system that can be used for internal

    application by organizations, or for certification, or for

    contractual purposes. It focuses on the effectiveness

    of the quality management system in meeting

    customer requirements.

    At the time of publication of this International

    Standard, ISO 9004 is under revision. The revised

    edition of ISO 9004 will provide guidance to

    management for achieving sustained success for

    any organization in a complex, demanding, and

    ever changing, environment. ISO 9004 provides

    a wider focus on quality management than ISO

    9001; it addresses the needs and expectations

    of all interested parties and their satisfaction, by

    the systematic and continual improvement of the

    organizations performance. However, it is not

    intended for certification, regulatory or contractual

    use.

    0.4 S tng thch vi cc h thng qun l khc

    Trong qu trnh xy dng tiu chun ny, cc

    iu khon ca tiu chun TCVN ISO 14001 :

    2005 c xem xt k cng nhm tng cng

    tnh tng thch ca hai tiu chun v li ch ca

    cng ng ngi s dng. Ph lc A nu ra s

    tng ng gia TCVN ISO 9001 : 2008 v TCVN

    ISO 14001 : 2005 (ISO 14001 : 2004).

    Tiu chun ny khng bao gm cc yu cu c

    th cho cc h thng qun l khc, nh cc h

    thng qun l mi trng, qun l an ton v

    sc kho ngh nghip, qun l ti chnh hoc

    qun l ri ro. Tuy nhin, tiu chun ny gip t

    0.4 Compatibility with other management systems

    During the development of this International

    Standard, due consideration was given to the

    provisions of ISO 14001 : 2004 to enhance the

    compatibility of the two standards for the

    benefit of the user community. Annex A shows

    the correspondence between ISO 9001:2008 and

    ISO 14001:2004.

    This International Standard does not include

    requirements specific to other management systems,

    such as those particular to environmental

    management, occupational health and safety

    management, financial management or risk

  • TCVN ISO 9001 : 2008

    11

    chc ho hp v hp nht h thng qun l

    cht lng ca mnh vi cc yu cu ca h

    thng qun l c lin quan. T chc c th iu

    chnh h thng qun l hin hnh ca mnh

    nhm mc ch thit lp mt h thng qun l

    cht lng ph hp vi cc yu cu ca tiu

    chun ny.

    management. However, this International Standard

    enables an organization to align or integrate its own

    quality management system with related

    management system requirements. It is possible for

    an organization to adapt its existing management system(s) in order to establish a quality management

    system that complies with the requirements of this

    International Standard.

  • TCVN ISO 9001 : 2008

    12

  • 13

    TIU CHUN QUC GIA * NATIONAL STANDARD TCVN ISO 9001 : 2008 Xut bn ln 3

    Third edition

    H thng qun l cht lng Cc yu cu

    Quality management system Requirements

    1 Phm vi p dng

    1.1 Khi qut

    Tiu chun ny quy nh cc yu cu i vi h

    thng qun l cht lng khi mt t chc

    a) cn chng t kh nng cung cp mt cch

    n nh sn phm p ng cc yu cu ca

    khch hng cng nh cc yu cu ca lut

    nh v ch nh thch hp; v

    b) mun nng cao s tho mn ca khch hng

    thng qua vic p dng c hiu lc h thng,

    bao gm c cc qu trnh ci tin lin tc h

    thng v m bo s ph hp vi cc yu cu

    ca khch hng, yu cu lut nh v ch nh

    c p dng.

    CH THCH 1: Trong tiu chun ny, thut ng "sn

    phm" ch p dng cho

    a) sn phm d kin cung cp cho khch hng hoc

    khch hng yu cu,

    b) mi u ra d kin l kt qu ca qu trnh to sn

    phm.

    CH THCH 2: Cc yu cu lut nh v ch nh c

    th c th hin nh cc yu cu php l.

    1.2 p dng

    Cc yu cu trong tiu chun ny mang tnh tng

    qut v nhm p dng cho mi t chc khng

    phn bit loi hnh, quy m v sn phm cung cp.

    1 Scope

    1.1 General

    This Standard specifies requirements for a quality

    management system where an organization

    a) needs to demonstrate its ability to consistently

    provide product that meets customer and

    applicable statutory and regulatory

    requirements, and

    b) aims to enhance customer satisfaction through

    the effective application of the system,

    including processes for continual improvement

    of the system and the assurance of conformity

    to customer and applicable statutory and

    regulatory requirements.

    NOTE 1 In this International Standard, the term product

    only applies to

    a) product intended for, or required by, a customer,

    b) any intended output resulting from the product realization

    processes.

    NOTE 2 Statutory and regulatory requirements can be

    expressed as legal requirements.

    1.2 Application

    All requirements of this International Standard are

    generic and are intended to be applicable to all

    organizations, regardless of type, size and product

    provided.

  • TCVN ISO 9001 : 2008

    14

    Khi c bt k yu cu no ca tiu chun ny khng

    th p dng c do bn cht ca t chc v c

    th ca sn phm, c th xem xt yu cu ny nh

    mt ngoi l.

    Khi c ngoi l, vic cng b ph hp vi tiu

    chun ny khng c chp nhn tr phi cc ngoi

    l ny c gii hn trong phm vi cc yu cu ca

    iu 7, v cc ngoi l ny khng nh hng n

    kh nng hay trch nhim ca t chc trong vic

    cung cp sn phm p ng cc yu cu ca khch

    hng, cc yu cu lut nh v ch nh thch hp.

    Where any requirement(s) of this International

    Standard cannot be applied due to the nature of an

    organization and its product, this can be considered

    for exclusion.

    Where exclusions are made, claims of conformity to

    this International Standard are not acceptable

    unless these exclusions are limited to requirements

    within clause 7, and such exclusions do not affect

    the organization's ability, or responsibility, to provide

    product that meets customer and applicable

    statutory and regulatory requirements.

    2 Ti liu vin dn

    Ti liu vin dn di y rt cn thit cho vic

    p dng tiu chun ny. i vi cc ti liu ghi

    nm cng b th p dng bn c nu. i vi

    cc ti liu khng ghi nm cng b th p dng

    bn mi nht, bao gm c cc sa i.

    TCVN ISO 9000 : 2007, H thng qun l cht

    lng - C s v t vng.

    3 Thut ng v nh ngha

    Tiu chun ny s dng cc thut ng v nh

    ngha trong TCVN ISO 9000.

    Trong tiu chun ny, thut ng "sn phm"

    cng c ngha "dch v".

    4 H thng qun l cht lng

    4.1 Yu cu chung

    T chc phi xy dng, lp vn bn, thc hin,

    duy tr h thng qun l cht lng v ci tin

    lin tc hiu lc ca h thng theo cc yu cu

    ca tiu chun ny.

    2 Normative reference

    The following referenced documents are

    indispensable for the application of this

    document. For dated references, only the edition

    cited applies. For undated references, the latest

    edition of the referenced document (including any

    amendments) applies.

    IS0 9000 : 2005, Quality management systems

    Fundamentals and vocabulary.

    3 Terms and definitions

    For the purposes of this document, the terms and

    definitions given in ISO 9000 apply.

    Throughout the text of this International Standard,

    wherever the term product occurs, it can also

    mean service.

    4 Quality management system

    4.1 General requirements

    The organization shall establish, document,

    implement and maintain a quality management

    system and continually improve its effectiveness in

    accordance with the requirements of this

    International Standard.

  • TCVN ISO 9001 : 2008

    15

    T chc phi

    a) xc nh cc qu trnh cn thit trong h

    thng qun l cht lng v p dng chng

    trong ton b t chc (xem 1.2),

    b) xc nh trnh t v mi tng tc ca cc

    qu trnh ny,

    c) xc nh cc chun mc v phng php

    cn thit m bo vn hnh v kim sot cc

    qu trnh ny c hiu lc,

    d) m bo sn c cc ngun lc v thng tin

    cn thit h tr vic vn hnh v theo di

    cc qu trnh ny,

    e) theo di, o lng khi thch hp v phn

    tch cc qu trnh ny, v

    f) thc hin cc hnh ng cn thit t

    c kt qu d nh v ci tin lin tc cc

    qu trnh ny.

    T chc phi qun l cc qu trnh theo cc yu

    cu ca tiu chun ny.

    Khi t chc chn ngun bn ngoi cho bt k qu

    trnh no nh hng n s ph hp ca sn

    phm vi cc yu cu, t chc phi m bo

    kim sot c nhng qu trnh . Cch thc v

    mc kim sot cn p dng cho nhng qu

    trnh s dng ngun bn ngoi ny phi c xc

    nh trong h thng qun l cht lng.

    CH THCH 1: Cc qu trnh cn thit i vi h thng qun l cht lng nu trn bao gm c cc qu

    trnh v cc hot ng qun l, cung cp ngun lc,

    to sn phm, o lng, phn tch v ci tin.

    CH THCH 2: Qu trnh s dng ngun bn ngoi l

    qu trnh t chc cn cho h thng qun l cht lng

    ca mnh v la chn bn ngoi thc hin.

    CH THCH 3: Vic m bo kim sot cc qu trnh

    s dng ngun bn ngoi khng loi tr c trch

    The organization shall

    a) determine the processes needed for the quality

    management system and their application

    throughout the organization (see 1.2),

    b) determine the sequence and interaction of these

    processes,

    c) determine criteria and methods needed to ensure

    that both the operation and control of these

    processes are effective,

    d) ensure the availability of resources and

    information necessary to support the operation and

    monitoring of these processes,

    e) monitor, measure where applicable, and analyse

    these processes, and

    f) implement actions necessary to achieve planned

    results and continual improvement of these

    processes.

    These processes shall be managed by the

    organization in accordance with the requirements of

    this Standard.

    Where an organization chooses to outsource any

    process that affects product conformity to

    requirements, the organization shall ensure control

    over such processes. The type and extent of control

    to be applied to these outsourced processes shall

    be defined within the quality management system.

    NOTE 1 Processes needed for the quality management

    system referred to above include processes for management

    activities, provision of resources, product realization,

    measurement, analysis and improvement.

    NOTE 2 An outsourced process is a process that the

    organization needs for its quality management system and

    which the organization chooses to have performed by an

    external party.

    NOTE 3 Ensuring control over outsourced processes does

    not absolve the organization of the responsibility of

  • TCVN ISO 9001 : 2008

    16

    nhim ca t chc v s ph hp vi tt c cc yu

    cu ca khch hng, lut nh v ch nh. Loi v

    mc kim sot cn p dng vi cc qu trnh s

    dng ngun bn ngoi c th b nh hng bi cc yu

    t nh

    a) tc ng tim n ca qu trnh s dng ngun bn

    ngoi n kh nng ca t chc trong vic cung cp

    sn phm ph hp vi cc yu cu,

    b) mc chia s vic kim sot qu trnh,

    c) kh nng t c kim sot cn thit thng qua

    vic p dng 7.4.

    4.2 Yu cu v h thng ti liu

    4.2.1 Khi qut

    Cc ti liu ca h thng qun l cht lng

    phi bao gm

    a) cc vn bn cng b v chnh sch cht

    lng v mc tiu cht lng,

    b) s tay cht lng,

    c) cc th tc dng vn bn v h s theo yu

    cu ca tiu chun ny, v

    d) cc ti liu, bao gm c h s, c t chc xc

    nh l cn thit m bo hoch nh, vn hnh v

    kim sot c hiu lc cc qu trnh ca t chc.

    CH THCH 1: Khi thut ng "th tc dng vn bn" xut hin trong tiu chun ny, th th tc phi c

    xy dng, lp thnh vn bn, thc hin v duy tr. Mt

    ti liu ring r c th cp ti yu cu vi mt hay

    nhiu th tc. Yu cu v th tc dng vn bn c th

    c cp trong nhiu ti liu.

    CH THCH 2: Mc vn bn ho h thng qun l cht lng ca mi t chc c th khc nhau tu thuc

    vo

    a) quy m ca t chc v loi hnh hot ng,

    b) s phc tp v s tng tc gia cc qu trnh, v

    c) nng lc nhn s.

    CH THCH 3: H thng ti liu c th bt k dng hoc loi phng tin no.

    conformity to all customer, statutory and regulatory

    requirements. The type and extent of control to be applied

    to the outsourced process can be influenced by factors such

    as

    a) the potential impact of the outsourced process on the

    organizations capability to provide product that conforms

    to requirements,

    b) the degree to which the control for the process is shared,

    c) the capability of achieving the necessary control through

    the application of 7.4.

    4.2 Documentation requirements

    4.2.1 General

    The quality management system documentation

    shall include

    a) documented statements of a quality policy and

    quality objectives,

    b) a quality manual,

    c) documented procedures and records required by

    this International Standard, and

    d) documents, including records determined by the

    organization to be necessary to ensure the effective

    planning, operation and control of its processes.

    NOTE 1 Where the term documented procedure appears within this International Standard, this means that the

    procedure is established, documented, implemented and

    maintained. A single document may address the

    requirements for one or more procedures. A requirement for

    a documented procedure may be covered by more than one

    document.

    NOTE 2 The extent of the quality management system

    documentation can differ from one organization to another due

    to

    a) the size of organization and type of activities,

    b) the complexity of processes and their interactions, and

    c) the competence of personnel.

    NOTE 3 The documentation can be in any form or type of

    medium.

  • TCVN ISO 9001 : 2008

    17

    4.2.2 S tay cht lng

    T chc phi thit lp v duy tr s tay cht

    lng trong bao gm

    a) phm vi ca h thng qun l cht lng,

    bao gm c cc ni dung chi tit v l gii v

    bt c ngoi l no (xem 1.2),

    b) cc th tc dng vn bn c thit lp cho

    h thng qun l cht lng hoc vin dn n

    chng v,

    c) m t s tng tc gia cc qu trnh trong

    h thng qun l cht lng.

    4.2.3 Kim sot ti liu

    Cc ti liu theo yu cu ca h thng qun l

    cht lng phi c kim sot. H s cht

    lng l mt loi ti liu c bit v phi c

    kim sot theo cc yu cu nu trong 4.2.4 .

    T chc phi lp mt th tc dng vn bn

    xc nh vic kim sot cn thit nhm:

    a) ph duyt ti liu v s tha ng trc khi

    ban hnh,

    b) xem xt, cp nht khi cn v ph duyt li

    ti liu,

    c) m bo nhn bit c cc thay i v

    tnh trng sa i hin hnh ca ti liu,

    d) m bo cc phin bn ca cc ti liu

    thch hp sn c ni s dng,

    e) m bo ti liu lun r rng v d nhn

    bit,

    f) m bo cc ti liu c ngun gc bn ngoi m

    t chc xc nh l cn thit cho vic hoch nh v

    vn hnh h thng qun l cht lng c nhn

    bit v vic phn phi chng c kim sot, v

    g) ngn nga vic v tnh s dng cc ti liu

    4.2.2 Quality manual

    The organization shall establish and maintain a

    quality manual that includes

    a) the scope of the quality management system,

    including details of and justification for any

    exclusions (see 1.2),

    b) the documented procedures established for the

    quality management system, or reference to them,

    and

    c) a description of the interaction between the

    processes of the quality management system.

    4.2.3 Control of documents

    Documents required by the quality management

    system shall be controlled. Records are a special

    type of document and shall be controlled according

    to the requirements given in 4.2.4.

    A documented procedure shall be established to

    define the controls needed

    a) to approve documents for adequacy prior to

    issue,

    b) to review and update as necessary and

    re-approve documents,

    c) to ensure that changes and the current revision

    status of documents are identified,

    d) to ensure that relevant versions of applicable

    documents are available at points of use,

    e) to ensure that documents remain legible and

    readily identifiable,

    f) to ensure that documents of external origin

    determined by the organization to be necessary for

    the planning and operation of the quality

    management system are identified and their

    distribution controlled, and

    g) to prevent the unintended use of obsolete

    trantuannov@yahoo.com

  • TCVN ISO 9001 : 2008

    18

    li thi v p dng cc du hiu nhn bit thch

    hp nu chng c gi li v bt k mc ch

    no.

    4.2.4 Kim sot h s

    Phi kim sot h s c thit lp cung

    cp bng chng v s ph hp vi cc yu cu

    v vic vn hnh c hiu lc ca h thng qun

    l cht lng.

    T chc phi lp mt th tc bng vn bn

    xc nh cch thc kim sot cn thit i vi

    vic nhn bit, bo qun, bo v, s dng, thi

    gian lu gi v hu b h s.

    H s phi lun r rng, d nhn bit v d s

    dng.

