ISO/DIS 9001:2015. Version 1.1: 12/19/ Whittington & Associates, LLC Slide 1. ISO 9001 Standard

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1 ISO/DIS 9001:2015 Plan for the Changes Whittington & Associates, LLC 6175 Hickory Flat Highway, Suite , Canton, GA Version 1.1: 12/19/ Whittington & Associates, LLC Slide 1 ISO 9001 Standard Most adopted management system standard Defines criteria for quality management system Certification in supply chain gives confidence Better process understanding and control Reduced defects, waste, and business risk Improved product and service quality Enhanced levels of customer satisfaction Version 1.1: 12/19/ Whittington & Associates, LLC Slide 2 Requirements V Whittington & Associates, LLC Page 1

2 ISO 9001 Certificates Certificates at YE 2013 = 1,129,446 (up 3%) 1. China = 337, Italy = 160, Germany = 56, Japan = 45, United Kingdom = 44, Spain = 42, India = 40, United States = 34,869 (up 33%) Version 1.1: 12/19/ Whittington & Associates, LLC Slide 3 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 1.1: 12/19/ Whittington & Associates, LLC Slide 4 Requirements V Whittington & Associates, LLC Page 2

3 Reasons for Revision Standards reviewed every 5 years for relevance. ISO 9001 needs update for: Changing e-business and quality environment More applicability for service organizations Integration with other management system standards Adoption of the new Annex SL clause structure Use of the revised quality management principles Introduction of new management and quality concepts ISO 9001:2015 will replace ISO 9001:2008. Version 1.1: 12/19/ Whittington & Associates, LLC Slide 5 ISO 9001:2015 Timeline Stages Release Ballot Closes Committee Draft (CD) 4/2013 6/2013 7/2013 Draft Standard (DIS) 5/2014 7/2014 8/2014 Final Draft Standard (FDIS) 3/2015 7/2015 8/2015 ISO 9001 Publication 9/2015? ISO 9001:2008 No certifications after 8/2016 (2/2017). Depends on CB. Certificates not valid after September Version 1.1: 12/19/ Whittington & Associates, LLC Slide 6 Requirements V Whittington & Associates, LLC Page 3

4 Related Standards ISO 27001:2013 Issued 9/2013 (using Annex SL) ISO 9000:2015 9/2015 (parallel to ISO 9001) ISO 14001:2015 9/2015 AS9100:2016 4/2016 TL9000: /2016 ISO 45001:2016 Voting closed on CD 10/2014 ISO/TS 16949:201x Working Group Formed ISO 13485:2016 Not Annex SL (DIS failed 10/2014) Version 1.1: 12/19/ Whittington & Associates, LLC Slide 7 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 1.1: 12/19/ Whittington & Associates, LLC Slide 8 Requirements V Whittington & Associates, LLC Page 4

5 Clause Structure 0. Introduction 1. Scope 2. Normative References 3. Terms and Definitions 4. Context of the Organization 5. Leadership 6. Planning for the Quality Management System 7. Support 8. Operation 9. Performance Evaluation 10. Improvement Annex A Clarification of New Structure, Terminology, and Concepts Annex B Quality Management Principles Annex C The ISO Portfolio of Quality Management Standards Refer to Clause Mapping handouts (9001:2008 to 9001:2015, and 9001:2015 to 9001:2008) Version 1.1: 12/19/ Whittington & Associates, LLC Slide 9 Quality Management Principles Revised Quality Management Principles: 1. Customer Focus (same title; adds looking at customer interactions to add value) 2. Leadership (same title; adds aligning strategy, policy, and resources) 3. Engagement of People (was Involvement of People; adds empowering and engaging) 4. Process Approach (merged with System Approach; reworded for clarity) Version 1.1: 12/19/ Whittington & Associates, LLC Slide 10 Requirements V Whittington & Associates, LLC Page 5

6 Quality Management Principles 5. Improvement (replaces Continual Improvement ; adds that is essential to maintain performance, react to changes, create opportunities) 6. Evidence-based Decision Making (replaces Factual Approach to Decision Making ; adds that informed decisions are more likely to produce desired results) 7. Relationship Management (replaces Mutually Beneficial Supplier Relationships ; expands from suppliers to include interested parties) Refer to Quality Management Principles handout (compares new principles to old principles). Version 1.1: 12/19/ Whittington & Associates, LLC Slide 11 Requirement Grouping PLAN 4. Context of the Organization 5. Leadership 6. Planning for the QMS 7. Support DO CHECK ACT 8. Operation * 9. Performance Evaluation 10. Improvement * Most of the unique ISO 9001 requirements are in this clause. Version 1.1: 12/19/ Whittington & Associates, LLC Slide 12 Requirements V Whittington & Associates, LLC Page 6

