1. 2005-09-21ABNT Conference, Sao Paulo1 ISO 9000 and Sectoral Documents: ISO’s view ABNT Conference São Paulo, 2005-09-21 Charles Corrie Secretary ISO/TC 176/SC 2

2. 2005-09-21ABNT Conference, Sao Paulo2 What is already available ?

3. 2005-09-21ABNT Conference, Sao Paulo3 Established management system standards ISO 9000 – Quality ISO 14000 – Environment ISO/IEC 17799 – Information Security IEC 60300 - Dependability ISO 22000 - Food Safety ISO 10006 - Project management ISO/IEC Guide 73 - Risk Management Terminology

4. 2005-09-21ABNT Conference, Sao Paulo4 ISO management system standards under development ISO/IEC 20000 - I.T Services Management ISO/PAS 28000 - Security management ISO/29000 - Social responsibility Risk Management

5. 2005-09-21ABNT Conference, Sao Paulo5 ISO’s Sectoral documents ISO 13485 – ISO 9000 for Regulated Medical Devices ISO 15161 – ISO 9000/HACCP for Food ISO/TS 16949 – ISO 9001 for Automotive ISO/TS 29001 – ISO 9001 for Petro-Chemicals ISO/IEC 90003 – ISO 9000 for Software ISO/IWA 1 – ISO 9000 for Healthcare ISO/IWA 2 – ISO 9000 for Education ISO/IWA 4 – ISO 9000 for Local Government ISO/TR 14061 – ISO 14001 for Forestry

6. 2005-09-21ABNT Conference, Sao Paulo6 External to ISO/IEC Malcolm Baldrige quality award, EFQM, Deming Prize ILO OSH 2001/ BS 8800 / OHSAS 18001 – Occupational Health and Safety SA 8000 – Social Accountability AS 9000/EN 9100 – Aerospace quality TL 9000 – Telecommunications quality AG 9000 – Crop production quality NSF HACCP 2002 – Food safety and quality FIDIC Guide on quality for Consulting Engineers International Martine Organization quality documents Chemical industries – Responsible cares (an IMS programme) IAEA – Atomic Industry quality UN Munitions/ Bomb disposal quality standard Plus many, many more.

7. 2005-09-21ABNT Conference, Sao Paulo7 New MSS fields under development nationally AS/NZ 4360 or PD 6668 – Risk management PD 75000 - Knowledge management BS 7000-5 – Obsolescence management BS 3843 or PAS 55 - Asset management Business Continuity management Personnel (e.g. UK “Investors in People” programme)

8. 2005-09-21ABNT Conference, Sao Paulo8 History

9. 2005-09-21ABNT Conference, Sao Paulo9 UK background 1977 Sir Frederick Warner’s report 'Standards and specifications in the engineering industries' was presented to the UK Government. This strongly recommended that all major purchasing organisations in the UK should use a common QA standard. This led to the publication of the BS 5750 series of generic quality assurance standards in 1979 1982 saw the introduction of 3 rd party assessments against BS 5750

10. 2005-09-21ABNT Conference, Sao Paulo10 Internationally 1979 ISO/TC 176 established 1987 ISO 9000 published 1992 ISO/IEC Directives included clause 6.6.4 (since revised in the 2001 edition to clause 6.8.2) 1994 QS 9000 (Automotive sector) documents published 1995 ISO/TC 210 for Medical devices established, and development of ISO 13485 started 1996 Pilot project for the development of ISO/TS 16949 (similar to QS 9000) approved 1999 ISO/TS 16949 published

11. 2005-09-21ABNT Conference, Sao Paulo11 ISO’s Rules

12. 2005-09-21ABNT Conference, Sao Paulo12 Clause 6.6.4 When a technical committee or sub-committee wishes to incorporate quality systems requirements in a standard for a product, process or service, the standard shall include a reference to the relevant quality systems standard (ISO 9001, ISO 9002, ISO 9003) It shall not add to, delete, change or interpret the requirements in the quality system standard

13. 2005-09-21ABNT Conference, Sao Paulo13 Clause 6.6.4 - continued Any requests for additions, deletions, changes or interpretations shall be submitted to the secretariat of ISO/TC 176/SC 2: Quality Systems When the industry or sector terminology is sufficiently different, a document explaining the relationship between the quality assurance terminology and the sector terminology may be prepared.

