Bob Alisic. ActinQ. Lisbon, December, 13 th, Part of slides was provided by Nigel Croft. V9-web

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1 Bob Alisic ActinQ Lisbon, December, 13 th, 2012 V9-web Part of slides was provided by Nigel Croft

2 25 years of ISO 9001 ISO 9001 ISO 9002 ISO 9003 ISO 9001 ISO 9002 ISO 9003 ISO 9001 ISO 9001 ISO 9001 ISO 9000 ISO 9004 ISO 9000 ISO 9004 ISO 9000 ISO 9004 ISO 9004 ISO

3 25 years of ISO 9001 # of Certificates (world wide) # of Certificates (Portugal)

4 25 years of ISO 9001 What happened more in 25 years? Google, Wikipedia, Facebook, Twitter.... ipod, ipad, iphone, Electronic photography,... e-market, Hybrid car, Electric car, e-books,... Landing on Mars, Fall of Berlin wall, Peace in Ireland, , Exchange collapse, Enron, Financial crisis, War on Balkan,... Lady Gaga, Adele, Female president in Brazil,... 4

5 25 years of ISO 9001 Two questions: 1. What parties faced impact of ISO 9001? 2. What was impact of ISO 9001 standard? 5

6 How to look on these questions? Is this glass half-empty or half-full? 100 ml 100 ml 6

7 Stakeholders of ISO 9001 The Organizations that implemented ISO 9001 Customers of The Organizations Certifying bodies National Standardization bodies Accreditation bodies Internal auditors inside The Organizations Members of Implementation teams and (some)managers inside The Organizations Consultants supporting ISO 9001 projects Trainers delivering IAT, LAT, Implementation T Suppliers to The Organizations Writers, publishers Others??? 7

8 The Organizations Information from research done by HBS among 1000 organizations, 500 with and 500 without QMS implemented and certified: Turnover 9% higher. Higher profit because of higher turnover. More salary increase (7%). More personnel needed (10%) because of higher turnover increase. In combination with ISO less waste and less incidents. Effects were much stronger in smaller organizations. 8

9 Other stakeholders during 25 years Let s make a very rough, simple calculation: QMS s in place at this moment; 25 years period of existence of ISO 9001; An average of QMS s operated during each year; An average age of QMS is 12,5 years; An average of 100 days to develop, implement and certify a QMS including training days; An average of 20 days per year to maintain a QMS including surveillance audit. Days spent in 25 years: Initial + Maintenance = days. 9

10 Impact on stakeholders of ISO # of persons trained as Internal or external Auditor 2. # of persons trained in Quality Tools and Methods 3. # of processes described, with performance indicators added and streamlined (improved) 4. # of design reviews with effect on product Q 5. # of complaints resolved better and faster by use of clear problem solving procedure 10

11 Impact on stakeholders of ISO # of supplier evaluations incl. feedback resulting in performance improvement 7. # of internal and external audits with improvements 8. # of Management Reviews resulting in improvements 9. # of customer surveys resulting in improvements 10. # of recalls prevented by use of QMS (costs!!) 11. # of failures prevented by use of QMS (costs!!) 11

12 Future of ISO 9001? 12

13 The Global Challenges Increased customer expectations for confidence in products and services.. Increasing use of QMS standards for global trade. Increasing use of ISO 9001 by various industry sectors. Credibility of 3rd party certification. Drive for greater efficiency (lean initiatives). Increased sophistication of quality management tools. Increasing regulatory emphasis on public health and safety (e.g. food; medical devices). Multiple management systems standards, programs and schemes. 13

14 The Global Challenges... Social equity Sustainable development Economic growth Environmental integrity 14

15 Overall Scenario of ISO/TC176: Development of generic quality management system standards that have broad application: all market sectors both private and public organizations Over 1,000,000 worldwide certifications to ISO 9001 BUT It s about more than just certification Certification to ISO 9001 should be a result of a wellimplemented quality management system! Other ISO/TC 176 products are aimed to assist organizations in improving their quality management system. 15

16 Key objectives for ISO 9001:2015 Update ISO 9001 to reflect modern business practices, changing business environment, technology (e.g. information technology), and business terminology Incorporate changes in quality management systems practices and technology since the last major revision to ISO 9001 Provide more emphasis on achieving product conformity Improve compatibility with other management system standards 16

17 Key inputs for ISO 9001:2015 TC176/SC2 Strategic Plan Greater emphasis on organization s ability to provide conforming products Output Matters! Greater clarity and simplicity of language for better implementation 12,000+ responses to online user survey Revision of the 8 Quality Management Principles Output from the Future Concepts Task Group Includes suggestions that could not be incorporated in the 2008 revision Output from the ISO Joint Technical Coordination Group (now published in the ISO Directives) 17

18 Generic MSS Plug in model designed by SAG MSS Sector MSS Examples: Automotive Aerospace Medical devices Quality MSS Environment MSS Safety MSS MSS CORE ELEMENTS + Element guidance Aspect guidance Toolkit standards 18

19 High level structure 1. Scope 2. Normative references 3. Terms and definitions 4. Context of the organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance evaluation 10. Improvement 19

20 Some of the topics addressed by the Future Concepts Task Group Integration of risk based thinking More emphasis on the Quality Management Principles Better alignment with business management processes Output matters (Product conformity and process effectiveness) Knowledge management Life cycle management (LCM) Improvement and innovation Time/Speed/Agility Technology and Changes in IT Incorporation of Quality Tools like 6σ, QFD, benchmarking etc 20

21 Agility versus Standardization Helping or hindering? Agility High 3 4 (Speed, Flexibility innovation) Low 1 2 Low High Reliability of processes 21

22 Development plan for ISO 9001:2015 June 2012 Nov 2012 Mar2013 Jan 2014 Sept2014 Jan 2015 Sept2015 Draft Design Spec & WD0 Approved Design Spec & WD1 CD for comment & ballot DIS for ballot Draft FDIS FDIS for ballot Publication SC2 Strategic Plan Review of QMP s User Survey TG Future Concept Papers ISO Directives Annex SL Verification and validation activities Interactions with SC1 (ISO 9000) on terminology issues Liaison with IAF & ISO/CASCO regarding transition 22

23 Conclusions New revision process for ISO 9001 started June 2012 Major changes likely Update ISO 9001 to reflect modern business practices, changing business environment etc. since last major revision Provide more emphasis on achieving product conformity Simplification of language Improve compatibility with other management system standards Validation projects will be undertaken with users Scheduled publication date is September 2015 TC176 will be working closely with IAF to define transition policy at the appropriate time 23

24 Questions? Thank you for your attention! 24

25 Contact information ActinQ consulting, training & auditing in Quality Bob Alisic Mobile: Website: 25