Preparing an enterprise for ISO 9000 certification

Introduction

The main purpose of a quality system is to satisfy the customers and users of the products and services of a company as to the suitability of the product or service for its designed purpose and/or its relative merits vis-à-vis the equivalent product or service of a competing supplier.

Although quality can be thought of as a "state of mind" and a quality culture is important in determining quality, it is necessary to construct and maintain a quality "system" if an organisation wishes to be able to monitor, assess and validate quality.

The quality system needs to be constructed to an agreed and approved model– a model which ensures that the system can "do its job" of measuring and assuring quality. The spread of external system models – such as ISO 9000 – testifies to the need for, and importance of, a shared,transferable model.

Defourney and Noye (1996) define a quality system using the ISO 8402 (1994)system architecture which identifies key components as being: organisational structure, procedures, processes and necessary resources to implement the administration of quality.

This last component is important: organisations need a quality "system"not only to have a formal set of policies and standards to create quality objectives and measure their achievement, but also to establish a set of processes and procedures that ensure quality is maintained and improved in the longer term (Long et al., 1991).

The quality system also ensures that quality is addressed throughout the various phases of a manufacturing or service delivery cycle, and through all parts of the organisation. Quality must be created, facilitated, supported and maintained in marketing and research, product design and development, process planning and development, purchasing, production or provision of service,verification, packing and storage, sales and distribution, installation and commissioning, technical assistance and servicing, after sales activities, and disposal or re-cycling at the end of useful life.

All the documented models of quality systems share fundamental components and attributes:

• they provide a structural context for "the system";

• they add a layer of administrative record-keeping; and

• they organise the set of human and material resources that populate the system.

An effective model has to ensure that all of these basic components are present in the final system, and that they are in balance (to ensure that the cost of maintaining quality is not excessive).

Structure

ISO 9004-1 (1994) suggests that the structural organisation of a quality system should involve four elements:

• 1.

  responsibility and authority;

• 2.

  the organisational structure, resources and personnel;

• 3.

  operational procedures;

• 4.

  configuration management.

Together these are used to build essential operating elements of quality assurance and control such as: quality loops (whereby feedback from one part of the system is used, with appropriate authority, to modify behaviour in another part of the system); and quality audits (where regular reviews of the current levels of quality are undertaken to assist in reviewing the efficacy of the system).

A simple structural model was employed as the basis of evaluation within the survey undertaken as the basis of this paper. This incorporated five elements:the organisation; the quality manual; the operational procedures; the quality registrations; and the internal quality audits.

Administration

The term "administration" is sometimes used as a pejorative,non-productive term. However, effective administration is essential for the effective delivery of most systems. Quality is no exception. Effective administration is one of the signs of proper "respect" for quality; it ensures that quality objectives are recorded and disseminated. Administration should make available the necessary personnel and material resources (Juran,1989). In fact, administration plays a major role within a quality system: it ensures that the responsibility for various aspects of quality is clear, that proper, complementary authority accompanies this responsibility, that the assignment and deployment of resources is carried out, that progress towards the quality objectives can be measured and that the system itself can be evaluated over time.

Human and material resources

Most systems rely for their efficacy on people. It is the ways in which the people that populate systems, processes and procedures carry out their tasks that determine the effectiveness and efficiency of those tasks. Well-organised,properly-qualified, well-trained and properly-motivated personnel are much more likely to ensure quality. Again, the role of administration (in its widest sense) is to provide programmes that ensure that these factors are present– that selection processes pay due regard to qualifications and experience,and that training programmes effectively diagnose skills and competency gaps and provide the means of plugging them. Managers and supervisors must then take these qualified and trained personnel and motivate them.

The ISO 9004-2 standard (1994) suggests that organisations must also provide appropriate working conditions; and should ensure that everyone understands the influence and importance of quality and recognises the actions and behaviours that can improve quality.

The quality system must also ensure that all appropriate material resources are provided – at the right time, in the right place, and in the right quantities.

The study

A survey was undertaken in 1997 in France of 96 companies that had gone through the certification process for ISO 9002.

To collect the required data, a questionnaire was established. This recorded basic data about the size and nature of the company and used 13 variables to help in the evaluation of the three key factors of the quality system(identified above) and a further six variables to evaluate the degree of formalism in these systems.

Variables related to:

• the existence (or otherwise) of a quality policy and defined quality objectives;

• the structure of the organisation and the degree to which elements of any formal or informal quality system could be mapped on to this structure;

• the existence of any quality manual or other documentation;

• the existence of monitoring and evaluation processes that measured accomplishment of the quality objectives;

• the existence of appropriate personnel policies and procedures;

• processes and procedures for the provision of material resources;

• participation in quality levels by different sets and levels of employee.

