Document Revision Criteria


Question

Is there any criteria available for the frequency of document revision in ISO 9001 or ISO 13485?  Some organization don’t revise the documents for a period of more than 2-3 years.  The reason provided by the organization is that there were no changes during this period. Do ISO standards mandate the revision of documents within a certain time frame? Can we treat this as non-compliance, if the documents are not revised over a period of 2-3 years ?
Answer

There are no criteria nor a requirement for document revision in ISO 9001:2015, 7.5.

ISO 13485:2016, 4.2.4, states, “review, update as necessary and re-approve documents.” This leave the review to the discretion of the organization.

Thus, there is no mandatory review frequency and no non-conformance if documents are not revised within a determined time frame.  ISO 13485 does require a review, however. But, the frequency of the review is not mandated.

George Hummel

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