ISO 9001:2015 Expected Changes

Transcription

1 ISO 9001:2015 Expected Changes Paula Fyda, Steve Sabo Innovative Quality Solutions Co. ISO/TC 176/SC 2/WG23 N063 1

2 Purpose of presentation To provide an overview of the proposed revision of ISO 9001 which will be published in

3 Background to this presentation Developed by the ISO sub-committee responsible for communicating key information about the current revisions to ISO 9001 Supplemented with insights provided by SQA and Innovative Quality Solutions Risk-based Thinking - a key aspect of ISO 9001:2015 incorporated Information will be updated as the revision progresses 3

4 Disclaimers The presentation includes information related to the revision process up to and including December 2013 Further changes are likely to occur as the revision process progresses Final revision not scheduled for release until December 2015 Important to be aware of the proposed changes, but realize they may change 4

5 ISO facts ISO is owned by the International Organization for Standardization ISO is based in Switzerland, over 160 nations participate with approximately 20,000 standards all ISO standards are based on consensus ISO standards are usually developed by Technical Committees (TCs) or their sub-committees, or by Project Committees ISO work involves experts nominated by their national standards bodies 5

6 ISO 9001:2015 development process an international ballot agreed the need for revision there are several distinct stages when developing an ISO standard; the key ones being: 1. Working Drafts (WDs) 2. Committee Draft (CD) 3. Draft International Standard (DIS)* 4. Final Draft International Standard (FDIS) 5. International Standard (IS) The standard is published after approval of the FDIS by participating national standards bodies and is then reviewed at regular intervals. 6

7 Key perspectives ISO 9001 needs to: maintain relevance integrate with other management systems provide an integrated approach to organizational management provide a consistent foundation for the next 10 years reflect the increasingly complex environments in which organizations operate ensure the new standard reflects the needs of all potential user groups enhance an organization's ability to satisfy its customers 7

8 What was considered? the results of an extensive web-based user survey the increasing diversity of ISO 9001 users developments in knowledge and technologies broader user interests changes in industry 8

9 an emphasis on risk-based thinking Main changes increased emphasis on achieving value for the organization and its customers increased flexibility on the use of documentation more readily applicable by service type organizations customers remain the primary focus 9

10 Still based on the Process Approach General Plan-Do-Check-Act cycle Applied at process and system level Risk-based Thinking Effect of uncertainty on an expected result Compatible with other Management System Standards 10

11 General It is important to emphasize that organizations are not required to follow an identical clause- by clause sequence when defining their quality management system, and they are encouraged to use the Process approach as described. 11

12 High level structure a new common format has been developed for use in all management system standards standardized core text and structure standardized core definitions Organizations implementing multiple management systems (e.g. quality, environmental, information security) can achieve better integration and easier implementation The high level structure and common text is public information and can be found in Annex SL of the 12

13 1 Scope Structure 1/3 2 Normative references 3 Terms and definitions 4 Context of the organization Understanding the organization and its context Needs and expectations of interested parties Scope of QMS QMS and its processes 5 Leadership General Commitment Quality policy Roles, responsibilities and authorities 13

14 6 Planning for the QMS Actions to address risks and opportunities Objectives and plans to achieve them Planning of changes Structure 2/3 7 Support Resources Competence Awareness Communication Documented information 8 Operation Operational planning and control Determination of requirements for products and services; customer communication 14

15 8 Operation (cont). Design and development Control of externally provided products and services Production and service provision; changes Release of products and services Nonconforming process outputs, products, services 9 Performance evaluation Monitoring, measurement, analysis and evaluation (including customer satisfaction) Internal audit Management review 10 Improvement Nonconformity and Corrective Action Continual improvement Structure 3/3 15

16 Supporting documents certification transition plan and timeframe guidance documents on specific topics, e.g. the process approach comparison of ISO 9001:2008 and 9001:2015 frequently asked questions ISO website updates 16

17 ISO 9001:2015 Timeline June 2013 CD (Committee Draft) April 2014 DIS (Draft International Standard) July 2015 FDIS (Final Draft International Standard) September 2015 Published International Standard 17

18 ISO 9001:2015 Timeline Draft has been developed and submitted to the ISO and CEN member bodies for a 5 month parallel review Should the draft be accepted, a Final Draft, established on the basis of comments received, will be submitted to a parallel 2 month approval vote in ISO and formal vote in CEN 18

19 ISO 9001:2015 Certification Transition Timeline September 2015 Published International Standard September 2015 start of 3 years transition period to September

20 Other Important Information The revision of ISO 9001 will impact other related standards and documents. Expect changes to: - industry-specific standards - supporting documents 20

21 What should we do Ensure our organizations are aware of the key changes understand the key concepts plan to implement the new requirements stay informed as the revision proceeds take full advantage of the revision of ISO

22 Risk-based Thinking Provide an overview of how the future ISO 9001:2015 Standard addresses the topic of risk 22 22

23 Risk-based Thinking One of most significant changes to the ISO 9001 Standard Beneficial to any type, size of organization Remember that proposed document is still in draft form and subject to change 23 23

24 What is Risk-based Thinking? Risk-based thinking is something we all do automatically and often sub-consciously The concept of risk has always been implicit in ISO 9001 this revision makes it more explicit and builds it into the whole management system Risk-based thinking is already part of the process approach 24 24

25 What is Risk-based Thinking? (cont). Risk-based thinking makes preventive action part of the routine Risk is often thought of only in the negative sense Risk-based thinking can also help to identify opportunities. This can be considered to be the positive side of risk 25 25

26 Where is risk addressed in the current draft of ISO 9001:2015? 26 26

27 The main objectives of ISO 9001 to provide confidence in the organization s ability to consistently provide customers with conforming goods and services To enhance customer satisfaction The concept of risk in the context of ISO 9001 relates to the uncertainty in achieving these objectives 27

28 Where is Risk addressed in the ISO 9001:2015 Draft? Clause 4- Context of the Organization the organization is required to determine the risks which can affect its ability to meet its objectives Clause 5- Leadership Top management are required to commit to ensuring Clause 4 is followed Clause 6- Planning for the QMS the organization is required to take action to address risks and opportunities 28 28

29 Where is Risk addressed in the ISO 9001:2015 Draft? Clause 8- Operation the organization is required to have processes which identify and address risk in its operations Clause 9- Performance Evaluation the organization is required to monitor, measure, analyse and evaluate the risks and opportunities Clause 10- Improvement the organization is required to improve by responding to changes in risk 29 29

30 Why should we adopt Risk-based Thinking? to improve customer confidence and satisfaction to assure consistency in the quality of products and services to establish a proactive culture of prevention and improvement Successful companies intuitively take a riskbased approach 30 30

31 What should You do? Use a risk-driven approach in your organizational processes identify what the risks and opportunities are in your organization it depends on context ISO 9001:2015 will not automatically require you to carry out a full, formal risk assessment, or to maintain a risk register ISO ( Risk management Principles and guidelines ) will be a useful reference (but not mandated) 31 31

32 What should You do? (cont d) analyse and prioritize the risks and opportunities in your organization what is acceptable? what is unacceptable? plan actions to address the risks how can we avoid or eliminate the risk? how can we mitigate the risk? implement the plan take action check the effectiveness of the actions does it work? learn from experience continual improvement 32 32

33 Summary Draft Standard is out for vote until Expected to be published Three year transition to Important to be aware of proposed changes but realize this is only a draft Benefit from proposed changes * Risk-based thinking 33 33

34 Questions and Answers 34 34

35 Contact Information Paula Fyda: Steve Sabo: