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.
Please feel free to comment. If you want to know more about ISO consider attending one of our Quality Management Systems training courses.
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Well synopsized!
Given the EU GMPs requirements are far more detailed and comprehensive than ISO, what is the specific driver for a pharma/biopharma manufacturer to have ISO certification? Or is it a prerequisite?
GMP does give more detail on Documentation than ISO, but historically has not included the need to a Quality Policy or Quality Manual.
Many of the latest GMP quality initiatives are coming from ISO principles. Don’t also forget that ISO covers the whole organisation, whereas GMP does not.
Also see posts on GMP versus ISO 9001
Yes really nice information about ISO standard 9001 and its based on eight quality principle
Customer focus
Leadership
Involvement of people
Process approach
System approach
Continual improvement
Factual approach to decision making, and
Mutually beneficial supplier relationship
Thanks for Sharing information about ISO 9001 documents for quality management system. I
above mentioned clauses from 4 to 8 is an important clauses of ISO 9001
You have great perception about ISO 9001 documents. Great article! I am sure this is going to help a lot of people.