ISO 9001: 2015 Revision

Transcription

1 NQA Client Conference ISO 9001: 2015 Revision A Review of Format, Current Verbiage and Potential Outlook Timothy Woodcome Director, Conformity Assessment

2 Agenda Here we go again The ISO Revision Process New Structure: Annex SL Current ISO/CD 9001 Clauses Big Picture Take-Away s Wait for it Future Implications

3 The ISO Revision Process

4 ISO 9001 History TC176 formed 1st Edition 1 st Minor Revision 1 st Major Revision 2 nd Minor Revision 2 nd Major Revision?

5 ISO 9001:2015 Potential Timeline Activity Tentative Date Actual Date Design Specification May 2012 Formal Revision Start November 2012 CD April 2013 June 2013 DIS ~March 2014 June 2014?? FDIS ~March 2015 June 2015?? Publication ~September 2015 December 2015??

6 Certification Transition IAF Draft Guidance 3 Year Transition from ISO publication i.e Encouraging early start Audit Time TBD

7 ISO 9001 User Survey 11,722 responses; 122 countries 75% small/medium organizations

8 ISO 9001: 2015 must Remain relevant Integrate with other management systems Provide organizational management Foundation for next 10 years Reflect increasingly complex organizational environments Reflect needs of all potential users Enhance an organization s ability to satisfy customers

9 Annex SL

10 Why Annex SL? Increased compatibility ISO 14001, ISO 27001, ISO 22301, etc. ISO/IEC Directive High level structure Identical core text Common terms and definitions

11 Annex SL - 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 Continual Improvement

12 Annex SL Identical Core Text 4 - Context of the Organization 5 Leadership 6 Planning 7 Support 9 Performance Evaluation 10 Continual Improvement

13 Annex SL Common Terms/Definitions Documented Information Top Management Interested Party Risk Performance Competence Correction Corrective Action

14 ISO/CD 9001 Clauses

15 ISO/CD ISO9001 Clauses 4 Context of the Organization Understanding the organization and its context Understanding the needs and expectation of interested parties Determining the scope of the QMS Quality management system General Process Approach

16 ISO/CD ISO9001 Clauses 5 Leadership Leadership and commitment Leadership & Commitment with respect to QMS Leadership & Commitment with respect to customers Policy Organizational roles, responsibilities and authorities

17 ISO/CD ISO9001 Clauses 6 Planning Actions to address risks and opportunities Quality objectives and planning to achieve them Planning of changes

18 ISO/CD ISO9001 Clauses 7 Support 7.1 Resources General Infrastructure Process Environment Monitoring and measuring devices Knowledge 7.2 Competence 7.3 Awareness 7.4 Communication

19 ISO/CD ISO9001 Clauses 7 Support (cont d) 7.5 Documented information General Creating and updating Control of documented information

20 ISO/CD ISO9001 Clauses 8 Operation Operational planning and control Determination of market needs and interactions with customers General Determination of requirements related to goods and services Review of requirements related to goods and services Customer communication 8.3 Operational planning process

21 ISO/CD ISO9001 Clauses 8 Operation (cont d) 8.4 Control of external provision of goods and services General Type and extent of control of external provision Documented information for external providers 8.5 Development of goods and services Development processes Development controls Development transfer

22 ISO/CD ISO9001 Clauses 8 Operation (cont d) 8.6 Production of goods and provision of services Control of production of goods and provision of services Identification and traceability Property belonging to customers or external providers Provision of goods and services Post delivery activities Control of changes

23 ISO/CD ISO9001 Clauses 8 Operation (cont d) 8.7 Release of goods and services 8.8 Nonconforming goods and services

24 ISO/CD ISO9001 Clauses 9 Performance Evaluation Monitoring, measurement, analysis and evaluation General Customer Satisfaction Analysis and evaluation of data 9.2 Internal audit 9.3 Management review

25 ISO/CD ISO9001 Clauses 10 Improvement 10.1 Nonconformity and corrective action 10.2 Continual improvement

26 Take Away s

27 Risk-Driven Approach Pervades CD/ISO 9001 Implicit to Explicit inclusion 12+ mentions (Sections 4, 5, 6, 8, 9, 10) Process Approach ISO white paper on Risk Based Thinking Preventive Action is dead: LONG LIVE Preventive Action

28 Other Key Intents Emphasis on Performance, Value and Intended Outcomes Customer Focused De-emphasis on Prescriptive Requirements and Documented Procedures More applicable to service organizations

29 Some Mindset Shifts Context of the Organization Internal & External Strategic Direction & Intended Outcomes Interested Parties External Provision Purchasing & Outsourcing

30 The Small Stuff High Level Structure Documented Information Goods and Services No Management Representative No Quality Manual Zero Documented Procedures

31 Future Implications

32 Impact to Other QMS Standards AS 9100 vocal against ISO already includes risk TL 9000 pragmatic approach TS vocal against

33 Impact to Other QMS Standards Problems with disassociating from ISO 9001: Bandwidth to Maintain Copyright Organizational Exclusivity ( Lack of) These standards already ADD requirements Will that be part of the solution?? ISO/TC aware of stated positions

34 To-Do List STAY CALM and IMPROVE ON Seize the Opportunities Understand Key Concepts & Intents Review ISO Practice Risk Analysis/Assessment methodologies Conduct Situation Analysis (Context & Interested Parties) Plan how to approach new HLS

35 To-Do List Stay-Tuned NQA Content Future NQA Events DIS and FDIS Releases 2008 to 2015 Cross-Reference Official IAF/ANAB Transition Requirements

36 Contact NQA, USA (800) Timothy Woodcome