What is Documented information as per ISO 9001:2015?

As part of the alignment with other management system standards, a common clause on “documented information” has been adopted without significant change or addition in ISO 9001:2015.

Where appropriate, text elsewhere in this International Standard has been aligned with its requirements. Consequently, “documented information” is used for all document requirements. Where ISO 9001:2008 used specific terminology such as “document” or “documented procedures”, “quality manual” or “quality plan”, this edition of this International Standard defines requirements to “maintain documented information”.

Where ISO 9001:2008 used the term “records” to denote documents needed to provide evidence of conformity with requirements, this is now expressed as a requirement to “retain documented information”. The organization is responsible for determining what documented information needs to be retained, the period of time for which it is to be retained and the media to be used for its retention.

A requirement to “maintain” documented information does not exclude the possibility that the organization might also need to “retain” that same documented information for a particular purpose, e.g. to retain previous versions of it. Where this International Standard refers to “information” rather than “documented information” (e.g. in 4.1: “The organization shall monitor and review the information about these external and internal issues”), there is no requirement that this information is to be documented. In such situations, the organization can decide whether or not it is necessary or appropriate to maintain documented information.