Sample Article

An Introduction to ISO9000

A Primer on the Use of these Standards

In a Nutshell

The heart of the ISO 9000 series is a set of three internationally-accepted standards. These define the elements of a formal quality assurance system, as distinct from a total quality management system. The series also includes a growing number of guides on related topics.

The type of formal quality assurance system set out in these standards may be specified in a contractual agreement with a customer. It can also be audited and 'registered' by an accredited registration body. This registration may be an advantage, or even a requirement, for doing business with some customers – especially those based in Europe.

This type of system may also serve as one of the building blocks of an organization-wide total quality management strategy.

The standards are written in language appropriate for a manufacturing company, but can also be applied to other types of operation such as service companies.

History

The roots of the ISO 9000 standards originate in military procurement. Quality assurance of purchased goods has always been very important to the military, and failures have sometimes contributed to military disasters in the field.

The initial approach involved placing military personnel on suppliers' premises, and giving them the sole authority to certify whether the product met the contract requirements. Product conformance was established through inspection, and the inspectors were issued special stamps with which to mark each accepted (or rejected) item.

Over time this strategy was modified to enable much of this work to be delegated to supplier personnel. The supplier was required to document how this inspection system would be operated for each contract, who was responsible for maintaining it, and the records which would be kept to demonstrate the operation of this system. The purchaser could then turn over the stamps to the supplier, and simply audit the system from time to time against a standard set of requirements appended to the contract.

By the 1980's many western countries had developed fairly similar standards for this type of quality assurance system. In some countries, including the UK and Canada, these standards were also promoted for non-military procurement. Non-military versions of the standards were developed, and schemes set up for audit and registration.

In May 1980 the International Standards Organization (ISO) initiated the process of formulating a standard which would in effect merge these various different versions into one, and in 1987 the first edition of the ISO 9000 series, was issued. (The standards were reviewed and new revisions released in July 1994.)

These are the first international standards for a quality assurance system, and they represent the core elements which all participating organizations could agree to.

At this time Western management literacy in the quality sciences was extremely poor, and there was considerable controversy and confusion about quality. Any convergence of thinking was welcomed as a kind of anchor point. The emergence of a set of widely accepted standards therefore attracted unprecedented interest: forty-two countries participated actively in the development work. Over 50 countries subsequently endorsed the standards – usually re-issuing them unchanged as national standards, translated if necessary, and with a national standards number assigned.

The ISO standards tend to be a 'lowest common denominator', less stringent in places than some national standards. For this reason some countries, including Canada, have also developed supplementary standards which bridge gaps between ISO 9000 standards and their previous national standards.

The emergence of the European Community provided an additional impetus for the popularity of these standards. In order to facilitate the free movement of people and goods within its borders, the EEC has to harmonize many kinds of national standards. It was inevitable that the various national quality system standards and registration schemes should be harmonized. ISO 9000 standards were the obvious vehicle for accomplishing this harmonization, particularly in sectors which were already heavily regulated, such as the nuclear industry or medical devices.

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