BUSINESS ASSURANCE ISO 9001:2015 Draft …

1 BUSINESS ASSURANCE . ISO 9001:2015 Draft International Standard Overview A Survey of Proposed Changes to iso 9001 :2008. Burt Holm Northern District Sales Manager 1 DNV GL 2013 SAFER, SMARTER, GREENER. Who is DNV GL? Is now 2 DNV GL 2013. DNV founded in Norway 140 years ago Merged with GL in 2013. Certified Body/Registrar since 1990 (US). System Certification audits Training Sustainability Services Accredited through ANAB, RvA & UKAS. Multiple North American locations Multiple Global locations 3 DNV GL 2013. Change is on the way 4 DNV GL 2013. Agenda ISO Survey What is ISO. Why iso 9001 is being revised The ISO Framework What is changing The timeline for transition What to do now References and Resources 5 DNV GL 2013. iso 9001 Certifications in the US. 6 DNV GL 2013. iso 9001 Certifications Globally 7 DNV GL 2013. Types of Businesses Earning Certification Document: ISO/TC 176/SC 2/N 1017. 8 DNV GL 2013. Factors which Influenced Organization to Become Certified Document: ISO/TC 176/SC 2/N 1017.

2 9 DNV GL 2013. What is ISO? ISO is the International Organization for Standardization, headquartered in Geneva, Switzerland ISO is a worldwide federation of the national standards organizations of 157. countries ANSI is the US member body More than 19,000 International Standards and growing 10 DNV GL 2013. ISO/TC 176. Source: ISO 9001:2015 From CD to DIS, Dr. Nigel H Croft 2013. 11 DNV GL 2013. The ISO 9000 Document Group ISO 9000:2005 Fundamentals and Vocabulary iso 9001 :2008 Quality Management Systems Requirements ISO 9004:2009 Managing for the Sustained Success of an Organization The Certified Body or Registrar ISO 17021. IRCA and RAB QSA. IAF and Mandatory Documents 12 DNV GL 2013. Why iso 9001 is Being Revised Maintain Relevance Integration among all standards Consistent foundation for the long-term (next 10-25 years). Increase adoption of the standard Address increased variety of BUSINESS users Service industries Office environments Address increasing complexity of BUSINESS environment Non-office/virtual office 13 DNV GL 2013.

3 Caution and Disclaimer ISO 9001:2015 as a Draft International Standard is not available publicly No portion of the Draft International Standard may be Reproduced Transmitted Stored Copied, recorded, etc. Available information is from TC176 member organizations Public webinars Commentaries Limited information releases 14 DNV GL 2013. ISO and Management System Standards 2012: all Management Systems standards will have common Framework High level structure Common text and terminology New standards and revisions to existing standards The Common Framework: Appendix 3 of ISO/IEC Directives, Part 1 Annex SL. Annex SL is the generally used shorthand 15 DNV GL 2013. The Common Framework Standardize and effectively develop standards Enhance alignment and compatibility of standards Useful for organizations which pursue multiple standards Some standards already under Common Framework ISO 22000. ISO 20001. ISO 50001. Under revision to the Common Framework ISO 14001. ISO 27001.

4 iso 9001 . 16 DNV GL 2013. What is Changing? iso 9001 :2008 ISO 9001:2015 . 0. 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 5. Management Responsibility 5. Leadership 6. Resource Management 6. Planning 7. Product Realization 7. Support 8. Measurement, Analysis and Improvement 8. Operations 9. Performance Evaluations 17 DNV GL 2013. Key Changes Emphasis on Risk-based management Preventive action Increase emphasis on achieving value for organization and its customers Documented Information Decreased emphasis on documentation Expands concept of documentation Replaces Documents and Records Organizational Context Responsiveness to BUSINESS environment Outsourcing is now External Provision Enhanced leadership requirements No requirement for Management Representative No requirement for Quality Manual 18 DNV GL 2013.

5 High Level Structure New Clause Numbers 1. Scope 7. Support 2. Normative References 1. Resources 3. Terms and Definitions 2. Competence 4. Context of the Organization 3. Awareness 1. Understanding the Organization and its 4. Communications context 5. Documented Information 2. Needs and expectations 8. Operations 3. Scope 1. Operational planning and control 4. Management system 9. Performance evaluation 5. Leadership 1. Monitoring, measurement, analysis and 1. Management commitment evaluation 2. Policy 2. Internal audit 3. Roles, Responsibility and Authority 3. Management review 6. Planning 10. Improvement 1. Actions to address risks and 1. Nonconformity and corrective action opportunities 2. Continual improvement 2. Objectives and plans to achieve them 19 DNV GL 2013. 4. Context of the Organization 20 DNV GL 2013. 4. Context of the Organization 21 DNV GL 2013. 4. Context of the Organization 22 DNV GL 2013. Leadership 23 DNV GL 2013. Actions to address risks and opportunities 24 DNV GL 2013.

6 Resources 25 DNV GL 2013. Operational Planning and Control 26 DNV GL 2013. Control of external provision of goods and services 27 DNV GL 2013. 9. Performance Evaluation 28 DNV GL 2013. 10. Improvement 29 DNV GL 2013. Terminology: Changes and Concepts 1. Product is now Goods and Services 2. Process Approach is now stated requirement (Clause ). 3. Risk is defined as effect of uncertainty 1. ISO 31000. 4. Design and Development is now Development 5. Monitoring and Measurement are now separate 1. Monitoring: status of a system, a process or an activity 2. Measurement: a process to determine a value 6. Context of Organization 1. From stakeholders, industry groups, trading partners, others 2. Laws, regulations, standards, codes of practice, Industry regulation, corporate governance, others 3. Economic, financial, environmental, socail 4. Industry or government analysis 7. Media information 30 DNV GL 2013. Other Considerations Change to the standard brings challenges To the user community To Certified Bodies/Registrars iso 9001 :2008 is central to other standards AS9100 Aerospace TS16949 Automotive FSSC22001 Food Safety Comments and Feedback can still be provided to TC176.

7 31 DNV GL 2013. Tentative Transition Timeline February 2014 Draft July 2015 Final Draft September 2015. Innternational International Publish International Standard Standard Standard 32 DNV GL 2013. Tentative Implementation Timeline December 2015 2019 Complete 3- January 2016 Begin Publish International year Implementation Implementation Standard Period 33 DNV GL 2013. What should we be doing? Learn about the key changes Evaluate the impact on your organization Begin planning to revise your management system Keep informed of the Draft International Standard Begin a dialogue with your Registrar 34 DNV GL 2013. References and Resources Webinars demand/ Brand X. Google will net many similar reviews Detailed review including supporting standards General information only IAF. IRCA. 35 DNV GL 2013. Questions 36 DNV GL 2013. Thank you 37 DNV GL 2013. Burt Holm, Northern District Sales Manager Work Cell SAFER, SMARTER, GREENER. 38 DNV GL 2013.