The Future of Management ISO 9001:2015
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ISO 9001:2015 Presentation January 19, 2016
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The Future of Management ISO 9001:2015
- 1. The Future of Management ISO 9001:2015 Your Questions Answered Welcome and Thanks for Attending Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 1
- 2. Agenda • Introduction and Speakers • Consistent Management System Strucures- Annex SL • Expectations (stated but can it be backed up) • New, major, minor and nonexistent changes • Complexity of issues • Difficulties and Dangers • Why its great! • Transition – your system and certificates • Questions Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 2
- 3. Colin Gray & Cavendish Scott • Colin Gray – 30 years auditing, training and consulting. – IRCA, EG, PECB Lead Auditor – IRCA ISO 9001:2015 Lead Auditor instructor and training designer • Cavendish Scott, Inc. – ISO 9001:2015 consulting packages – Training, auditing and gap analysis – 30+ Years Experience – Guaranteed Success – IRCA ISO 9001:2015 Lead Auditor Training – ISO 9001, AS, 14001, 17025, 13485 Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 3
- 4. Management System Structure - Annex SL • Common structure – 4 QMS – 5 Leadership – 6 Planning – 7 Support processes – 8 Operations – 9 Measurement and analysis – 10 Improvement • Common terminology/definitions • ALL management system standards Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 4
- 5. Other Standards • ISO 14001, 27001 • ISO 45001 (OHSAS 18001) – new issue late 2016 • AS9100 – April 2016 • TS16949 – “boxed text” • ISO 13485 – FDIS Q1 2016 • ISO 17025 – DIS Mid 2016 Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 5
- 6. New Expectations • Leadership Involvement • Alignment of management system with strategic direction, – organizational context, interested parties, strategic direction reflected in management system planning • Risk based approach/thinking • Process approach • Flexibility in demonstration – Down to the organization to determine how to demonstrate conformance – no mandated procedures and few mandated records Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 6
- 7. ISO 9001:2015 Annex A • Annex A Clarification new structure, terminology and concepts – A1 Structure and terminology – A2 Products and services – A3 Understanding the needs and expectations of interested parties – A4 Risk based thinking – A5 Applicability – A6 Documented information – A7 Organizational knowledge – A8 Control of externally provided processes, products and services Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 7
- 8. 5.1 Leadership & commitment • 5.1.1 General • Top management shall demonstrate leadership and commitment with respect to the quality management system by: • a) taking accountability for the effectiveness of the quality management system; • b)ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization; • c) ensuring the integration of the quality management system requirements into the organization’s business processes; • d) promoting the use of the process approach and risk-based thinking; • e) ensuring that the resources needed for the quality management system are available; • f) communicating the importance of effective quality management and of conforming to the quality management system requirements; • g) ensuring that the quality management system achieves its intended results; • h) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system; • i) promoting improvement; • j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 8
- 9. Changes • New – Strategic, issues, interested parties, risk, opportunities – People – Knowledge – Change • Significant change – Scope, QMS – Leadership, Objectives – Communication – Externally Provided – Nonconformance and CA • Minor change – Design – Customer Requirements – Analysis, Improvement • None – Work Environment, Infrastructure – Measuring resources Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 9
- 10. Gray Areas to Watch • …shall consider…. – Meriam Webster – “to think about (something or someone) carefully especially in order to make a choice or decision” – ISO 14001:2015 Annex A.2 – “The word, ‘consider’ means it is necessary to think about the topic but it can be excluded…” • …to the extent necessary…. – Who decides the extent that is necessary? – How can you prove you went far enough? – Confident answers backed by data will be important Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 10
- 12. Complexity of Issues (4.1) • Organization purpose • Organization strategy for quality • External and Internal Issues • Interested Parties • Risks and Opportunities • QMS planning • Production/Service Planning • Communication • Knowledge • Objectives, measurements and analysis • Nonconformance and Corrective Action • Change • Etc. Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 12
- 13. Difficulties and Dangers • Less Prescriptive to demonstrate conformance – What procedures – What records – What will satisfy an auditor – What do we need to make sure we are effective – How will verbal evidence be treated • How do you demonstrate Leadership and Commitment • Auditing leadership – are internal auditors going to be comfortable challenging the CEO on his/her strategy? • Integration with business processes. Quality Manager promoted to top management? Attending senior meetings? • Interrelationships within the new structure Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 13
- 14. Benefits • Accountability of Leadership • Involvement of Leadership • Integration with strategic and business processes (new role for quality) • More comprehensive and successful QMS • Annex SL – common, consistent and a lot less likely to change • Fix poor processes – Preventive Action, Change, etc. • Deliberately Successful Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 14
- 15. Certification Transition • It’s a new standard – many additional requirements – losing 3 very minor requirements – Its going to take more time • You have to maintain conformance to 2008 until you are 2015 certified • Best at recertification • Don’t believe the hype – its going to cost you to update your certificate • Going forward may require more audit days (changes in MD5) • Deadlines – Sept 1 2017 No new certifications to 2008 – Sept 1 2018 standard withdrawn Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 15
- 16. QMS Transition 1. Understand impact and breadth of changes 2. Gap Assessment 3. Project Planning 4. Implementation 1. New designs, management involvement, strategic 2. New procedures – plus substantial training/support 3. Changed procedures – plus training/support 4. Document review 5. Internal audit 5. CB Audit – contact early – timing to start Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com
- 17. 17 Project Schedule Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 17 Third Party Audit Month 0 93 6 Assuming a Dedicated Resource is Assigned… Address Internal Audit Findings Perform Internal Audit Awareness Training Management Review Document Review Design, Document, Implement Solutions Gap Assessment
- 18. Critical Path • Leadership awareness, training and engagement • Redevelopment of processes, procedures for process approach • Structure, interrelationships, pervasiveness • New processes • New involvement of Quality into strategic and business processes • Substantial effort Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 18
- 19. Cavendish Scott, Inc. • Standard ISO 9001:2015 training classes – Free Webinars – Custom leadership training – Awareness presentations – ISO standard review – IRCA Transition Training – IRCA ISO 9001:2015 Lead Auditor • Standard ISO 9001:2016 transition consulting projects – Procedure development/change, leadership and management support/training, document review, auditing • Auditing, document review and gap analysis/project planning Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 19
Notes de l'éditeur
- January 19, Loveland Colorado. Tonight, the Northern Colorado ASQ (American Society for Quality) demonstrated the leading nature of their management team by holding a presentation looking at the future of management and management systems. Simultaneously CPR was interviewing a Northern Colorado business leader on the importance of and revival of manufacturing. A good day for Northern Colorado business. The ASQ Presentation was held at the premises of major northern Colorado manufacturer, and attendees were crammed to standing room only. Management topics were discussed by industry leaders and quality professionals with the emphasis on the future – systems for managing organizations.
