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Is your ISO 9001 Quality Manual Complete? Checklist Will Tell

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.
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.
Let's design our checklist as a three-column table. Let's title our columns: "No." for the standard section number, "Title/Requirement" for the content and "Addressed" for the location of the response. For example, clause 4 starts from its title: Quality management system. Let's enter this title. The entry in the "No." column is 4, The Title/Requirement column will state "Quality management system", and the "Addressed" column may indicate QM 4, meaning that this title or requirement is present in the Quality Manual, section 4.
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 appropriate education, 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 performing work affecting product quality shall be competent on the basis of training, 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.
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Article Source: http://articles.yournetguru.com

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