Some people call it "senior moments", some people call it "spaced it out", simply speaking, we all sometimes forget something - human nature.
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.
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.
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.
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.
Want to save time and get your ISO 9001 quality manual review checklist fast? Click links below to see how we can help you get started in no time! - 15246
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.
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.
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.
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.
Want to save time and get your ISO 9001 quality manual review checklist fast? Click links below to see how we can help you get started in no time! - 15246
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