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To be ISO 9000 compliant a document must:

  • be identifiable
  • be verifiable
  • be legible

identifiable

Each document must have some unique identification. this can be as simple as its title (you may only have one ’sales manual’ for example), or can be a more involved/useful numbering scheme (document 4.4.103, etc).

For most organisations the identifier is known. It is normally placed in the header/footer. A useful point is to make sure it appears on every page, even if the document is to be double-sided.

verifiable

Once we are able to identify if we’re reading the right document, we need to be able to verify it’s the right copy. This requires two things:

  • verify it’s the right version

    this requires some form of issue or version numbering. Simplest technique is either an issue date or a issue number. Unless there is some valid reason try not to use both together as it is overkill and can confuse people. Also if using issue dates for documents that do not change often it is possible to have a current version with an old issue date. If this could cause doubt (’why is the current version three years old?’) then consider using version numbers instead.
  • verify it’s complete

    this requires some form of numbering that allows you to know at a glance if the document is complete. For page numbering the common technique is the ‘page 3 of 6′ format. Another valid technique is to add a closing statement at the end, eg ‘this is the end of the xyz procedure’. For online documents, the verification is usually part of the design (eg a web page ends with a standard footer, etc).

legible

Finally, ISO documents need to be followed (like all documents, except this time an auditor comes and checks). However since no-one deliberately writes confusing and misleading documents I assume you have this point covered already. This section therefore address some of the definitions of ‘legible’ that a quality system auditor will be looking for.

When reviewing your document’s legibility it is worth understanding a little of how an auditor will review that legibility. An auditor will review a document for two main requirements.

  • Does it address all the requirements of the standard?
  • Is it likely to be followed?

The first point (addresses requirements) is not one of compliance, per se. It is determined by the design of your quality system. A document can be compliant with ISO 9000 but still be insufficient for certification if it does not address the certification requirements expected by your Quality Manual.

The latter point is gleaned from an impression of how easily the content can be understood and adhered to - the worse the impression the more likely that users will not have followed it, and thus the better the place to look to find inconsistencies between expected and actual behaviour. In essence, the more confusing the document, the more likely users will not have followed it, and the more time an auditor will spend looking for inconsistencies.

So what kind of particular questions will an auditor be asking when looking at a document?

  • Are the steps in any task clear and simple to follow?
  • Are responsibilities for the task clearly defined (by role, not name)?
  • Are references to other documents, or equipment, clear enough for users to follow correctly?
  • If records are kept of the task, are those records clearly defined?

documentation is compliant? now what?

Sitting above these individual document requirements is the issue of document control. This is the collective term for the procedures needed to look after our unique, verified, legible documents to ensure their content is correct and copies are given to the right people.

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