- ISO is responsible for thousands of standards. One frequent example is management system standards (27001, 9001, 14001, 45001, 22000) One complaint against ISO was the subtle difference between the standards, which are not substantive but which cause effort to address. Also an organization has a single was of operating. A single management system. That system has to/could meet different standards but with meaningful differences in standards it is difficult and costly to maintain. The solution is to publish a guide for the developers of all ISO standards that are management system standards. This resulted in a document (annex SL) that outlines the structure of an organizational management system. The structure will cope with different objectives (quality, environmental control, information security, safety, etc.) but assures consistency. All management system standards will be developed around this structure and common terminology. Standards developers may change the content of the requirements but they have to justify the change and the change has to be restricted. Annex SL is the solution. It ensures consistency between different standards, assures common terminology and greater consistency (changes will be rarer) This has been incorporated into 9001:2015
- Many standards are committed to this new approach while others have not. For instance 13485 will not adopt the new approach and sticks with the old structure of 9001:2008. Their argument, among others was that they were ahead of the 9001 development and thus they had to stick with their approach. Eventually we will see all management systems adopt this approach. “it just makes sense”
- During development of ISO 9001:2015, the committees and groups voiced their logic about the development. They talked about how they expected the new standard to be adopted. Some of these expectations got the backing of specific requirements in the standard. Others got commentary in Annex A and others got less traction.
- This annex provides commentary and help. A1 – relates to the adoption of annex SL A2 – emphasizes the applicability to services as well as products. A3 – is a description of a requirement 4.2 about interested parties and clarifies that you should understand their needs but need not address them. A4 – describes the requirement for risk but emphasizes a practice approach. Risk “management” is not mandatory A5 – replaces exclusions A6 – gives mention to some awkward terminology replacing records and documents with documented information A7 – discusses knowledge which is an obvious resource but which is new to ISO 9001. A8 – covers new terminology for purchasing and suppliers but also extends the need to in house/excluded, corporate provide services, etc.
- Note – a) is similar to g) (but different of course) Accountability is difficult to implement and audit – focus on effectiveness. c. Not a separate system – managements fault if it is. d. Must lead and commit to the process approach (no more ISO numbered procedures, focus on processes [inputs, outputs, controls, metrics, objectives, etc.] risk (preventive thinking) g. Focus on success. Demonstrate leading and committing to the principle of improving things. j. Demonstration of support
- Summary of the changes
- These occur in various places and are examples of the greater flexibility that ISO provides. Its down to you to consider but decide, and to do until its good enough for you – but be prepared to justify this and be wary that some auditors may not be as clear about this in the early days of auditing the standard.
- Basically the same… focus on PDCA
- One of the most important issues is that the restructuring of the QMS provides significant interaction and interdependency on processes. Way more that it has ever emphasized. For instance – here are places that your analysis of Issues could impact. And its vice versa. For instances, when a change occurs, you need to consider if that came about because of a change in environment/issues, what risks might change and does that mean different communication? Potentially extremely complicated. You cannot simply develop processes to meet the requirements (lilsted here) and operate them in isolation. Its complicated.
- Attention of management. Properly resourced, clear authority, focus on tangible business success True integration of a single system
- Ask your Certification Body. Soon. They would ideally provide a document that explains how they will treat some of the issues mentioned earlier – how will they look at “less or no” documentation, what about verbal evidence? What will/wont they accept to demonstrate “accountability”. They don’t have to do this but its not unreasonable to ask. Actually if they don’t do this they will have huge variation in how their auditors perform.
- A lot of effort.
- Longer than you think. Work back from your planned transition audit Start early
- Summary of the things to focus on Management understanding that this is not a simple paperwork fix is critical and the most significant. New processes (for which many quality people have been excluded and will have to learn before they adopt) are not insignificant. If you have a standards based documentation set – e.g. numbered after the standard, they redeleoping all documents for the process approach is significant.
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