Quality Manual Review Checklist for ISO 9001:2000 QMS

Some people call it "senior moments", some people call it "spaced it out", simply speaking, we all sometimes forget something - human nature.
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.
Obviously, there are numerous ways to design a checklist. Most typical format I have seen through my auditing career was a 3-column table allowing documentation of the number of the clause, the content of the requirement and the location of response to this particular clause. Take a look at the following example: Element 5 of the standard starts from the title: "Management responsibility". Clause 5.1 is a title also. Numbering these titles 5 and 5.1 respectively, placing these titles in the checklist and indicating where in the QMS these titles are located will give us a starting point.
Placing the titles and therefore establishing so to speak, the skeleton, of our checklist gives us a matrix to position other requirements. As an example take a look at the element 5. Since we already documented the titles 5 and 5.1, we need to "dig" deeper. The first requirement of the element 5.1 is: "Top management shall provide evidence of its commitment to the development and implementation of the QMS" So, we will add this requirement to our checklists as: element No. - 5.1, Title - as it stated above. When you fill out your checklist, you obviously need to indicate where this commitment is located. To evaluate if this requirement addressed satisfactorily in the manual, you may check if this commitment is supported by management review activities, allocation of resources, etc.
Using this approach of increasing level of details of your checklist, you will be able to create a checklist that meets needs of your organization and requirements of ISO 9001 standard.
You may wonder how this ISO 9001 quality manual review checklist will help you if you need to verify a manual for let's say ISO 9001, ISO 13485 and ISO 14001. Good point! Actually adding elements of other standards or regulations, such as Canadian medical device regulations, to your checklist follows the same process that we used before. When you identified those requirements that are specific to the additional documents, just put them in the appropriate places within the checklist that you already developed.
To see how easy it is to develop a checklist for ISO 9001 quality manual review, click the link below:

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