ISO 9001:2008
Revisions from ISO 9001:2000
Introduction:
ISO 9001 is now in its fourth edition. Starting with
the 1987 initial edition, it changed in 1994 and again in 2000. The
2000 change was pretty extensive. It introduced the concept of
process auditing and added a lot of emphasis to the importance of
top management to the effectiveness of quality management systems.
In November 2008, the fourth edition was released.
Download ISO 9001:2008 Checklist
Discussion:
On November 13, 2008, the fourth edition of ISO 9001
became official. It is referred to as ISO 9001:2008. The good news
is that it contains no substantive changes or new requirements. The
changes that were made were done for two reasons: 1) clarifications
to the requirements of ISO 9001:2000; 2) to improve alignment with
ISO 14001:2004.
The ANSI-ASQ National Accreditation Board (ANAB) has
issued two Heads-up documents that deal with the changes and
transition process for moving from ISO 9001:2000 to ISO 9001:2008.
These can be accessed from the ANAB web page www.anab.org. Refer to
Heads-up numbers 129 (migration) and 135 (where/how to buy the
standard.)
The transition/migration process has the following
requirements:
-
Twelve months after the release of
ISO 9001:2008, all new and re-certification audits
must be done to the ISO 9001:2008 standard.
-
Twenty-four months after release of
ISO 9001:2008, all ISO 9001:2000 certificates will
be invalid.
-
Upgrading from ISO 9001:2000 to ISO
9001:2008 requires a surveillance or
re-certification audit to be conducted.
If you are certified to ISO 9001:2000, you can
continue with that revision level for a period of time depending
where your organization is within its current three-year certificate
cycle. Each certification/registration body (CRB) will have its own
practices/rules regarding when and under what conditions an existing
certification can be upgraded to ISO 9001:2008. However, in all
cases, there must be either a surveillance or re-certification audit
executed before an ISO 9001:2000 certificate can be upgraded to ISO
9001:2008.
How can an organization demonstrate to its CRB that
is has reviewed the changes to ISO 9001:2000, analyzed the
new/changed wording of ISO 9001:2008 and, if required, made
modifications to its quality management system (QMS)? One way is to
use the following checklist. It has been developed based on the key
clauses of ISO 9001:2008, clauses 4 thru 8.
Download ISO 9001:2008 Checklist
How to Use the Checklist:
-
First and foremost – obtain at least
one copy of ISO 9001:2008. (See ANAB Heads-up No.
135 for directions on how to obtain a copy.)
-
Next, determine if the existing
documented QMS and actual practices meet the
requirements of ISO 9001:2008. The checklist has
three categories:
-
Meets this
requirement
-
Needs some
modification
-
Clause not
applicable.
-
(If you check this box, remember
that only sub-clauses in section 7 can be claimed to
be not applicable, and your scope statement and
related documentation must contain justification for
such exclusions.)
-
For each clause/sub-clause, use the
Comments/Notation cells to annotate where the
requirement is met. This may be a reference to a
document, policy, procedure, work instruction,
process document, etc.
-
When completed, notify your CRB that
you are ready to be audited in accordance with the
requirements of ISO 9001:2008. The completed
checklist will provide one form of objective
evidence (at the minimum, it will be a solid
audit-trail) that your organization has completed an
analysis of ISO 9001:2008 and, if applicable, made
required changes to its QMS.
Download ISO 9001:2008 Checklist

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