Is your ISO 9001 Quality Manual Complete? Checklist Will Tell
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.
It happens with quality and environmental manuals too. Quite often some requirements of ISO 9001:2000 standard are not present in quality manuals.
Luckily we have a simple way out – we can use a quality manual review checklist. Depending on how detailed your manual is, what standards it addresses, the manual can become an intricate document. In my auditing practice I encountered numerous QMS where quality manuals did not reflect all required elements of the standard. Using a checklist will help you remember to address all the applicable requirements of the 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.
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.
When you document all applicable requirements of ISO 9001 standard in your checklist, you will be able to verify if your quality manual meets the requirement of your company and the 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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Filed under: Management