ISO 9001 Quality Manual Checklist
Remember how on that business trip, you opened your briefcase only to realize that your laptop power cord is still in the office? Don’t worry, we are all human beings and now and then forget something.
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.
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 3-4 column 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 recording section’s titles: 6 – Resource management; 6.1 Provision of resources, 6.2 – Human resources, 6.2.1 – General, etc.
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.
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.
Check out hyperlinks below to read our paper on design of checklists – it is easy, simple and saves time.
Tuning up your ISO 9001 2000 Quality Manual? It is east to learnhow to write a Quality Manual that will work for you and your ISO 9001 registrar.
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