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, ...