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Overview
of the Standard ISO 9001:2008 Quality Management: Requirements
ISO
9001:2008 specifies requirements for a quality management system where an
organization:
Needs to demonstrate its ability to
consistently provide product that meets customer and applicable statutory and
regulatory requirements, and aims to enhance customer satisfaction through the
effective application of the system, including processes for continual
improvement of the system and the assurance of conformity to customer and
applicable statutory and regulatory requirements.
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All
requirements of ISO 9001:2008 are generic and are intended to be applicable to
all organizations, regardless of type, size and product provided.
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All requirements of ISO 9001:2008 are generic and are intended to be applicable
to all organizations, regardless of type, size and product provided.
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Where
any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an
organization and its product, this can be considered for exclusion.
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Where
exclusions are made, claims of conformity to ISO 9001:2008 are not acceptable
unless these exclusions are limited to requirements within Clause 7, and such
exclusions do not affect the organization's ability, or responsibility, to
provide product that meets customer and applicable statutory and regulatory
requirements.
Introduction to the
Checklist
The process of defining what is necessary for compliance with a quality
management process standard such as “ISO Standard 9001:2008” is often
confusing and laborious because the directions contained in the standards are
unclear or ambiguous. To aid in
determining what is actually “required” by the document in the way of
physical evidence of compliance, the experts at SEPT have produced this
checklist. This checklist is
constructed around a classification scheme of physical evidence comprised of
policies, procedures, plans, records, documents, audits, and reviews. There must be an accompanying record of some type when an
audit or review has been accomplished. This
record would define the findings of the review or audit and any corrective
action to be taken. For the sake
of brevity this checklist does not call out a separate record for each review
or audit. All procedures should
be reviewed but the checklist does not call out a review for each procedure,
unless the standard calls out the procedure review. In this checklist “manuals, reports, scripts and
specifications” are included in the document category.
When the subject standard references another standard for physical
evidence, the checklist does not call out the requirements of the referenced
standard.
The Author has carefully reviewed the document “ISO Standard 9001:2008
Quality Management – Requirements" and defined the physical evidence
required based upon this classification scheme.
SEPT has conducted a second review of the complete list to ensure that
the documents’ producers did not leave out a physical piece of evidence that
a “reasonable person” would expect to find.
It could certainly be argued that if the document did not call it out
then it is not required; however if the standard was used by an organization
to improve its process, then it would make sense to recognize missing
documents. Therefore, there are
documents specified in this checklist that are implied by the standard, though
not specifically called out in the document, and they are designated by an
asterisk (*) throughout this checklist. If
a document is called out more than one time, only the first reference is
stipulated.
There are occasional situations in which a procedure or document is not
necessarily separate and could be contained within another document.
For example, the "Design and Development Verification Plan"
could be a part of the "Design and Development Plan".
The Author has called out these individual items separately to ensure
that the organization does not overlook any facet of physical evidence. If the organization does not require a separate document, and
an item can be a subset of another document or record, then this fact should
be denoted in the detail section of the checklist for that item.
This should be done in the form of a statement reflecting that the
information for this document may be found in section XX of Document XYZ.
If the organizational requirements do not call for this physical
evidence for a particular project, this should also be denoted with a
statement reflecting that this physical evidence is not required and why.
The reasons for the evidence not being required should be clearly
presented in this statement. Further
details on this step are provided in the Detail Steps section of the
introduction. The size of these
documents could vary from paragraphs to volumes depending upon the size and
complexity of the project or business requirements.
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Revision
History
Original edition:
Checklist for ISO
9001:2000
2008 Edition of the
checklist: This
checklist replaces the previous version, providing alignment with the 2008
standard.
General
Principles of the ISO Standard 9001:2008 Quality Management - Requirements
Checklist
This checklist was prepared by analyzing each clause of this document for the
key words that signify a:
- Policy
- Procedure
- Plan
- Records
- Document
( Including Manuals, Reports, and Specifications)
- Audit
- Review
This
checklist specifies evidence that is unique.
After reviewing the completed document, the second review was conducted
from a common sense “reasonable man” approach.
If a document or other piece of evidence appeared to be required, but
was not called out in the document, then it is added with an asterisk (*)
after its notation in the checklist. The
information was transferred into checklist tables, based on the type of
product or evidence. Required
items are denoted by an underline to aid use of the checklist.
Using
the Checklist
When
a company is planning to use "ISO 9001:2008 Quality Management Systems
– Requirements" standard, the company should review the evidence
checklist. If the company’s
present process does not address an ISO 9001:2008 standard product, then this
question should be asked: Is the
evidence product required for the type of business of the company?
If in the view of the company the evidence is not required, the
rationale should be documented and inserted in the checklist and quality
manual. This rationale should
pass “the reasonable person rule.”
If the evidence is required, plans should be prepared to address the
missing item(s).
Detail
Steps
An
organization should compare the proposed output of their organization against
the checklist. In doing this,
they will find one of five conditions that exist for each item listed in the
checklist. The following five
conditions and the actions required by these conditions are listed in the
table below.
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Condition
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Action Required
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1.
The title of the documented evidence specified by the checklist
(document, plan, etc) agrees
with the title of the evidence being planned by the organization.
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Record
in checklist that the organization is compliant.
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2.
The title of the documented evidence specified by the checklist
(document, etc) disagrees with
the title of the evidence planned by the organization but the content is
the same.
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Record
in the checklist the evidence title the organization uses and record that
the organization is compliant, and the evidence is the same although the
title is different.
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3.
The title of the documented evidence specified by the checklist
(document, etc) is combined with
another piece of evidence.
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Record
in the checklist the title of the evidence (document, etc) in which this
information is contained.
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4.
The title of the documented evidence specified by the checklist
(document, etc) is not planned by
the organization because it is not required.
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Record
in the checklist that the evidence is not required and the rationale for
this decision.
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5.
The title of the documented evidence called out by the checklist
(document, etc) is not planned by the
organization and should be
planned by it.
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Record
in the checklist when this evidence will be planned and reference a plan
for accomplishing the task.
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