ISO 9001 Clause (s) or Section

General content

Notes

Section 0 Introduction

Explanation of the “process
approach”, “PDCA”, the ISO 9000 process model and compatibility with other
management standards

This section sets the scene for
the use of the standard. Its intent is to emphasise these important points of
understanding. In reality few people pay it much attention as it is not formally “assessed” during an audit. This may explain why many companies that adopt ISO 9001 have a weak understanding of “process management” and “PDCA”

Section 1 Scope

Explanation of how the standard
should be applied in terms of its scope and reference points

This section identifies those
parts of ISO 9001 that can be excluded from the assessment (only parts of section 7) and explains the only justification for such an exclusion (e.g.
you may only exclude clause 7.3 “design and development” if you have no design function or process)

Section 2 Normative references

Explains how the terms used
within the standard should be applied

It identifies that all references within ISO 9001 should relate to ISO 9000 definitions

Section 3 Terms and definitions

Explanation of a small number
of key terms and definitions

Clarification of how the terms
“product” and “supply chain” should be used

Note: sections 0-3 set the scene. They aim to help the effective and appropriate
use of the remaining clauses of ISO 9001. Sections 4-8 define the specific
system requirements. It is these requirements that are assessed during a full
systems audit to ISO 9001 by a third party certification body