PLEASE NOTE: THIS ARTICLE IS NO LONGER RELEVANT AS THE 2015 VERSION DOES NOT INCLUDE ANY SPECIFIC REQUIREMENTS FOR DOCUMENTATION
The ISO 9001 standard is the international standard for Quality Management Systems. During its review in the late 1990 they removed its “obsession” of needing a documented procedure to cover most tasks. This is because organisations vary in size and complexity, and it may not be necessary to control an activity via an approved procedure. There are many things that we do in life every day that are not subject to a formal procedure, yet we do them without any problems.
The current 2008 version of ISO 9001 requires 6 documented procedures. These are as follows:
Control of documents (4.2.3)
Control of records (4.2.4)
Internal audit (8.2.2)
Control of non-conforming product (8.3)
Corrective action (8.5.2)
Preventive action (8.5.3)
Procedures can be combined if needed, such as a procedure that covers both control of documents and records.
You also need to have a Quality Manual (4.2.1b) that describes the whole quality management system. In addition you also need to have a Quality Policy (4.2.1a) and Quality Objectives (4.2.1a). These are not strictly speaking procedures, but are documents.
An organisation can also chose to have additional procedures to control activities as it sees necessary (4.2.1d). So they may well have more than the 6 required approved procedures, but that is their choice.
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