Transition to ISO 9001:2015

Transcription

1 Transition to ISO 9001:2015 Whittington & Associates, LLC 6175 Hickory Flat Highway, Suite , Canton, GA Version 1.6: 02/01/ Whittington & Associates, LLC Slide 1 Introduction Prepare for your transition to ISO 9001:2015: Annex SL high level clause structure Common requirements and definitions New and changed requirements Word counts show shift in emphasis Guidance on transition activities Suggestions for transition timing Version 1.6: 02/01/ Whittington & Associates, LLC Slide 2 Requirements V Whittington & Associates, LLC Page 1

2 ISO 9001 History 1947 ISO Founded 1979 BS 5750 Introduction 1980 TC 176 Formed 1987 ISO 9001 Introduction 1994 ISO 9001 Revision 2000 ISO 9001 Major Revision 2008 ISO 9001 Revision 2015 ISO 9001 Major Revision Version 1.6: 02/01/ Whittington & Associates, LLC Slide 3 Reasons for Revision Standards reviewed every 5 years for relevance. ISO 9001:2008 needed update for: Changing e-business, global economy, and risks More applicability for service organizations Use of the revised quality management principles Improved application of the process approach Adoption of the new Annex SL clause structure Integration with other management system standards ISO 9001:2015 will replace ISO 9001:2008. Version 1.6: 02/01/ Whittington & Associates, LLC Slide 4 Requirements V Whittington & Associates, LLC Page 2

3 Annex SL High level structure developed by JTCG (Joint Technical Coordination Group) For use by all management system standards Aligns format, text, terms, and definitions Standards can still add unique requirements New clause structure is for stating requirements rather than model for documenting your quality management system. Version 1.6: 02/01/ Whittington & Associates, LLC Slide 5 Dates for Related Standards ISO 27001:2013 Issued 9/2013 (using Annex SL) ISO 9000:2015 Released 9/2015 ISO/TS 9002:201x CD level ISO 14001:2015 Released 9/2015 AS9100:2016 4/2016 (and AS9110, AS9120) TL 9000, R6.0 Release 2Q 2016; Effective 9/15/16 ISO 45001:2016 DIS Stage; Anticipated 10/2016 ISO/TS 16949:2016 Projected as 12/2016 ISO 13485:2016 In Publication (not Annex SL) Version /01/ Whittington & Associates, LLC Slide 6 Requirements V Whittington & Associates, LLC Page 3

4 Clause Structure 0. Introduction 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 Annex A Clarification of New Structure, Terminology, and Concepts Annex B Other International Standards on Quality Management and Quality Management Systems Developed by ISO/TC 176 Version 1.6: 02/01/ Whittington & Associates, LLC Slide 7 Requirement Grouping PLAN 4. Context of the Organization 5. Leadership 6. Planning DO CHECK ACT 7. Support 8. Operation * 9. Performance Evaluation 10. Improvement * Most of the unique ISO 9001 requirements are in clause 8. Version 1.6: 02/01/ Whittington & Associates, LLC Slide 8 Requirements V Whittington & Associates, LLC Page 4

5 Key Changes Revised clause structure, core text, common definitions, and new concepts Same core Annex SL requirements across multiple management system standards Much easier to implement and audit an integrated management system Retained ISO 9001:2008 requirements are moved to new clauses, mostly in clause 8 (Read Introduction and Annex A before Requirement clauses) Version 1.6: 02/01/ Whittington & Associates, LLC Slide 9 Terminology Changes ISO 9001:2008 ISO 9001:2015 Products Exclusions Management representative Documented procedures Records Work environment Purchased product Supplier Products and services Not used (as applicable; as necessary) Not used (responsibilities still covered) [Maintain] Documented information [Retain] Documented information Environment for operation of processes Externally provided products & services External provider Version 1.6: 02/01/ Whittington & Associates, LLC Slide 10 Requirements V Whittington & Associates, LLC Page 5