Questions asked incorporated a five-point scale to measure the degree of existence/usage or absence of the particular variable.

Statistical software (SPSS) was used to carry out the analysis. First, a Principal Components Analysis was carried out. This showed that four components were responsible for the significant differences between organisations. A Factorial Analysis was then carried out on these components. This resulted in the formation of five groups of companies based on the nature of their quality systems. Finally, a Discriminant Analysis was carried out both to indicate the main differences between the groups and to show the similarities between companies in the same group. This allowed the companies to be categorised into five groups.

Company groupings

A simple summary of the main characteristics of each group is:

Group 1 (16 companies)

• no quality system;

• concern about quality is expressed;

• some quality actions.

Group 2 (14 companies)

• no formal quality system;

• recent commitment to improving quality;

• elements of an informal system can be identified;

• no formal quality objectives.

Group 3 (26 companies)

• all components of a quality system can be identified, though some are not yet "mature".

Group 4 (18 companies)

• defined quality policy;

• most components of a formal quality system.

Group 5 (17 companies)

• defined quality policy;

• formal quality system;

• real commitment to quality is evident.

In terms of the key components, obviously Group 5 companies could provide evidence that they were aware of these various components, could demonstrate all"in action" and could be shown to have them "in balance". Group 3 and 4 companies tended to prioritise one or more of the components to the detriment of the other(s); and Group 1 and 2 companies showed awareness only of the "human and material resources" component. Thus, though they carried out tasks that would be present in any quality system, these tasks were often inadequately linked together and were sometimes of only limited effectiveness. They had little idea of their levels of quality, nor of the quality they were aiming for.

(It was apparent that "human and material resources" are prioritised and well-managed in almost all companies.)

This simple categorisation of companies can be set against the company size in terms of number of employees – see Table I.

This identifies an important – and perhaps slightly surprising –issue. Of companies categorised as Group 1, about 70 per cent have more than 50 employees. Although the number of companies in the sample is small, this suggests that the absence of an effective quality system is not exclusive to small companies.

The formal structure of the quality system

The study looked at the degree to which the quality system was formalised. This showed that:

• a formal and documented quality policy existed in only 25 per cent of companies;

• quality objectives were evident in 28 per cent of companies, and accomplishment of them was measured in 26 per cent of companies;

• 28 per cent of companies had a formal quality programme.

Conclusions

If an organisation wishes to effectively manage its product/service delivery processes to ensure the quality of provision, it must consider not just how it manages activity; it must set operational activity within a defined quality framework consisting of a formal quality policy, established and agreed quality objectives and a quality programme that both addresses achievement of these objectives and measures progress towards and accomplishment of them.

The study shows that it is possible to categorise companies according to how they address quality issues – both formally and informally – and thus how probable it is that they can ensure and assure quality.

Although the last decade is often described as hosting a "quality revolution", the study shows that significant numbers of both large and small organisations have no formal quality policy, system or programme.

An organisation wishing to move towards formal quality accreditation, must address each of the three fundamental aspects of a quality system and must ensure that all three are in balance.

Denise Dumke de MedeirosUniversidade Federal de Pernambuco, Recife, Brazil

References

Defourney, V. and Noye, D. (1996), Du bon Usage des Mots de la Qualite – Les Principaux Termes: Definitions et Commentaires, INSEP Editions,Paris.

Juran, J.M. (1989), Planifier la Qualite, AFNOR, Paris.

Long, A.A., Dale, B.G. and Younger, A. (1991), "A study of BS. 5750 aspirations in small companies", Quality and Reliability Engineering International, Vol. 7, pp. 27-33.

Standard ISO 8402 (1994), Quality Management and Quality Assurance – Vocabulary, International Organisation for Standardisation, Geneva.

Standard ISO 9004-1 (1994), Quality Management and Quality System Elements – Part 1: Guidelines, International Organisation for Standardisation,Geneva.

Standard ISO 9004-2 (1994), Quality Management and Quality System Elements – Part 2: Guidelines for Services, International Organisation for Standardisaton, Geneva.

Action points

• •

  Key components of an effective quality system include:

  • – organisational structure,– procedures,–processes,– necessary resources to implement administration.

• •

  Effective administration needs amongst other fundamental tasks to make available necessary personnel and material resources.

• •

  Companies should seek to develop:

  • – a defined quality policy,– a formal quality system,– a real and evident commitment to quality.

• •

  An effective quality programme will not only address achievement of objectives but also measure progess towards them.