A Review ISO 9001:2015 Draft

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1 A Review ISO 9001:2015 Draft ISO 9001 Why is it changing? Disclaimers Verbal statements made by the presenter may represent personal opinions and/or interpretations. The presentation includes information related to the revision process up to and including April 2015.Further changes may occur QUEST GLOBAL MANAGEMENT SERVICES

2 ISO 9001 History 1st edition ISO 9001:1987 (20 elements) 2st edition ISO 9001:1994 (small revision) 3rd edition ISO 9001:2000 (process approach) 4th edition ISO 9001:2008 (minor revision) 5th edition FDIS (New Structure & Risk Based Thinking) Publication Sep Projected 9/23/2015 QUEST GLOBAL MANAGEMENT SERVICES 2

3 Reason for Revision The world changes: Increased prominence of services Globalization More complex supply chain Increased interested parties expectations Information availability ISO standards are reviewed for suitability and effectiveness every 5-8 years (last update in 2008) Need the New Common Structure Easier to integrated to others standards 3

4 ISO 9001 Under Revision Review based on ISO Working Draft /13. Further revisions likely to occur. Firms may wish to consider these changes and plan accordingly. New revisions slated for release Sept 2015 with full implementation Sept Draft revisions now 21 pages of requirements compared to 9 pages in the 2008 revised standard 4

5 Objective of Revisions Enhance an organization s ability to satisfy customers. Maintain relevance, provide integrated approach to organizational management, and integrate with other management systems. Reflect needs of all user groups and increasingly complex operating environments. Set a consistent foundation for next 10 years. 5

6 What s New? Risk management is being added with focus on risk-based thinking. Identification of risk and risk control now a requirement. Standardized core text, structure, definitions enable organizations with multiple management systems to achieve improved integration & implementation. Major focus on achieving value for organization and its customers. Revisions allow ISO 9001 to be more applicable by service-based organizations. Primary focus remains on Customers! 6

7 QMS Structure Re-organized 4.Context of Organization addresses needs and expectations of interested parties, scope of QMS 5. Leadership 6. Planning addresses management commitment, policy, roles, responsibility & authority includes risks, opportunities, objectives and plans to achieve them, the planning of changes 7

8 Structure Re-organized 7. Support includes resources, competence, awareness, communication, documented information 8. Operation includes planning & control, determine market needs, interaction w/customers, planning process, control of external provisions of goods/services, production of goods, provision of services, release of goods/services, non-conforming goods/services 8

9 Structure Outlined 9. Performance Evaluation includes monitoring, measurement, analysis & evaluation, internal audit, management review 10. Improvement addresses non-conformity & corrective action, improvement 9

10 Timeline to Revision Release and Client Transition June 2013 CD (Committee Draft) April 2014 DIS (Draft International Standard) July 2015 FDIS (Final Draft International Standard) 10 September 2015 (Published International Standard)

11 Timeline to Revision Release and Client Transition September 2015 Published International Standard September 2015 start of 3 years transition period to September

12 SOME NEW ELEMENTS OF THE NEW VERSION THE CLAUSES ARE 10 USING THE NEW "HIGH-LEVEL STRUCTURE": 1. Scope 2. Normative references 3. Terms and definitions 4. Context of the organisation 5. Leadership 6. Planning for the quality management system 7. Support 8. Operation 9. Performance evaluation 10. Improvement 12

13 What has changed ISO 9001:2008 ISO DIS 9001: Introduction 0 Introduction 1 Scope 1 Scope 2 Normative references 2 Normative references 3 Terms and definitions 3 Terms and definitions 4 Quality management system 4 Context of the organization 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the quality management system 4.1 General requirements 4.4 Quality management system and its processes 4.2 Documentation requirements 7.5 Documented information 13

14 ISO 9001:2008 ISO DIS 9001: Management responsibility 5 Leadership 5.1 Management commitment 5.1 Leadership and commitment 5.2 Customer focus Customer focus 5.3 Quality policy 5.2 Quality policy 6 Planning for the quality management system 6.1 Actions to address risks and opportunities 5.4 Planning 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes 5.3 Organizational roles, responsibilities and 5.5 Responsibility, authority and authorities communication 7.4 Communication 5.6 Management review 9.3 Management review 14

15 ISO 9001:2008 ISO DIS 9001: Resource management 7 Support 6.1 Provision of resources 7.1 Resources 6.2 Human resources 7.2 Competence 7.3 Awareness 7.4 Communication 6.3 Infrastructure Infrastructure 6.4 Work environment Environment for the operation of processes 15

16 ISO 9001:2008 ISO DIS 9001: Product realization 8 Operation 7.1 Planning of product realization 8.1 Operational planning and control 7.2 Customer-related processes 7.3 Design and development 7.4 Purchasing 8.2 Determination of requirements for products and services 8.3 Design and Development of products and services 8.4 Control of externally provided products and services 7.5 Production and service provision 8.5 Production and service provision 7.6 Control of monitoring and measuring equipment Monitoring and measuring resources 8.6 Release of products and services 16

17 ISO 9001:2008 ISO DIS 9001: Measurement, analysis and improvement 9 Performance evaluation 8.1 General 9.1 Monitoring, measurement, analysis and evaluation 8.2 Monitoring and measurement 8.3 Control of nonconforming product 9.2 Internal audit 9.3 Management review 8.7 Control of nonconforming process outputs, products and services 9.1 Monitoring, measurement, analysis and evaluation 8.4 Analysis of data 9.1 Monitoring, measurement, analysis and evaluation 8.5 Improvement 10 Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual Improvement 17

18 18 What Should an Organization do Now? Nothing at this time ( well almost nothing) ( well almost nothing). Still too early in the 2015 revision process of ISO 9001 to make any significant changes to an existing QMS. Some issues drafted may change or disappear in upcoming drafts or with final version. Looking ahead existing registered system documentation should conform with some small adjustments. In most cases, existing registered organizations should have enough documentation and records. Since risk is documented in most sections of proposed revision to ISO 9001, consider starting your risk management plan, if you don t have one. Begin thinking how to address risk in your business.

19 What do you need to do? Go for ISO Certification Transition to ISO 9001:2015 Transition period is three year Still in draft version 19

20 20

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