Is your ISO 9001 Quality Manual Complete? Checklist Will Tell

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.

Fortunately, there is a simple solution – use a checklist. A quality 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 the quality manual. Using a checklist will help you remember to address all the requirements. This is why many registrars use quality manual review checklists. If you are in the process of developing or tuning up your quality manual, you might ask your registrar for a checklist. If your registrar doesn’t have it, we will develop our own.

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.

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.

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