​The ISO 9001:2015 Quality Standard and ISO 14001:2015 Environmental Management Standard raise two key questions for many of our customers.

 Firstly, what does the term Documented Information mean exactly?

Secondly, what documented information are you required to maintain or retain?

ISO make its intent very clear.

One of the “most important objectives in the revision of the ISO 9000 series of standards” has been:

 “b. for the amount and detail of documentation required to be more relevant to the desired results of the           organisation’s process activities”.

Source: Guidance on the requirements for Documented Information of ISO 9001:2015 (www.iso.org/tc176/sc02/public)

There you go – straight from the horse’s mouth. Need more? ISO includes the following statement as a Note in requirement 7.5.1 of both 2015 Standards.

The extent of documented information for a quality management system can differ from one organisation to another due to:
— the size of organisation and its type of activities, processes, products and services;
—  the complexity of processes and their interactions;
—  the competence of persons”.

Clearly, ISO is enabling you to develop a level of documentation that suits your organisation and is sufficient to allow you to control and improve environmental or quality performance.

ISO has also substantially reduced the mandatory documentation required under ISO 9001:2008 and ISO 14001:2015, including:

​Now that you know where ISO is coming from, let’s look at our two questions.

Firstly, what does the term Documented Information mean exactly?

ISO defines “Documented Information” as “information required to be controlled and maintained by an organization and the medium on which it is contained” (ISO 14001:2015 – 3.3.2).

Secondly, what documented information are you required to maintain or retain?

The 2015 Standards introduce new terminology for a document (now “Maintained As” or “Maintain” documented information (the word “define” is also used)) and “record” (now “Retained As” documented information).

Examples are given in the diagram below.

 ​We like making compliance seriously simple.

For a full listing of all the documented information you must maintain or retain, visit our Resources Page.

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