Slide 1: ISO 9001 Revision: Introduction to ISO 9001:2015
ISO 9001 REVISION INTRODUCTION TO ISO 9001: 2015
Slide 2: Agenda
AGENDA Introduction Structure and Terminology Changes to ISO 9001 Future Developments How SGS can support you 2 © SGS Group Management SA – 2014 – All rights reserved - SGS is a registered trademark of SGS Group Management SA
Slide 3: Introduction
INTRODUCTION ISO/DIS 9001 Issued May 2014 ISO/FDIS 9001 Issued July 2015 ISO 9001: 2015 Issued September 2015 Final stage in the revision process 3 © SGS Group Management SA – 2014 – All rights reserved - SGS is a registered trademark of SGS Group Management SA
Slide 4: Structure & Terminology
STRUCTURE & TERMINOLOGY ISO 9001: 2015 adopts Annex SL Framework Standardized structure format Incorporates common Definitions Text and requirements in many areas 4 © SGS Group Management SA – 2014 – All rights reserved - SGS is a registered trademark of SGS Group Management SA
Slide 5: Annex SL Framework
ANNEX SL FRAMEWORK 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 5 © SGS Group Management SA – 2014 – All rights reserved - SGS is a registered trademark of SGS Grou
Slide 6: Terminology
TERMINOLOGY ISO 9001: 2008 ISO 9001: 2015 ‘Products’ ‘Products and services’ ‘Documentation’ ‘Records’ ‘Documented information’ ‘Work environment’ ‘Environment for the operation of processes’ ‘Externally provided processes, products and ‘Purchased product’ services’ ‘Supplier’ ‘External provider’ ‘P
Slide 7: Changes to ISO 9001
CHANGES TO ISO 9001 CONTEXT OF THE INTERESTED LEADERSHIP ORGANIZATION PARTIES RISKS AND DOCUMENTED OTHER OPPORTUNITIES INFORMATION CHANGES 7 © SGS Group Management SA – 2014 – All rights reserved - SGS is a registered trademark of SGS Group Management SA
Slide 8: Organizational Context
ORGANIZATIONAL CONTEXT A Quality Management System (QMS) cannot exist in isolation Internal and external issues Interested parties QMS scope of applicability Risks and opportunities these represent 8 © SGS Group Management SA – 2014 – All rights reserved - SGS is a registered trademark of
Slide 9: Interested Parties
INTERESTED PARTIES Who are the ‘interested parties’ relevant to an organizations QMS? What are their needs and expectations? How does an organization establish who and what they are? What ongoing review of the ‘who’ and ‘what’ takes place? 9 © SGS Group Management SA – 2014 – All rights rese
Slide 10: Leadership
LEADERSHIP Now an emphasis on leadership rather than simply management More direct involvement in an organization’s QMS Specific ‘Management Representative’ no longer required 10 © SGS Group Management SA – 2014 – All rights reserved - SGS is a registered trademark of SGS Group Management SA
Slide 11: Risks and Opportunities
RISKS AND OPPORTUNITIES What risks and opportunities have the potential to impact (negatively or positively) on the operation and performance of an organization’s QMS. What action needs to be taken to: Remove or reduce risks Take advantage of opportunities 11 © SGS Group Management SA – 2014
Slide 12: Documented Information
DOCUMENTED INFORMATION No longer any specific requirements relating to a Quality Manual or to documented procedures Terms ‘documented procedure’ and ‘record’ used in have both been replaced throughout ISO 9001: 2015 by the term ‘documented information’ 12 © SGS Group Management SA – 2014 – All r
Slide 13: Other Changes
OTHER CHANGES Process approach Competence Organizational knowledge External provision of goods and services Preventive action 13 © SGS Group Management SA – 2014 – All rights reserved - SGS is a registered trademark of SGS Group Management SA
Slide 14: Summary
SUMMARY The ISO 9001: 2015 requirements encourage organizations to use more external focus in a broader risk-based approach to Quality Management Adoption of the Annex SL framework will help with alignment and integration of other management system standards Gives greater flexibility to indivi
Slide 15: Future Development
FUTURE DEVELOPMENT Organizations already certified to ISO 9001:2008 will have three years in which to transfer to the new version of the Standard. Based on the final publication date, this transition period would end September 2018. 15 © SGS Group Management SA – 2014 – All rights reserved - SGS
Slide 16: SGS Solutions for a Smooth Transition
SGS SOLUTIONS FOR A SMOOTH TRANSITION Training ISO 9001: 2015 Annex SL – IRCA approved CPD course Risk-Based Thinking –IRCA approved CPD course Empowering Leadership Needs Assessment/Gap Analysis Certification 16 © SGS Group Management SA – 2014 – All rights reserved - SGS is a registe
Slide 17: Why Work with SGS?
WHY WORK WITH SGS? LARGEST LOCAL AND MOST WIDELY PROVIDER INTERNATIONAL ACCREDITED OF AUDITS, PROJECT CERTIFICATION CERTIFICATION MANAGEMENT BODY AND PERFORMANCE ASSESSMENTS EXPERIENCED WORLDWIDE IMPARTIAL AND AND RESULTS- NETWORK INDEPENDENT ORIENTED AUDITORS AND TUTORS 17 © SGS Group Management SA
Slide 18: How We Build Stakeholder Value
HOW WE BUILD STAKEHOLDER VALUE SGS SOLUTIONS – BUILDING STAKEHOLDER VALUE MANAGEMENT SYSTEMS PERFORMANCE SGS ACADEMY COMPLIANCE ASSESSMENTS Learning and development solutions Audit and certification services for Tailored assessments for internal that transform people and compliant processes and and
Slide 19: www.sgs.com
WWW.SGS.COM WWW.SGS.COM/ISO9001-2015TRANSITION CERTIFICATION@SGS.COM TRAINING@SGS.COM