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.
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.
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.
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.
To see how easy it is to develop a checklist for ISO 9001 quality manual review, click the link below:
