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Revisiting the ISO 9000 quality system on the eve of change
Revisiting the ISO 9000 quality system on the eve of change
The ISO 9000 series of standards originated in the engineering and production sectors of industry. Thanks to this legacy, even now many of the terms used seem more appropriate for the manufacturing sector. The standard can however be interpreted into virtually any sector. Indeed, institutional bodies such as the BSI have issued numerous guidelines to aid interpretation for different sectors. In this review we sketch the brief history of standards and their role in quality and hence management of processes.
Several tools and techniques have, over time, been developed to help in achieving, improving and sustaining quality. They can be grouped under three categories:
quality assurance; and
Collectively they are referred to as the quality trilogy, after Joseph Juran, who first defined the three categories.
Quality improvement covers actions that are taken throughout the organisation to improve the effectiveness of activities and processes to yield added market value (customer satisfaction) and internal efficiency (profits). Quality improvement is about raising the standard of performance and setting a higher goalpost for future achievement.
Quality assurance covers all planned and systematic actions necessary to provide confidence that requirements of quality will be fulfilled by the system.
Quality control covers operational techniques and activities that are used to bring about quality.
2.0 Evolution of the quality standards
Most current quality systems standards evolved from military QA standards, notably the Allied Quality Assurance Procedures (AQAP) series published between 1968 and 1970. In the period 1983-1986 the British Standard, BS 5750 was used. Subsequently this formed the basis for the ISO 9000 series, which was launched in 1987 (see Figure 1).
The use of the standard has grown considerably since its birth. The 1987 version was superseded by the merging of BS EN ISO into a new version in 1994. Most of the changes made in this interim update were aimed at simplifying and harmonising the implementation of the standard and the assessment process. The numbering of the standard also changed slightly to reflect both national and international standard referencing systems; for example, in the UK the reference is now BS EN ISO 9000.
The ISO 9000 series of standards is currently in widespread use, with its adoption in more than 100 countries worldwide as the standard for quality management systems.
The standard is due to be re-issued in a new version during the course of this year. The update will:
Focus more on organisational processes.
Place more emphasis on improvement.
Improve relevance to service industries.
3.0 The ISO 9000 structure
The structure is currently divided into a number of documents under three general headings:
Quality management and quality assurance standards (ISO 9000).
Quality management and quality assurance elements (ISO 9004).
Quality systems assessment models (ISO 9001, 9002, 9003).
ISO 9000 and ISO 9004 documents are intended as guidelines only and cannot be used as ''audit'' standards. ISO 9001, ISO 9002 and ISO 9003, are sometimes termed "working models," because they can either be used as a basis for assessment or used as the basis of specifying contractual agreement between two parties.
3.1 Quality management and quality assurance standards. The ISO 9000 is split into a series of sub-part guidelines. These are briefly elaborated below:
ISO 9000 - 1 Guidelines for selection and use. This document provides guidance to organisations on the concepts, characteristics, types and use of Quality Systems Standards. It provides guidance on how to select the working model or audit standard most applicable to any particular organisation, product or service. It also cross-references the corresponding clauses of the key documents in the ISO 9000 "family."
ISO 9000 - 2 Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003. This part of the standard gives guidance to users, such as suppliers, subcontractors and auditors into the application of the working models. It was developed to improve consistency, precision, clarity and understanding of the working models; it does not add to or change in any way the requirements of the working models.
ISO 9000 3 - Guidelines for the application of ISO 9001 to the development, supply and maintenance of software. This section of the standard provides guidance to those organisations developing quality systems specifically for developing, supplying and maintaining software. The guideline suggests ways of producing software by management control and specific methods, which enable the customer's requirements to be met.
The primary aim is to prevent non-conformities from occurring at all stages from development through to maintenance. It is adopted as the ''core'' to the TICKIT scheme, which seeks to provide a method of more specific assessment for organisations involved in software development and maintenance.
ISO 9000 - 4 Guideline for dependability programme management. This part of the standard gives guidance on dependability programme management. Dependability is an important characteristic of a product or service. This document outlines the activities or reliability performance and maintainability performance. The providers of services such as transportation, electricity and information services often have very high customer requirements for dependability. Increasingly these types of industry are establishing dependability programmes.
3.2 Quality systems audit standards.
ISO 9001 model for quality assurance in design/development, production installation and servicing. The ISO 90001 model is the most demanding; it encompasses all the requirements of ISO 9002 and ISO 9003 plus the additional aspect of design control. It covers circumstances in which the supplier may be responsible for conceptual design and development work, in addition to production or service delivery.
ISO 9002 model for quality assurance in production, installation and servicing. ISO 9002 may be contractually specified when the supplier is responsible for assuring the product or service quality during the course of production, installation, and after sales service. It can also apply when non-conceptual design work is involved, for example design against a specified code, although organisations in this situation should seriously consider the benefits they can achieve from using the ISO 9001 model. The document is virtually identical to ISO 9001 in all respects other than design, which is not covered. Most organisations (possibly up to 70 per cent) find that ISO 9002 is most suited to their needs.
ISO 9003 model for quality assurance in final inspection and test. ISO 9003 provides a model for use when conformance to specified requirements can be assured solely by final inspection and test, for example where a supplier is issued with material by the purchaser for machining, the result of which is subsequently verifiable by inspection only. It is thus very limited in its requirements. Very few organisations seek certification against this model and, in fact, most certification organisations no longer offer an assessment to ISO 9003 in their portfolio.
3.3 Use of the ISO standard
The standard can be used in three ways:
Guidance to organisations developing their management systems.
As a purchasing standard, contractually specified.
As an assessment standard, by either second party (customer) or third party organisations (independent assessment bodies).
The proliferation of guidelines demonstrates that the requirements of the ISO 9001 and ISO 9004 are not easily interpreted to non-manufacturing industries. During the course of this year there are plans to achieve harmony between the standards and remove the manufacturing bias that persists to this day.
3.4 Benefits of an ISO based quality system.
There are several benefits to be derived from installing a quality system that meets ISO 9000. The ISO 9000 model of a quality system is built on a principle of achieving customer satisfaction by preventing non-conformity at all stages in the supply chain. Through this system, tasks can be carried out right first time. This eliminates errors and waste and results in improved productivity and profit.
Quality systems enable a company to achieve, sustain and improve quality in the most effective and efficient way. It is not possible to achieve and sustain quality over the long term unless quality is organised for. Quality does not come by chance, it has to be systematically worked toward. Quality systems can be an asset or a hindrance, depending on the way they are used. They enable achievement of aims by laying rules and procedures and organising the infrastructure and resources around activities involved in the attainments of desired ends. Quality systems thereby induce conformance and prevent non-conformance.
The typical focus of a quality system is at the operational level. Translated in lay terms, a quality system built on ISO 9000 guidelines facilitates systematic improvement of work processes. Clearly then, a good quality system is pre-requisite for managing processes effectively and efficiently. However, the success of this is determined by the capacity to apply the guidelines. This means that the standard must be easily understood, and widely applicable. This demands a simple and generic framework that can be implemented with ease across all industries and situations. This is the test, if the ISO series is to survive as an effective system for managing processes. On the eve of impending change, it is hoped that any overhaul of the ISO series will involve simplification without weakening the integrity of the system.
Pervaiz K. Ahmed