    5 Trch nhim ca lnh o

    5.1 Cam kt ca lnh o

    Lnh o cao nht phi cung cp bng chng

    v s cam kt ca mnh i vi vic xy dng

    v thc hin h thng qun l cht lng v ci

    tin lin tc hiu lc ca h thng bng cch

    a) truyn t cho t chc v tm quan trng

    ca vic p ng cc yu cu ca khch hng

    cng nh cc yu cu ca lut nh v ch

    nh,

    b) thit lp chnh sch cht lng,

    c) m bo vic thit lp cc mc tiu cht lng,

    d) tin hnh vic xem xt ca lnh o, v

    e) m bo sn c cc ngun lc.

    5.2 Hng vo khch hng

    Lnh o cao nht phi m bo rng cc yu

    cu ca khch hng c xc nh v p ng

    nhm nng cao s tho mn khch hng (xem

    7.2.1 v 8.2.1).

    documents, and to apply suitable identification to

    them if they are retained for any purpose.

    4.2.4 Control of records

    Records established to provide evidence of

    conformity to requirements and of the effective

    operation of the quality management system shall

    be controlled.

    The organization shall establish a documented

    procedure to define the controls needed for the

    identification, storage, protection, retrieval, retention

    and disposition of records.

    Records shall remain legible, readily identifiable and

    retrievable.

    5 Management responsibility

    5.1 Management commitment

    Top management shall provide evidence of its

    commitment to the development and

    implementation of the quality management system

    and continually improving its effectiveness by

    a) communicating to the organization the

    importance of meeting customer as well as statutory

    and regulatory requirements,

    b) establishing the quality policy,

    c) ensuring that quality objectives are established,

    d) conducting management reviews, and

    e) ensuring the availability of resources.

    5.2 Customer focus

    Top management shall ensure that customer

    requirements are determined and are met with the

    aim of enhancing customer satisfaction (see 7.2.1

    and 8.2.1).

    trantuannov@yahoo.com

  • TCVN ISO 9001 : 2008

    19

    5.3 Chnh sch cht lng

    Lnh o cao nht phi m bo rng chnh

    sch cht lng

    a) ph hp vi mc ch ca t chc,

    b) bao gm vic cam kt p ng cc yu cu

    v ci tin lin tc hiu lc ca h thng qun

    l cht lng,

    c) cung cp c s cho vic thit lp v xem

    xt cc mc tiu cht lng,

    d) c truyn t v thu hiu trong t chc,

    v

    e) c xem xt lun thch hp.

    5.4 Hoch nh

    5.4.1 Mc tiu cht lng

    Lnh o cao nht phi m bo rng cc mc

    tiu cht lng, bao gm c nhng iu cn thit

    p ng cc yu cu ca sn phm [xem 7.1

    a)], c thit lp ti cc cp v b phn chc

    nng lin quan trong t chc. Mc tiu cht lng

    phi o c v nht qun vi chnh sch cht

    lng.

    5.4.2 Hoch nh h thng qun l cht lng

    Lnh o cao nht phi m bo

    a) tin hnh hoch nh h thng qun l cht

    lng p ng cc yu cu nu trong 4.1

    cng nh cc mc tiu cht lng, v

    b) tnh nht qun ca h thng qun l cht

    lng c duy tr khi cc thay i i vi h

    thng qun l cht lng c hoch nh v

    thc hin.

    5.3 Quality policy

    Top management shall ensure that the quality policy

    a) is appropriate to the purpose of the organization,

    b) includes a commitment to comply with

    requirements and continually improve the

    effectiveness of the quality management system,

    c) provides a framework for establishing and

    reviewing quality objectives,

    d) is communicated and understood within the

    organization, and

    e) is reviewed for continuing suitability.

    5.4 Planning

    5.4.1 Quality objectives

    Top management shall ensure that quality

    objectives, including those needed to meet

    requirements for product [see 7.1 a)], are

    established at relevant functions and levels within

    the organization. The quality objectives shall be

    measurable and consistent with the quality policy.

    5.4.2 Quality management system planning

    Top management shall ensure that

    a) the planning of the quality management system

    is carried out in order to meet the requirements

    given in 4.1, as well as the quality objectives, and

    b) the integrity of the quality management system is

    maintained when changes to the quality

    management system are planned and implemented.

  • TCVN ISO 9001 : 2008

    20

    5.5 Trch nhim, quyn hn v trao i thng tin

    5.5.1 Trch nhim v quyn hn

    Lnh o cao nht phi m bo cc trch

    nhim v quyn hn c xc nh v thng

    bo trong t chc.

    5.5.2 i din ca lnh o

    Lnh o cao nht phi ch nh mt thnh vin

    trong ban lnh o ca t chc, ngoi cc trch

    nhim khc, phi c trch nhim v quyn hn

    sau

    a) m bo cc qu trnh cn thit ca h thng

    qun l cht lng c thit lp, thc hin v

    duy tr;

    b) bo co cho lnh o cao nht v kt qu

    hot ng ca h thng qun l cht lng v

    v mi nhu cu ci tin, v

    c) m bo thc y ton b t chc nhn thc

    c cc yu cu ca khch hng.

    CH THCH: Trch nhim ca i din lnh o v

    cht lng c th bao gm c quan h vi bn ngoi

    v cc vn c lin quan n h thng qun l cht

    lng.

    5.5.3 Trao i thng tin ni b

    Lnh o cao nht phi m bo thit lp cc

    qu trnh trao i thng tin thch hp trong t

    chc v c s trao i thng tin v hiu lc ca

    h thng qun l cht lng.

    5.6 Xem xt ca lnh o

    5.6.1 Khi qut

    Lnh o cao nht phi nh k xem xt h

    thng qun l cht lng, m bo n lun

    thch hp, tha ng v c hiu lc. Vic xem

    xt ny phi nh gi c c hi ci tin v

    5.5 Responsibility, authority and communi-cation

    5.5.1 Responsibility and authority

    Top management shall ensure that responsibilities

    and authorities are defined and communicated

    within the organization.

    5.5.2 Management representative

    Top management shall appoint a member of the

    organizations management who, irrespective of

    other responsibilities, shall have responsibility and

    authority that includes

    a) ensuring that processes needed for the quality

    management system are established, implemented

    and maintained,

    b) reporting to top management on the performance

    of the quality management system and any need for

    improvement, and

    c) ensuring the promotion of awareness of customer

    requirements throughout the organization.

    NOTE The responsibility of a management representative

    can include liaison with external parties on matters relating to

    the quality management system.

    5.5.3 Internal communication

    Top management shall ensure that appropriate

    communication processes are established within the

    organization and that communication takes place

    regarding the effectiveness of the quality

    management system.

    5.6 Management review

    5.6.1 General

    Top management shall review the organizations

    quality management system, at planned intervals, to

    ensure its continuing suitability, adequacy and

    effectiveness. This review shall include assessing

  • TCVN ISO 9001 : 2008

    21

    nhu cu thay i i vi h thng qun l cht

    lng, k c chnh sch cht lng v cc mc

    tiu cht lng.

    H s xem xt ca lnh o phi c duy tr

    (xem 4.2.4)

    5.6.2 u vo ca vic xem xt

    u vo ca vic xem xt ca lnh o phi

    bao gm thng tin v

    a) kt qu ca cc cuc nh gi,

    b) phn hi ca khch hng,

    c) vic thc hin cc qu trnh v s ph hp

    ca sn phm,

    d) tnh trng ca cc hnh ng khc phc v

    phng nga,

    e) cc hnh ng tip theo t cc cuc xem

    xt ca lnh o ln trc,

    f) nhng thay i c th nh hng n h

    thng qun l cht lng, v

    g) cc khuyn ngh v ci tin.

    5.6.3 u ra ca vic xem xt

    u ra ca vic xem xt ca lnh o phi bao

    gm mi quyt nh v hnh ng lin quan n

    a) vic ci tin hiu lc ca h thng qun l cht

    lng v ci tin cc qu trnh ca h thng,

    b) vic ci tin sn phm lin quan n cc

    yu cu ca khch hng, v

    c) nhu cu v ngun lc.

    6 Qun l ngun lc

    6.1 Cung cp ngun lc

    T chc phi xc nh v cung cp cc ngun

    lc cn thit

    a) thc hin v duy tr h thng qun l cht

    lng, ci tin lin tc hiu lc ca h thng

    opportunities for improvement and the need for

    changes to the quality management system,

    including the quality policy and quality objectives.

    Records from management reviews shall be

    maintained (see 4.2.4).

    5.6.2 Review input

    The input to management review shall include

    information on

    a) results of audits,

    b) customer feedback,

    c) process performance and product conformity,

    d) status of preventive and corrective actions,

    e) follow-up actions from previous management

    reviews,

    f) changes that could affect the quality management

    system, and

    g) recommendations for improvement.

    5.6.3 Review output

    The output from the management review shall

    include any decisions and actions related to

    a) improvement of the effectiveness of the quality

    management system and its processes,

    b) improvement of product related to customer

    requirements, and

    c) resource needs.

    6 Resource management

    6.1 Provision of resources

    The organization shall determine and provide the

    resources needed

    a) to implement and maintain the quality

    management system and continually improve its

  • TCVN ISO 9001 : 2008

    22

    , v

    b) nng cao s tho mn khch hng bng

    cch p ng cc yu cu ca khch hng.

    6.2 Ngun nhn lc

    6.2.1 Khi qut

    Nhng ngi thc hin cc cng vic nh

    hng n s ph hp vi cc yu cu ca sn

    phm phi c nng lc trn c s c gio

    dc, o to, c k nng v kinh nghim thch

    hp.

    CH THCH: S ph hp vi cc yu cu ca sn

    phm c th b nh hng trc tip hoc gin tip bi

    nhng ngi thc hin nhim v bt k trong h thng

    qun l cht lng.

    6.2.2 Nng lc, o to v nhn thc

    T chc phi

    a) xc nh nng lc cn thit ca nhng ngi

    thc hin cc cng vic nh hng n s ph

    hp vi cc yu cu ca sn phm,

    b) tin hnh o to hay nhng hnh ng

    khc t c nng lc cn thit, khi thch

    hp,

    c) nh gi hiu lc ca cc hnh ng c

    thc hin,

    d) m bo rng nhn s ca t chc nhn

    thc c mi lin quan v tm quan trng ca

    cc hot ng ca h v h ng gp nh th

    no i vi vic t c mc tiu cht lng,

    v

    e) duy tr h s thch hp v gio dc, o to, k

    nng v kinh nghim (xem 4.2.4).

    6.3 C s h tng

    T chc phi xc nh, cung cp v duy tr c

    s h tng cn thit t c s ph hp

    vi cc yu cu ca sn phm. C s h tng

    effectiveness, and

    b) to enhance customer satisfaction by meeting

    customer requirements.

    6.2 Human resources

    6.2.1 General

    Personnel performing work affecting conformity to

    product requirements shall be competent on the

    basis of appropriate education, training, skills and

    experience.

    NOTE Conformity to product requirements can be affected

    directly or indirectly by personnel performing any task within

    the quality management system.

    6.2.2 Competence, training and awareness

    The organization shall

    a) determine the necessary competence for

    personnel performing work affecting conformity to

    product requirements,

    b) where applicable, provide training or take other

    actions to achieve the necessary competence,

    c) evaluate the effectiveness of the actions taken,

    d) ensure that its personnel are aware of the

    relevance and importance of their activities and how

    they contribute to the achievement of the

    quality objectives, and

    e) maintain appropriate records of education,

    training, skills and experience (see 4.2.4).

    6.3 Infrastructure

    The organization shall determine, provide and

    maintain the infrastructure needed to achieve

    conformity to product requirements. Infrastructure

  • TCVN ISO 9001 : 2008

    23

    bao gm v d nh:

    a) nh ca, khng gian lm vic v cc

    phng tin km theo,

    b) trang thit b qu trnh (c phn cng v

    phn mm), v

    c) dch v h tr (nh vn chuyn hoc trao

    i thng tin hay h thng thng tin).

    6.4 Mi trng lm vic

    T chc phi xc nh v qun l mi trng

    lm vic cn thit t c s ph hp i

    vi cc yu cu ca sn phm.

    CH THCH: Thut ng mi trng lm vic lin quan ti

    cc iu kin tin hnh cng vic, bao gm cc yu t vt l,

    mi trng v cc yu t khc (nh ting n, nhit ,

    m, chiu sng hoc thi tit).

    7 To sn phm

    7.1 Hoch nh vic to sn phm

    T chc phi lp k hoch v trin khai cc qu

    trnh cn thit i vi vic to sn phm. Hoch

    nh vic to sn phm phi nht qun vi cc

    yu cu ca cc qu trnh khc ca h thng

    qun l cht lng (xem 4.1).

    Trong qu trnh hoch nh vic to sn phm, khi

    thch hp, t chc phi xc nh nhng iu sau

    y:

    a) cc mc tiu cht lng v cc yu cu i

    vi sn phm;

    b) nhu cu thit lp cc qu trnh v ti liu

    cng nh vic cung cp cc ngun lc c th

    i vi sn phm;

    c) cc hot ng kim tra xc nhn, xc nhn

    gi tr s dng, cc hot ng theo di, o

    lng, kim tra v th nghim c th cn thit

    i vi sn phm v cc tiu ch chp nhn

    sn phm;

    includes, as applicable

    a) buildings, workspace and associated utilities,

    b) process equipment (both hardware and software),

    and

    c) supporting services (such as transport or

    communication or information systems).

    6.4 Work environment

    The organization shall determine and manage the

    work environment needed to achieve conformity to

    product requirements.

    NOTE The term work environment relates to those

    conditions under which work is performed including

    physical, environmental and other factors (such as noise,

    temperature, humidity, lighting or weather).

    7 Product realization

    7.1 Planning of product realization

    The organization shall plan and develop the

    processes needed for product realization. Planning

    of product realization shall be consistent with the

    requirements of the other processes of the quality

    management system (see 4.1).

    In planning product realization, the organization

    shall determine the following, as appropriate:

    a) quality objectives and requirements for the

    product;

    b) the need to establish processes and documents,

    and to provide resources specific to the product;

    c) required verification, validation, monitoring,

    measurement, inspection and test activities specific

    to the product and the criteria for product

    acceptance;

  • TCVN ISO 9001 : 2008

    24

    d) cc h s cn thit cung cp bng

    chng rng cc qu trnh thc hin v sn

    phm to thnh p ng cc yu cu (xem

    4.2.4).

    u ra ca vic hoch nh phi c th hin

    ph hp vi phng php tc nghip ca t

    chc.

    CH THCH 1: Ti liu quy nh cc qu trnh ca h thng qun l cht lng (bao gm c cc qu trnh to

    sn phm) v cc ngun lc c s dng i vi mt

    sn phm, d n hay hp ng c th c th c coi

    nh mt k hoch cht lng.

    CH THCH 2: T chc cng c th p dng cc yu cu nu trong 7.3 trin khai qu trnh to sn phm.

    7.2 Cc qu trnh lin quan n khch hng

    7.2.1 Xc nh cc yu cu lin quan n sn phm

    T chc phi xc nh

    a) yu cu do khch hng a ra, gm c yu

    cu v cc hot ng giao hng v sau giao

    hng;

    b) yu cu khng c khch hng cng b

    nhng cn thit cho vic s dng quy nh hoc

    s dng d kin, khi bit;

    c) yu cu lut nh v ch nh p dng cho

    sn phm, v

    d) mi yu cu b sung c t chc cho l

    cn thit.

    CH THCH: Cc hot ng sau giao nhn bao gm, v

    d nh, cc hnh ng theo nhng iu khon bo

    hnh, ngha v hp ng nh dch v bo tr v cc

    dch v b tr nh ti ch hoc loi b cui cng.

    7.2.2 Xem xt cc yu cu lin quan n sn phm

    T chc phi xem xt cc yu cu lin quan

    d) records needed to provide evidence that the

    realization processes and resulting product meet

    requirements (see 4.2.4).

    The output of this planning shall be in a form

    suitable for the organizations method of operations.

    NOTE 1 A document specifying the processes of the quality

    management system (including the product realization

    processes) and the resources to be applied to a specific

    product, project or contract, can be referred to as a quality

    plan.

    NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization

    processes.

    7.2 Customer-related processes

    7.2.1 Determination of requirements related to the product

    The organization shall determine

    a) requirements specified by the customer, including

    the requirements for delivery and post-delivery

    activities,

    b) requirements not stated by the customer but

    necessary for specified or intended use, where

    known,

    c) statutory and regulatory requirements applicable

    to the product, and

    d) any additional requirements considered

    necessary by the organization.

    NOTE Post-delivery activities include, for example,

    actions under warranty provisions, contractual obligations

    such as maintenance services, and supplementary services

    such as recycling or final disposal.