14. 2005-09-21ABNT Conference, Sao Paulo14 Clause 6.8.2 Sector Policy When an ISO or IEC committee wishes to develop quality management system requirements or guidance for a particular product or industry/economic sector it shall respect the following rules. a) Normative reference shall be made to ISO 9001:2000 in its entirety or, subject to the “applicability” provisions detailed in the scope of ISO 9001:2000, to its clauses or subclauses. Alternatively, subject to the “applicability” provisions detailed in the scope of ISO 9001:2000, the clauses or subclauses may be reproduced verbatim.

15. 2005-09-21ABNT Conference, Sao Paulo15 Clause 6.8.2 continued b) If text from ISO 9001:2000 is reproduced in the sector document, it shall be distinguished from the other elements of the sector document [see d)]. c) Terms and definitions specified in ISO 9000:2000 shall be referred to in a normative manner or reproduced verbatim. d) The guidance and criteria provided in Quality management systems — Guidance and criteria for the development of documents to meet needs of specific product and industry/economic sectors, approved by ISO/TC 176, shall be considered not only when determining the need for a sector- specific requirements or guidance document but also in the document development process.

16. 2005-09-21ABNT Conference, Sao Paulo16 6.6.4 to 6.8.2 changes 6.6.4 permits only the development of terminology documents to explain the difference between quality and sector terminology. The presumption is that ISO 9001 is sufficient 6.8.2 permits the development of sector documents, provided certain conditions are adhered to, i.e. it recognizes that ISO 9001 may no longer be sufficient

17. 2005-09-21ABNT Conference, Sao Paulo17 Why the change ? ISO recognized the change in market conditions (i.e. ISO/TS 16949:1999 already published, ISO 13485 development ongoing) ISO 9001:2000 was significantly different from previous editions: It became more generic, and less manufacturing oriented It became less prescriptive It contained requirements that could not be applied by regulators, e.g. for the achievement of “customer satisfaction” ISO 9002 and ISO 9003 were withdrawn as options to ISO 9001

18. 2005-09-21ABNT Conference, Sao Paulo18 Other ISO effects In response to industry concerns about the proliferation of management system standards, in 2001 ISO published ISO Guide 72 “Guidelines for the justification and development of management system standards” This was supposed to create an additional hurdle before projects on MSS could be started.

19. 2005-09-21ABNT Conference, Sao Paulo19 Other ISO effects In 1999 ISO redefined its product offerings. It launched a new set of products aimed at the pre-standardization market, e.g.: Publicly Available Specifications (PASs) International Workshop Agreements (IWAs) This has allowed a number of sectors to by- pass the requirements of clause 6.8.2, or the need for an ISO Guide 72 justification.

20. 2005-09-21ABNT Conference, Sao Paulo20 Other ISO effects ISO has sought: to reduce instances of breach of copyright on ISO 9001, and to obtain revenue from ISO 9001, by the issuing of licenses for the use of ISO 9001 in sector documents (e.g. TL 9000; NSF HACCP 2002)

21. 2005-09-21ABNT Conference, Sao Paulo21 How have the sectors responded ? A majority have developed guidance documents on the application of ISO 9001 in their specific sector Quite a few have taken ISO 9001 as the core basis for a sector requirements document, that includes additional sector specific requirements Very few have developed additional guidance on top of ISO 9004 (e.g. IWA1 Healthcare) One has adopted ISO 9001 as its core, but deleted specific requirements (ISO 13485 Regulated Medical Devices)

22. 2005-09-21ABNT Conference, Sao Paulo22 How should the development of sector documents be viewed ?

23. 2005-09-21ABNT Conference, Sao Paulo23 ISO/TS 16949 Pilot Project During the 1980s and early 1990s, changes in the automotive sector meant that manufacturers were no longer the sole customers of individual suppliers, but that they were one of many. Additionally, globalization and integration within the automotive sector (e.g. Ford/Mazda, VW/ SEAT, Daimler/Chrysler, Renault/Toyota) meant that the manufacturers needed to standardize their quality processes and procedures This has been driven further by the desire to reduce the number of “Tier 1” suppliers, and the adoption of lean production techniques.

