Overview of ISO9001

The remit of Technical Committee 176 (who maintain ISO9001) was to align the wording of the standard with ISO14001 and to make the wording more consistent, without significantly changing the meaning of the standard.

As a result, the changes are mainly limited to moving sentences around with some clauses, adding extra notes and so on. If your current system meets ISO9001:2000, it should probably meet ISO9001:2008. But there are a few changes that may mean that you might have to make changes. These are described in the following "clause by clause" pages.

I have marked significant changes using blue text, to help you identify them.

1 to 3 -  Scope, Normative References, Terms and Definitions

These clauses are not generally considered to form an "active" part of ISO9001. They are usually taken to be part of the introduction. It is possible to audit against each of these clauses, but it is rare to find an assessor who will do that. However, clause 1 does contain a specific set of requirements.

4 - Quality Management System

Your Quality Management System must contain various elements. This clause describes the requirements for your Quality Manual, control of documents, control of records, etc.

5 - Management Responsibility

Your "Top Management" must fulfil their part of this process. The standard states what it requires from them..

6 - Resource Management

You must supply sufficient resources so that your system can work. This includes facilities, people, training, supporting services, equipment, etc.

7 - Product Realization

You must control the process from quotation/receipt of order through design of product or service, procurement of parts, manufacture of goods or provision of your service, through to delivery and subsequent servicing. 

8 - Measurement, Analysis & Improvement

You must ensure that the services and/or products that you provide to your Customers are correct. 

You must check the goods or services and must obtain information about how "suitable" they are, then analyse that information and use it to improve your system.

You must monitor and evaluate how effectively your systems provide acceptable product and/or services, that meet all relevant requirements.

You must also control things that go wrong and seek ways to fix them, and to correct the underlying system and to prevent mistakes.