6 Standard Comparisons - Part 1 Counts 2008 Edition 2015 Edition Requirement Pages Definitions (ISO 9000) Shall Procedure 10 0 Documented Procedure 6 0 Process Record 29 0 Documented Information 0 41 Version 1.6: 02/01/ Whittington & Associates, LLC Slide 11 Standard Comparisons - Part 2 Counts 2008 Edition 2015 Edition Strategic Direction 0 4 Risk 0 16 Knowledge 0 12 Performance 4 16 Output 9 21 Change Issues 0 8 Resources 7 15 Version 1.6: 02/01/ Whittington & Associates, LLC Slide 12 Requirements V Whittington & Associates, LLC Page 6

7 Requirement Changes Context of Organization (4.1) Understand your business environment Determine and monitor internal and external issues Interested Parties (4.2, A.3) Determine relevant needs of relevant interested parties Scope of Quality Management System (4.3) Focus on scope and applicable requirements Scope available as documented information Applicability (4.3, A.5) No exclusions term Apply all requirements if applicable within scope Maintain as documented information Version 1.6: 02/01/ Whittington & Associates, LLC Slide 13 Additional Changes Products and Services (A.2) Most outputs include both products and services Service output realized at interface with customer Process Approach (4.4, d) Moved from Introduction to Requirements Management must promote process approach Organizational Knowledge (7.1.6, A.7) Determine knowledge for operation and conformity Maintain knowledge and make available as needed Know how to acquire, access, update knowledge Version 1.6: 02/01/ Whittington & Associates, LLC Slide 14 Requirements V Whittington & Associates, LLC Page 7

8 More Changes Leadership (5) Top management more accountable for system Policy and objectives compatible with strategy Documented Information (7.5, A.6) Less emphasis on documentation No mention of documented procedures or records Documents and records = documented information Documents if maintain documented information Records if retain documented information Version 1.6: 02/01/ Whittington & Associates, LLC Slide 15 Even More Changes Externally Provided Processes, Products, and Services (8.4) Replaces section on Purchasing Addresses all forms of external provision purchasing from a supplier arrangement with associate company outsourcing of processes Control of Changes (8.5.6) Review and control production or service changes Retain documented information on review; actions Version 1.6: 02/01/ Whittington & Associates, LLC Slide 16 Requirements V Whittington & Associates, LLC Page 8

9 Further Changes Monitoring and Measuring Resources (7.1.5) Replaces section on calibration of equipment Introduces use of term resources Adds verification of conformity of services Humans may carry out activity without equipment Improvement (10) Expansion of different types of improvement correction, corrective action, continual improvement, breakthrough change, innovation, and re-organization. Version 1.6: 02/01/ Whittington & Associates, LLC Slide 17 Other Changes Risk-Based Thinking (6.1, A.4) Not really new; Informally do it already Determine and address risks and opportunities Use planning events to identify and analyze risks Increase likelihood of reaching quality objectives Reduce probability of negative results Don t want to say we should ve seen that coming Replaces the Preventive Action requirements Risk only mentioned in ISO 9001:2008, clause 0.1 Now mentioned 16 times in Requirements Version 1.6: 02/01/ Whittington & Associates, LLC Slide 18 Requirements V Whittington & Associates, LLC Page 9

10 And These Changes Quality Manual - Not Required Some of its requirements are now in 4.3 and 4.4 Must maintain documented information Could decide to keep a revised policy manual Any contractual requirements for documents? Will potential customers still request a copy? Management Representative - Not Required Old requirements are now in 5.3 (Organizational Roles, Responsibilities, and Authorities) MR unnecessary if system is embedded in business Could retain role, but more done by top management Version 1.6: 02/01/ Whittington & Associates, LLC Slide 19 Transition to ISO 9001:2015 Synchronize with your external audit schedule Complete transition prior to September 2018 Obtain funding for your transition activities Arrange for training on ISO 9001:2015 Understand context of organization Determine internal and external issues Determine relevant interested parties Document QMS scope and any exclusions Version 1.6: 02/01/ Whittington & Associates, LLC Slide 20 Requirements V Whittington & Associates, LLC Page 10

