Markku iso 9001

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  • 1. ISO 9001:201519.12.2012Markku AhlbergA-Quality Oymarkku.ahlberg@elisanet.fi

2. A-Quality Oy A-Quality Oy (perustettu 1989) Toim.joht Markku Ahlberg TkL, insev evp, Pvlaatujoht 1997-2008 Toimialat: Auditoinnit (ISO 9001, ISO 14001, AQAP) Koulutustilaisuudet Konsultointi Ptevyydet: IRCA parvioija vuodesta 1990 Inspecta Sertifiointi Oy parvioija vuodesta 1990 Jsenyydet ISO TC 176 national committee (SFS TK 105) (1995-2011) NATO AC 327 (1997 2008)markku.ahlberg@elisanet.fi 2 3. ISO 9001Schedule of versions ISO 9001:1987 ISO 9001:1994 ISO 9001:2000 ISO 9001:2008 ISO 9001:2015 (estimation)markku.ahlberg@elisanet.fi3 4. ISO 9001Likely revision timing for ISO 9001 March 2012 Vote to revise June 2012Issue NWIP November 2012 Start work at plenary meeting December 2013 First CD issued June 2014DIS for ballot September 2015 FDIS ballot December 2015 ISO 9001:2015 issuedmarkku.ahlberg@elisanet.fi4 5. ISO Guide 83 Draft, voting terminated 2011-09-06 High level structure and identical text formanagement system standards and commoncore management system terms anddefinitions markku.ahlberg@elisanet.fi 5 6. ISO Guide 83Results of the ballot (30.9.2011) 19 approval 6 disapproval AUS, CAN, FRA,GER,POL,USA 3 abstention6/25 = 24 %, approved markku.ahlberg@elisanet.fi 6 7. ISO 9001:2015ISO on saanut kesll 2012 ptkseen tyn, jossa johtamisjrjestelmstandardeille (management system standards) on luotu yhteinen rakenne, terminologia ja mritelmt.Kolme johtamisjrjestelmstandardia on jo julkaistu uudessa harmonisoidussa muodossa, seitsemn kohdalla ty on meneilln. ISO 9001 ja ISO 14001 seuraavat versiot tulevat noudattamaan uusittua rakennettamarkku.ahlberg@elisanet.fi 7 8. ISO 9001:2015 Kolme johtamisjrjestelmstandardia onjo julkaistu uudessa harmonisoidussamuodossa ISO 30301:2011 Information and documentation ISO 22301:2012 Societal security ISO 20121:2012 Event sustainability management systems markku.ahlberg@elisanet.fi8 9. ISO 9001:2015Kaikien johtamisjrjestelmstandardeja laativien teknisten komiteoiden on noudatettava ISO/IEC Directives, Part 1 Consolidated ISO Supplement - Procedures spesific to ISO dokumentissa esitetty rakennettaTss harmonisoidaan standardin rakenne, terminogia ja mritelmt, mutta annetaan standardien kehittjille joustavuutta integroida heidn spesifiset tekniset aiheet ja vaatimuksetmarkku.ahlberg@elisanet.fi 9 10. ISO 9001:2015Common high-level structure1. Scope2. Normative reference3. Terms and definitions4. Context of the organisation5. Leadership6. Planning7. Support8. Operation9. Performance evalution10. Improvementmarkku.ahlberg@elisanet.fi 10 11. ISO 9001:2015Contents4. Context of the organisation 4.1 Determine external and internal issues of the organisation 4.2 Understand the needs and expectations of interested parties 4.3 Determine the scope of the quality management system (QMS) 4.4 Establish, implement, maintain and continually improve the QMS markku.ahlberg@elisanet.fi11 12. ISO 9001:2015Contents5. Leadership 5.1 Top management to demonstrate leadership and commitment Ensuring policies and objectives are established Ensuring the QMS requirements are integrated into the businessprocesses Ensuring resources are available Promoting continual improvement 5.2 Establish quality policy that provides a framework forsetting quality objectives 5.3 Top management shall ensure assignment of roles andresponsibilitiesmarkku.ahlberg@elisanet.fi 12 13. ISO 9001:2015ContentsExample of identical text: 5.3 Top management shall ensure thatresponsibilities and authorities for relevantroles are assigned and communicatedwithin the organization markku.ahlberg@elisanet.fi13 14. ISO 9001:2015Contents6. Planning Risks and opportunities, objectives and plans 6.1 Ensure the QMS can achieve intended outcomes, prevent or reduce undesired effects, and achieve continual improvement 6.2 Ensure quality objectives are consistent with quality policy, measurable, communicated, monitored and updated markku.ahlberg@elisanet.fi14 15. ISO 9001:2015Contents6. Planning Risks and opportunities, objectives andplans The new text recognizes the use of the broadconcept of risk and the need to understandrisk in the context of the managementsystem markku.ahlberg@elisanet.fi15 16. ISO 9001:2015Contents7. Support Resources, competence, awareness, communication 7.1 The organization shall provide the infrastructure, including buildings, workspaces, utilities, process equipment and supporting services 7.2 Ensure competence of individuals based on education, training or experience 7.3 Ensure awareness of quality policy, benefits of improved quality performance and implications of not conforming to management system requirements 7.4 Creating, updating and controlling documented informationmarkku.ahlberg@elisanet.fi 16 17. ISO 9001:2015Contents7. Support Resources, Competence, Awareness,Communication, Documented information There are subtle language issues such aschange from document and records todocumented information markku.ahlberg@elisanet.fi17 18. ISO 9001:2015Contents8. Operation 8.1 Planning of product realization 8.2 Requirements related to product 8.3 Customer communication 8.4 Design and development processes 8.5 Purchasing 8.6 Control and validation of production and service provision 8.7 Identification 8.8 Care of customer property 8.9 Preservation of productmarkku.ahlberg@elisanet.fi18 19. ISO 9001:2015Contents9. Performance evalution Monitoring, measurement, analysis, evaluation, internal audits and management review 9.1 Measure customer satisfaction 9.2 Monitor and measurement of processes and product 9.3 Control of monitoring and measurement equipment markku.ahlberg@elisanet.fi19 20. ISO 9001:2015Contents10. ImprovementNonconformities, corrective action andcontinual improvement 10.1 Analysis of data Information relating to conformity to requirements and customer satisfaction Characteristics and trends Opportunities for preventive action Information concerning suppliers markku.ahlberg@elisanet.fi 20 21. ISO 9001:2015Contents10. ImprovementNonconformities, corrective action andcontinual improvement It also encourages everyone to viewpreventive action as a broader concept thansimply preventing an incident from re-occurring markku.ahlberg@elisanet.fi21