subject: Quality Manual Review Checklist For Iso 9001:2000 Qms [print this page] 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.
The same thing happens when writing ISO 9001 quality manuals - very often some of the requirements of the standard are forgotten and not addressed.
Well, let's talk about how to remember all those elements of the standard. Even if your quality manual is for just one standard and you have a lot of exclusions, the manual still may be a rather detailed document. Even after years and years of consulting and auditing, I would not be certain that I could prepare a quality manual from scratch without a checklist to reflect all the requirements of ISO 9001:2000 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.
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.
Following this process of increasing details within your checklist, you eventually will get to the level when your checklist will be practical for your business and at the same time will make sure it verifies compliance with the standard.
This far we spoke about a checklist for just one, ISO 9001 Standard. However, rarely companies establish management systems to comply with one standard. Very often business have to comply with numerous standards and regulations. For example, medical device manufacturers are expected to comply not only with ISO 13485, but also with FDA Regulations. Checklist for an integrated management system will be prepared the same way as the one for ISO 9001 standard. You just need to add to your list those requirements that are not included in the set of requirements which you started from.
To see how easy it is to develop a checklist for ISO 9001 quality manual review, click the link below:
