Document Review: Do I Have To?

ISO 9001 requires that your procedures and work instructions are always accurate

Deciding how to control your documents can be difficult. ISO 9001, the quality management system (QMS) standard from the International Organization for Standardization (ISO), requires you maintain accurate and up-to-date procedures, but doesn’t give a lot of guidance on how to get there. Between the requirements and the implementation lie grey areas and confusion. Let’s take a look at the difference between what is required and what is a good idea in the world of document review.

When I say procedures, what does that include?

A procedure is a way of carrying out an activity; it explains who does what, where, and when; it’s a document that defines a process. ISO requires that your procedures, work instructions, etc. are always accurate and truly represent the steps to completing a process. How you ensure that accuracy is up to you.

A procedure could describe the process for obtaining customer feedback (e.g., using scheduled customer surveys, or calling customers and saying specific scripts). Review procedures to ensure workers have the most current, complete, and accurate information to do their job.

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Comments

Procedures

Hello Miriam,

Nice article, thank you. I often use two meanings for "procedure". One is the ISO 9000/quality system context in which procedures are level 2 documents, distinguished from level 3 work instructions. Another meaning for me is "all written processes" or even "all processes whether written or not". Of course some people like to debate this meaning. In your article you seem to use procedures to mean "all written processes". Do you agree with that usage? If not, what term do you use when you want to say, "procedures and work instructions, but not forms"?

Jim Cook

Procedures vs Work Instructions

Thanks for your readership Jim! Ahh...the old pyramid of procedures, work instructions, etc. You are correct, I talk about procedures in general terms because in my view everything that provides a way to do something is a procedure. So a Work Instructions is in essence a step-by-step procedure to do something. I probably should have said Documents. I do think Work Instructions should also be reviewed along with forms and any other policy or procedures. Reviewing all these "documents" on some kind of frequency should help keep the system in check - should people not be diligent about updating documents when processes change. Hope this helps! Miriam

Updating Quality Manual

Hi Miriam.

If you audit a plant and found out that the Quality Manual was created 4 years ago - would it be a major non-conformance or a minor non-conformance? Several members of the Quality Management team are not connected in the company.

Reynaldo

Re-authorization of Manual post Management Change

Hi Miriam,

Thanks for the great article and sharing your expertise.

Does a manual have to be re-authorized once the top management changes? For example, a CEO who authorized the manual is succeded, does the new CEO have to re-authorize and sign the same?

Thanks,

Rohit

Need clarification

Dear Ma, your article is very helpfu. Thanks

Please i need a clarification on the below question:

Does a manual/procedure have to be re-authorized once the top management changes? For example, the authorized person who prepared the documents resigned from the company, and a new person employed?

Thank you in advance