11 Transition to Risk-based Thinking Promote risk-based thinking as a preventive tool Determine risks and opportunities Plan actions to address risks and opportunities Understand your options for dealing with risks Plan how to integrate actions into processes Evaluate effectiveness of the actions on risks Review effectiveness of these actions on risks See ISO for risk management guidance Consider ISO for business continuity Version 1.6: 02/01/ Whittington & Associates, LLC Slide 21 Transition Guidance Advise top management of new responsibilities Ensure visible leadership and accountability Align quality policy and objectives with strategy Make policy available to interested parties? Apply process approach to all key processes Integrate requirements into business processes Decide on Management Representative role Keep or disburse requirements to Management Perform gap analysis against new requirements Version 1.6: 02/01/ Whittington & Associates, LLC Slide 22 Requirements V Whittington & Associates, LLC Page 11

12 More Transition Guidance Review transition guidance from your registrar Develop your ISO 9001:2015 transition plan How communicate plan to your organization? How will you mobilize staff for implementation? Keep required procedures until transitioned Conduct more frequent management reviews Conform to ISO 9001:2008 planning (5.4.2, 5.6) Update existing system for new requirements (Identify specific evidence to prove conformity) Version 1.6: 02/01/ Whittington & Associates, LLC Slide 23 Additional Transition Guidance Keep your current documents if working well Will you restructure and renumber documents? Remove references to old standard and clauses Consider adding new requirements in phases Decide changes needing change management Assess new requirements using internal audits Be aware that more audit time will be needed Use transition to improve quality and business Consider integration of management systems Version 1.6: 02/01/ Whittington & Associates, LLC Slide 24 Requirements V Whittington & Associates, LLC Page 12

13 Transition Timing Plan transition audit for next recertification Use of recertification audit will add fewer days Recertify to ISO 9001:2008 if date is too soon Skip to next surveillance for transition audit Surveillance will become new recertification Move to annual surveillance for more prep time Can add special audit for transition, if preferred Could use pre-assessment to ensure readiness Don t get caught part in 2008 and part in 2015 Version 1.6: 02/01/ Whittington & Associates, LLC Slide 25 Summary of Changes Annex SL clause structure and common text Expanded applicability to service organizations Organizational issues and interested parties Alignment of QMS and business strategy Focus on risk planning, actions, and monitoring Expanded focus on process approach Emphasis on outputs and performance Demonstration of management leadership Version 1.6: 02/01/ Whittington & Associates, LLC Slide 26 Requirements V Whittington & Associates, LLC Page 13

14 Summary of Changes Maintenance of organizational knowledge Purchasing covers all external provision More planning and control of changes Removal of old requirements: QM, MR, and PA Ensuring product and service claims can be met Improvement for future needs and expectations What do you think are other significant changes? Which changes most impact your organization? Version 1.6: 02/01/ Whittington & Associates, LLC Slide 27 Presentation Handouts Clause Maps 1. ISO 9001:2008 > ISO 9001:2015 (2 pages) 2. ISO 9001:2015 > ISO 9001:2008 (3 pages) 3. Annex SL Appendix 2 (11 pages) 4. Clause Quick Reference (2 pages) 5. Required Documented Information (3 pages) 6. Quality Management Principles (4 pages) 7. Risk Assessment Worksheets (4 pages) Version 1.6: 02/01/ Whittington & Associates, LLC Slide 28 Requirements V Whittington & Associates, LLC Page 14

15 Questions If you have questions about ISO 9001:2015, contact Larry Whittington at , or Version 1.6: 02/01/ Whittington & Associates, LLC Slide 29 Requirements V Whittington & Associates, LLC Page 15