Requirements

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4.0 QUALITY MANAGEMENT SYSTEM

Element 4.0 of ISO 9001:2000 is the first element of relevancy to the requirements of your business' quality management system. It is broken down into 2 distinct parts: "General Requirements", and "Documentation Requirements".

 

4.1 General Requirements

This talks about having a documented quality management system which needs to be kept current further more the quality management system should:

• identify all processes involved (and their sequences)
• ensure that these processes are effective - monitor, measure, and improve these processes
• and finally have sufficient resources.

Now this general requirement is duplicating requirements found in subsequent clauses. But I guess it’s good to reinforce these important aspects.

 

4.2.1 Documentation Requirements:

This is more specific and indicates the type & documentation required, namely:

• Quality policies and objectives
• A documented quality manual
• Documented procedures where required
• Records needed to demonstrate compliance.

 

4.2.2 Quality Manual:

It is necessary to document the scope of your quality management system including any relevant exclusions. Remember possible exclusions are only allowed from Requirement 7.0 Product/Service Realisation NO OTHERS. Also state the interaction between processes.

 

4.2.3 Control of Documents:

A document is defined as something describing HOW a practice is carried out. A real corner stone requirement. Ensure that only the correct documents are in use and formally issued to the right locations/ personnel. Controlled documents must be reviewed and approved prior to issuing. Ensure that a document register is kept. Regularly review the documents for suitability.

 

4.2.4 Control of Records:

A record is proof that an activity has taken place. In ISO terms, if it is not recorded it has not happened. So if it’s important, record it! Records, once created, must be stored safely and be easily retrievable when necessary. Furthermore, you must define

• how long you keep the records for
• where are they kept or stored
• how are they to be disposed