7 Key Changes Revised clause structure, core text, common definitions, and new concepts Same core Annex SL requirements across multiple management system standards 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 Clauses) Version 1.1: 12/19/ Whittington & Associates, LLC Slide 13 Requirement Changes Context of Organization (4.2, A.3) Determine and monitor internal-external issues Determine needs of relevant interested parties Scope of Quality Management System (4.3) Focus on scope and applicable requirements Scope available as documented information Applicability (A.5) No longer using the term exclusion Determine if a requirement can t be applied Maintain as documented information per 4.3 Version 1.1: 12/19/ Whittington & Associates, LLC Slide 14 Requirements V Whittington & Associates, LLC Page 7

8 Additional Changes Products and Services (A.2) Changes emphasize it applies to all suppliers Not just for those providing physical products Process Approach (4.4, e) Moved from Introduction to Requirements Management: 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 or access more knowledge Version 1.1: 12/19/ Whittington & Associates, LLC Slide 15 More Changes Leadership (5) Top management more accountable for system Policy and objectives compatible with strategy Documented Information (7.5, A.6) No mention of documented procedures or records Documents and records = documented information Documents if maintain documented information Records if retain documented information Refer to Required Documented Information handout (lists required documents and records). Version 1.1: 12/19/ Whittington & Associates, LLC Slide 16 Requirements V Whittington & Associates, LLC Page 8

9 Even More Changes Externally Provided 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 any unplanned changes Keep documented information on review / actions Version 1.1: 12/19/ Whittington & Associates, LLC Slide 17 Further Changes Control of Monitoring and Measuring Resources (7.1.5) Replaces section on calibration of equipment Uses term resources instead of equipment Humans may carry out activity without equipment Calibrated equipment now called instruments Improvement (10) Expansion of different types of improvement reactive, incremental, breakthrough innovation, transformation Version 1.1: 12/19/ Whittington & Associates, LLC Slide 18 Requirements V Whittington & Associates, LLC Page 9

10 Other Changes Risk-Based Approach (6.1, A.4) Determine and address risks and opportunities Use planning events to identify and analyze risks Don t want to say we should ve seen that coming Replaces the Preventive Action requirements Refer to Risk Management handout (worksheets for risk assessment and mitigation actions). Version 1.1: 12/19/ Whittington & Associates, LLC Slide 19 Risk-Based Approach Risk now considered throughout the standard: 4.1.f - Determine risks; take actions to address b - Ensure risks determined and addressed Plan to determine risks that need to be addressed to achieve intended results Plan actions to address risks; integrate into processes; evaluate effectiveness of actions a - Consider risks in post-delivery activities e - Review effectiveness of actions on risks. Version 1.1: 12/19/ Whittington & Associates, LLC Slide 20 Requirements V Whittington & Associates, LLC Page 10

11 Consequences and Constraints Risk relates to consequences and constraints : 6.3.a - Consequences of planned system changes a - Constraints on existing internal resources Consequences of unintended process changes e - Consequences of product or service failure a.2 - Consequences of nonconformities Version 1.1: 12/19/ Whittington & Associates, LLC Slide 21 Even More Changes Quality Manual not required Requirements addressed are now in 4.3, 4.4 (Scope of QMS; QMS and its processes) Must maintain documented information Could decide to keep revised policy manual Management Representative not required Old requirements are now in 5.3, Organizational Roles, Responsibilities, and Authorities Unnecessary if system is embedded in business Could retain role, but more by top management Version 1.1: 12/19/ Whittington & Associates, LLC Slide 22 Requirements V Whittington & Associates, LLC Page 11

12 9.2 Internal Audit Conduct internal audits at planned intervals to provide information on whether the system: a) Conforms to: - organization s own requirements for its quality management system - the requirements of ISO 9001 b) Is effectively implemented and maintained (Requirements in blue are from Annex SL core text) (Requirements in black were added for ISO 9001) Version 1.1: 12/19/ Whittington & Associates, LLC Slide Internal Audit The organization must: a) Plan, establish, implement, and maintain an audit program that includes: frequency, methods, and responsibilities planning requirements and reporting Consider: quality objectives and importance of concerned processes customer feedback and changes impacting the organization results of previous audits Version 1.1: 12/19/ Whittington & Associates, LLC Slide 24 Requirements V Whittington & Associates, LLC Page 12

