ISO 9001:201519.12.2012Markku AhlbergA-Quality Oymarkku.ahlberg@elisanet.fi
A-Quality Oy• A-Quality Oy (perustettu 1989)• Toim.joht Markku Ahlberg    – TkL, insev evp, Pvlaatujoht 1997-2008• Toimial...
ISO 9001Schedule of versions•   ISO 9001:1987•   ISO 9001:1994•   ISO 9001:2000•   ISO 9001:2008•   ISO 9001:2015 (estimat...
ISO 9001Likely revision timing for ISO 9001•   March 2012     Vote to revise•   June 2012      Issue NWIP•   November 2012...
ISO Guide 83• Draft, voting terminated 2011-09-06• High level structure and identical text for  management system standard...
ISO Guide 83Results of the ballot (30.9.2011)• 19 approval• 6 disapproval   – AUS, CAN, FRA,GER,POL,USA• 3 abstention6/25 ...
ISO 9001:2015•      ISO on saanut kesällä 2012 päätökseen työn,       jossa johtamisjärjestelmästandardeille       (manage...
ISO 9001:2015• Kolme johtamisjärjestelmästandardia on  jo julkaistu uudessa harmonisoidussa  muodossa   – ISO 30301:2011 I...
ISO 9001:2015•      Kaikien johtamisjärjestelmästandardeja       laativien teknisten komiteoiden on noudatettava       “IS...
ISO 9001:2015Common high-level structure1. Scope2. Normative reference3. Terms and definitions4. Context of the organisati...
ISO 9001:2015Contents4. Context of the organisation• 4.1 Determine external and internal issues of the   organisation• 4.2...
ISO 9001:2015Contents5. Leadership• 5.1 Top management to demonstrate leadership and   commitment    – Ensuring policies a...
ISO 9001:2015ContentsExample of identical text:• 5.3 Top management shall ensure that  responsibilities and authorities fo...
ISO 9001:2015Contents6. Planning   Risks and opportunities, objectives and plans• 6.1 Ensure the QMS can achieve intended ...
ISO 9001:2015Contents6. Planning   Risks and opportunities, objectives and  plans• The new text recognizes the use of the ...
ISO 9001:2015Contents7. Support   Resources, competence, awareness, communication• 7.1 The organization shall provide the ...
ISO 9001:2015Contents7. Support   Resources, Competence, Awareness,  Communication, Documented information• There are subt...
ISO 9001:2015Contents8. Operation• 8.1 Planning of product realization• 8.2 Requirements related to product• 8.3 Customer ...
ISO 9001:2015Contents9. Performance evalution   Monitoring, measurement, analysis, evaluation,   internal audits and manag...
ISO 9001:2015Contents10. Improvement  Nonconformities, corrective action and  continual improvement• 10.1 Analysis of data...
ISO 9001:2015Contents10. Improvement  Nonconformities, corrective action and  continual improvement• It also encourages ev...
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Markku iso 9001

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Markku iso 9001

  1. 1. ISO 9001:201519.12.2012Markku AhlbergA-Quality Oymarkku.ahlberg@elisanet.fi
  2. 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• Pätevyydet: – IRCA pääarvioija vuodesta 1990 – Inspecta Sertifiointi Oy pääarvioija vuodesta 1990• Jäsenyydet – ISO TC 176 national committee (SFS TK 105) (1995-2011) – NATO AC 327 (1997 – 2008) markku.ahlberg@elisanet.fi 2
  3. 3. ISO 9001Schedule of versions• ISO 9001:1987• ISO 9001:1994• ISO 9001:2000• ISO 9001:2008• ISO 9001:2015 (estimation) markku.ahlberg@elisanet.fi 3
  4. 4. ISO 9001Likely revision timing for ISO 9001• March 2012 Vote to revise• June 2012 Issue NWIP• November 2012 Start work at plenary meeting• December 2013 First CD issued• June 2014 DIS for ballot• September 2015 FDIS ballot• December 2015 ISO 9001:2015 issued markku.ahlberg@elisanet.fi 4
  5. 5. ISO Guide 83• Draft, voting terminated 2011-09-06• High level structure and identical text for management system standards and common core management system terms and definitions markku.ahlberg@elisanet.fi 5
  6. 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. 7. ISO 9001:2015• ISO on saanut kesällä 2012 päätökseen työn, jossa johtamisjärjestelmästandardeille (management system standards) on luotu yhteinen rakenne, terminologia ja määritelmät.• Kolme johtamisjärjestelmästandardia on jo julkaistu uudessa harmonisoidussa muodossa, seitsemän kohdalla työ on meneillään. ISO 9001 ja ISO 14001 seuraavat versiot tulevat noudattamaan uusittua rakennetta markku.ahlberg@elisanet.fi 7
  8. 8. ISO 9001:2015• Kolme johtamisjärjestelmästandardia on jo julkaistu uudessa harmonisoidussa muodossa – ISO 30301:2011 Information and documentation – ISO 22301:2012 Societal security – ISO 20121:2012 Event sustainability management systems markku.ahlberg@elisanet.fi 8
  9. 9. ISO 9001:2015• Kaikien johtamisjärjestelmästandardeja laativien teknisten komiteoiden on noudatettava “ISO/IEC Directives, Part 1 – Consolidated ISO Supplement - Procedures spesific to ISO” dokumentissa esitettyä rakennetta• Tässä harmonisoidaan standardin rakenne, terminogia ja määritelmät, mutta annetaan standardien kehittäjille joustavuutta integroida heidän spesifiset tekniset aiheet ja vaatimukset markku.ahlberg@elisanet.fi 9
  10. 10. ISO 9001:2015Common high-level structure1. Scope2. Normative reference3. Terms and definitions4. Context of the organisation5. Leadership6. Planning7. Support8. Operation9. Performance evalution10. Improvement markku.ahlberg@elisanet.fi 10
  11. 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.fi 11
  12. 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 business processes – Ensuring resources are available – Promoting continual improvement• 5.2 Establish quality policy that provides a framework for setting quality objectives• 5.3 Top management shall ensure assignment of roles and responsibilities markku.ahlberg@elisanet.fi 12
  13. 13. ISO 9001:2015ContentsExample of identical text:• 5.3 Top management shall ensure that responsibilities and authorities for relevant roles are assigned and communicated within the organization markku.ahlberg@elisanet.fi 13
  14. 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.fi 14
  15. 15. ISO 9001:2015Contents6. Planning Risks and opportunities, objectives and plans• The new text recognizes the use of the broad concept of risk and the need to understand risk in the context of the management system markku.ahlberg@elisanet.fi 15
  16. 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 information markku.ahlberg@elisanet.fi 16
  17. 17. ISO 9001:2015Contents7. Support Resources, Competence, Awareness, Communication, Documented information• There are subtle language issues such as change from document and records to documented information markku.ahlberg@elisanet.fi 17
  18. 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 product markku.ahlberg@elisanet.fi 18
  19. 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.fi 19
  20. 20. ISO 9001:2015Contents10. Improvement Nonconformities, corrective action and continual 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. 21. ISO 9001:2015Contents10. Improvement Nonconformities, corrective action and continual improvement• It also encourages everyone to view preventive action as a broader concept than simply preventing an incident from re- occurring markku.ahlberg@elisanet.fi 21

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