    7.2.2 Review of requirements related to the product

    The organization shall review the requirements

  • TCVN ISO 9001 : 2008

    25

    n sn phm. Vic xem xt ny phi c tin

    hnh trc khi t chc cam kt cung cp sn

    phm cho khch hng (v d nh np n d

    thu, chp nhn hp ng hay n t hng,

    chp nhn s thay i trong hp ng hay n

    t hng) v phi m bo rng

    a) yu cu v sn phm c nh r;

    b) cc yu cu trong hp ng hoc n t

    hng khc vi nhng g nu trc phi

    c gii quyt; v

    c) t chc c kh nng p ng cc yu cu

    nh.

    Phi duy tr h s cc kt qu ca vic xem xt v

    cc hnh ng ny sinh t vic xem xt (xem

    4.2.4).

    Khi khch hng a ra cc yu cu khng bng

    vn bn, cc yu cu ca khch hng phi

    c t chc khng nh trc khi chp

    nhn.

    Khi yu cu v sn phm thay i, t chc phi

    m bo rng cc ti liu lin quan c sa

    i v cc c nhn lin quan nhn thc c

    cc yu cu thay i .

    CH THCH: Trong mt s tnh hung, v d nh trong bn hng qua internet, vi mi ln t hng, vic xem xt mt

    cch chnh thc l khng thc t. Thay vo , vic xem xt

    c th c thc hin i vi cc thng tin lin quan v sn

    phm nh danh mc cho hng hay ti liu qung co.

    7.2.3 Trao i thng tin vi khch hng

    T chc phi xc nh v sp xp c hiu qu

    vic trao i thng tin vi khch hng c lin

    quan ti

    a) thng tin v sn phm;

    b) x l cc yu cu, hp ng hoc n t

    hng, k c cc sa i, v

    c) phn hi ca khch hng, k c cc khiu

    ni.

    related to the product. This review shall be

    conducted prior to the organizations commitment to

    supply a product to the customer (e.g. submission of

    tenders, acceptance of contracts or orders,

    acceptance of changes to contracts or orders) and

    shall ensure that

    a) product requirements are defined,

    b) contract or order requirements differing from

    those previously expressed are resolved, and

    c) the organization has the ability to meet the

    defined requirements.

    Records of the results of the review and actions

    arising from the review shall be maintained (see

    4.2.4).

    Where the customer provides no documented

    statement of requirement, the customer requirements

    shall be confirmed by the organization before

    acceptance.

    Where product requirements are changed, the

    organization shall ensure that relevant documents

    are amended and that relevant personnel are made

    aware of the changed requirements.

    NOTE In some situations, such as internet sales, a formal

    review is impractical for each order. Instead the review can

    cover relevant product information such as catalogues or

    advertising material.

    7.2.3 Customer communication

    The organization shall determine and implement

    effective arrangements for communicating with

    customers in relation to

    a) product information,

    b) enquiries, contracts or order handling, including

    amendments, and

    c) customer feedback, including customer

    complaints.

  • TCVN ISO 9001 : 2008

    26

    7.3 Thit k v pht trin

    7.3.1 Hoch nh thit k v pht trin

    T chc phi lp k hoch v kim sot vic

    thit k v pht trin sn phm.

    Trong qu trnh hoch nh thit k v pht trin

    t chc phi xc nh

    a) cc giai on ca thit k v pht trin,

    b) vic xem xt, kim tra xc nhn v xc

    nhn gi tr s dng thch hp cho mi giai

    on thit k v pht trin, v

    c) trch nhim v quyn hn i vi cc hot

    ng thit k v pht trin.

    T chc phi qun l s tng giao gia cc

    nhm khc nhau tham d vo vic thit k v

    pht trin nhm m bo s trao i thng tin

    c hiu qu v phn cng trch nhim r rng.

    Kt qu hoch nh phi c cp nht mt

    cch thch hp trong qu trnh thit k v pht

    trin.

    CH THCH: Vic xem xt, kim tra xc nhn v xc

    nhn gi tr s dng ca thit k v pht trin c cc

    mc ch ring bit. C th tin hnh v lp h s

    ring r hoc kt hp cc hot ng ny sao cho ph

    hp vi sn phm v t chc.

    7.3.2 u vo ca thit k v pht trin

    u vo lin quan n cc yu cu i vi sn

    phm phi c xc nh v duy tr h s (xem

    4.2.4). u vo phi bao gm

    a) yu cu v chc nng v cng dng,

    b) yu cu lut nh v ch nh thch hp,

    c) khi thch hp thng tin nhn c t cc

    thit k tng t trc , v

    d) cc yu cu thit yu khc cho thit k v

    pht trin.

    7.3 Design and development

    7.3.1 Design and development planning

    The organization shall plan and control the design

    and development of product.

    During the design and development planning, the

    organization shall determine

    a) the design and development stages,

    b) the review, verification and validation that are

    appropriate to each design and development stage,

    and

    c) the responsibilities and authorities for design

    and development.

    The organization shall manage the interfaces

    between different groups involved in design and

    development to ensure effective communication and

    clear assignment of responsibility.

    Planning output shall be updated, as appropriate, as

    the design and development progresses.

    NOTE Design and development review, verification and

    validation have distinct purposes. They can be conducted

    and recorded separately or in any combination, as suitable

    for the product and the organization.

    7.3.2 Design and development Inputs

    Inputs relating to product requirements shall be

    determined and records maintained (see 4.2.4).

    These inputs shall include

    a) functional and performance requirements,

    b) applicable statutory and regulatory requirements,

    c) where applicable, information derived from

    previous similar designs, and

    d) other requirements essential for design and

    development.

  • TCVN ISO 9001 : 2008

    27

    u vo ny phi c xem xt v s tha

    ng. Cc yu cu phi y , r rng v

    khng mu thun vi nhau.

    7.3.3 u ra ca thit k v pht trin

    u ra ca thit k v pht trin phi dng

    thch hp kim tra xc nhn theo u vo

    ca thit k v pht trin v phi c ph

    duyt trc khi ban hnh.

    u ra ca thit k v pht trin phi

    a) p ng cc yu cu u vo ca thit k

    v pht trin,

    b) cung cp cc thng tin thch hp cho vic

    mua hng, sn xut v cung cp dch v,

    c) bao gm hoc vin dn ti cc chun mc

    chp nhn ca sn phm, v

    d) xc nh cc c tnh ct yu cho an ton

    v s dng ng ca sn phm.

    CH THCH: Thng tin cho qu trnh sn xut v cung

    cp dch v c th bao gm chi tit v vic bo ton

    sn phm.

    7.3.4 Xem xt thit k v pht trin

    Ti nhng giai on thch hp, vic xem xt

    thit k v pht trin mt cch c h thng phi

    c thc hin theo hoch nh (xem 7.3.1)

    a) nh gi kh nng p ng cc yu cu ca

    cc kt qu thit k v pht trin, v

    b) nhn bit mi vn trc trc v xut

    cc hnh ng cn thit.

    Nhng ngi tham gia vo vic xem xt phi

    bao gm i din ca tt c cc b phn chc

    nng lin quan ti (cc) giai on thit k v

    pht trin ang c xem xt. Phi duy tr h

    s v cc kt qu xem xt v mi hnh ng

    cn thit (xem 4.2.4).

    The inputs shall be reviewed for adequacy.

    Requirements shall be complete, unambiguous and

    not in conflict with each other.

    7.3.3 Design and development outputs

    The outputs of design and development shall be in a

    form suitable for verification against the design and

    development input and shall be approved prior to

    release.

    Design and development outputs shall

    a) meet the input requirements for design and

    development,

    b) provide appropriate information for purchasing,

    production and service provision,

    c) contain or reference product acceptance criteria,

    and

    d) specify the characteristics of the product that

    are essential for its safe and proper use.

    NOTE Information for production and service provision can

    include details for the preservation of product.

    7.3.4 Design and development review

    At suitable stages, systematic reviews of design and

    development shall be performed in accordance with

    planned arrangements (see 7.3.1)

    a) to evaluate the ability of the results of design

    and development to meet requirements, and

    b) to identify any problems and propose necessary

    actions.

    Participants in such reviews shall include

    representatives of functions concerned with the

    design and development stage(s) being reviewed.

    Records of the results of the reviews and any

    necessary actions shall be maintained (see 4.2.4).

  • TCVN ISO 9001 : 2008

    28

    7.3.5 Kim tra xc nhn thit k v pht trin

    Vic kim tra xc nhn phi c thc hin

    theo cc b tr hoch nh (xem 7.3.1)

    m bo rng u ra thit k v pht trin p

    ng cc yu cu u vo ca thit k v pht

    trin. Phi duy tr h s cc kt qu kim tra

    xc nhn v mi hnh ng cn thit (xem

    4.2.4).

    7.3.6 Xc nhn gi tr s dng ca thit k v pht trin

    Xc nhn gi tr s dng ca thit k v pht trin

    phi c tin hnh theo cc b tr hoch nh

    (xem 7.3.1) m bo rng sn phm to ra c

    kh nng p ng cc yu cu s dng d kin hay

    cc ng dng quy nh khi bit. Khi c th, phi

    tin hnh xc nhn gi tr s dng trc khi chuyn

    giao hay s dng sn phm. Phi duy tr h s cc

    kt qu ca vic xc nhn gi tr s dng v mi

    hnh ng cn thit (xem 4.2.4).

    7.3.7 Kim sot thay i thit k v pht trin

    Cc thay i ca thit k v pht trin phi

    c nhn bit v duy tr h s. Nhng thay i

    ny phi c xem xt, kim tra xc nhn v

    xc nhn gi tr s dng mt cch thch hp v

    c ph duyt trc khi thc hin. Vic xem

    xt cc thay i thit k v pht trin phi bao

    gm vic nh gi tc ng ca s thay i ln

    cc b phn cu thnh v sn phm c

    chuyn giao. Phi duy tr h s cc kt qu ca

    vic xem xt cc thay i v hnh ng cn

    thit (xem 4.2.4).

    7.4 Mua hng

    7.4.1 Qu trnh mua hng

    T chc phi m bo sn phm mua vo ph

    hp vi cc yu cu mua sn phm quy

    7.3.5 Design and development verification

    Verification shall be performed in accordance with

    planned arrangements (see 7.3.1) to ensure that the

    design and development outputs have met the

    design and development input requirements.

    Records of the results of the verification and, any

    necessary actions shall be maintained (see 4.2.4).

    7.3.6 Design and development validation

    Design and development validation shall be

    performed in accordance with planned

    arrangements (see 7.3.1) to ensure that the

    resulting product is capable of meeting the

    requirements for the specified application or

    intended use, where known. Wherever practicable,

    validation shall be completed prior to the delivery or

    implementation of the product. Records of the

    results of validation and any necessary actions shall

    be maintained (see 4.2.4).

    7.3.7 Control of design and development changes

    Design and development changes shall be identified

    and records maintained. The changes shall be

    reviewed, verified and validated, as appropriate, and

    approved before implementation. The review of

    design and development changes shall include

    evaluation of the effect of the changes on

    constituent parts and product already delivered.

    Records of the results of the review of changes and

    any necessary actions shall be maintained (see

    4.2.4).

    7.4 Purchasing

    7.4.1 Purchasing process

    The organization shall ensure that purchased

    product conforms to specified purchase

  • TCVN ISO 9001 : 2008

    29

    nh. Cch thc v mc kim sot p dng

    cho ngi cung ng v sn phm mua vo ph

    thuc vo s tc ng ca sn phm mua vo

    i vi vic to ra sn phm tip theo hay thnh

    phm.

    T chc phi nh gi v la chn ngi cung

    ng da trn kh nng cung cp sn phm ph

    hp vi cc yu cu ca t chc. Phi xc nh

    cc tiu ch la chn, nh gi v nh gi li.

    Phi duy tr h s cc kt qu ca vic nh gi

    v mi hnh ng cn thit ny sinh t vic

    nh gi (xem 4.2.4).

    7.4.2 Thng tin mua hng

    Thng tin mua hng phi miu t sn phm

    c mua, nu thch hp c th bao gm

    a) yu cu v ph duyt sn phm, cc th tc,

    qu trnh v thit b,

    b) yu cu v trnh con ngi, v

    c) yu cu v h thng qun l cht lng.

    T chc phi m bo s tha ng ca cc

    yu cu mua hng quy nh trc khi thng

    bo cho ngi cung ng.

    7.4.3 Kim tra xc nhn sn phm mua vo

    T chc phi lp v thc hin cc hot ng

    kim tra hoc cc hot ng khc cn thit

    m bo rng sn phm mua vo p ng cc

    yu cu mua hng quy nh.

    Khi t chc hoc khch hng c nh thc

    hin cc hot ng kim tra xc nhn ti c s

    ca ngi cung ng, t chc phi cng b vic

    sp xp kim tra xc nhn d kin v phng

    php thng qua sn phm trong thng tin mua

    hng.

    requirements. The type and extent of control applied

    to the supplier and the purchased product shall be

    dependent upon the effect of the purchased product

    on subsequent product realization or the final

    product.

    The organization shall evaluate and select suppliers

    based on their ability to supply product in

    accordance with the organizations requirements.

    Criteria for selection, evaluation and re-evaluation

    shall be established. Records of the results of

    evaluations and any necessary actions arising from

    the evaluation shall be maintained (see 4.2.4).

    7.4.2 Purchasing information

    Purchasing information shall describe the product to

    be purchased, including where appropriate

    a) requirements for approval of product, procedures,

    processes and equipment,

    b) requirements for qualification of personnel, and

    c) quality management system requirements.

    The organization shall ensure the adequacy of

    specified purchase requirements prior to their

    communication to the supplier.

    7.4.3 Verification of purchased product

    The organization shall establish and implement the

    inspection or other activities necessary for ensuring

    that purchased product meets specified purchase

    requirements.

    Where the organization or its customer intends to

    perform verification at the suppliers premises, the

    organization shall state the intended verification

    arrangements and method of product release in the

    purchasing information.

  • TCVN ISO 9001 : 2008

    30

    7.5 Sn xut v cung cp dch v

    7.5.1 Kim sot sn xut v cung cp dch v

    T chc phi lp k hoch, tin hnh sn xut

    v cung cp dch v trong iu kin c kim

    sot. Khi c th, cc iu kin c kim sot

    phi bao gm

    a) s sn c thng tin m t cc c tnh ca

    sn phm,

    b) s sn c cc hng dn cng vic khi cn,

    c) vic s dng cc thit b thch hp,

    d) s sn c v vic s dng cc thit b theo

    di v o lng,

    e) thc hin vic theo di v o lng, v

    f) thc hin cc hot ng thng qua sn

    phm, giao hng v sau giao hng.

    7.5.2 Xc nhn gi tr s dng ca cc qu trnh sn xut v cung cp dch v

    T chc phi xc nhn gi tr s dng ca mi

    qu trnh sn xut v cung cp dch v c kt

    qu u ra khng th kim tra xc nhn bng

    cch theo di hoc o lng sau v v vy

    nhng sai st ch c th tr nn r rng sau khi

    sn phm c s dng hoc dch v c

    chuyn giao.

    Vic xc nhn gi tr s dng phi chng t kh

    nng ca cc qu trnh t c kt qu

    hoch nh.

    i vi cc qu trnh ny, khi c th, t chc

    phi sp xp nhng iu sau:

    a) cc chun mc nh xem xt v ph

    duyt cc qu trnh,

    b) ph duyt thit b v trnh con ngi,

    7.5 Production and service provision

    7.5.1 Control of production and service provision

    The organization shall plan and carry out production

    and service provision under controlled conditions.

    Controlled conditions shall include, as applicable

    a) the availability of information that describes the

    characteristics of the product,

    b) the availability of work instructions, as

    necessary,

    c) the use of suitable equipment,

    d) the availability and use of monitoring and

    measuring equipment,

    e) the implementation of monitoring and

    measurement, and

    f) the implementation of product release, delivery

    and post-delivery activities.

    7.5.2 Validation of processes for production and service provision

    The organization shall validate any processes for

    production and service provision where the resulting

    output cannot be verified by subsequent monitoring

    or measurement and, as a consequence,

    deficiencies become apparent only after the product

    is in use or the service has been delivered.

    Validation shall demonstrate the ability of these

    processes to achieve planned results.

    The organization shall establish arrangements for

    these processes including, as applicable

    a) defined criteria for review and approval of the

    processes,

    b) approval of equipment and qualification of

    personnel,

  • TCVN ISO 9001 : 2008

    31

    c) s dng cc phng php v th tc c th,

    d) cc yu cu v h s (xem 4.2.4); v

    e) ti xc nhn gi tr s dng.

    7.5.3 Nhn bit v xc nh ngun gc

    Khi thch hp, t chc phi nhn bit sn phm

    bng cc bin php thch hp trong sut qu

    trnh to sn phm.

    T chc phi nhn bit c trng thi ca sn

    phm tng ng vi cc yu cu theo di v o

    lng trong sut qu trnh to sn phm.

    T chc phi kim sot vic nhn bit duy nht

    sn phm v duy tr h s (xem 4.2.4) khi vic

    xc nh ngun gc l mt yu cu.

