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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.
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.
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.
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.
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.
The process above described a way to prepare a checklist
      for verifying quality manual for one standard. In
fact, many organizations develop management systems for
  more than one standard. As an auditor, very often I see
  integrated ISO 9001 / ISO 14001 management systems.
  Don't panic! The process is the same: integrate specific
   clauses on the second standard into your list which is
               based on the starting standard.
Check out hyperlinks below to read our paper on design of
       checklists - it is easy, simple and saves time.
https://winbigdiscount.com/

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Quality Manual Review Checklist for ISO 9001:2000 QMS

  • 1. Some people call it "senior moments", some people call it "spaced it out", simply speaking, we all sometimes forget something - human nature.
  • 2. The same thing happens when writing ISO 9001 quality manuals - very often some of the requirements of the standard are forgotten and not addressed.
  • 3. 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.
  • 4. 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.
  • 5. 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.
  • 6. 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.
  • 7. 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.
  • 8. The process above described a way to prepare a checklist for verifying quality manual for one standard. In fact, many organizations develop management systems for more than one standard. As an auditor, very often I see integrated ISO 9001 / ISO 14001 management systems. Don't panic! The process is the same: integrate specific clauses on the second standard into your list which is based on the starting standard.
  • 9. Check out hyperlinks below to read our paper on design of checklists - it is easy, simple and saves time.