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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.
The same thing happens when writing ISO 9001 quality manuals - very often some of the requirements of the standard are forgotten and not addressed.
Fortunately, there is a simple solution - use a checklist. Aquality manual for ISO 9001 standard can be a somewhat complex document. It is not unusual that some of requirements may be missed and not addressed in thequality manual. Using a checklist will help you remember to address all the requirements. This is why manyregistrars use quality manual review checklists. If you are in the process of developing or tuning up your qualitymanual, you might ask your registrar for a checklist. If your registrar doesnt have it, we will develop our own.
It is relatively easy to develop a checklist for ISO 9001:2000 quality manual. We can start from the "30-thousand feet" view by establishing a framework similar to a table of contents. You can list titles of the elements that are applicable to your QMS, such as the Scope, Application, Terms and definitions, Quality management system, General requirements, etc.
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 3-4column 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 recordingsections titles: 6 - Resource management; 6.1 Provision of resources, 6.2 - Human resources, 6.2.1 - General, etc.
After creating this Table of contents, continue adding other requirements for the corresponding clauses of the standard. We will review element 6.2.2 as an example. The first requirement of this element is: "Personnel performing work affecting product quality shall be competent on the basis of appropriateeducation, training, skills and experience." Depending on how detailed you want your checklist to be, you may include the entire requirement or split it into sub- elements: 6.2.2.i - Personnel performing work affecting product quality shall be competent on the basis of appropriate education; 6.2.2.ii - Personnel performingwork affecting product quality shall be competent on the basis of training, etc.
Following this process of increasing details within yourchecklist, you eventually will get to the level when your checklist will be practical for your business and at thesame time will make sure it verifies compliance with the standard.
The process above described a way to prepare a checklist for verifying quality manual for one standard. Infact, many organizations develop management systems for more than one standard. As an auditor, very often I see integrated ISO 9001 / ISO 14001 management systems. Dont 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.