    CH THCH: Trong mt s lnh vc cng nghip, qun l cu hnh l phng php duy tr vic nhn bit v

    xc nh ngun gc.

    7.5.4 Ti sn ca khch hng

    T chc phi gi gn ti sn ca khch hng khi

    chng thuc s kim sot ca t chc hay c

    t chc s dng. T chc phi nhn bit, kim

    tra xc nhn, bo v ti sn do khch hng

    cung cp s dng hoc hp thnh sn

    phm. Khi c bt k ti sn no ca khch hng

    b mt mt, h hng hoc c pht hin khng

    ph hp cho vic s dng, t chc u phi

    thng bo cho khch hng v phi duy tr h s

    (xem 4.2.4).

    CH THCH: Ti sn ca khch hng c th bao gm c s hu tr tu v d liu c nhn.

    7.5.5 Bo ton sn phm

    T chc phi bo ton sn phm trong qu trnh

    x l ni b v giao hng n v tr d kin

    nhm duy tr s ph hp vi cc yu cu. Khi

    thch hp, vic bo ton phi bao gm nhn

    bit, xp d (di chuyn), bao gi, lu gi v bo

    c) use of specific methods and procedures,

    d) requirements for records (see 4.2.4), and

    e) revalidation.

    7.5.3 Identification and traceability

    Where appropriate, the organization shall identify

    the product by suitable means throughout product

    realization.

    The organization shall identify the product status

    with respect to monitoring and measurement

    requirements throughout product realization.

    Where traceability is a requirement, the organization

    shall control the unique identification of the product

    and maintain records (see 4.2.4).

    NOTE In some industry sectors, configuration management

    is a means by which identification and traceability are

    maintained.

    7.5.4 Customer property

    The organization shall exercise care with customer

    property while it is under the organizations control

    or being used by the organization. The organization

    shall identify, verify, protect and safeguard customer

    property provided for use or incorporation into the

    product. If any customer property is lost, damaged

    or otherwise found to be unsuitable for use, the

    organization shall report this to the customer and

    maintain records (see 4.2.4).

    NOTE Customer property can include intellectual property

    and personal data.

    7.5.5 Preservation of product

    The organization shall preserve the product during

    internal processing and delivery to the intended

    destination in order to maintain conformity to

    requirements. As applicable, preservation shall

    include identification, handling, packaging, storage

  • TCVN ISO 9001 : 2008

    32

    qun. Vic bo ton cng phi p dng vi cc

    b phn cu thnh ca sn phm.

    7.6 Kim sot thit b theo di v o lng

    T chc phi xc nh vic theo di v o lng

    cn thc hin v cc thit b theo di, o lng

    cn thit cung cp bng chng v s ph

    hp ca sn phm vi cc yu cu xc nh.

    T chc phi thit lp cc qu trnh m bo

    rng vic theo di v o lng c th tin hnh

    v c tin hnh mt cch nht qun vi cc

    yu cu theo di v o lng.

    Khi cn m bo kt qu ng, thit b o lng

    phi

    a) c hiu chun hoc kim tra xc nhn, hoc c

    hai, nh k hoc trc khi s dng, da trn cc

    chun o lng c lin kt vi chun o lng

    quc gia hay quc t; khi khng c cc chun ny th

    cn c c s dng hiu chun hoc kim tra

    xc nhn phi c lu h s (xem 4.2.4);

    b) c hiu chnh hoc hiu chnh li, khi cn;

    c) c du hiu nhn bit xc nh tnh trng

    hiu chun;

    d) c gi gn trnh b hiu chnh lm mt

    tnh ng n ca cc kt qu o;

    e) c bo v trnh h hng hoc suy gim

    cht lng trong khi di chuyn, bo dng v lu

    gi.

    Ngoi ra, t chc phi nh gi v ghi nhn gi

    tr hiu lc ca cc kt qu o lng trc

    khi thit b c pht hin khng ph hp vi

    yu cu. T chc phi tin hnh hnh ng

    thch hp i vi thit b v bt k sn phm

    no b nh hng.

    and protection. Preservation shall also apply to the

    constituent parts of a product.

    7.6 Control of monitoring and measuring equipment

    The organization shall determine the monitoring and

    measurement to be undertaken and the monitoring

    and measuring equipment needed to provide

    evidence of conformity of product to determined

    requirements.

    The organization shall establish processes to

    ensure that monitoring and measurement can be

    carried out and are carried out in a manner that is

    consistent with the monitoring and measurement

    requirements.

    Where necessary to ensure valid results, measuring

    equipment shall

    a) be calibrated or verified, or both, at specified

    intervals, or prior to use, against measurement

    standards traceable to international or national

    measurement standards; where no such standards

    exist, the basis used for calibration or verification

    shall be recorded (see 4.2.4);

    b) be adjusted or re-adjusted as necessary;

    c) have identification in order to determine its

    calibration status;

    d) be safeguarded from adjustments that would

    invalidate the measurement result;

    e) be protected from damage and deterioration

    during handling, maintenance and storage.

    In addition, the organization shall assess and record

    the validity of the previous measuring results when

    the equipment is found not to conform to

    requirements. The organization shall take

    appropriate action on the equipment and any

    product affected.

  • TCVN ISO 9001 : 2008

    33

    Phi duy tr h s (xem 4.2.4) v kt qu hiu

    chun v kim tra xc nhn.

    Khi s dng phn mm my tnh theo di v

    o lng cc yu cu quy nh, phi khng nh

    kh nng tho mn vic ng dng d kin. Vic

    ny phi c tin hnh trc ln s dng u

    tin v c xc nhn li khi cn.

    CH THCH: Vic xc nhn kh nng p ng ng dng d

    kin ca phn mm my tnh thng bao gm vic kim tra xc

    nhn v qun l cu hnh duy tr tnh thch hp s dng

    ca phn mm .

    8 o lng, phn tch v ci tin

    8.1 Khi qut

    T chc phi hoch nh v trin khai cc qu

    trnh theo di, o lng, phn tch v ci tin

    cn thit

    a) chng t s ph hp vi cc yu cu ca

    sn phm,

    b) m bo s ph hp ca h thng qun l

    cht lng, v

    c) ci tin lin tc hiu lc ca h thng qun

    l cht lng.

    iu ny phi bao gm vic xc nh cc

    phng php c th p dng, k c cc k

    thut thng k, v mc s dng chng.

    8.2 Theo di v o lng

    8.2.1 S tho mn ca khch hng

    T chc phi theo di cc thng tin lin quan n

    s chp nhn ca khch hng v vic t chc c

    p ng yu cu ca khch hng hay khng, coi

    nh mt trong nhng thc o mc thc

    hin ca h thng qun l cht lng. Phi xc

    nh cc phng php thu thp v s dng cc

    thng tin ny.

    CH THCH: Theo di cm nhn ca khch hng c th

    Records of the results of calibration and verification

    shall be maintained (see 4.2.4).

    When used in the monitoring and measurement of

    specified requirements, the ability of computer

    software to satisfy the intended application shall be

    confirmed. This shall be undertaken prior to initial

    use and reconfirmed as necessary.

    NOTE Confirmation of the ability of computer software to

    satisfy the intended application would typically include its

    verification and configuration management to maintain its

    suitability for use.

    8 Measurement, analysis and improvement

    8.1 General

    The organization shall plan and implement the

    monitoring, measurement, analysis and

    improvement processes needed

    a) to demonstrate conformity to product

    requirements,

    b) to ensure conformity of the quality management

    system, and

    c) to continually improve the effectiveness of the

    quality management system.

    This shall include determination of applicable

    methods, including statistical techniques, and the

    extent of their use.

    8.2 Monitoring and measurement

    8.2.1 Customer satisfaction

    As one of the measurements of the performance of

    the quality management system, the organization

    shall monitor information relating to customer

    perception as to whether the organization has met

    customer requirements. The methods for obtaining

    and using this information shall be determined.

    NOTE Monitoring customer perception can include

  • TCVN ISO 9001 : 2008

    34

    bao gm vic thu thp u vo t cc ngun nh kho

    st v s tha mn ca khch hng, d liu khch hng

    v cht lng sn phm giao nhn, kho st kin ngi

    s dng, phn tch thua l kinh doanh, nhng khen ngi,

    cc yu cu bo hnh v bo co ca i l.

    8.2.2 nh gi ni b

    T chc phi tin hnh nh gi ni b nh k

    theo k hoch xc nh h thng qun l

    cht lng

    a) c ph hp vi cc b tr sp xp c

    hoch nh (xem 7.1) i vi cc yu cu ca

    tiu chun ny v vi cc yu cu ca h thng

    qun l cht lng c t chc thit lp, v

    b) c c thc hin v duy tr mt cch hiu lc.

    T chc phi hoch nh chng trnh nh gi, c

    ch n tnh trng v tm quan trng ca cc qu

    trnh v cc khu vc c nh gi, cng nh kt

    qu ca cc cuc nh gi trc. Chun mc,

    phm vi, tn sut v phng php nh gi phi

    c xc nh. Vic la chn cc chuyn gia nh

    gi v tin hnh nh gi phi m bo c tnh

    khch quan v cng bng ca qu trnh nh gi.

    Cc chuyn gia nh gi khng c nh gi

    cng vic ca mnh.

    Phi thit lp mt th tc dng vn bn xc nh

    trch nhim v yu cu i vi vic hoch nh v

    tin hnh nh gi, lp h s v bo co kt qu.

    Phi duy tr h s nh gi v cc kt qu nh

    gi (xem 4.2.4).

    Lnh o chu trch nhim v khu vc c nh

    gi phi m bo tin hnh khng chm tr mi s

    khc phc cng nh cc hnh ng khc phc cn

    thit loi b s khng ph hp c pht hin

    v nguyn nhn ca chng. Cc hot ng tip theo

    phi bao gm vic kim tra xc nhn cc hnh ng

    c tin hnh v bo co kt qu kim tra xc

    nhn (xem 8.5.2).

    obtaining input from sources such as customer satisfaction

    surveys, customer data on delivered product quality, user

    opinion surveys, lost business analysis, compliments,

    warranty claims and dealer reports.

    8.2.2 Internal audit

    The organization shall conduct internal audits at

    planned intervals to determine whether the quality

    management system

    a) conforms to the planned arrangements (see 7.1),

    to the requirements of this International Standard

    and to the quality management system

    requirements established by the organization, and

    b) is effectively implemented and maintained.

    An audit programme shall be planned, taking into

    consideration the status and importance of the

    processes and areas to be audited, as well as the

    results of previous audits. The audit criteria, scope,

    frequency and methods shall be defined. The

    selection of auditors and conduct of audits shall

    ensure objectivity and impartiality of the audit

    process. Auditors shall not audit their own work.

    A documented procedure shall be established to

    define the responsibilities and requirements for

    planning and conducting audits, establishing

    records and reporting results.

    Records of the audits and their results shall be

    maintained (see 4.2.4).

    The management responsible for the area being

    audited shall ensure that any necessary corrections

    and corrective actions are taken without undue

    delay to eliminate detected nonconformities and

    their causes. Follow-up activities shall include the

    verification of the actions taken and the reporting of

    verification results (see 8.5.2).

  • TCVN ISO 9001 : 2008

    35

    CH THCH: Xem hng dn trong TCVN ISO 19011.

    8.2.3 Theo di v o lng cc qu trnh

    T chc phi p dng cc phng php thch

    hp cho vic theo di v, khi c th, o lng

    cc qu trnh ca h thng qun l cht lng.

    Cc phng php ny phi chng t kh nng

    ca cc qu trnh t c cc kt qu

    hoch nh. Khi khng t c cc kt qu theo

    hoch nh, phi tin hnh vic khc phc v

    hnh ng khc phc thch hp.

    CH THCH: xc nh cc phng php thch hp,

    t chc nn xem xt loi v phm vi theo di hoc o

    lng thch hp vi mi qu trnh trong mi tng quan

    vi nh hng ca nhng qu trnh ny ti s ph hp

    vi cc yu cu ca sn phm cng nh hiu lc ca h

    thng qun l cht lng.

    8.2.4 Theo di v o lng sn phm

    T chc phi theo di v o lng cc c tnh

    ca sn phm kim tra xc nhn rng cc

    yu cu v sn phm c p ng. Vic ny

    phi c tin hnh nhng giai on thch

    hp ca qu trnh to sn phm theo cc sp

    xp hoch nh (xem 7.1). Phi duy tr bng

    chng v s ph hp vi tiu ch chp nhn.

    H s phi ch ra (nhng) ngi c quyn thng

    qua sn phm giao cho khch hng (xem 4.2.4).

    Vic thng qua sn phm v chuyn giao dch

    v cho khch hng ch c tin hnh sau khi

    hon thnh tho ng cc hot ng theo

    hoch nh (xem 7.1), nu khng th phi c

    s ph duyt ca ngi c thm quyn v, nu

    c th, ca khch hng.

    8.3 Kim sot sn phm khng ph hp

    T chc phi m bo rng sn phm khng

    ph hp vi cc yu cu c nhn bit v

    kim sot phng nga vic s dng hoc

    NOTE See ISO 19011 for guidance.

    8.2.3 Monitoring and measurement of processes

    The organization shall apply suitable methods for

    monitoring and, where applicable, measurement of

    the quality management system processes. These

    methods shall demonstrate the ability of the

    processes to achieve planned results. When

    planned results are not achieved, correction and

    corrective action shall be taken, as appropriate.

    NOTE When determining suitable methods, it is advisable

    that the organization consider the type and extent of

    monitoring or measurement appropriate to each of its

    processes in relation to their impact on the conformity to

    product requirements and on the effectiveness of the quality

    management system.

    8.2.4 Monitoring and measurement of product

    The organization shall monitor and measure the

    characteristics of the product to verify that product

    requirements have been met. This shall be carried

    out at appropriate stages of the product realization

    process in accordance with the planned

    arrangements (see 7.1). Evidence of conformity with

    the acceptance criteria shall be maintained.

    Records shall indicate the person(s) authorizing

    release of product for delivery to the customer (see

    4.2.4).

    The release of product and delivery of service to the

    customer shall not proceed until the planned

    arrangements (see 7.1) have been satisfactorily

    completed, unless otherwise approved by a relevant

    authority and, where applicable, by the customer.

    8.3 Control of nonconforming product

    The organization shall ensure that product which

    does not conform to product requirements is

    identified and controlled to prevent its unintended

  • TCVN ISO 9001 : 2008

    36

    chuyn giao ngoi d kin. Phi thit lp mt

    th tc dng vn bn xc nh vic kim sot

    v trch nhim, quyn hn c lin quan i vi

    vic x l sn phm khng ph hp.

    Khi thch hp, t chc phi x l sn phm

    khng ph hp bng mt hoc mt s cch sau:

    a) tin hnh loi b s khng ph hp c

    pht hin;

    b) cho php s dng, thng qua hoc chp

    nhn c nhn nhng bi ngi c thm quyn

    v, khi c th, bi khch hng;

    c) tin hnh loi b khi vic s dng hoc p

    dng d kin ban u.

    d) tin hnh hnh ng thch hp vi nhng

    tc ng hoc hu qu tim n ca s khng

    ph hp nu sn phm khng ph hp c

    pht hin sau khi chuyn giao hoc bt u

    s dng.

    Khi sn phm khng ph hp c khc phc,

    chng phi c kim tra xc nhn li

    chng t s ph hp vi cc yu cu.

    Phi duy tr h s (xem 4.2.4) v bn cht ca

    s khng ph hp v bt k hnh ng tip

    theo no c tin hnh, k c cc nhn

    nhng c c.

    8.4 Phn tch d liu

    T chc phi xc nh, thu thp v phn tch

    cc d liu thch hp chng t s ph hp

    v tnh hiu lc ca h thng qun l cht

    lng v nh gi xem vic ci tin lin tc

    hiu lc ca h thng qun l cht lng c

    th tin hnh u. iu ny bao gm c cc

    d liu c to ra do kt qu ca vic theo

    di, o lng v t cc ngun thch hp khc.

    use or delivery. A documented procedure shall be

    established to define the controls and related

    responsibilities and authorities for dealing with

    nonconforming product.

    Where applicable, the organization shall deal with

    nonconforming product by one or more of the

    following ways:

    a) by taking action to eliminate the detected

    nonconformity;

    b) by authorizing its use, release or acceptance

    under concession by a relevant authority and, where

    applicable, by the customer;

    c) by taking action to preclude its original intended

    use or application.

    d) by taking action appropriate to the effects, or

    potential effects, of the nonconformity when

    nonconforming product is detected after delivery or

    use has started.

    When nonconforming product is corrected it shall be

    subject to re-verification to demonstrate conformity to

    the requirements.

    Records of the nature of nonconformities and any

    subsequent actions taken, including concessions

    obtained, shall be maintained (see 4.2.4).

