This very interactive Course is primarily designed for existing ISO 9001: 2008 IRCA Registered QMS Auditors and Lead Auditors who wish to update their knowledge and skills to cover the ISO 9001: 2015 standard. The course will however be extremely useful for anyone who wishes to understand how ISO 9001 has evolved to meet the needs of the modern world - whether they are top management, auditees, consultants, implementers or quality professionals.
Lectures are kept to a minimum with most of the learning being achieved by carefully designed exercises. In particular this is done by performing real auditing on a sophisticated Company simulation. The purpose of this being to determine whether or not the Company has successfully managed the transition from ISO 9001:2008 to ISO 9001: 2015.
- Module 1 covers the changes arising as a result of the adoption of Annex SL.
- Module 2 covers the changes arising as a result of amendments to the quality management system (QMS) specific content of ISO 9001: 2008.
On successfully completing the course delegates should be able to:
- Know and understand Annex SL as a framework for ISO management systems
- Know and understand the requirements of ISO 9001: 2015
- Be able to effectively audit ISO 9001:2015 based QMS requirements.
In order that the course flows logically it does not focus on Annex SL on the first day and ISO 9001: 2015 on the second day. Instead the content of the two modules is combined throughout the two days. This means we can work through Annex SL step by step whilst looking at the additional requirements that ISO 9001 adds above and beyond each clause of Annex SL. The course starts by looking at the shape of Annex SL – which is the shape that all ISO management standards, for all technical disciplines, will now have to follow. The idea being that if an organisation wants to have an integrated management system, covering for example ISO 9001, ISO 14001 (Environmental) and ISO 45001 (the 2016 standard for Health and Safety) then the system becomes easier to implement and maintain. This is because all three standards will have the same basic wording so that common elements such as documented systems, internal audits, management review and external suppliers are similar in all three standards.
The key concepts in ISO 9001:2015 are explained, for example covering:
- How the standard is an evolution rather than a revolution
- The seven quality principles that drive ISO 9001:2015
- The updated Plan Do Check Act cycle
- More emphasis on a process approach
- The idea of ‘context’ or how an organisation fits within the business universe by looking at all interested parties and not just the customer
- The focus on internal as well as external parties
- The concept of documented information
- The removal of ‘Exclusions’ from ISO 9001
- How top management has to actively drive the system and cannot delegate everything to the Quality Manager or Quality Management Representative
- How the emphasis has moved from ISO specifying mandatory procedures and records to the organisation identifying what they need to run the organisation effectively
- The inclusion of ‘risks’ and ‘opportunities’ as a requirement within the standard
- How auditing needs to become more sophisticated to cover situations where a system works well but conformance has to be mainly determined by interview rather than records.
The Course then moves on to developing the practical skills auditors will need in the real world when auditing to the new standard. This is achieved by delegates performing face-to-face interviews and audits on a realistic Case Study Company - the Company concerned having performed a gap-analysis to determine compliance to the new standard before creating and implementing a plan for updating their management system. This exercise incorporates all the key changes contained within the new standard.
Please note: As this course covers Module 1 for Annex SL, then once you have successfully completed this course, you do not have to repeat Module 1 for other ISO management standards.
For example you would only need to attend a half-day IRCA Registered Course to cover transition to the ISO 14001 standard.