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ISO 9001-2015 Revision Training Presentation

ISO 9001 is a great tool that is used for managing an organization and implementing continuous improvement. More than one million organizations worldwide are certified to ISO 9001 in order to help ensure that good quality products and services are provided to customers.

Get an in-depth overview of the upcoming changes to ISO 9001:2015, including:
- Revision timing and roll out
- Details on structure change
- In-depth review of changes including risk assessment
- Transitioning from ISO 9001:2008 to ISO 9001:2015 timing and requirements
- and more.

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ISO 9001-2015 Revision Training Presentation

  1. 1. DQS-UL Management Systems Solutions © October 29, 2014 Cindy Soltis UL DQS Inc. ISO 9001:2015 Overview 1
  2. 2. DQS-UL Management Systems Solutions © Revision Process Overview 2
  3. 3. DQS-UL Management Systems Solutions © Why are revisions needed? •Web-based ISO 9001 user survey in 2011 - 122 countries input •International ballot decision to revise in 2012 All ISO standards are considered for revision periodically to assure relevance and adequacy. •Increasing diversity of ISO 9001 users •Developments in knowledge and technologies •Broader user interests •Changes in industry Revision Considerations
  4. 4. DQS-UL Management Systems Solutions © Development of ISO 9001 1987: Quality assurance  20 elements 1994: Small revision 2000: Quality management  process approach  2008: Minor revision 2015: Planned publication of the revised standard  New structure, including risk based thinking 4
  5. 5. DQS-UL Management Systems Solutions © ISO 9001:2015 Timeline June 2013: CD (Committee Draft) May 2014: DIS (Draft International Standard) July 2015: FDIS (Final Draft International Standard) September 2015: IS International Standard 2015 2014 2013 Transition period for certification
  6. 6. DQS-UL Management Systems Solutions © ISO 9001:2015 Certification Transition September 2015: Start of 3 years transition period to September 2018 2018 2017 2016 2015 September 2015: Published International Standard Transition Timeline for ISO 14001 not yet determined but likely three years
  7. 7. DQS-UL Management Systems Solutions © Main objectives for ISO 9001:2015 Maintain current focus on effective process management to produce desired outcomes Apply the new High Level Structure of ISO Directives to enhance compatibility and alignment with other management system standards Simplified language and writing styles to aid understanding and consistent interpretations of requirements 7 Source: Design specification for the revised ISO 9001
  8. 8. DQS-UL Management Systems Solutions © Summary of Changes 8
  9. 9. DQS-UL Management Systems Solutions © General Changes to ISO 9001 High level structure and core text from „annex SL“ Increased requirements for top management commitment and involvement. Emphasis on risk-based thinking Increased emphasis on achieving value for the organization and its customers (“output matters”) Need to understand the context of the organization and the needs and expectations of interested parties Increased flexibility on the use of documentation 9
  10. 10. DQS-UL Management Systems Solutions © Consistent structure for MS ISO/IEC Directives, Part 1, Consolidated ISO supplement, 2013, Annex SL, Appendix 2 sets out the high level structure, identical core text and common terms and core definitions that are to form, when possible, the nucleus of future and revised management system standards such as ISO 9001 and ISO 14001. High level structure and common text is public information and can be found in Annex SL of the www.iso.org/directives 10 Organizations implementing multiple management systems (e.g. quality, environmental, information security) can achieve better integration and easier implementation
  11. 11. DQS-UL Management Systems Solutions © High Level Structure 1. Scope 2. Normative reference 3. Terms and definitions 4. Context of the organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance evaluation 10. Improvement ISO 9001: Annex A-C – Clarifications, Quality Management Principles, QMS family of stds 11
  12. 12. DQS-UL Management Systems Solutions © ISO/TC 176/SC 2/WG23 N063 1 Scope 2 Normative references 3 Terms and definitions 4 Context of the organization •Understanding the organization and its context •Understanding the needs and expectations of interested parties •Determining the scope of QMS •Quality management system and its processes 5 Leadership •Leadership and commitment •Quality policy •Organizational roles, responsibilities and authorities 6 Planning •Actions to address risks and opportunities •Quality objectives and planning to achieve them •Planning of changes New structure - Details (9001)
  13. 13. DQS-UL Management Systems Solutions © ISO/TC 176/SC 2/WG23 N063 New structure - Details (9001) 7 Support •Resources •Competence •Awareness •Communication •Documented information 8 Operation •Operational planning and control •Determination of requirements for products and services •Design and development of products and services •Control of externally provided products and services •Production and service provision •Release of products and services •Control of nonconforming process outputs, products & services
