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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.