ISO 9001: Summary of contents
ISO 9001 (and the other documents within the series) are subject to copyright. Consequently we can’t reproduce the standard in its entirety. To study the content in detail you will need to acquire a genuine standard for reference purposes. Standards can be purchased from BSI, follow this link to purchase on line
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However, we will explore the contents of the standard at summary level, to help you understand its content and application. The following table summarises the main requirements of ISO 9001. The “notes” column will help you understand the general intent and application of each part
ISO 9001 Clause (s) or Section |
General content |
Notes |
Section 0 Introduction |
Explanation of the “process |
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 |
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 |
It identifies that all references within ISO 9001 should relate to ISO 9000 definitions |
Section 3 Terms and definitions |
Explanation of a small number |
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
|
Section 4 Quality Management |
This section defines the |
These requirements will be assessed at a high level during a stage 1 third party assessment. The auditor will take a general view whether there is a general sufficiency of documentation to make a more detailed (stage 2) assessment worthwhile Control of Documents and Control of Records are mandatory procedures |
Section 5 Management |
This section identifies a set |
These are aspects of the system that cannot be delegated in their entirety to the QA Manager. It includes requirements to provide resources, clarify responsibilities and reporting lines, ensure communication processes are effective and to actively participate in management review and objective setting |
Section 6 Resource management
|
Section includes · · · |
Often viewed almost as an “any other business” section of the standard, it includes Human Resource requirements (including training), Infrastructure requirements (ensuring sufficiency of workspace, equipment and so on), and environmental control requirements (this could cover maintenance of standards in a “clean room” or a “dark room”, or temperature, noise or humidity control requirements |
Section 7 Product realisation
|
Defines the controls associated |
Product realisation? Generally this is not a term in common everyday use and the title itself causes a certain amount of confusion. Let’s simplify it. “Product Realisation” can mean “Production” or “Manufacturing” in a manufacturing operation, or it would translate as “Service Delivery” in a service provider. Substitute these terms and it will all make so much more sense The section covers a range of typical operational control issues, such as operation planning (7.1), ordering and contracts processes (7.2), Design (7.3), Purchasing – this includes supplier approval- (7.4), general process control – including preservation and prevention of damage to customer property and traceability (7.5) and calibration (7.6) Clauses form this section may be excluded if they do not apply to the company’s sphere of work (clause 1.2 refers) |
Section 8 Measurement, analysis |
This is the section that can be · · · |
Most of the clauses within this section have a direct interface with clause 5.6 (management review) as they generate important performance data that should be used to inform future policy and decision making. The remaining 4 mandatory procedural requirements are contained within this section, they are: 8.2.2 Internal audits 8.3 Control of non-conforming product 8.5.2 Corrective action 8.5.3 Preventative action |
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