Volume 6 · Issue 8 · August 2001
Preparing for the Future of ISO 9001:2000
A Registrar Q&A
The ISO 9001:2000 TransitionQuestion 6
Many organizations will be making the transition from
ISO 9001/2/3:1994 to ISO 9001:2000 conformance and registration
in the next 3 years. However, the requirements of ISO 9001:2000
and the steps an ISO 9001/2/3:1994-registered organization
canand cannottake in a successful upgrade are
not always clear for those used to the older editions of the
quality system conformance standards.
Since March 2001, each month THE OUTLOOK has been
submitting to representatives of several registrars a question
on ISO 9001:2000s requirements with consideration of
making the transition from ISO 9001/2/3:1994. The purpose
of these questions and answers is to make you, the reader,
more comfortable with the new standard and aware of both what
is required that must be addressed in upgrading your organizations
quality management system (QMS) and what should be considered
in conducting the upgrade.
These registrar representatives have accepted an invitation
to participate in this question and answer series to help
bring a range of perspectives on the issues being addressed.
In addition, Randy Dougherty, Director of Registrar Programs
of the Registrar Accreditation Board (RAB), will be providing
insights on some of these questions and the issues behind
them in light of the answers from the registrars.
This months question received answers from four registrar
representatives and RAB.
The Smith Organization has a quality system registered to
ISO 9002:1994, and the contents of the quality manual follow
the 20-clause structure of ISO 9001:1994s Section 4,
including the numbering. What is the best and most easy-to-understand
way for the Smith Organization to revise its quality manual
to conform to the requirements contained in Sections 4-8 of
Jim Scott, Vice President, Registration, AQSR International,
If the Smith Organizations existing ISO 9002:1994-registered
quality system has been effective, it should not be necessary
to recreate the quality manual.
If the organization has a mature documentation system, I
would recommend that it prepare a matrix of the clauses and
subclauses of ISO 9001:2000, Quality management systemsRequirements,
with a complete cross-referencing of its requirements to Smiths
existing Level 1-4 ISO 9002:1994 quality system documentation.
Other changes to the manual will be required to satisfy new
and changed requirements in ISO 9001:2000, particularly for
an organization with an ISO 9002 system, but creating the
matrix will allow the organization to easily see and make
the other changes that are needed.
Rudy Frueboes, Technical Manager, DNV Certification
The quality manual must address each specific requirement
of ISO 9001:2000 and its applicability within the Smith Organizations
scope and method of operation. The level of detail must extend
to the subclause level (e.g., Subclause 7.3.3, Design and
If a particular clause of Section 7, Product Realization,
has been determined to be inapplicable to the scope of the
Smith Organizations operations, then it should be so
noted in the quality manual. Justification for the exclusion
per Clause 1.2, ScopeApplication, must be clearly stated
in the manual.
The quality manual must contain or reference the documented
procedures of the organizations QMS and describe the
interaction of the processes included in the QMS. Simply put,
the quality manual should address all processes associated
with fulfilling QMS requirements. In satisfying Clause 4.1(a),
Quality Management SystemGeneral Requirements, which
requires an organization to identify the processes needed
for the QMS, a flow chart specifying the processes and their
interactions is one method that could be used to comply with
Subclause 4.2.2(c), Documentation RequirementsQuality
Manual, which requires the Smith Organization to describe
the interaction between the QMSs processes.
Considering what I noted above and the long-term implications
of implementing and continually improving a QMS that is being
revised from an ISO 9002:1994-registered quality system, it
is my opinion and belief that the "best and most easy-to-understand
way for the Smith Organization to revise its quality manual
to conform to the requirements contained in Sections 4-8 of
ISO 9001:2000" is to completely restructure its existing
manual to follow the format of ISO 9001:2000.
A matrix may be used to correlate the existing lower level
QMS documentation to the revised quality manual. It should
be stressed that a complete revision of the quality manual
to follow the format of the 2000 edition of ISO 9001 is not
required by DNV Certification and, as such, each organization
needs to determine how best to address the requirements to
suit its own circumstances, including the Smith Organization.
Daniel Désilets, DirectorSystems Registration
(North America), Intertek Testing Services, N.A.
The best system is the system that best suits the needs
of the Smith Organization! Therefore, if the organization
is comfortable with its ISO 9002:1994-conforming 20-clause
structure quality manual, it should stick with it.
On ISOs web site (www.iso.ch), the following answer
has been provided in the FAQ (Frequently Asked Questions)
section to a question regarding whether an organization has
to reorganize its documentation around the ISO 9001:2000 structure:
If your current quality management system is successfully
implemented, satisfies the needs and objectives of your
organization, reflects the way your organization works,
addresses all of the new requirements, no changes are required.
However, if your current documented system does not address
all of the new requirements, additional documentation may
Clause 4.1 of ISO 9001:2000 provides the recipe for developing
a QMS that complies with the requirements of the standard.
It is a straightforward, 6-step process that an organization
should apply, followed by a gap analysis to establish its
level of conformity with the requirements of ISO 9001:2000
from two standpoints: documentation and implementation.
