Documents required by ISO 9001

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.

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7 Comments

Stephanie on March 6, 2012 at 10:10 am

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?

Dominic Parry on March 6, 2012 at 4:14 pm

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.
Reply
Dominic Parry on March 6, 2012 at 10:56 pm

Also see posts on GMP versus ISO 9001
Reply

normas iso 9001 on February 21, 2013 at 11:44 am

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

ISO Manual on July 27, 2013 at 11:35 am

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

isocertificationias on October 18, 2013 at 6:47 am

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

iso 9001 documents on October 25, 2013 at 11:37 am

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

Let us know what you think Cancel reply

Stephanie on March 6, 2012 at 10:10 am

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?
- Dominic Parry on March 6, 2012 at 4:14 pm
  
  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.
- Dominic Parry on March 6, 2012 at 10:56 pm
  
  Also see posts on GMP versus ISO 9001
normas iso 9001 on February 21, 2013 at 11:44 am

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
ISO Manual on July 27, 2013 at 11:35 am

Thanks for Sharing information about ISO 9001 documents for quality management system. I
isocertificationias on October 18, 2013 at 6:47 am

above mentioned clauses from 4 to 8 is an important clauses of ISO 9001
iso 9001 documents on October 25, 2013 at 11:37 am

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