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.
Please feel free to comment. If you want to know more about ISO consider attending one of our Quality Management Systems training courses.
Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.
Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.
While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.
About the author
Andy Martin
Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew. Following this he had a number of roles culminating when he took over as QA Microbiology Manager. In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions. Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.
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There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.
Our 2-day course is updated for Annex 1 changes
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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.