13 9.2 Internal Audit b) Define audit criteria and scope for each audit c) Select auditors and conduct audits to ensure an objective and impartial audit process d) Ensure results of audits are reported to relevant management e) Take necessary correction and corrective actions without undue delay f) Retain documented evidence of implementation of audit program and audit results Version 1.1: 12/19/ Whittington & Associates, LLC Slide 25 Internal Audit Changes Drops requirement for a documented procedure Establish, implement, and maintain audit program Clarifies frequency and methods for audit program Clarifies audit criteria and scope for each audit Consider quality objectives and customer feedback Consider any changes impacting the organization Drops reference to follow-up audit activities No mention of auditors not auditing their own work Need evidence of audit program implementation Version 1.1: 12/19/ Whittington & Associates, LLC Slide 26 Requirements V Whittington & Associates, LLC Page 13

14 Internal Audit Guidance Management accountable for effective system More reliance on auditors for actionable insights Increased internal auditor role and importance Auditors are catalyst for improvement Auditors must learn the new requirements Allocate extra time to prepare for audits Consider more time for audit durations Version 1.1: 12/19/ Whittington & Associates, LLC Slide 27 Internal Audit Tips Understand business and strategic direction Know context of organization and its issues Be aware of interested parties and requirements Understand scope and acceptable exclusions Focus on identified risks and opportunities Conduct risk-based audits for more value Adjust audit procedure and report content Revise audit checklists for new requirements Version 1.1: 12/19/ Whittington & Associates, LLC Slide 28 Requirements V Whittington & Associates, LLC Page 14

15 More Internal Audit Tips Focus on new requirements during transition See if top management is more engaged Expand emphasis on the process approach Focus on new process performance indicators Move from procedure audits to process audits Be prepared to audit undocumented processes Consider need for new sources of evidence Version 1.1: 12/19/ Whittington & Associates, LLC Slide 29 What Next? Don t rush to change your current system Prepare now for changes using the DIS level Wait and implement changes at FDIS level Remember the transition period will be 3 years Understand risk-based approach (6.1, A.4) Use ISO as risk management resource Understand context of organization and interested parties (4.1, A.3, 4.2, QMP 7) Version 1.1: 12/19/ Whittington & Associates, LLC Slide 30 Requirements V Whittington & Associates, LLC Page 15

16 Next Steps Apply process approach to all key processes Consider integration of management systems Advise top management of new responsibilities Arrange for training on ISO 9001:2015 Perform gap analysis against new requirements Review transition guidance from your registrar Develop your ISO 9001:2015 transition plan Conduct more frequent management reviews Version 1.1: 12/19/ Whittington & Associates, LLC Slide 31 Additional Steps Conform to ISO 9001:2008 planning (5.4.2, 5.6) Be aware that more audit time will be needed Keep your current documents if working well Will you restructure and renumber documents? Change references to old standard and clauses Consider adding new requirements in phases Synchronize with current external audit plan Assess new requirements using internal audits Use transition to improve quality and business Version 1.1: 12/19/ Whittington & Associates, LLC Slide 32 Requirements V Whittington & Associates, LLC Page 16

17 Transition Guidance Almost to ISO 9001:2008 Complete certification before 9/2016 Move to ISO 9001:2015 by 9/2018 Certified to ISO 9001:2008 Start planning with ISO/DIS 9001:2015 Begin implementing with ISO/FDIS 9001:2015 Just starting on certification Skip use of ISO 9001:2008 Begin with ISO/FDIS 9001:2015 Version 1.1: 12/19/ Whittington & Associates, LLC Slide 33 Presentation Handouts 1. Presentation Slides (6 pages) 2. Clause Mapping ISO 9001:2008 to ISO 9001:2015 (2 pages) ISO 9001:2015 to ISO 9001:2008 (3 pages) 3. Required Documented Information (4 pages) 4. Quality Management Principles (4 pages) 5. Risk Management Worksheets (4 pages) Version 1.1: 12/19/ Whittington & Associates, LLC Slide 34 Requirements V Whittington & Associates, LLC Page 17

18 Questions If you have questions about ISO/DIS 9001:2015, please contact me at , or send an to Version 1.1: 12/19/ Whittington & Associates, LLC Slide 35 Requirements V Whittington & Associates, LLC Page 18