  14. 14. DQS-UL Management Systems Solutions © ISO/TC 176/SC 2/WG23 N063 New structure - Details (9001) 9 Performance evaluation •Monitoring, measurement, analysis and evaluation •Internal audit •Management review 10 Improvement •General •Nonconformity and corrective action •Continual Improvement
  15. 15. DQS-UL Management Systems Solutions © High Level Structure Question Will certified organizations be required to revise their management system manuals to align with the high level structure and terms? 15
  16. 16. DQS-UL Management Systems Solutions © Other ISO 9001 Changes Explicit requirement for process approach Preventive action disappears as explicit requirement – included in risk-based approach More readily applicable by “service” type organizations Enhance requirements for competence of personnel Revised Quality Management Principles 16 Customers remain the primary focus
  17. 17. DQS-UL Management Systems Solutions © Details of Selected Changes 17
  18. 18. DQS-UL Management Systems Solutions © Context of the Organization (New) •The organization shall •determine external & internal issues that are relevant to its purpose & its strategic direction and that affect its ability to achieve the intended results of its QMS •shall monitor and review the information about these external and internal issues 4.1 Understanding the organization and its context ISO/ DIS 9001:2014 18
  19. 19. DQS-UL Management Systems Solutions © Interested Parties (New) •Due to their impact or potential impact on the organization’s ability to consistently provide products & services that meet customer & applicable statutory & regulatory requirements, the organization shall determine •The interested parties that are relevant to the QMS •The requirements of these interested parties that are relevant to the QMS •The organization shall monitor & review the information about these interested parties and their relevant requirements 4.2 Understanding the needs and expectations of interested parties ISO/ DIS 9001:2014 19
  20. 20. DQS-UL Management Systems Solutions © Risk based thinking ISO 9001:2015 will require a risk based approach in organizational processes •identify what the risks and opportunities are in the organization – it depends on context •ISO 9001:2015 will not require a full, formal risk assessment nor a “risk register” •Risk based approach addressed in all Sections 4 to 10 with primary requirement in 6.1 •ISO 31000 (“Risk management — Principles and guidelines”) will be useful but not mandated. 20
  21. 21. DQS-UL Management Systems Solutions © Risk based approach Risk: Effect of uncertainty on an expected result Note 1: An effect is a deviation from the expected — positive or negative. Note 2: Uncertainty is the state, even partial, of efficiency of information related to, understanding or knowledge of, an event, its consequence, or likelihood. Note 3: Risk is often characterized by reference to potential events and consequences or combination of these Note 4: Risk is often expressed in terms of a combination of the consequences of an event and the associated likelihood of occurence. 21 Source: ISO/DIS 9001, 3.09
  22. 22. DQS-UL Management Systems Solutions © What does 6.1 require an organization do? Learn from experience – continual improvement Check the effectiveness of the actions – does it work? Implement the plan – take action Plan actions to address the risks Analyse and prioritize your risks and opportunities Identify what YOUR risks and opportunities are – it depends on context 22
  23. 23. DQS-UL Management Systems Solutions © 7 Quality Management Principles Customer focus Leadership Engagement of people Process approach Improvement Evidence- based decision making Relationship management 23 Annex B
  24. 24. DQS-UL Management Systems Solutions © No Management Representative? While no explicit requirement for a “Management Representative”, 5.3 requires that: •Top management shall assign the responsibility and authority for: •Ensuring that the QMS conforms to the requirements of the standard •Reporting on the performance of the QMS, on opportunities for improvement and on the need for change or innovation, and especially for reporting to top management 24
  25. 25. DQS-UL Management Systems Solutions © ISO/TC 176/SC 2/WG23 N063 Scope / Exclusions ISO/DIS 9001:2014 continues to allow for exclusions (2008 version: 1.2 Application) •Not restricted to specific section (2008 “Clause 7”) •Only allowed if requirement cannot be applied •Documented Justification required
  26. 26. DQS-UL Management Systems Solutions © ISO/TC 176/SC 2/WG23 N063 Documented Information From Annex SL Appendix 2 core text replaces the terms ‘document’ and ‘record’ throughout the standard by ‘documented information’. Documented information can be in any format and media and from any source. Documented information can refer to the management system/ processes, information created in order for the organization to operate (documentation) or evidence of results achieved (records).
