Understanding the Role of Procedures in QMS Documents

After receiving this and similar questions from our readers regarding referencing procedures in the Process Map or Quality Manual, we chose to examine the best alternatives for including documents in those QMS documents.

Do Procedures Need to Appear in the Process Map?

First of all, procedures do not necessarily have to be included in the Process Map, but the processes do. We at Mireaux like to pair processes with a corresponding procedure when those processes have a one-to-one relationship to the procedures, but it is not a requirement. Therefore, if the procedure you are creating introduces another process in your business that affects, or is part of your QMS, then it may be necessary to alter your Process Map to reflect the change.

Referencing Procedures in the Quality Manual

However, this addresses the first part of our reader’s question, the second part regarding inclusion of documents into the Quality Manual is a different issue and similar to a question another reader asked:

“I was going through all of our documents today and noticed there are several procedures that are not referenced in the API Q1 Quality Manual. Do we need to go back and add a reference to all of these procedures in the Quality Manual?”

Two Approaches to Referencing Procedures

The question revolves now as whether ALL procedures need to be referenced in the Quality Manual or not. There are two schools of thought regarding adding all procedures in the Quality Manual:

• One is to refer to ALL procedures in the Quality Manual.
• The other is to refer only to those procedures that are relevant to the core requirements of the standard you are trying to satisfy (ISO 9001, API Q1, API Spec Q2, etc.).

Which Approach Does Mireaux Recommend?

If you know me, you probably already know that I belong to the second school. In my view, only the core procedures should be referenced, especially if the company has a lot of procedures. Hence, for companies with a small number of procedures, this is a non-issue. But for companies with a large quantity of procedures, trying to reference all procedures in the Quality Manual can become a concern – which is almost nonsense to have an issue when you have done such a great job of creating procedures for your organization.

How to Decide Whether to Update Your Quality Manual

At Mireaux, we coach our Clients that if there are too many procedures, chances are some are probably good candidates to be work instructions, especially if they depict tactical instructions on how to do a job. So, if you create a procedure, just ask yourself whether they represent a new process or whether it affects any core requirements of the standard. If your answer is yes to either question, then look for the correct area of the Quality Manual to word it in, otherwise you don’t have to change anything. For example, if the procedure you created involves finance instructions, then chances are no changes to the Quality Manual or Process Map are needed because the standard (assuming ISO 9001 or API Q1/Q2) has no requirements specific to Accounting –unless you are certifying the Accounting functions.

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