CHANGES UNDER ISO 9001:2015 AND HOW THEY WILL IMPACT AUDITORS AND QUALITY PROFESSIONALS

1. CHANGES UNDER ISO 9001:2015 AND HOW THEY WILL IMPACT AUDITORS AND QUALITY PROFESSIONALS • Richard Green, Head of Technical Services, • IRCA

2. ‘Spare me the jargon’ EQMS User Group 2015 Richard Green, Head of Technical Services

3. The Jargon Wall Risk The Norwegian Blue Leadership Annex SL Documented information Context Opportunities How far is London Waterloo? Don’t panic Mr Mainwaring! Auditor - > Assessor

4. The Jargon Wall Risk The Norwegian Blue Leadership Annex SL Documented information Context Opportunities How far is London Waterloo? Don’t panic Mr Mainwaring! Auditor - > Assessor

5. Annex SL ‘The most important management system event since the launch of ISO 9001 itself’ (IRCA) ISO problem –> ISO solution It is called Annex SL because it comes after Annex SK and before Annex SM (in ISO Directives Part 1) Annex SL = ‘The management system writers’ standard’

6. High Level Structure Identical Core Text Common Terms and Core Definitions Annex SL 5.  Leadership 5.1  Leadership and commitment Top management shall demonstrate leadership and commitment with respect to the XXX management system by: - ensuring that the XXX policy and XXX objectives are established and are compatible with the strategic direction of the organization - ensuring the integration of the XXX management system requirements into the organization’s business processes; - ensuring that the resources needed for the XXX management system are available Organization Interested Party Requirement Management system Top management Effectiveness Policy Objective Risk Competence Process Performance Outsource Monitoring Measurement Audit Conformity Nonconformity Corrective action Continual improvement Documented Information Clause 1 - Scope Clause 2 - Normative references Clause 3 - Terms and definitions Clause 4 - Context of the organization Clause 5 - Leadership Clause 6 - Planning Clause 7 - Support Clause 8 - Operation Clause 9 - Performance evaluation Clause 10 - Improvement

7. Annex SL ‘The adoption of Annex SL is the beginning of the end of the conflicts, duplication, confusion and misunderstanding arising from different management system standards’ Mike James, LRQA.

8. The Jargon Wall Risk The Norwegian Blue Leadership Annex SL Documented information Context Opportunities How far is London Waterloo? Don’t panic Mr Mainwaring! Auditor - > Assessor

9. How far is London Waterloo? 1.9 miles 113 miles The length of a journey depends not just on the destination but also, crucially, the start point.

10. The Jargon Wall Risk The Norwegian Blue Leadership Annex SL Documented information Context Opportunities How far is London Waterloo? Don’t panic Mr Mainwaring! Auditor - > Assessor

11. Leadership ‘management commitment’ replaced by ‘Leadership and commitment’ 3.05 - ‘top management’ – the person or group of people who directs or controls and organization at the highest level’. Top Managers -> There’s now stuff you cannot delegate but HAVE to do yourselves. ENSURING vs ENGAGING/ PROMOTING/ SUPPORTING Beware, the audit team cometh……

12. The Jargon Wall Risk The Norwegian Blue Leadership Annex SL Documented information Context Opportunities How far is London Waterloo? Don’t panic Mr Mainwaring! Auditor - > Assessor

13. The Norwegian Blue ‘The management representative ‘This is a dead parrot. It has ceased to be’

14. The Jargon Wall Risk The Norwegian Blue Leadership Annex SL Documented information Context Opportunities How far is London Waterloo? Don’t panic Mr Mainwaring! Auditor - > Assessor

15. Context of the organisation CONTEXT OF THE ORGANIZATION Determination of Scope of the XXX Management System (i.e. its’ boundaries and applicability) Determine those internal and external issue with the potential to affect the XXX management systems’ ability to achieve it’s intended results Determination of XXX policy and XXX objectives Determine the requirements of relevant interested parties (stakeholders) that are relevant to the XXX management system Determination of risk and opportunities as part of Planning Determination of processes necessary for considering and controlling ‘organisational knowledge’

16. Context of the organisation ‘The good news is that if your organisation was still in business when you left this morning the chances are it’s already got a pretty good understanding of what its’ Context is’. Unlike this lot!

17. The Jargon Wall Risk The Norwegian Blue Leadership Annex SL Documented information Context Opportunities How far is London Waterloo? Don’t panic Mr Mainwaring! Auditor - > Assessor

18. Risk 3.09 - risk ‘effect of uncertainty’ Note 1 to entry: An ‘effect’ is a deviation from the expected — positive or negative. Technical Committee 176 - ‘Holy wars’

19. Risk • 1. Determine the risks and opportunities that need to be addressed to: • give assurance that the XXX management system can achieve its intended outcome(s); • prevent, or reduce, undesired effects; • achieve continual improvement. • 2. The organization shall plan: • actions to address these risks and opportunities; • how to integrate and implement the actions into its XXX management system processes and evaluate the effectiveness of these actions. Annex SL does not prescribe or mandate a risk management methodology

20. The Jargon Wall Risk The Norwegian Blue Leadership Annex SL Documented information Context Opportunities How far is London Waterloo? Don’t panic Mr Mainwaring! Auditor - > Assessor

21. Policy Documented Information XXX Manual XXX Procedures Records and Forms Documented Information More freedom to decide what information you want to hold and how you want to hold it. Standards now refer to ‘retaining’ or ‘maintaining’ specific ‘documented information’. Documented information is media agnostic. You don’t have to throw out your XXX manual and XXX procedures if you don’t want to. If they work for you – keep them! Typical pre Annex SL documentation ‘pyramid’ Post Annex SL

22. The Jargon Wall Risk The Norwegian Blue Leadership Annex SL Documented information Context Opportunities How far is London Waterloo? Don’t panic Mr Mainwaring! Auditor - > Assessor

23. Auditor -> Assessor The way audits are planned, conducted and reported will need to change. Auditors will increasingly need to use their judgement = less black and white, more grey Auditors will need to upskill – increasing not just their knowledge of the new requirements but also their interpersonal skills, technical skills and sector awareness

24. The Jargon Wall Risk The Norwegian Blue Leadership Annex SL Documented information Context Opportunities How far is London Waterloo? Don’t panic Mr Mainwaring! Auditor - > Assessor

25. Opportunities For organisations – cost and efficiency savings if operating more than one management system. For quality managers – a greater duplication of requirements = less work to manage systems. More people helping you – no longer the ‘lone champion’ For auditors - should eventually make life easier for auditors = common requirements (but will bring other challenges)

26. The Jargon Wall Risk The Norwegian Blue Leadership Annex SL Documented information Context Opportunities How far is London Waterloo? Don’t panic Mr Mainwaring! Auditor - > Assessor

27. ‘Don’t panic Mr. Mainwaring’ • ISO 9001:2015 - September - 3 year transition • ISO 14001:2015 - October - 3 year transition • Increase awareness in your organisation • Speak to your certification body • Develop a transition plan • Upskill where necessary • Realise the opportunities We can help so stay in touch!

28. Thank you Richard Green, Head of Technical Services rgreen@irca.org