Posted by & filed under ISO9001:2015.

 I have seen comments recently via LinkedIn where some contributors to the quality groups seem to be under the impression that no, or little, documentation is required to meet the ISO9001:2015 standard. No such luck; there are specific requirements under “Documented Information” and other clauses of the draft revision.

“Documented information”  replaces “Documentation Requirements”. It is defined as “information that is controlled and maintained by an organisation and the medium on which it is contained.” It can be in any format and media and from any source.  This will certainly include electronic media and the authorised signatories.

Although it appears that organisations will be able to choose when documentation is or is not required, records for quality-critical processes will have to be produced and maintained in current revision status, as before.

Question:  where in your organisation are documents required (records) or when can judgement of experienced and qualified staff be accepted in lieu of documents?

Documents can include those required to describe and manage the management system
and related processes. This means that all quality-critical processes, policies and procedures must be examined for evidence of results achieved.

A written and published quality policy is also required; (register on this website to see example).

The requirements are clear in that the quality policy shall

  • be available as documented information

  • be communicated within the organization

  • be available to interested parties, as appropriate.

  • be reviewed for continuing suitability


Ask the question:

If an assessor was examining your organization, would he or she be able to find the evidence (validation and verification) that the requirements of the standard and the quality system objectives had been met?

I think we will be relying on documented evidence as much as ever. I would be happy to hear from anyone who thinks otherwise.

Don’t be in hurry to throw out documentation or to abandon the Master Document List.



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