ISO 9001 Requirements
ISO 9001 Requirements Clause 7.5 Documented information
ISO has provided substantial guidance on Documented Information. So rather than reinventing the wheel, I will provide you their formal guidance below. I will follow that with specific guidance of my own to wrap this section up.
Annex A (Informative) (from the ISO 9001 standard)
A.6 Documented information
As part of the alignment with other management system standards, a common clause on “documented information” has been adopted without significant change or addition (see7.5). Where appropriate, text elsewhere in this International Standard has been aligned with its requirements. Consequently, “documented information” is used in all document requirements.
Where ISO 9001:2008 used specific terminology such as” document” or “documented procedures”, “quality manual” or “quality plans”, 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 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 must 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.
Also refer to the ISO Guidance on the requirements for Documented Information of ISO 9001:2015
This article is an extract from my eCourse “Understanding ISO 9001:2015”. The rest of the article on this clause discusses in detail the specific controls to address each of the specific requirements of clause 7.5