  27. 27. DQS-UL Management Systems Solutions © ISO 14001 Changes 27 6.1.2 Environmental Aspects: Now includes consideration of a life cycle perspective when evaluating environmental aspects 6.1.3 Legal Requirements & other requirements: now ‘Compliance obligations’ 6.2 Environmental objectives: Performance indicators are to be defined for each environmental objective 8.1 Supply chain planning & control: New requirement to ensure outsourced processes, design process/ life cycle related environmental requirements are controlled or influenced 9.1.2 Evaluation of compliance: New requirement for the evaluation process with including a requirement for the organization to maintain knowledge and understanding of its compliance status.
  28. 28. DQS-UL Management Systems Solutions © Transition Process 28
  29. 29. DQS-UL Management Systems Solutions © Transition Planning Guidance IAF issued Draft Transition Planning Guidance for ISO 9001:2015 available here: http://isotc.iso.org/livelink/livelink/open/tc176SC2public Guidance intended for: Organizations certified to ISO 9001:2008 Accreditation Bodies Certification Bodies Training Bodies & Consultants Draft will not be finalized until ISO 9001:2015 is published, but it gives all parties the opportunity to prepare 29
  30. 30. DQS-UL Management Systems Solutions © Transition Planning Transition period from September 2015 to September 2018 18 months after publication (March 2017), initial certifications shall be to ISO 9001:2015 Existing certificates must upgrade by September 2018 through a transition audit Transition audits during a scheduled surveillance or recertification audits will more audit time A staged approach to transition is allowed. Audit records must show progress. We will encourage customers to transition during their recertification audit to minimize the additional costs 30
  31. 31. DQS-UL Management Systems Solutions © Certification Body Activities Auditors •Comprehensive training of auditors at DIS Stage •Additional training on differences at FDIS and ISO stages •Verify Auditor Competence Accreditation Body •Apply for Accreditation after Auditor training •Complete CB Transition Audit focused on changes and the CB’s transition plan (May include Witness audit) Certified Customers •Start briefing customers at DIS stage •Preliminary Evaluations allowed •Perform Transition audit (Surveillance, Recertification or Special) •Verify closure of any nonconformities •Issue certificate to ISO 9001:2015 31
  32. 32. DQS-UL Management Systems Solutions © Sector Standard Impact Revision of Sector standards will follow after the ISO standards are published. Sector Representatives are actively engaged and have influenced the ISO 9001 revisions •Aerospace – AS9100 (likely release early 2016) •Telecom – TL9000 •Automotive – ISO/TS16949 •Exception – Medical Device – ISO 13485:2015 revision aligns with ISO 9001:2008 structure 32
  33. 33. DQS-UL Management Systems Solutions © Questions? Contact me: Cindy Soltis Business Manager Cindy.Soltis@us.dqs-ul.com 33