    8.4 Analysis of data

    The organization shall determine, collect and

    analyse appropriate data to demonstrate the

    suitability and effectiveness of the quality

    management system and to evaluate where

    continual improvement of the effectiveness of the

    quality management system can be made. This

    shall include data generated as a result of

    monitoring and measurement and from other

    relevant sources.

  • TCVN ISO 9001 : 2008

    37

    Vic phn tch d liu phi cung cp thng tin

    v:

    a) s tho mn khch hng (xem 8.2.1);

    b) s ph hp vi cc yu cu v sn phm (xem

    8.2.4);

    c) c tnh v xu hng ca cc qu trnh v

    sn phm, k c cc c hi cho hnh ng

    phng nga (xem 8.2.3 v 8.2.4), v

    d) ngi cung ng (xem 7.4).

    8.5 Ci tin

    8.5.1 Ci tin lin tc

    T chc phi ci tin lin tc hiu lc ca h thng

    qun l cht lng thng qua vic s dng chnh

    sch cht lng, mc tiu cht lng, kt qu nh

    gi, phn tch d liu, hnh ng khc phc, phng

    nga v s xem xt ca lnh o.

    8.5.2 Hnh ng khc phc

    T chc phi thc hin hnh ng nhm loi b

    nhng nguyn nhn ca s khng ph hp

    ngn nga vic ti din. Hnh ng khc phc

    phi tng ng vi tc ng ca s khng ph

    hp gp phi.

    Phi lp mt th tc dng vn bn xc nh

    cc yu cu i vi

    a) vic xem xt s khng ph hp (k c cc

    khiu ni ca khch hng),

    b) vic xc nh nguyn nhn ca s khng ph

    hp,

    c) vic nh gi nhu cu thc hin cc hnh

    ng m bo rng s khng ph hp khng

    ti din,

    d) vic xc nh v thc hin cc hnh ng cn

    thit,

    e) vic lu h s cc kt qu ca hnh ng

    The analysis of data shall provide information relating

    to

    a) customer satisfaction (see 8.2.1),

    b) conformity to product requirements (see 8.2.4),

    c) characteristics and trends of processes and

    products including opportunities for preventive

    action (see 8.2.3 and 8.2.4), and

    d) suppliers (see 7.4).

    8.5 Improvement

    8.5.1 Continual improvement

    The organization shall continually improve the

    effectiveness of the quality management system

    through the use of the quality policy, quality

    objectives, audit results, analysis of data, corrective

    and preventive actions and management review.

    8.5.2 Corrective action

    The organization shall take action to eliminate the

    causes of nonconformities in order to prevent

    recurrence. Corrective actions shall be appropriate

    to the effects of the nonconformities encountered.

    A documented procedure shall be established to

    define requirements for

    a) reviewing nonconformities (including customer

    complaints),

    b) determining the causes of nonconformities,

    c) evaluating the need for action to ensure that

    nonconformities do not recur,

    d) determining and implementing action needed,

    e) records of the results of action taken (see 4.2.4),

  • TCVN ISO 9001 : 2008

    38

    c thc hin (xem 4.2.4), v

    f) vic xem xt hiu lc ca cc hnh ng khc

    phc thc hin.

    8.5.3 Hnh ng phng nga

    T chc phi xc nh hnh ng nhm loi b

    nguyn nhn ca s khng ph hp tim n

    ngn chn s xut hin ca chng. Cc hnh

    ng phng nga c tin hnh phi tng

    ng vi tc ng ca cc vn tim n.

    Phi lp mt th tc dng vn bn xc nh

    cc yu cu i vi

    a) vic xc nh s khng ph hp tim n v

    cc nguyn nhn ca chng,

    b) vic nh gi nhu cu thc hin cc hnh ng

    phng nga vic xut hin s khng ph hp,

    c) vic xc nh v thc hin cc hnh ng cn

    thit,

    d) h s cc kt qu ca hnh ng c

    thc hin (xem 4.2.4), v

    e) vic xem xt hiu lc ca cc hnh ng

    phng nga thc hin.

    and

    f) reviewing the effectiveness of corrective action

    taken.

    8.5.3 Preventive action

    The organization shall determine action to eliminate

    the causes of potential nonconformities in order to

    prevent their occurrence. Preventive actions shall

    be appropriate to the effects of the potential

    problems.

    A documented procedure shall be established to

    define requirements for

    a) determining potential nonconformities and their

    causes,

    b) evaluating the need for action to prevent

    occurrence of nonconformities,

    c) determining and implementing action needed,

    d) records of results of action taken (see 4.2.4),

    and

    e) reviewing the effectiveness of preventive action

    taken.

  • TCVN ISO 9001 : 2008

    39

    Ph lc A (tham kho)

    S tng ng gia TCVN ISO 9001 : 2008 v TCVN ISO 14001 : 2005

    Bng A.1 - S tng ng gia TCVN ISO 9001 : 2008 v TCVN ISO 14001 : 2005 TCVN ISO 9001 : 2008 TCVN ISO 14001 : 2005

    Li gii thiu (ch c tiu ) Khi qut Cch tip cn theo qu trnh Mi quan h vi TCVN ISO 9004 S tng thch vi cc h thng qun l khc

    0.1 0.2 0.3 0.4

    Li gii thiu

    Phm vi p dng (ch c tiu ) 1 1 Phm vi p dng Khi qut 1.1 p dng 1.2

    Ti liu vin dn 2 2 Ti liu vin dn

    Thut ng v nh ngha 3 3 Thut ng v nh ngha

    H thng qun l cht lng (ch c tiu ) 4 4 Yu cu ca h thng qun l mi trng (ch c tiu )

    Yu cu chung 4.1 4.1 Yu cu chung Yu cu v h thng ti liu (ch c tiu ) 4.2 Khi qut 4.2.1 4.4.4 Ti liu S tay cht lng 4.2.2 Kim sot ti liu 4.2.3 4.4.5 Kim sot ti liu Kim sot h s 4.2.4 4.5.4 Kim sot h s Trch nhim ca lnh o (ch c tiu ) 5

    Cam kt ca lnh o 5.1 4.2 4.4.1

    Chnh sch mi trng Ngun lc, vai tr, trch nhim v quyn hn

    Hng vo khch hng 5.2 4.3.1 4.3.2 4.6

    Kha cnh mi trng Yu cu v php lut v yu cu khc Xem xt ca lnh o

    Chnh sch cht lng 5.3 4.2 Chnh sch mi trng

    Hoch nh (ch c tiu ) 5.4 4.3 Lp k hoch (ch c tiu )

    Mc tiu cht lng 5.4.1 4.3.3 Mc tiu, ch tiu v chng trnh

    Hoch nh h thng qun l cht lng 5.4.2 4.3.3 Mc tiu, ch tiu v chng trnh

    Trch nhim, quyn hn v trao i thng tin (ch c tiu )

    5.5

    Trch nhim v quyn hn 5.5.1 4.1 4.4.1

    Yu cu chung Ngun lc, vai tr, trch nhim v quyn hn

    i din ca lnh o 5.5.2 4.4.1 Ngun lc, vai tr, trch nhim v quyn hn

    Trao i thng tin ni b 5.5.3 4.4.3 Trao i thng tin

    Xem xt ca lnh o (ch c tiu ) 5.6 4.6 Xem xt ca lnh o Khi qut 5.6.1 4.6 Xem xt ca lnh o u vo ca vic xem xt 5.6.2 4.6 Xem xt ca lnh o u ra ca vic xem xt 5.6.3 4.6 Xem xt ca lnh o Qun l ngun lc (ch c tiu ) 6 Cung cp ngun lc 6.1 4.4.1 Ngun lc, vai tr, trch nhim v quyn hn Ngun nhn lc (ch c tiu ) 6.2 Khi qut 6.2.1 4.4.2 Nng lc, o to v nhn thc Nng lc, o to v nhn thc 6.2.2 4.4.2 Nng lc, o to v nhn thc

    C s h tng 6.3 4.4.1 Ngun lc, vai tr, trch nhim v quyn hn

    Mi trng lm vic 6.4

  • TCVN ISO 9001 : 2008

    40

    Annex A (informative)

    Correspondence between ISO 9001:2008 and ISO 14001:2004

    Table A.1 Correspondence between ISO 9001:2008 and ISO 14001:2004

    ISO 9001:2008 ISO 14001:2004 Introduction (title only) General Process approach Relationship with ISO 9004 Compatibility with other management systems

    0.1 0.2 0.3 0.4

    Introduction

    Scope (title only) General Application

    1 1.1 1.2

    1 Scope

    Normative references 2 2 Normative references Terms and definitions 3 3 Terms and definitions Quality management system (title only) 4 4 Environmental management system requirements

    (title only)General requirements 4.1 4.1 General requirements Documentation requirements (title only) 4.2 General 4.2.1 4.4.4 Documentation Quality manual 4.2.2 Control of documents 4.2.3 4.4.5 Control of documents Control of records 4.2.4 4.5.4 Control of records Management responsibility (title only) 5 Management commitment 5.1 4.2

    4.4.1Environmental policy Resources, roles, responsibility and authority

    Customer focus 5.2 4.3.1 4.3.2 4.6

    Environmental aspects Legal and other requirements Management review

    Quality policy 5.3 4.2 Environmental policy Planning (title only) 5.4 4.3 Planning (title only) Quality objectives 5.4.1 4.3.3 Objectives, targets and programme(s) Quality management system planning 5.4.2 4.3.3 Objectives, targets and programme(s) Responsibility, authority and communication (title only)

    5.5

    Responsibility and authority 5.5.1 4.1 4.4.1

    General requirements Resources, roles, responsibility and authority

    Management representative 5.5.2 4.4.1 Resources, roles, responsibility and authority Internal communication 5.5.3 4.4.3 Communication Management review (title only) 5.6 4.6 Management review General 5.6.1 4.6 Management review Review input 5.6.2 4.6 Management review Review output 5.6.3 4.6 Management review Resource management (title only) 6 Provision of resources 6.1 4.4.1 Resources, roles, responsibility and authority Human resources (title only) 6.2 General 6.2.1 4.4.2 Competence, training and awareness Competence, training and awareness 6.2.2 4.4.2 Competence, training and awareness Infrastructure 6.3 4.4.1 Resources, roles, responsibility and authority Work environment 6.4

  • TCVN ISO 9001 : 2008

    41

    Bng A.1 S tng ng gia TCVN ISO 9001 : 2008 v TCVN ISO 14001 : 2005 (kt thc)

    TCVN ISO 9001 : 2008 TCVN ISO 14001 : 2005 To sn phm (ch c tiu ) 7 4.4 Thc hin v iu hnh

    Hoch nh vic to sn phm 7.1 4.4.6 Kim sot iu hnh

    Cc qu trnh lin quan n khch hng (ch c tiu )

    7.2

    Xc nh cc yu cu lin quan n sn phm 7.2.1 4.3.1 4.3.2 4.4.6

    Kha cnh mi trng Yu cu v php lut v yu cu khc Kim sot iu hnh

    Xem xt cc yu cu lin quan n sn phm 7.2.2 4.3.1 4.4.6

    Kha cnh mi trng Kim sot iu hnh

    Trao i thng tin vi khch hng 7.2.3 4.4.3 Trao i thng tin

    Thit k v pht trin (ch c tiu ) 7.3

    Hoch nh thit k v pht trin 7.3.1 4.4.6 Kim sot iu hnh

    u vo ca thit k v pht trin 7.3.2 4.4.6 Kim sot iu hnh

    u ra ca thit k v pht trin 7.3.3 4.4.6 Kim sot iu hnh

    Xem xt thit k v pht trin 7.3.4 4.4.6 Kim sot iu hnh

    Kim tra xc nhn thit k v pht trin 7.3.5 4.4.6 Kim sot iu hnh

    Xc nhn gi tr s dng ca thit k v pht trin

    7.3.6 4.4.6 Kim sot iu hnh

    Kim sot thay i thit k v pht trin 7.3.7 4.4.6 Kim sot iu hnh

    Mua hng (ch c tiu ) 7.4

    Qu trnh mua hng 7.4.1 4.4.6 Kim sot iu hnh

    Thng tin mua hng 7.4.2 4.4.6 Kim sot iu hnh

    Kim tra xc nhn sn phm mua vo 7.4.3 4.4.6 Kim sot iu hnh

    Sn xut v cung cp dch v (ch c tiu ) 7.5

    Kim sot sn xut v cung cp dch v 7.5.1 4.4.6 Kim sot iu hnh

    Xc nhn gi tr s dng ca cc qu trnh sn xut v cung cp dch v

    7.5.2 4.4.6 Kim sot iu hnh

    Nhn bit v xc nh ngun gc 7.5.3

    Ti sn ca khch hng 7.5.4

    Bo ton sn phm 7.5.5 4.4.6 Kim sot iu hnh

    Kim sot phng tin theo di v o lng 7.6 4.5.1 Gim st v o lng

    o lng, phn tch v ci tin (ch c tiu ) 8 4.5 Kim tra

    Khi qut 8.1 4.5.1 Gim st v o lng

    Theo di v o lng (ch c tiu ) 8.2

    S tho mn ca khch hng 8.2.1

    nh gi ni b 8.2.2 4.5.5 nh gi ni b

    Theo di v o lng cc qu trnh 8.2.3 4.5.1 4.5.2

    Gim st v o lng nh gi s tun th

    Theo di v o lng sn phm 8.2.4 4.5.1 4.5.2

    Gim st v o lng nh gi s tun th

    Kim sot sn phm khng ph hp 8.3 4.4.7 4.5.3

    S chun b sn sng v p ng vi tnh trng khn cp S khng ph hp, hnh ng khc phc v hnh ng phng nga

    Phn tch d liu 8.4 4.5.1 Gim st v o lng

    Ci tin (ch c tiu ) 8.5

    Ci tin lin tc 8.5.1 4.2 4.3.3 4.6

    Chnh sch mi trng Mc tiu, ch tiu v chng trnh Xem xt ca lnh o

    Hnh ng khc phc 8.5.2 4.5.3 S khng ph hp, hnh ng khc phc v hnh ng phng nga

    Hnh ng phng nga 8.5.3 4.5.3 S khng ph hp, hnh ng khc phc v hnh ng phng nga

  • TCVN ISO 9001 : 2008

    42

    Table A.1 Correspondence between ISO 9001:2008 and ISO 14001:2004 (continued)

    ISO 9001:2008 ISO 14001:2004 Product realization (title only) 7 4.4 Implementation and operation (title only) Planning of product realization 7.1 4.4.6 Operational control Customer-related processes (title only) 7.2 Determination of requirements related to the product

    7.2.1 4.3.1 4.3.2 4.4.6

    Environmental aspects Legal and other requirements Operational control

    Review of requirements related to the product 7.2.2 4.3.1 4.4.6

    Environmental aspects Operational control

    Customer communication 7.2.3 4.4.3 Communication Design and development (title only) 7.3 Design and development planning 7.3.1 4.4.6 Operational control Design and development inputs 7.3.2 4.4.6 Operational control Design and development outputs 7.3.3 4.4.6 Operational control Design and development review 7.3.4 4.4.6 Operational control Design and development verification 7.3.5 4.4.6 Operational control Design and development validation 7.3.6 4.4.6 Operational control Control of design and development changes 7.3.7 4.4.6 Operational control Purchasing (title only) 7.4 Purchasing process 7.4.1 4.4.6 Operational control Purchasing information 7.4.2 4.4.6 Operational control Verification of purchased product 7.4.3 4.4.6 Operational control Production and service provision (title only) 7.5 Control of production and service provision 7.5.1 4.4.6 Operational control Validation of processes for production and service provision

    7.5.2 4.4.6 Operational control

    Identification and traceability 7.5.3 Customer property 7.5.4 Preservation of product 7.5.5 4.4.6 Operational control Control of monitoring and measuring equipment 7.6 4.5.1 Monitoring and measurement Measurement, analysis and improvement (title only) 8 4.5 Checking (title only) General 8.1 4.5.1 Monitoring and measurement Monitoring and measurement (title only) 8.2 Customer satisfaction 8.2.1 Internal audit 8.2.2 4.5.5 Internal audit Monitoring and measurement of processes 8.2.3 4.5.1

    4.5.2 Monitoring and measurement Evaluation of compliance

    Monitoring and measurement of product 8.2.4 4.5.1 4.5.2

    Monitoring and measurement Evaluation of compliance

    Control of nonconforming product 8.3 4.4.7 4.5.3

    Emergency preparedness and response Nonconformity, corrective action and preventive action

    Analysis of data 8.4 4.5.1 Monitoring and measurement Improvement (title only) 8.5 Continual improvement 8.5.1 4.2

