What Is Documented Information In ISO 9001?
Before the release of ISO 9001:2015, there used to be two terms in ISO 9001: Documents and Records.
- Documents describe what needs to be done, and this includes quality manual, procedures, work instructions etc. Documents get changed or revised with time.
- Records are evidence of work been done. Records can not be changed (generally) and are retained.
In the 2015 version of ISO 9001, these two terms (documents and records) have been combined together and are now called Documented Information.
Documented Information (ISO 9001:2008 vs. ISO 9001:2015)
Where ISO 9001:2008 used terms such as “documents” or “documented procedures,” ISO 9001:2015 defines requirements to “maintain documented information.”
Where ISO 9001:2008 used the term “records” needed to provide evidence of conformity with requirements, ISO 9001:2015 expresses it as a requirement to “retain documented information”.