Achieving standards of quality, the ISO 9000 (3)

Achieving standards of quality, the ISO 9000 (3)

By Simon Potter

This is the third in a series of three articles. It focuses on
registration procedures of ISO 9000, the international quality
system standard.

JAKARTA (JP): Registration to ISO 9000 is not difficult,
providing that the necessary preparation has been completed
first. Some 70 percent of applications however, fail on the first
attempt. This figure is surprisingly high. But it does not, as
some would claim, demonstrate the difficulty of obtaining
registration, rather the lack of adequate preparation on the part
of those who apply.

A knee-jerk application in the face of competitive threats, or
customer requirements, will more often than not result in
failure.

A well-considered application, as part of long term strategic
planning, for companies with long established traditions of
quality, is more likely to meet with success.

So before you rush headlong into applying for ISO
registration, do your homework first. It is imperative, if your
application is to be successful, for you to have had some
experience of operating a quality system. Ideally you should
already be operating a quality system which meets the technical
requirements of the part of ISO 9000 to which you seek
registration (ISO 9001, 9002, 9003).

The system should be fully documented with a quality manual,
work instructions and other materials.

Once your quality system has been running smoothly for a
decent length of time (not less that six months) and the
documentation is complete you are then ready to start the
registration process moving.

First, you need to find an ISO 9000 registrar whose scope of
accreditation covers your field of activity. In Indonesia at the
moment there are three registrars, in Jakarta, Bandung and Bogor,
and they are only accredited to work in certain areas. The
Sucofindo Registrar for Quality Assurance in Pasar Minggu for
example cover the following industries: electrical appliances,
rubber and rubber products, plastic products, textile products,
soft drinks and wood panel and timber mills.

You then need to make a formal application, and you will then
undergo a series of assessments. First, the registrar will want
to see your documentation and then he will conduct an on-site
assessment of the quality system. Any areas which do not conform
to the standard will have to be remedied. Finally you will be
asked to pay the associated fees.

Registration to ISO, however, may not automatically guarantee
access to the European Community (EC). There is no obligation on
the part of member nations and their companies to recognize ISO
9000 certification granted by registrars whose authority is not
traceable to the British National Accreditation Council for
Certifying Bodies (NACCB), or to an EC approved equivalent.

So, even though registrations issued by non NACCB registrars
are worthwhile, they do not carry the same weight in the EC as
registrations granted by NACCB accredited registrars. As Industry
Week magazine pointed out in August 1991, ISO 9000 registration
in one country does not necessarily translate into recognition
and acceptance in another.

The credentials of potential registrars should therefore be
examined very carefully. First of all, ensure that the
registrar's scope covers your facility. Then, ascertain which
body accredited the registrar to provide ISO 9000 registration
(NACCB or equivalent?). Find out if his ISO 9000 registration
mark is recognized and accepted in the EC and in countries where
you want to do business.

On request, registrars will sometimes conduct a comprehensive
"pre-assessment" of the facility before a formal application is
made. This is in order to verify that the facility is operating a
quality system, which comprises at least the essential
requirements of ISO 9000. Companies with no experience of ISO
9000 would be wise to request such a pre-assessment as part of
their implementation process.

A formal application for registration is then made to the
registrar, complete with application fee. Usually the firm is
asked to complete a questionnaire about its' operation and, from
this, an initial judgment is made as to the firm's state of
readiness for ISO 9000 registration.

Usually registrars will also review the facility's quality
system manual and other documentation before conducting an on-
site assessment. If, during this review, it becomes apparent that
the quality system has serious non-conformances, the registrar
will inform the facility. The registration process is then
suspended until the facility can demonstrate that non-
conformities have been rectified.

Registrars are, incidentally, forbidden to give guidance as to
the correction of non-conformances or to give any further
assistance, in the form of training or consultancy services. This
is to ensure objectivity and impartiality on their behalf.

If the registrar is satisfied that the system depicted in the
quality manual conforms to ISO 9000 standards, he will then
schedule an on-site assessment of the facility.

The company can usually chose the date of the initial
assessment, and can expect a thorough inspection of its facility,
quality system, records, and other documentation.

The assessment team will inspect the facility and its process,
first of all to determine that the quality manual actually
represents the quality system in operation in the facility. They
will also seek to determine that the quality system is adequate
to the purposes of the process concerned, and is capable of
ensuring that output will conform to documented requirements.

The assessors will review the assessment procedure with
facility management before the formal inspection begins.
Inspection basically involves the following:

A detailed review of the quality system, to determine if it
conforms with the standard.

Facility tours, employee interviews, and reviews of
documentation.

Inspection of critical quality system functions, such as
internal audits, management reviews, corrective action and
documentation changes.

Afterwards, the assessors will make a verbal report of their
findings to facility management. Their finding will be divided
into three categories: observations; non-conformances of a
relatively insignificant nature; and `minor' and `major' non-
conformances.

Minor non-conformances will not necessarily halt the
registration process (assuming they are corrected before the
first semi-annual surveillance assessment is made), but major
non-conformances usually stop the registration process in its'
tracks until they are corrected.

The assessment team issues a written report as well, which
includes necessary corrective actions and deadlines for
completing them. A full or partial reassessment may be undertaken
to confirm that corrective actions have been made.

When this phase is concluded, the registrar issues a
certificate of registration.

Many managers will want to know how much ISO 9000 registration
costs -- and how long it takes. The cost depends on a number of
factors, such as the size and type of the facility applying for
registration, and the range of fees requested by registrars.

Timing is another variable issue. If all goes well you can
expect about 12 weeks from application to registration.

Once your facility is certified to ISO 9001, 9002 or 9003, it
will be awarded a certificate, which bears the registrar's mark,
as well as the logo of the accrediting body (such as NACCB). The
certificate will also carry a unique registration number.

The certificate can be shown to customers and others as
evidences of the objective approval of your facility's quality
system. You can use your registration logos in advertising, and
your company name can appear in directories of ISO registered
firms that are consulted by purchasing executives in the EC and
elsewhere.

Registration is not the end of the process, far from it. You
must maintain your registration and this will involve payment of
an annual fee and the review and approval of any changes made to
your quality system. You will also be subjected to "surveillance
assessments" every six months which evaluate changes, follow up
on prior corrective actions and verify that the quality system
continues to conform to requirements. These assessments follow
the same general routine as the registration assessment.

Registration is easy to maintain, as long as you pay your dues
to keep your quality system in line with the standard.
Registration can, however, be suspended for serious non-
conformances, misuses of registration logo or documents, and
other significant violations. Suspension will last at least until
the facility implements and documents corrective actions.
Termination can result from the failure to correct serious non-
conformances.

Most facilities, however, find that ISO 9000 registration is
easy to maintain. When implemented properly, ISO 9000 quality
systems tend to become second nature -- as central to the
facility as the product or service it produces.

The writer works at the Indonesian Institute for Productivity,
Jakarta.

Window: Once your facility is certified to ISO 9001, 9002 or 9003, it
will be awarded a certificate, which bears the registrar's
mark, ...