    4.3.3 4.6

    Environmental policy Objectives, targets and programme(s) Management review

    Corrective action 8.5.2 4.5.3 Nonconformity, corrective action and preventive action

    Preventive action 8.5.3 4.5.3 Nonconformity, corrective action and preventive action

  • TCVN ISO 9001 : 2008

    43

    Bng A.2 S tng ng gia TCVN ISO 14001 : 2005 v TCVN ISO 9001 : 2008

    TCVN ISO 14001 : 2005 TCVN ISO 9001 : 2008 Li gii thiu 0

    0.1 0.2 0.3 0.4

    Li gii thiu (tiu ) Khi qut Cch tip cn theo qu trnh Quan h vi TCVN ISO 9004 S tng thch vi cc h thng qun l khc

    Phm vi p dng 1 1 1.1 1.2

    Phm vi p dng Khi qut p dng

    Ti liu vin dn 2 2 Ti liu vin dn Thut ng v nh ngha 3 3 Thut ng v nh ngha Yu cu ca h thng qun l mi trng (ch c tiu )

    4 4 H thng qun l cht lng

    Yu cu chung 4.1 4.1 5.5 5.5.1

    Yu cu chung Trch nhim, quyn hn v trao i thng tin Trch nhim v quyn hn

    Chnh sch mi trng 4.2 5.1 5.3 8.5.1

    Cam kt ca lnh o Chnh sch cht lng Ci tin lin tc

    Lp k hoch (ch c tiu ) 4.3 5.4 Hoch nh Kha cnh mi trng 4.3.1 5.2 Hng vo khch hng 7.2.1 Xc nh cc yu cu lin quan n sn phm 7.2.2 Xem xt cc yu cu lin quan n sn phm Yu cu v php lut v yu cu khc 4.3.2 5.2

    7.2.1 Hng vo khch hng Xc nh cc yu cu lin quan n sn phm

    Mc tiu, ch tiu v chng trnh 4.3.3 5.4.1 5.4.2 8.5.1

    Mc tiu cht lng Hoch nh h thng qun l cht lng Ci tin lin tc

    Thc hin v iu hnh 4.4 7 To sn phm (ch c tiu ) Ngun lc, vai tr, trch nhim v quyn hn 4.4.1 5.1

    5.5.1 5.5.2 6.1 6.3

    Cam kt ca lnh o Trch nhim v quyn hn i din ca lnh o Cung cp cc ngun lc C s h tng

    Nng lc, o to v nhn thc 4.4.2 6.2.1 6.2.2

    (Ngun nhn lc) Khi qut Nng lc, o to v nhn thc

    Trao i thng tin 4.4.3 5.5.3 7.2.3

    Trao i thng tin ni b Trao i thng tin vi khch hng

    Ti liu 4.4.4 4.2.1 (Yu cu v h thng ti liu) Khi qut Kim sot ti liu 4.4.5 4.2.3 Kim sot ti liu

  • TCVN ISO 9001 : 2008

    44

    Table A.2 Correspondence between ISO 14001:2004 and ISO 9001:2008

    ISO 14001:2004 ISO 9001:2008 Introduction

    0.1 0.2 0.3 0.4

    Introduction (title only) General Process approach Relationship with ISO 9004 Compatibility with other management systems

    Scope 1 1 1.1 1.2

    Scope (title only) General Application

    Normative references 2 2 Normative references Terms and definitions 3 3 Terms and definitions Environmental management system requirements (title only)

    4 4 Quality management system (title only)

    General requirements 4.1 4.1 5.5

    5.5.1

    General requirements Responsibility, authority and communication (title only) Responsibility and authority

    Environmental policy 4.2 5.1 5.3 8.5.1

    Management commitment Quality policy Continual improvement

    Planning (title only) 4.3 5.4 Planning (title only) Environmental aspects 4.3.1 5.2

    7.2.1

    7.2.2

    Customer focus Determination of requirements related to the product Review of requirements related to the product

    Legal and other requirements 4.3.2 5.2 7.2.1

    Customer focus Determination of requirements related to the product

    Objectives, targets and programme(s) 4.3.3 5.4.1 5.4.2 8.5.1

    Quality objectives Quality management system planning Continual improvement

    Implementation and operation (title only) 4.4 7 Product realization (title only) Resources, roles, responsibility and authority 4.4.1 5.1

    5.5.1 5.5.2 6.1 6.3

    Management commitment Responsibility and authority Management representative Provision of resources Infrastructure

    Competence, training and awareness 4.4.2 6.2.1 6.2.2

    (Human resources) General Competence, training and awareness

    Communication 4.4.3 5.5.3 7.2.3

    Internal communication Customer communication

    Documentation 4.4.4 4.2.1 (Documentation requirements) General Control of documents 4.4.5 4.2.3 Control of documents

  • TCVN ISO 9001 : 2008

    45

    Bng A.2 S tng ng gia TCVN ISO 14001 : 2005 v TCVN ISO 9001 : 2008 (kt thc)

    TCVN ISO 14001 : 2004 TCVN ISO 9001 : 2008 Kim sot iu hnh 4.4.6 7.1

    7.2 7.2.1 7.2.2 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5 7.5.1 7.5.2 7.5.5

    Hoch nh to sn phm Cc qu trnh lin quan n khch hng (ch c tiu ) Xc nh cc yu cu lin quan n sn phm Xem xt cc yu cu lin quan n sn phm Hoch nh thit k v pht trin u vo ca thit k v pht trin u ra ca thit k v pht trin Xem xt thit k v pht trin Kim tra xc nhn thit k v pht trin Xc nhn gi tr s dng ca thit k v pht trin Kim sot thay i thit k v pht trin Qu trnh mua hng Thng tin mua hng Kim tra xc nhn sn phm mua vo Sn xut v cung cp dch v (ch c tiu )Kim sot sn xut v cung cp dch v Xc nhn gi tr s dng ca cc qu trnh sn xut v cung cp dch v Bo ton sn phm

    S chun b sn sng v p ng vi tnh trng khn cp

    4.4.7 8.3 Kim sot sn phm khng ph hp

    Kim tra (ch c tiu ) 4.5 8 o lng, phn tch v ci tin (ch c tiu )

    Gim st v o lng 4.5.1 7.6 8.1 8.2.3 8.2.4 8.4

    Kim sot thit b theo di v o lng (o lng, phn tch v ci tin) Khi qut Theo di v o lng cc qu trnh Theo di v o lng sn phm Phn tch d liu

    nh gi s tun th 4.5.2 8.2.3 Theo di v o lng qu trnh

    8.2.4 Theo di v o lng sn phm

    S khng ph hp, hnh ng khc phc v hnh ng phng nga

    4.5.3 8.3 8.4 8.5.2 8.5.3

    Kim sot sn phm khng ph hp Phn tch d liu Hnh ng khc phc Hnh ng phng nga

    Kim sot h s 4.5.4 4.2.4 Kim sot h s

    nh gi ni b 4.5.5 8.2.2 nh gi ni b

    Xem xt ca lnh o 4.6 5.1 5.6 5.6.1 5.6.2 5.6.3 8.5.1

    Cam kt ca lnh o Xem xt ca lnh o (ch c tiu ) Khi qut u vo ca vic xem xt u ra ca vic xem xt Ci tin lin tc

  • TCVN ISO 9001 : 2008

    46

    Table A.2 Correspondence between ISO 14001:2004 and ISO 9001:2008 (continued)

    ISO 14001:2004 ISO 9001:2008 Operational control 4.4.6 7.1

    7.2 7.2.1

    7.2.2 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5 7.5.1 7.5.2

    7.5.5

    Planning of product realization Customer-related processes (title only) Determination of requirements related to the product Review of requirements related to the product Design and development planning Design and development inputs Design and development outputs Design and development review Design and development verification Design and development validation Control of design and development changes Purchasing process Purchasing information Verification of purchased product Production and service provision (title only) Control of production and service provision Validation of processes for production and service provision Preservation of product

    Emergency preparedness and response 4.4.7 8.3 Control of nonconforming product Checking (title only) 4.5 8 Measurement, analysis and improvement (title only)Monitoring and measurement 4.5.1 7.6

    8.1 8.2.3 8.2.4 8.4

    Control of monitoring and measuring equipment (Measurement, analysis and improvement) GeneralMonitoring and measurement of processes Monitoring and measurement of product Analysis of data

    Evaluation of compliance 4.5.2 8.2.3 8.2.4

    Monitoring and measurement of processes Monitoring and measurement of product

    Nonconformity, corrective action and preventive action

    4.5.3 8.3 8.4 8.5.2 8.5.3

    Control of nonconforming product Analysis of data Corrective action Preventive action

    Control of records 4.5.4 4.2.4 Control of records Internal audit 4.5.5 8.2.2 Internal audit Management review 4.6 5.1

    5.6 5.6.1 5.6.2 5.6.3 8.5.1

    Management commitment Management review (title only) General Review input Review output Continual improvement

  • TCVN ISO 9001 : 2008

    47

    Ph lc B (tham kho)

    Nhng thay i gia TCVN ISO 9001 : 2008 so vi TCVN ISO 9001 : 2000

    Bng B.1 Nhng thay i gia TCVN ISO 9001 : 2008 so vi TCVN ISO 9001 : 2000 iu khon

    ca TCVN ISO 9001 : 2000

    on/Hnh/Bng/Ch

    thch

    B sung (B) hoc Xa (X)

    Ni dung thay i

    X Vic thit k v p dng h thng qun l cht lng ca mt t chc ph

    thuc vo cc nhu cu khc nhau, cc mc tiu ring bit, cc sn phm cung

    cp, cc qu trnh c s dng, quy m v cu trc ca t chc.

    0.1 on 1,

    cu 2

    B Vic thit k v p dng h thng qun l cht lng ca mt t chc ph thuc vo

    a) mi trng hot ng, cc thay i v nhng ri ro trong mi trng ,

    b) cc nhu cu khc nhau,

    c) cc mc tiu ring bit,

    d) cc sn phm cung cp,

    e) cc qu trnh c s dng,

    f) quy m v c cu ca t chc.

    Cu 3 thnh on mi

    Mc ch ca tiu chun ny khng nhm dn n s ng nht v cu trc ca

    cc h thng qun l cht lng hoc s ng nht ca h thng ti liu.

    0.1 on 4 B Tiu chun quc t ny c th c s dng cho ni b v t chc bn ngoi,

    k c cc t chc chng nhn, nh gi kh nng p ng cc yu cu ca

    khch hng, cc yu cu lut nh v ch nh p dng cho sn phm v cc

    yu cu ring ca t chc

    0.2 on 2 X + B vn hnh mt cch c hiu lc, t chc phi xc nh v qun l nhiu hot

    ng c lin h mt thit vi nhau. Hot ng hoc mt t hp cc hot ng

    tip nhn cc u vo v chuyn thnh cc u ra c th c coi nh mt

    qu trnh.

    0.2 on 3 B Vic p dng mt h thng cc qu trnh trong t chc, cng vi s nhn bit

    v mi tng tc gia cc qu trnh nh vy, v s qun l chng to thnh

    u ra mong mun, c th c coi nh "cch tip cn theo qu trnh".

    0.3 on 1 X + B n bn ny ca TCVN ISO 9001 v ISO 9004 c xy dng nh l mt cp

    thng nht l cc tiu chun v h thng qun l cht lng, Hai tiu chun

    ny c thit k s dng ng thi, nhng cng c th c s dng mt

    cch c lp. Mc d hai tiu chun ny c phm vi khc nhau, nhng chng

    c cu trc tng t thun tin cho vic s dng nh mt cp thng nht.

    0.3 on 3 B Vo thi im cng b tiu chun ny, ISO 9004 ang c sot xt. Bn tiu

    chun ISO 9004 c sot xt s a ra hng dn cho lnh o t

    c nhng thnh cng bn vng cho mi t chc trong mt mi trng

    phc tp vi nhng i hi kht khe v lin tc thay i. ISO 9004 quan

    tm n qun l cht lng rng hn so vi TCVN ISO 9001; tiu chun

    ny hng vo nhu cu v mong i ca tt c cc bn quan tm cng

    nh vic tha mn ca h thng qua vic ci tin lin tc v c h thng

    cc hot ng ca t chc. Tuy nhin, tiu chun ny khng dng

    chng nhn, quy nh bt buc hoc k kt hp ng.

  • TCVN ISO 9001 : 2008

    48

    Table B.1 Changes between ISO 9001:2000 and ISO 9001:2008

    ISO 9001:2000

    Clause No.

    Paragraph/

    Figure/ Table/ Note

    Addition (A) or

    Deletion (D)

    Amended text

    D The design and implementation of an organization's quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization.

    0.1 Para 1, sentence 2

    A The design and implementation of an organization's quality management system is influenced by

    a) its organizational environment, change in that environment, and the risksassociated with that environment;

    b) its varying needs;

    c) its particular objectives;

    d) the products it provides;

    e) the processes it employs;

    f) its size and organizational structure.

    Sentence 3 Now a new para

    It is not the intent of this International Standard to imply uniformity in thestructure of quality management systems or uniformity of documentation.

    0.1 Para 4 A This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, statutory and regulatory requirements applicable to the product, and the organization's own requirements.

    0.2 Para 2 D + A For an organization to function effectively, it has to identify determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process.

    0.2 Para 3 A The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the process approach.

    0.3 Para 1 D + A The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of are quality management system standards which have been designed to complement each other, but can also be used independently. Although the two International Standards have different scopes, they have similar structures in order to assist their application as a consistent pair.

    0.3 Para 3 D + A At the time of publication of this International Standard, ISO 9004 is under revision. The revised edition of ISO 9004 will provide guidance to management for achieving sustained success for any organization in a complex, demanding, and ever changing, environment. ISO 9004 provides a wider focus on quality management than ISO 9001; it addresses the needs and expectations of all interested parties and their satisfaction, by the systematic and continual improvement of the organizations performance. However, it is not intended for certification, regulatory or contractual use.

  • TCVN ISO 9001 : 2008

    49

    Bng B.1 Nhng thay i gia TCVN ISO 9001 : 2008 so vi TCVN ISO 9001 : 2000 (tip theo)

    iu khon ca TCVN ISO 9001 :

    2000

    on/Hnh/Bng/Ch

    thch

    B sung (B) hoc Xa (X)

    Ni dung thay i

    0.4 on 1 X + B Tiu chun ny c lin kt vi TCVN ISO 14001: 1996 nhm tng tng thch ca hai tiu chun i vi li ch ca cng ng ngi s dng. Trong qu trnh xy dng tiu chun ny, cc iu khon ca tiu chun TCVN ISO 14001 : 2005 c xem xt k cng nhm tng cng tnh tng thch ca hai tiu chun v li ch ca cng ng ngi s dng. Ph lc A nu ra s tng ng gia TCVN ISO 9001 : 2008 v TCVN ISO 14001 : 2005.

    im a) B a) cn chng t kh nng cung cp mt cch n nh sn phm p ng cc yu cu ca khch hng cng nh cc yu cu lut nh v ch nh thch hp, v

    im b)

    B

    b) mun nng cao s tho mn ca khch hng thng qua vic p dng c hiu lc h thng, bao gm c cc qu trnh ci tin lin tc h thng v m bo s ph hp vi cc yu cu ca khch hng, yu cu lut nh v ch nh c p dng

    Ch thch X Ch thch - Trong tiu chun ny, thut ng "sn phm" ch p dng cho sn phm nhm cho khch hng hoc khch hng yu cu.

    B CH THCH 1: Trong tiu chun ny, thut ng "sn phm" ch p dng cho a) sn phm d kin cung cp cho khch hng hoc khch hng yu cu, b) mi u ra d kin l kt qu ca qu trnh to sn phm.

    1.1

    Ch thch 2 mi

    B CH THCH 2: Cc yu cu lut nh v ch nh c th c th hin nh cc yu cu php l.

    1.2 on 3 B Khi c ngoi l, vic cng b ph hp vi tiu chun ny khng c chp nhn tr phi cc ngoi l ny c gii hn trong phm vi cc yu cu ca iu 7, v cc ngoi l ny khng nh hng n kh nng hay trch nhim ca t chc trong vic cung cp sn phm p ng cc yu cu ca khch hng v cc yu cu lut nh v ch nh thch hp.

    2 on 1 B Ti liu vin dn di y rt cn thit cho vic p dng tiu chun ny. i vi cc ti liu ghi nm cng b th p dng bn c nu. i vi cc ti liu khng ghi nm cng b th p dng bn mi nht, bao gm c cc sa i.

    X + B TCVN ISO 9000:20002007 (ISO 9000:2005) H thng qun l cht lng C s v t vng

    3 on 2, 3 X Cc thut ng sau, c s dng trong n bn ny ca TCVN ISO 9001 m t chui cung cp, c thay i phn nh t vng c s dng hin hnh: ngi cung ng t chc khch hng Thut ng "t chc" thay th cho thut ng "ngi cung ng" c s dng trc y trong TCVN ISO 9001: 1996 (ISO 9001: 1994) ch n v p dng tiu chun ny. Thut ng "ngi cung ng" lc ny c s dng thay cho thut ng "ngi thu ph".

