Understanding ISO 9001 Clause 7.5.2 Creating and updating (Documented information)

Unlock effective documentation strategies with Clause 7.5.2 Creating and Updating.

Today I'm going to cover clause 7.5.2 Creating and updating which is a subclause of Clause 7.5 Documented Information. 

This clause states that ...

When creating and updating documented information, the organization shall ensure appropriate:

a) identification and description (e.g. a title, date, author, or reference number)

You will see that ISO 9001 has kindly provided some examples of which they say are title, date, author, or reference number. When we are looking for documentation, we want to understand what it is - so that is identification and description.

This could possibly be the name of the documented information which should be relevant to what the file actually is. It would be great if there was a date or a revision or version number included as well because when we are looking for documented information, we want to know whether it is current or not. 

Some documented information might also have who the author is. These are all just examples, so it doesn't mean that all of them are mandatory, however, you need to decide what form of identification and descriptors you will use and is relevant to your own business or system. 

Then there is ...

b) format (e.g. language, software version, graphics) and media (e.g paper, electronic)

Documented information can be in many formats and media. I'm probably stating the obvious there, but when we think of documented information, we might traditionally just go back to thinking about written procedures, however, documented information can be in the form of:

• images or graphics
• software
• marketing collateral
• video training that you produce

All of those types of documented information still need this identification and description, but you need to determine what these different formats and media are. And getting right back to basics it could be as simple as being in paper format or electronic. You need to determine this format and media for your own business and system and what is most relevant.

And then finally ...

c) review and approval for suitability and adequacy

Part of your system or your process when you create and update your documented information is that you need to have some sort of review and approval process. You might have a Subject Matter Expert document a new procedure or update an existing procedure, however, it still should always go through a review process to ensure that someone is checking to determine its accuracy, whether it actually makes sense and can be followed and then for final approval. Also determine who is the most competent to approve that final revision of your documented information prior to release, whether that release is internal or external.

I hope that explains this little tiny part of Clause 7.5 Documented information, which is all about creating and updating your documented information.

If you haven't already, check out ISO 9001 Clause 7.5.1 and ISO 9001 Clause 7.5.3 to get a full understanding of the overarching Clause 7.5 Documented information.

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