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.
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.
Obviously, there are numerous ways to design a checklist. Most typical format I have seen through my auditing career was a 3-column table allowing documentation of the number of the clause, the content of the requirement and the location of response to this particular clause. Take a look at the following example: Element 5 of the standard starts from the title: "Management responsibility". Clause 5.1 is a title also. Numbering these titles 5 and 5.1 respectively, placing these titles in the checklist and indicating where in the QMS these titles are located will give us a starting point.
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.
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:
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.
Obviously, there are numerous ways to design a checklist. Most typical format I have seen through my auditing career was a 3-column table allowing documentation of the number of the clause, the content of the requirement and the location of response to this particular clause. Take a look at the following example: Element 5 of the standard starts from the title: "Management responsibility". Clause 5.1 is a title also. Numbering these titles 5 and 5.1 respectively, placing these titles in the checklist and indicating where in the QMS these titles are located will give us a starting point.
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.
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:
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Working on your ISO 9001 2000 Quality Manual? Learn how to write a Quality Manual that will work for you and your ISO 9001 registrar.
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