    4.1 im a) X + B a) nhn bit xc nh cc qu trnh cn thit trong h thng qun l cht lng v p dng chng trong ton b t chc (xem 1.2),

  • TCVN ISO 9001 : 2008

    50

    Table B.1 Changes between ISO 9001:2000 and ISO 9001:2008 (continued)

    ISO 9001:2000

    Clause No.

    Paragraph/ Figure/ Table/ Note

    Addition (A) or

    Deletion (D)

    Amended text

    0.4 Para 1 D + A This International Standard has been aligned with ISO 14001:1996 in order to enhance the compatibility of the two standards for the benefit of the usercommunity.

    During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility ofthe two standards for the benefit of the user community. Annex A shows the correspondence between ISO 9001:2008 and ISO 14001:2004.

    1.1 Bullet a)

    Bullet b)

    Note

    A

    A

    D

    A

    a) needs to demonstrate its ability to consistently provide product that meetscustomer and applicable statutory and regulatory requirements, and

    b) aims to enhance customer satisfaction through the effective application of thesystem, including processes for continual improvement of the system and theassurance of conformity to customer and applicable statutory and regulatoryrequirements.

    NOTE In this International Standard, the term product applies only to theproduct intended for, or required by, a customer.

    NOTE 1 In this International Standard, the term product only applies to

    a) a product intended for, or required by, a customer,

    b) any intended output resulting from the product realization processes.

    NOTE 2 Statutory and regulatory requirements can be expressed as legalrequirements.

    1.2 Para 3 A Where exclusions are made, claims of conformity to this InternationalStandard are not acceptable unless these exclusions are limited torequirements within Clause 7, and such exclusions do not affect theorganization's ability, or responsibility, to provide product that meets customer andapplicable statutory and regulatory requirements.

    The following referenced documents are indispensable for the application of thisdocument. For dated references, only the edition cited applies. For undatedreferences, the latest edition of the referenced document (including anyamendments) applies.

    2 Para 1 A

    D + A ISO 9000:20002005, Quality management systems Fundamentals andvocabulary

    3 Paras 2, 3 D The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used: supplier organization customer The term organization replaces the term supplier used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term supplier now replaces the term subcontractor.

    4.1 Bullet a) D + A a) identify determine the processes needed for the quality management systemand their application throughout the organization (see 1.2),

  • TCVN ISO 9001 : 2008

    51

    Bng B.1 Nhng thay i gia TCVN ISO 9001 : 2008 so vi TCVN ISO 9001 : 2000 (tip theo)

    iu khon ca TCVN ISO 9001 :

    2000

    on/Hnh/Bng/Ch

    thch

    B sung (B) hoc Xa (X)

    Ni dung thay i

    4.1 im e) B e) theo di, o lng khi thch hp v phn tch cc qu trnh ny, v

    4.1 on 4 X + B Khi t chc chn ngun bn ngoi cho bt k qu trnh no nh hng n

    s ph hp ca sn phm vi cc yu cu, t chc phi m bo kim sot

    c nhng qu trnh . Cch thc v mc kim sot cn p dng cho

    nhng qu trnh s dng ngun bn ngoi ny phi c xc nh trong h

    thng qun l cht lng.

    4.1 Ch thch 1 X + B Ch thch 1 - Cc qu trnh cn thit i vi h thng qun l cht lng nu

    trn cn bao gm c cc qu trnh v cc hot ng qun l, cung cp

    ngun lc, to sn phm, o lng, phn tch v ci tin.

    4.1 Ch thch 2

    & 3 mi

    B CH THCH 2: Qu trnh s dng ngun bn ngoi l qu trnh t chc

    cn cho h thng qun l ca mnh v la chn t chc bn ngoi thc

    hin.

    CH THCH 3: Vic m bo kim sot cc qu trnh s dng ngun bn

    ngoi khng loi tr c trch nhim ca t chc v s ph hp vi tt c

    cc yu cu ca khch hng, lut nh v ch nh. Cch thc v mc

    kim sot cn p dng vi cc qu trnh s dng ngun bn ngoi c th b

    nh hng bi cc yu t nh

    a) tc ng tim n ca qu trnh s dng ngun bn ngoi n kh nng

    ca t chc trong vic cung cp sn phm ph hp vi yu cu,

    b) mc chia s vic kim sot qu trnh,

    c) kh nng t c kim sot cn thit thng qua vic p dng 7.4.

    4.2.1 im c) B c) cc th tc dng vn bn v h s theo yu cu ca tiu chun ny, v

    4.2.1 im d) X + B d) cc ti liu, bao gm c h s cn c t chc xc nh l cn thit

    m bo vic hoch nh, vn hnh v kim sot c hiu lc cc qu trnh

    ca t chc, v

    4.2.1 im e) X e) cc h s theo yu cu ca tiu chun ny (xem 4.2.4).

    4.2.1 Ch thch 1 B Ch thch 1 Khi thut ng "th tc dng vn bn" xut hin trong tiu chun

    ny, th th tc phi c xy dng, lp thnh vn bn, thc hin v duy

    tr. Mt ti liu ring r c th cp ti yu cu vi mt hay nhiu th tc.

    Yu cu v th tc dng vn bn c th c cp trong nhiu ti liu.

    4.2.3 im f) B f) m bo cc ti liu c ngun gc bn ngoi m t chc xc nh l cn

    thit cho vic hoch nh v vn hnh h thng qun l cht lng c nhn bit v vic phn phi chng c kim sot, v

  • TCVN ISO 9001 : 2008

    52

    Table B.1 Changes between ISO 9001:2000 and ISO 9001:2008 (continued)

    ISO 9001:2000

    Clause No.

    Paragraph/ Figure/

    Table/ Note

    Addition (A) or

    Deletion (D)

    Amended text

    4.1 Bullet e) A e) monitor, measure where applicable, and analyse these processes, and

    4.1 Para 4 D + A Where an organization chooses to outsource any process that affects productconformity with to requirements, the organization shall ensure control over suchprocesses. The type and extent of control to be applied to these outsourcedprocesses shall be defined within the quality management system.

    4.1 Note 1 D + A NOTE 1 Processes needed for the quality management system referred toabove should include processes for management activities, provision ofresources, product realization, and measurement, analysis and improvement.

    NOTE 2 An outsourced process is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party.

    4.1 New

    Notes 2 & 3

    A

    NOTE 3 Ensuring control over outsourced processes does not absolve theorganization of the responsibility of conformity to all customer, statutory andregulatory requirements. The type and extent of control to be applied to theoutsourced process can be influenced by factors such as

    a) the potential impact of the outsourced process on the organization's capability to provide product that conforms to requirements,

    b) the degree to which the control for the process is shared,

    4.2.1 Bullet c) A c) documented procedures and records required by this International Standard,and

    4.2.1 Bullet d) A + D d) documents, including records, needed determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.and

    4.2.1 Bullet e) D e) records required by this International Standard (see 4.2.4).

    4.2.1 Note 1 A NOTE 1 Where the term documented procedure appears within thisInternational Standard, this means that the procedure is established,documented, implemented and maintained. A single document may address therequirements for one or more procedures. A requirement for a documentedprocedure may be covered by more than one document.

    4.2.3 Bullet f) A f) to ensure that documents of external origin determined by the organization tobe necessary for the planning and operation of the quality management system are identified and their distribution controlled, and

  • TCVN ISO 9001 : 2008

    53

    Bng B.1 Nhng thay i gia TCVN ISO 9001 : 2008 so vi TCVN ISO 9001 : 2000 (tip theo)

    iu khon ca TCVN ISO 9001 :

    2000

    on/Hnh/Bng/Ch

    thch

    B sung (B) hoc Xa (X)

    Ni dung thay i

    4.2.4 on 1 X + B Phi lp v duy tr Phi kim sot h s c thit lp cung cp bng

    chng v s ph hp vi cc yu cu v vic vn hnh c hiu lc ca h

    thng qun l cht lng Cc h s cht lng phi r rng, d nhn bit v

    d s dng.

    T chc phi lp mt th tc bng vn bn xc nh vic kim sot cn

    thit i vi vic nhn bit, bo qun, bo v, s dng, xc nh thi gian

    lu gi v hu b cc h s.

    H s phi lun lun r rng, d nhn bit v d s dng.

    5.5.2 on 1 B Lnh o cao nht phi ch nh mt thnh vin trong ban lnh o ca t

    chc, ngoi cc trch nhim khc, phi c trch nhim v quyn hn sau

    6.2.1 on 1

    Ch thch

    mi

    B+X

    B

    Nhng ngi thc hin cc cng vic nh hng n s ph hp vi cc

    yu cu ca cht lng sn phm phi c nng lc trn c s c gio

    dc, o to, c k nng v kinh nghim thch hp.

    CH THCH: S ph hp i vi cc yu cu ca sn phm c th b nh

    hng trc tip hoc gin tip bi nhng ngi thc hin nhim v bt k

    trong h thng qun l cht lng.

    6.2.2 Tiu B + X Nng lc, o to v nhn thc v o to

    6.2.2 im a) v

    b)

    B + X a) xc nh nng lc cn thit ca nhng ngi thc hin cc cng vic nh

    hng n s ph hp vi cc yu cu cht lng ca sn phm,

    b) tin hnh o to hay nhng hnh ng khc p ng cc nhu cu

    ny, t c nng lc cn thit, khi thch hp.

    6.3 im c) B c) dch v h tr (nh vn chuyn hoc trao i thng tin hay h thng thng

    tin).

    6.4 Ch thch

    mi

    B CH THCH: Thut ng "mi trng lm vic" lin quan ti cc iu kin

    tin hnh cng vic bao gm cc yu t vt l, mi trng v cc yu t

    khc (nh ting n, nhit , m, chiu sng hoc thi tit).

    7.1 im b) B + X b) nhu cu thit lp cc qu trnh v ti liu, cng nh cung cp cc ngun

    lc c th i vi sn phm;

    7.1 im c) B c) cc hot ng kim tra xc nhn, xc nhn gi tr s dng, theo di, o

    lng, kim tra v th nghim c th cn thit i vi sn phm v cc tiu

    ch chp nhn sn phm;

    im c) X + B c) yu cu ch nh v lut nh lin quan p dng cho sn phm, v

    im d) X + B d) mi yu cu b sung c t chc xc nh. cho l cn thit

    7.2.1

    Ch thch

    mi

    B CH THCH: Cc hot ng sau giao nhn bao gm, v d nh, cc hnh

    ng theo nhng iu khon bo hnh, ngha v hp ng nh dch v bo

    tr v cc dch v b tr nh ti ch hoc loi b cui cng.

  • TCVN ISO 9001 : 2008

    54

    Table B.1 Changes between ISO 9001:2000 and ISO 9001:2008 (continued)

    ISO 9001:2000

    Clause No.

    Paragraph/ Figure/

    Table/ Note

    Addition (A) or

    Deletion (D)

    Amended text

    4.2.4 Para 1 D + A Records shall be established and maintained to provide evidence of conformity torequirements and of the effective operation of the quality management system shallbe controlled. Records shall remain legible, readily identifiable and retrievable. The organization shall establish a documented procedure shall be established todefine the controls needed for the identification, storage, protection, retrieval, retentiontime and disposition of records. Records shall remain legible, readily identifiable and retrievable.

    5.5.2 Para 1 A Top management shall appoint a member of the organization's management who,irrespective of other responsibilities, shall have responsibility and authority thatincludes

    6.2.1 Para 1 New Note

    A + D A

    Personnel performing work affecting conformity to product quality requirementsshall be competent on the basis of appropriate education, training, skills andexperience. NOTE Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality management system.

    6.2.2 Clause title A + D Competence, training and awareness and training

    6.2.2 Bullets a) & b)

    A + D a) determine the necessary competence for personnel performing work affectingconformity to product quality requirements, b) where applicable, provide training or take other actions to satisfy these needsachieve the

    t6.3 Bullet c) A c) supporting services (such as transport, communication or information systems).

    6.4 New Note A NOTE The term work environment relates to those conditions under which work isperformed i l di h i l i t l d th f t ( h i t t

    7.1 Bullet b) A + D b) the need to establish processes and documents, and to provide resources specificto the product;

    7.1 Bullet c) A c) required verification, validation, monitoring, measurement, inspection and testactivities specific to the product and the criteria for product acceptance;

    7.2.1 Bullet c) Bullet d), New Note

    D + A D + A A

    c) statutory and regulatory requirements related applicable to the product, and d) any additional requirements determined considered necessary by the organization.NOTE Post-delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.

  • TCVN ISO 9001 : 2008

    55

    Bng B.1 Nhng thay i gia TCVN ISO 9001 : 2008 so vi TCVN ISO 9001 : 2000 (tip theo)

    iu khon ca TCVN ISO 9001 :

    2000

    on/Hnh/Bng/Ch

    thch

    B sung (B) hoc Xa (X)

    Ni dung thay i

    7.3.1 Ch thch

    mi

    B CH THCH: Vic xem xt, kim tra xc nhn v xc nhn gi tr s dng

    ca thit k v pht trin c cc mc ch ring bit. C th tin hnh v lp

    h s ring r hoc kt hp cc hot ng ny sao cho ph hp vi sn

    phm v t chc.

    7.3.3 on 1 X + B u ra ca thit k v pht trin phi dng sao cho c th kim tra xc

    nhn dng thch hp kim tra xc nhn theo u vo ca thit k v

    pht trin v phi c ph duyt trc khi ban hnh.

    7.3.3 Ch thch

    mi

    B CH THCH: Thng tin cho qu trnh sn xut v cung cp dch v c th

    bao gm chi tit v vic bo ton sn phm.

    7.5.1 im d) X + B d) s sn c v vic s dng cc phng tin thit b theo di v o lng,

    7.5.1 im f) B f) thc hin cc hot ng thng qua sn phm, giao hng v sau giao hng.

    7.5.2 on 1 X + B T chc phi xc nhn gi tr s dng ca mi qu trnh sn xut v cung

    cp dch v c kt qu u ra khng th kim tra xc nhn bng cch theo

    di hoc o lng sau . iu ny bao gm mi qu trnh m v v vy,

    nhng sai st ch c th tr nn r rng sau khi sn phm c s dng

    hoc dch v c chuyn giao.

    7.5.3 on 2 B T chc phi nhn bit c trng thi ca sn phm tng ng vi cc

    yu cu theo di v o lng trong sut qu trnh to sn phm.

    7.5.3 on 3 X + B T chc phi kim sot v lu h s vic nhn bit duy nht sn phm v

    duy tr h s (xem 4.2.4) khi vic xc nh ngun gc l mt yu cu.

    on 1,

    Cu 3

    X + B Khi c bt k ti sn no ca khch hng b mt mt, h hng hoc c

    pht hin khng ph hp cho vic s dng, u phi c thng bo cho

    khch hng v cc h s phi c duy tr t chc u phi thng bo cho

    khch hng v phi duy tr h s (xem 4.2.4).

    7.5.4

    Ch thch B Ch thch - Ti sn ca khch hng c th bao gm c s hu tr tu v d

    liu c nhn.

    7.5.5 on 1 X + B T chc phi bo ton s ph hp ca sn phm trong qu trnh x l ni

    b v giao hng n v tr d kin nhm duy tr s ph hp vi cc yu cu.

    Khi thch hp, vic bo ton ny phi bao gm nhn bit, xp d (di

    chuyn), bao gi, lu gi v bo qun. Vic bo ton cng phi p dng vi

    cc b phn cu thnh ca sn phm.

    7.6 Tiu X + B Kim sot phng tin thit b theo di v o lng

    7.6 on 1 X + B T chc phi xc nh vic theo di v o lng cn thc hin v cc

    phng tin thit b theo di, o lng cn thit cung cp bng chng v

    s ph hp ca sn phm vi cc yu cu xc nh (xem 7.2.1).

  • TCVN ISO 9001 : 2008

    56

    Table B.1 Changes between ISO 9001:2000 and ISO 9001:2008 (continued)

    ISO 9001:2000

    Clause No.

    Paragraph/ Figure/

    Table/ Note

    Addition (A) or

    Deletion (D)

    Amended text

    7.3.1 New Note A NOTE Design and development review, verification and validation have distinctpurposes. They can be conducted and recorded separately or in any combination, assuitable for the product and the organization.

    7.3.3 Para 1 D + A The outputs of design and development shall be provided in a form that enablesin a form suitable for verification against the design and development input and shallbe approved prior to release.

    7.3.3 New Note A NOTE Information for production and service provision can include details for thepreservation of product.

