ISO 9001 Frequently Asked Questions (FAQ's) Cut and Pasted from the ISO Site - Update August 2022

Peter Fraser

Trusted Information Resource
Oh Sydney...(!)
<6. What is meant by the process approach?
The process approach is one of the seven principles of the Standard. Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system.
The rationale is that the quality management system consists of interrelated processes. Understanding how results are produced by this system enables an organization to optimize the system and its performance.>
So the definition of a management system has changed (again)? ISO 9000:2015 states: "A QMS comprises activities by which the organization identifies its objectives and determines the processes and resources required to achieve desired results" - so it doesn't involve actually achieving anything other than identifying and determining something.
Yet in Annex SL: "management system = set of interrelated or interacting elements of an organization to establish policies and objectives and processes to achieve those objectives" — so we are back to "doing" as well as "preparing".
Oh for a single, clear Glossary!

Sidney Vianna

Post Responsibly
Being 100% honest, Peter, I am not overly concerned with the apparent lack of coherent definitions for what a quality system is. For the overwhelming majority of people implementing the standard, such inconsistencies have zero impact.

To me, one of the BIGGEST flaws by the TC 176 SC2 is their inability to explain to users that the quality system is (or has to be) seamlessly embedded in the organization's operational processes and business practices. Sure, the standard itself requires that in 5.1.1.c) ensuring the integration of the quality management system requirements into the organization’s business processes; but there is no real support guidance material connecting the dots to inexperienced users. That's why, to this day, so many people don't understand what a quality system really is and have a huge challenge identifying the "processes that comprise the quality system". The way is described in these definitions is so out of touch with real world organizations that makes it unrelatable.

Peter Fraser

Trusted Information Resource

I agree to an extent, but I would be much happier if they started from the position that an organisation has one management system, and QHSE management etc is part of that existing system.
So a QMS is "those aspects of an Organisation’s (single) management system which impact on the Organisation’s capability to deliver outputs that produce satisfied stakeholders"
- where the (business) management system is “the interrelated or interacting elements which establishes and maintains business policy and objectives and seeks to achieve those objectives”.
The same QMS logic applies to an “environmental management system”, or an “information management system”, whereby you identify those aspects of the (single) system that impact on the element in question.
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