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Documents required by ISO 9001

March 2, 2012

Dominic Parry

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.

Please feel free to comment.  If you want to know more about ISO consider attending one of our Quality Management Systems training courses.

7 Comments

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  1. Stephanie #
    March 6, 2012

    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?

    • March 6, 2012

      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.

    • March 6, 2012

      Also see posts on GMP versus ISO 9001

  2. February 21, 2013

    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

  3. July 27, 2013

    Thanks for Sharing information about ISO 9001 documents for quality management system. I

  4. October 18, 2013

    above mentioned clauses from 4 to 8 is an important clauses of ISO 9001

  5. October 25, 2013

    You have great perception about ISO 9001 documents. Great article! I am sure this is going to help a lot of people.

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