    7.5.1 Bullet d) D + A d) the availability and use of monitoring and measuring devices equipment,

    7.5.1 Bullet f) A f) the implementation of product release, delivery and post-delivery activities.

    7.5.2 Para 1 D + A The organization shall validate any processes for production and service provisionwhere the resulting output cannot be verified by subsequent monitoring ormeasurement This includes any processes where and, as a consequence, deficienciesbecome apparent only after the product is in use or the service has been delivered.

    7.5.3 Para 2 A The organization shall identify the product status with respect to monitoring andmeasurement requirements throughout product realization.

    7.5.3 Para 3 D + A Where traceability is a requirement, the organization shall control and recordthe unique identification of the product and maintain records (see 4.2.4).

    7.5.4 Para 1, Sentence 3 Note

    D + A A

    If any customer property is lost, damaged or otherwise found to be unsuitable for use,this shall be reported to the customer and records maintained the organizationshall report this to the customer and maintain records (see 4.2.4). NOTE Customer property can include intellectual property and personal data.

    7.5.5 Para 1 D + A The organization shall preserve the conformity of product during internal processingand delivery to the intended destination in order to maintain conformity torequirements. This As applicable, preservation shall include identification,handling, packaging, storage and protection. Preservation shall also apply to theconstituent parts of a product.

    7.6 Title D + A Control of monitoring and measuring devices equipment

    7.6 Para 1 D + A The organization shall determine the monitoring and measurement to be undertakenand the monitoring and measuring devices equipment needed to provide evidenceof conformity of product to determined requirements (see 7.2.1).

  • TCVN ISO 9001 : 2008

    57

    Bng B.1 Nhng thay i gia TCVN ISO 9001 : 2008 so vi TCVN ISO 9001 : 2000 (tip theo)

    iu khon ca TCVN ISO 9001 :

    2000

    on/Hnh/Bng/Ch

    thch

    B sung (B) hoc Xa (X)

    Ni dung thay i

    7.6 im a) B a) c hiu chun hoc kim tra xc nhn, hoc c hai, nh k hoc trc

    khi s dng, da trn cc chun o lng c lin kt vi chun o lng

    quc gia hay quc t; khi khng c cc chun ny th cn c c s dng

    hiu chun hoc kim tra xc nhn phi c lu h s (xem 4.2.4);

    7.6 im c) X + B c) c nhn bit gip xc nh trng thi hiu chun;

    c) c du hiu nhn bit xc nh tnh trng hiu chun;

    7.6 on 4,

    Cu 3

    on 5

    mi,

    khng c

    thay i

    Phi duy tr h s (xem 4.2.4) v kt qu hiu chun v kim tra xc nhn.

    7.6 Ch thch X + B Ch thch - Xem hng dn trong ISO 10012-1 v ISO 10012-2.

    CH THCH: Vic xc nhn kh nng p ng ng dng d kin ca phn

    mm my tnh thng bao gm vic kim tra xc nhn v qun l cu hnh

    duy tr tnh thch hp s dng ca phn mm .

    8.1 im a) X + B a) chng t s ph hp vi cc yu cu ca sn phm,

    8.2.1 Ch thch B CH THCH: Theo di s cm nhn ca khch hng c th bao gm

    vic thu thp u vo t cc ngun nh kho st v s tha mn ca

    khch hng, d liu khch hng v cht lng sn phm giao nhn,

    kho st kin ngi s dng, phn tch thua l kinh doanh, nhng khen

    ngi, cc yu cu bo hnh v bo co ca i l.

    8.2.2 on 3 mi B Phi thit lp mt th tc dng vn bn xc nh trch nhim v yu cu

    i vi vic hoch nh v tin hnh nh gi, lp h s v bo co kt qu.

    8.2.2 on 3

    (Nay l

    on 4)

    X + B Trch nhim v cc yu cu v vic hoch nh v tin hnh cc nh gi,

    v vic bo co kt qu v duy tr h s (xem 4.2.4) phi c xc nh

    trong mt th tc dng vn bn.

    Phi duy tr h s nh gi v cc kt qu nh gi (xem 4.2.4).

    8.2.2 on 4,

    Cu 1

    (Nay l

    on 5)

    B Lnh o chu trch nhim v khu vc c nh gi phi m bo tin

    hnh khng chm tr mi s khc phc cng nh cc hnh ng khc phc

    cn thit loi b s khng ph hp c pht hin v nguyn nhn ca

    chng.

    8.2.2 Ch thch X + B CH THCH: Xem hng dn trong ISO 10011-1, ISO 10011-2 v 10011-3.

    TCVN ISO 19011.

    8.2.3 on 1,

    Cu 3

    X Khi khng t c cc kt qu theo hoch nh, phi tin hnh vic khc

    phc v hnh ng khc phc thch hp m bo s ph hp ca sn

    phm.

  • TCVN ISO 9001 : 2008

    58

    Table B.1 Changes between ISO 9001:2000 and ISO 9001:2008 (continued)

    ISO 9001:2000

    Clause No.

    Paragraph/ Figure/

    Table/ Note

    Addition (A) or

    Deletion (D)

    Amended text

    7.6 Bullet a) A a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded (see 4.2.4);

    7.6 Bullet c) D + A c) be identified to enable the calibration status to be determined; c) have identification in order to determine its calibration status;

    7.6 Para 4, Sentence 3

    Now new para 5, without change.

    Records of the results of calibration and verification shall be maintained (see 4.2.4).

    7.6 Note D + A NOTE See ISO 10012-1 and ISO 10012-2 for guidance NOTE Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.

    8.1 Bullet a) D + A a) to demonstrate conformity of the product to product requirements,

    8.2.1 New Note A NOTE Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims and dealer reports.

    8.2.2 New Para 3 A A documented procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results.

    8.2.2 Para 3 Now para 4 D + A

    The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure. Records of the audits and their results shall be maintained (see 4.2.4).

    8.2.2 Para 4 Sentence 1

    Now para 5 A

    The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.

    8.2.2 Note D + A NOTE See ISO 10011-1, ISO 10011-1 and ISO 10011-3. See ISO 19011 for guidance.

    8.2.3 Para 1 Sentence 3

    D When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product.

  • TCVN ISO 9001 : 2008

    59

    Bng B.1 Nhng thay i gia TCVN ISO 9001 : 2008 so vi TCVN ISO 9001 : 2000 (tip theo)

    iu khon ca TCVN ISO 9001 :

    2000

    on/Hnh/Bng/Ch

    thch

    B sung (B) hoc Xa (X)

    Ni dung thay i

    8.2.3 Ch thch B CH THCH: xc nh cc phng php ph hp, t chc nn xem xt loi v phm vi theo di hoc o lng thch hp vi mi qu trnh trong mi tng quan vi nh hng ca nhng qu trnh ny ti s ph hp vi cc yu cu ca sn phm cng nh hiu lc ca h thng qun l cht lng.

    8.2.4 on 1 B T chc phi theo di v o lng cc c tnh ca sn phm kim tra xc nhn rng cc yu cu v sn phm c p ng. Vic ny phi c tin hnh nhng giai on thch hp ca qu trnh to sn phm theo cc xp xp hoch nh (xem 7.1). Phi duy tr bng chng v s ph hp tiu ch chp nhn.

    on 2 X + B Bng chng ca s ph hp vi cc chun mc chp nhn phi c duy tr. H s phi ch ra (nhng) ngi c quyn thng qua sn phm giao cho khch hng (xem 4.2.4).

    on 3 X + B Ch c thng qua sn phm v chuyn giao dch v Vic thng qua sn phm v chuyn giao dch v cho khch hng ch c tin hnh sau khi hon thnh tho ng cc hot ng theo hoch nh (xem 7.1), nu khng th phi c s ph duyt ca ngi c thm quyn v, nu c th, ca khch hng.

    8.3 on 1, Cu 2

    X + B Phi xc nh trong mt th tc dng vn bn vic kim sot, cc trch nhim v quyn hn c lin quan i vi sn phm khng ph hp.

    Phi thit lp mt th tc dng vn bn xc nh vic kim sot, trch nhim v quyn hn c lin quan i vi vic x l sn phm khng ph hp.

    8.3 on 2 B Khi thch hp, t chc phi x l sn phm khng ph hp bng mt hoc mt s cch sau:

    8.3 im d) mi

    B d) tin hnh hnh ng thch hp vi nhng tc ng hoc hu qu tim n ca s khng ph hp nu sn phm khng ph hp c pht hin sau khi chuyn giao hoc bt u s dng.

    on 3 Chuyn thnh on 4

    Phi duy tr h s (xem 4.2.4) v bn cht ca s khng ph hp v bt k hnh ng tip theo no c tin hnh, k c cc nhn nhng c c.

    on 4 Chuyn thnh on 3

    Khi sn phm khng ph hp c khc phc, chng phi c kim tra xc nhn li chng t s ph hp vi cc yu cu.

    on 5 Chuyn thnh im d)

    mi

    Khi sn phm khng ph hp c pht hin sau khi chuyn giao hoc bt u s dng, t chc phi c cc hnh ng thch hp i vi cc tc ng hoc hu qu tim n ca s khng ph hp.

  • TCVN ISO 9001 : 2008

    60

    Table B.1 Changes between ISO 9001:2000 and ISO 9001:2008 (continued)

    ISO 9001:2000

    Clause No.

    Paragraph/ Figure/

    Table/ Note

    Addition (A) or

    Deletion (D)

    Amended text

    8.2.3 New Note A NOTE When determining suitable methods, it is advisable that the organization consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system.

    8.2.4 Para 1

    Para 2

    Para 3

    A

    D + A

    D + A

    The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria shall be maintained.

    Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4).

    Product release and service delivery The release of product and delivery of service to the customer shall not proceed until the planned arrangements (see7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.

    8.3 Para 1, Sentence 2

    D + A The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.

    A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming product.

    8.3 Para 2 A Where applicable, the organization shall deal with nonconforming product by one or more of the following ways:

    8.3 New bullet d)

    A

    d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.

    Para 3

    Moved to be Para 4

    Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4)

    Para 4

    Moved to be Para 3

    When nonconforming product is corrected it shall be subject to re-verification todemonstrate conformity to the requirements.

    Para 5 Now new bullet d)

    Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).

    When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.

  • TCVN ISO 9001 : 2008

    61

    Bng B.1 Nhng thay i gia TCVN ISO 9001 : 2008 so vi TCVN ISO 9001 : 2000 (kt thc)

    iu khon ca TCVN ISO 9001 :

    2000

    on/Hnh/Bng/Ch

    thch

    B sung (B) hoc Xa (X)

    Ni dung thay i

    8.4 im b) X + B b) s ph hp vi cc yu cu v sn phm (xem 7.2.1) (xem 8.2.4);

    8.4 im c) B c) c tnh v xu hng ca cc qu trnh v sn phm, k c cc c hi

    cho hnh ng phng nga (xem 8.2.3 v 8.2.4), v

    8.4 im d) B d) ngi cung ng (xem 7.4).

    8.5.2 on 1 B T chc phi thc hin hnh ng nhm loi b nhng nguyn nhn ca s

    khng ph hp ngn nga vic ti din.

    8.5.2 im f) B f) vic xem xt hiu lc ca cc hnh ng khc phc thc hin.

    8.5.3 im e) B e) vic xem xt hiu lc ca cc hnh ng phng nga thc hin.

    Ph lc A Ton b X + B c cp nht phn nh mi tng quan gia TCVN ISO 9001:2008 vi

    TCVN ISO 14001:2005

    Ph lc B Ton b X + B c cp nht phn nh mi tng quan gia TCVN ISO 9001:2008 vi

    TCVN ISO 9001:2000

    Th mc ti

    liu tham kho

    Cc ti liu

    tham kho

    mi v sa

    i

    X + B c cp nht phn nh cc tiu chun mi (bao gm c ISO 9004, hin

    ang c sot xt), cc phin bn tiu chun mi hoc cc tiu chun

    hy b.

    Table B.1 Changes between ISO 9001:2000 and ISO 9001:2008 (continued)

    ISO 9001:2000

    Clause No.

    Paragraph/ Figure/

    Table/ Note

    Addition (A) or

    Deletion (D)

    Amended text

    8.4 Bullet b) Bullet c)

    D + A A

    b) conformity to product requirements (see 7.2.1) (see 8.2.4), c) characteristics and trends of processes and products, including opportunities for preventive action (see 8.2.3 and 8.2.4), and

    8.5.2 Para 1 D + A The organization shall take action to eliminate the cause causes of nonconformitiesin order to prevent recurrence.

    8.5.2 Bullet f) A f) reviewing the effectiveness of the corrective action taken.

    8.5.3 Bullet e) A e) reviewing the effectiveness of the preventive action taken.

    Annex A All D + A Updated to reflect ISO 9001:2008 versus ISO 14001:2004

    Annex B All D + A Updated to reflect ISO 9001:2008 versus ISO 9001:2000

    Bibliography New and amended

    f

    D + A Updated to reflect new standards (including ISO 9004, currently under revision), new editions of standards, or withdrawn standards.

  • TCVN ISO 9001 : 2008

    62

    Th mc ti liu tham kho Bibliography

    [1] ISO 9004:1), Managing for the sustained success of an organization A quality management

    approach (Qun l t chc thnh cng bn vng Phng php qun l cht lng)

    [2] ISO 10001:2007, Quality management Customer satisfaction Guidelines for codes of conduct

    for organizations (H thng qun l cht lng S tha mn ca khch hng Hng dn v quy phm

    o c i vi t chc)

    [3] TCVN ISO 10002:2007, H thng qun l cht lng S tha mn ca khch hng Hng dn

    v x l khiu ni trong t chc

    [4] ISO 10003:2007, Quality management Customer satisfaction Guidelines for dispute

    resolution external to organizations (H thng qun l cht lng S tha mn ca khch hng Hng

    dn gii quyt tranh chp bn ngoi t chc)

    [5] TCVN ISO 10005:2007, H thng qun l cht lng Hng dn lp k hoch cht lng

    [6] ISO 10006:2003, Quality management systems Guidelines for quality management in projects (H

    thng qun l cht lng Hng dn qun l cht lng d n)

    [7] TCVN ISO 10007:2008, H thng qun l cht lng Hng dn qun l cu hnh

    [8] TCVN ISO 10012:2007, H thng qun l o lng Yu cu i vi qu trnh o v thit b o

    [9] ISO/TR 10013:2001, Guidelines for quality management system documentation (Hng dn i vi

    h thng ti liu qun l cht lng)

    [10] TCVN ISO 10014:2008, Qun l cht lng Hng dn thu c cc li ch kinh t v ti chnh

    [11] TCVN ISO 10015:2008, Qun l cht lng Hng dn o to

    [12] TCVN 7781:2008, Hng dn s dng k thut thng k trong TCVN ISO 9001

    [13] ISO 10019:2005, Guidelines for the selection of quality management system consultants and use of

    their services (Hng dn la chn t vn h thng qun l cht lng v s dng dch v t vn)

    [14] TCVN ISO 14001:2004, H thng qun l mi trng Cc yu cu v hng dn s dng

    [15] TCVN ISO 19011:2003, Hng dn nh gi h thng qun l cht lng v/hoc h thng qun l

    mi trng

    [16] IEC 60300-1:2003, Dependability management Part 1: Dependability management systems (Qun

    l tnh tin cy Phn 1: Cc h thng qun l tnh tin cy)

    [17] IEC 61160:2006, Design review (Xem xt thit k)

    1) To be published. (Revision of ISO 9004:2000)

  • TCVN ISO 9001 : 2008

    63

    [18] ISO/IEC 90003:2004, Software engineering Guidelines for the application of ISO 9001:2000

    to computer software (K thut phn mm Hng dn p dng ISO 9001 cho phn mm my tnh)

    [19] Quality management principles 2), ISO, 2001 (Cc nguyn tc qun l cht lng)

    [20] ISO 9000 Selection and use 2), ISO, 2008 (ISO 9000 La chn v s dng

    [21] ISO 9001 for Small Businesses What to do; Advice from ISO/TC 176 3), ISO, 2002 (ISO 9001 cho

    doanh nghip nh - Phi lm g; Li khuyn ca Ban k thut ISO/TC 176)

    [22] ISO Management Systems 4) (H thng qun l ca ISO)

    [23] Reference web sites (Tham kho cc trang web) :

    http://www.iso.org

    http://www.tc176.org

    http://www.iso.org/tc176/sc2

    http://www.iso.org/tc176/ISO9001AuditingPracticesGroup

    _______________________________

    2) Available from website: http://www.iso.org 3) To be updated and aligned with ISO 9001:2008. 4) A bimonthly publication which provides comprehensive coverage of international developments relating to ISO's management system standards, including news of their implementation by diverse organizations around the world.

    Available from ISO Central Secretariat (sales@iso.org).