24. 2005-09-21ABNT Conference, Sao Paulo24 ISO/TS 16949 Pilot Project For suppliers the change has been: General MotorsIndividual requirements FordIndividual requirements ChryslerIndividual requirements

25. 2005-09-21ABNT Conference, Sao Paulo25 ISO/TS 16949 Pilot Project For suppliers the change has been: Reduced Individual QS 9000 requirements(aligned to ISO 9001) General Motors Ford+ Chrysler

26. 2005-09-21ABNT Conference, Sao Paulo26 ISO/TS 16949 Pilot Project For suppliers the change has been: Reduced Individual ISO/TS 16949 requirements(based on ISO 9001) General Motors Ford+ Chrysler French Manufacturers German Manufacturers (Japanese interest)

27. 2005-09-21ABNT Conference, Sao Paulo27 ISO/TS 16949 Pilot Project For the future, there is a commitment from the International Automotive Task Force to participate fully in the development of any future edition of ISO 9001, to see if this will enable them to remove the need for ISO/TS 16949, and to move to just using ISO 9001 In this light, the development of ISO/TS 16949 was seen as being a beneficial global step to bringing a major sector to the international arena, and to harmonizing the sector’s requirements. Other sectors are being invited to follow a similar path within ISO/TC 176

28. 2005-09-21ABNT Conference, Sao Paulo28 ISO/TS 16949 Pilot Project One consequence of the publication of a separate ISO document for the sector has been its ability to refer to this document for a unique system of certification of suppliers. This model is being looked at closely by other sectors.

29. 2005-09-21ABNT Conference, Sao Paulo29 How have the suppliers reacted ? Back in the 1970s when the idea of generic standards was first promoted, it was almost entirely just hardware manufacturing industry suppliers who were affected by multiple audits by their customers (usually the military or major utilities) against their individual quality standards. Today, other industries (e.g. electronics, logistics) are facing similar pressures, but based on the need to comply with multiple sector quality documents They are beginning to raise their concerns about auditing and certification to ISO

30. 2005-09-21ABNT Conference, Sao Paulo30 What are the sectors looking for ? From the International Aerospace Quality Group (www.iaqg.org )www.iaqg.org “...continuously improve the processes used by the supply chain to deliver consistently high quality products...” “… common aerospace quality standards and requirements…” “… process of continuous improvement at suppliers…”

31. 2005-09-21ABNT Conference, Sao Paulo31 What are the sectors looking for ? From the International Aerospace Quality Group (www.iaqg.org )www.iaqg.org The whole Supply Chain will benefit from Safety and quality improvements Waste and cost reductions Consistency and clarity of approach, requirements and documentation Reduction in multiple oversight audits Improved relationships

32. 2005-09-21ABNT Conference, Sao Paulo32 What are the sectors looking for ? These statements do not appear to indicate that there has been any discussion on suppliers working in multiple sectors, yet automotive (TS 16949) and aerospace (AS 9000/ EN 9100) probably have the highest commonality of suppliers across any two sectors Also, the approach to AS 9000/EN 9100 accreditation and certification appears to be diverging from that of TS 16949

33. 2005-09-21ABNT Conference, Sao Paulo33 Result Diverging views on the benefits of sectoral documents between the major manufacturers and the suppliers

34. 2005-09-21ABNT Conference, Sao Paulo34 Where does ISO sit ?

35. 2005-09-21ABNT Conference, Sao Paulo35 Contradictions ISO has established firm rules concerning sector documents ….. But then appears to break them. Has this been disastrous ? From ISO’s viewpoint- NO Why ? Because it has allowed many sectors that did not previously consider international standardization (healthcare, education, local government) to come to the table, which in the longer term may be beneficial to ISO.

36. 2005-09-21ABNT Conference, Sao Paulo36 The bigger picture ISO is currently trying to formulate a strategy for the development of management systems standards overall. There are now so many different elements of management being standardized, that this effect is considered more urgent than the need to revise its approach towards sectors. There are major pressures being put on ISO to look at “Integrated” management systems. While the leading players that dominate the sectors are organized and will be invited to participate in these discussions, the suppliers are insufficiently organized at this time to have a significant impact.

37. 2005-09-21ABNT Conference, Sao Paulo37 Conclusion We will continue with the dilemma of sectoral documents for the future.

38. 2005-09-21ABNT Conference, Sao Paulo38 Thank you for your attention Charles Corrie Secretary ISO/TC 176/SC 2