Advice on writing your ISO9001-2008 quality system documents

If you’re reading this, chances are you’ve thought about writing your company’s quality system documentation. This would include your quality manual, procedures, maybe some forms, and maybe some work instructions.

In ISO9001-2008, a documented quality manual and documented procedures are required. There are 6 quality procedures that are required under ISO9001-2008, but everyone ends up with more than 6. The 6 required procedures are as follows: Control of nonconforming materials, internal audit, control of documents, control of records, corrective actions, and preventive actions. You’ll very likely want to write up some more procedures for your organization. Procedures such as how to issue a purchase order, how to process a sales order, receiving inspection, shipping inspection, etc, are all very commonly used.

Now don’t go overthinking this. This does not mean that you have to have a 50 page manual. Each of these procedures could be written in a paragraph or 2 if that’s all you need to adequately describe how you do it. I generally like to keep each procedure down to 1 or 2 pages, maximum. Unless they are particularly complicated, most documented procedures can be written on 1 page.

Your quality manual can also be very simple. It could be a matter of 3 or 4 pages. Each paragraph could say something like “We conduct periodic internal audits. The internal audit procedure is the responsbility of the Quality Manager. See procedure number 8 for how we conduct internal audits.”

You don’t necessarily have to have a documented procedure for everything you do. For example, in ISO9001-2008 it’s a requirement that you evaluate and approve vendors. You may find it very useful to have a documented procedure on how this is done, but it’s not a requirement. If your organization is very small, and the vendor evaluation process can be covered by training, you may not need to document this process. Of course you’d better be prepared to defend yourself during your third-party audit. But if you can intelligently describe the process to the auditor, and you’ve got the records to prove that you’re in compliance with the ISO9001 standard, then you don’t necessarily need a documented procedure.

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2 Responses to “Advice on writing your ISO9001-2008 quality system documents”

  1. Mari says:

    Management review is NOT a requested (mandatory) procedure! Please, please, STOP missinforming people!!!

  2. Joe Monahan says:

    I’ve clients who have written their QMS using only the ISO9001:2008 text, again, “only” the ISO text
    (example: – 5.4.1 Quality Objectives – Top management shall ensure that quality objectives, etc.”)

    They want to know what specifies that they have to describe their system.

    (“Just because 4.1 says that they have to determine processes etc. what says the quality manual is required to have each ISO requirement documented with their processes in the quality manual? Can’t the quality manual just say that we shall do – without actually writing it out?”)

    (Yes, they really believe this – yes, they can actually read – no, they really don’t understand)

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