ISO 9001 Quality Manual Checklist
Written by Mark Kaganov   
Tuesday, 06 October 2009 14:33
Did you ever arrive at your campsite and realize that you forgot your fishing rod or charcoal for the grill? Most likely at one time or another each of us have found ourselves in situations where we were so busy preparing for an event that we forgot something important.
by MarkKaganov


Did you ever arrive at your campsite and realize that you forgot your fishing rod or charcoal for the grill? Most likely at one time or another each of us have found ourselves in situations where we were so busy preparing for an event that we forgot something important.

Through my auditing career I found that often companies forget to include in their quality manuals various requirements of the standard.

Luckily we have a simple way out - we can use a quality manual review checklist. Depending on how detailed your manual is, what standards it addresses, the manual can become an intricate document. In my auditing practice I encountered numerous QMS where quality manuals did not reflect all required elements of the standard. Using a checklist will help you remember to address all the applicable requirements of the standard.

Creating a checklist for ISO 9001 standard is a relatively simple task. We basically need to transform the standard from its explicit set of requirements into a condensed list. Let's start from a big picture and make sure that our manual includes all elements of the standard that we wish to address in our quality manual, such as Application (1.2), Quality management system (4), Management responsibility (5), and so on.

Depending on the level of details that you wish to include in your checklist, this document may become a busy procedure. For practical purposes, I recommend a 3-4 column table for Clause number, spelled-out requirement and space for documenting where the response to a requirement is located in the QMS. In case of element six, as an example, we may begin from recording section's titles: 6 - Resource management; 6.1 Provision of resources, 6.2 - Human resources, 6.2.1 - General, etc.

This was a good start, but a list of titles of the standard will not help us a lot. To continue populating our checklist, we will include the requirements of sub-clauses of the standard. Let's explore element 4. We already indicated that the title of the section is present in our manual. Next, element 4.1 is a title also: General requirements. Similar to the title of the section 4, we can add it to our list. Under the section 4.1, we may start listing actual requirements. For example, the first requirement states: "The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with this international standard." Our checklist should prompt us to verify that our manual includes commitments to all these activities. For example, for the element 4.1.a, the checklist may indicate: "No."- 4.1.a, "Title/Requirement" - Identification of processes for QMS; "Addressed" - QM/4.1.a.

When you document all applicable requirements of ISO 9001 standard in your checklist, you will be able to verify if your quality manual meets the requirement of your company and the standard.

The process above described a way to prepare a checklist for verifying quality manual for one standard. In fact, many organizations develop management systems for more than one standard. As an auditor, very often I see integrated ISO 9001 / ISO 14001 management systems. Don't panic! The process is the same: integrate specific clauses on the second standard into your list which is based on the starting standard.

Check out hyperlinks below to read our paper on design of checklists - it is easy, simple and saves time.

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Ready to start working on your Quality Manual? Check out our ISO Checklist page to see how this publicatioon can help you writing your ISO 9001 Quality Manual.
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