By Mike Richman
This regular column in The Auditor is intended to shine a light on the people, standards, and events that mean the most to auditors and registered organizations.
In this segment, we chat with Joana dos Guimarães Sá, the co-convener of ISO 9001 APG, the Auditing Practices Group of the committee responsible for ISO 9001, ISO/TC 176. She is offering a presentation titled, “Scope and Applicability in ISO 9001:2015” during Exemplar Global’s forthcoming Future of Auditing Expo.
Mike Richman: Joana, why is scope such an important concept for auditors to understand in the current version of ISO 9001?
Joana dos Guimarães Sá: First, because there was a careful rewording of this section (in the 2015 version of the standard) to reinforce and clarify the requirements related to the scope of the QMS, its application, and its boundaries. This revision of the QMS scope requirements makes them closer to the needs of the certification’s scope. Furthermore, it establishes an important linkage between the relevant issues identified at a context level to the determination of scope by the organization, which is a very important audit trail.
Second, the scope of the QMS changes with time as organizations also change, and understanding this dynamic is very important in the auditing process.
Third, the scope of the QMS has many implications in determining the scope, preparation, and execution of the audit itself.
ISO 9001 APG felt the need to revise the existing paper on these topics to reflect more deeply on these changes and to address the relationship with the scope of the audit. This newly revised paper will soon be available here. At this site you will find several other valuable resources as well.
MR: In your upcoming presentation at the Future of Auditing Expo, you are also going to discuss non-applicable requirements of the standard. How do organizations and auditors determine that, and how is this different from the “allowed exclusions” language in previous versions of ISO 9001?
JdGS: During the ISO 9001:2015 revision process, WG 24 was very careful in introducing this shift. The group clarified that this was not a question of choice or tailoring (in principle, everything in the standard is applicable), however, the need was recognized to accommodate situations where it is perfectly justifiable not to apply certain requirements.
MR: How does scope and applicability affect interested external parties, particularly customers of the organization?
JdGS: I would put your question in the reverse order! How do interested external parties, particularly customers of the organization, affect the scope of the QMS? The standard makes the importance of this linkage very clear in clause 4.3. The scope is determined by the organization considering the issues identified in the context analysis, where their relevant issues are determined.
We hope that auditors will read ISO 9001 APG’s forthcoming paper and do a thorough evaluation of scope, leading to scope statements that clearly reflect the products and services the organization demonstrates it is able to provide. This will improve customer confidence.
Exemplar Global’s Future of Auditing Expo will take place October 14–31. Click here to register.
About the author
Mike Richman is the principal of Richman Business Media Consulting, a marketing and public relations company working with clients in the worlds of manufacturing, consumer products, politics, and education. Richman also hosts the web television program NorCal News Now, which focuses on social, economic, and political issues in California. He is a contributor to (and former publisher of) Quality Digest.