The Smith Organization should then determine what it will
do to "fill the gap". This part is relatively simple,
although it has to be performed by well-informed people in
order to be successful. While ISO 9001:2000 is relatively
simple, it takes some time and effort to really understand
the "nature and extent" of its requirements. Therefore,
before undertaking this task, the Smith Organization should
ensure that those assigned to this task are knowledgeable.
Training and publications on this subject are numerous. Furthermore,
outsourcing of this service may also be a good alternative.
In trying to "fill the gap", organizations need
to be careful "how" as well as "where"
in the system they are going to "add" the new requirements
of ISO 9001:2000. Nevertheless, the sensitive part relates
to those requirements of ISO 9001/2:1994 that are no longer
required by the 2000 version. Before taking these requirements
out of its system, the Smith Organization should seriously
consider the impact of deleting these requirements. Examples
of ISO 9001:1994 requirements that could be deleted include
the need for purchasing documents, several of the "exotic"
requirements in Clause 4.11, Control of Inspection, Measuring
and Test Equipment, and periodic assessment of product in
storage in ISO 9001:1994. If such a requirement provides added
value to the organization, it should be maintained since nothing
in ISO 9001:2000 conflicts with what is required in ISO 9001/2:1994
and vice versa.
The same principle applies to the need for procedures. In
large organizations, it is felt that most procedures should
and will be maintained whether or not they are no longer required
by ISO 9001:2000. In smaller organizations, the decision to
maintain or not maintain procedures should be based on the
risk associated with the process itself and the level of comfort
of the users with the said procedure.
There is no doubt that ISO 9001:2000 offers the Smith Organization
and all others the possibility of making its QMS documentation
much lighter. However, organizations must remember that the
purpose of the documentation is to help them maintain their
systems. Trying to make it too "light" may result
in a "loss of control", even if it is an ISO 9001:2000
A. Joseph Falcsik, Certification Director, SRI Quality
Organizations that have a fully functional ISO 9001/2/3:1994-registered
quality system have several methods available for converting
their quality manual to conform with ISO 9001:2000.
One method the Smith Organization could choose would be to
retain the quality manual from its current ISO 9002-registered
quality system and develop/implement any additional requirements
to meet ISO 9001:2000. A customized matrix could then be developed
or the organization might consider using Annex B of ISO 9001:2000,
Correspondence Between ISO 9001:2000 and ISO 9001:1994, to
develop an appropriate cross-reference matrix.
Another method would be to revise and update all documentation
that was initially developed and implemented to conform with
ISO 9002:1994 (policies, procedures and work instructions)
and transfer/renumber the documents utilizing the aforementioned
Annex B to guide the reorganization.
A third method worth mentioning would be for the Smith Organization
to go back to the "drawing board" and literally
follow the ISO 9001:2000 documentation requirements as noted
under Clause 4.2, particularly the quality manual specifications
in Subclause 4.2.2.
The current trend in the ISO 9000 community is to initially
upgrade an ISO 9001/2-registered quality system to meet the
revised requirements of ISO 9001:2000 by applying the first
method (developing a matrix and cross-referencing) and adding
any ISO 9001:2000 requirements that an organizations
quality system does not already address. The Smith Organization,
and/or your organization for that matter, may be registered
to ISO 9002:1994 but have a quality system that already exceeds
what is required by ISO 9001:2000 because of customer requirements
or internal efforts to improve its QMS.
When the ISO 9001/2/3:1994-registered system appears to be
well-transitioned and internal audits prove out its continued
effectiveness, a final conversion could then be developed
Commentary Randy Dougherty, Director of Registrar Programs,
I have obtained the following comments from Norm Siefert,
one of RABs accreditation auditors, in response to Question
The ultimate extent of action by the Smith Organization or
any other organization registered to ISO 9002:1994 will depend
largely upon its size and the complexity and distribution
of its existing quality manual. Considerations that must be
addressed before revising the quality manual can be summed
up in the following questions:
- Is the organization multisite with a common quality system?
- Is the quality manuals distribution all hard copy
- How complex is the quality system and the manual?
- Is the quality manual truly a stand-alone policy document
or does it involve second- and third-tier documents and
all types of cross-references?
Further, the Smith Organization must consider the extent
of retraining, and the value thereof, that must occur depending
on the extent of document changes.
For many organizations that have a 20-clause structuring
at the core of its quality manual, documentation and communicationswith
the traditional numbering of Level I, II and III documentsan
easy-to-understand approach that should be considered may
consist of the following steps:
- Establish a steering committee to review the existing
manual to assure inclusion of applicable new specific ISO
- Use the ISO 9001:1994 to ISO 9001:2000 cross-reference
included as Annex B in ISO 9001:2000 as a guide to analyzing
the reorganization of clauses and requirements.
- Make content changes to the quality manual as needed.
- Add to the organizations existing quality manual
the cross-reference index from ISO 9001:2000.
- Retrain employees on the organizations manual content
changes and the reasons for the changes.
There are other methods the Smith Organization could apply,
but this is one alternative that would work well.
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