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.
Through my auditing career I found that often companies forget to include in their quality manuals various requirements of the standard.
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.
It is relatively easy to develop a checklist for ISO 9001:2000 quality manual. We can start from the “30-thousand feet” view by establishing a framework similar to a table of contents. You can list titles of the elements that are applicable to your QMS, such as the Scope, Application, Terms and definitions, Quality management system, General requirements, 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.
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.
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.
To see how easy it is to develop a checklist for ISO 9001 quality manual review, click the link below:
