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.

Actually, designing a quality manual review checklist is a pretty straightforward process. You may begin from establishing, so to speak, a table of contents or a top-level list containing section titles. Element eight, for example, may be started as 8 - Management, analysis and improvement; 8.1 General, 8.2 - Monitoring and measurement, etc.

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.

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.

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