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Documents vs Records

What's the difference between a Document and a Record for ISO 9001?


Even though ISO 9001 calls them both "documented information", you don't want to confuse "Records" with "Documents", because they are handled quite differently.

In ISO 9001, a Document is information that must be "maintained" and a Record is information that must be "retained".

A Document will only have one valid version. It's describing the plan for how things should be done. Policies, procedures, manuals, specifications, SDS, are all examples of documents. A document gets updated (creating a new version that supersedes the old version). Keeping the information up to date is what ISO 9001 means by the information being "maintained".

A Record captures data and provides evidence of something that happened on a particular date (and time). Tax returns, meeting minutes, batch records, production reports, site safety inspections, audit reports, are all examples of records. You don't edit a record. To capture new data you'll create a new record, but this doesn't make the old record invalid. You can have many valid records and you're likely to want to view many of them at once - e.g. to see how the data changes over time. Records need to be stored and this is what ISO 9001 means by the information being "retained".

What about Forms?

Many people find it confusing when you're talking about a "form". Is a form a document or is it a record?

It changes!

The empty form is a document (this is the plan for what data you want to capture)

The completed form is a record (it holds data captured at a particular moment in time.)

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