ISO 9000: Help or Hoax?

Patrick O’Connor’s essay ISO 9000: Help or Hoax? was published in Quality World in 1991 and collected into his book In My Humble Opinion, available for free download here.

Few listened to the advice of this experienced reliability engineer.  The ISO beast got fed and grew enough tentacles to feature in a Manga film. John Seddon repeats O’Connor’s conclusion: Abandon ISO 9000.

The essay  predates the full horror and delusion of more recent laboratory standards derived from it such as ISO 17025 and ISO 15189.  O’Connor concludes:

“The only rational solution to the situation that has been allowed to develop is to dismantle the structures that have been built around the standard, and to remove all aspects of compulsion, whether stated or implied. The standard should be used only as a guide to what should be included in a minimal quality system. The systems for accreditation and registration should be abandoned.”

Read the entire essay below:

ISO 9000: Help or Hoax? 

Patrick D.T. O’Connor


The international standard for quality systems, IS09000, has been developed to provide a framework for assessing the extent to which an organisation (a company, business unit, or provider of goods or services) meets criteria related to the quality of the goods or services provided. The concept has been developed from the US Military Standard for quality, MIL-Q-9858, which was introduced in the 1950’s as a means of assuring the quality of products built for the US military services. The UK Ministry of Defence developed a similar standard (Def Stan 05-21), as did NATO (AQAP-l).

The original aim of supplier registration was to provide assurance that the suppliers of equipment operated auditable quality management systems, and that they maintained and complied with written procedures for processes such as fault detection and correction, calibration, control of subcontractors, and segregation of defective items. They had to maintain a “Quality Manual”, to describe the organisation and responsibilities for quality.

It is relatively easy to appreciate the motivation of large government purchasing agencies to impose such standards on their suppliers. However, it is widely accepted that the approach has not been very effective, despite the very high costs involved. The major difference between ISO9000 and its defence-related predecessors is not in its content, but in the way that it is applied. The suppliers of defence equipment were assessed against the standards by their customers. By contrast, the ISO9000 approach relies on “third party” assessment. Certain organisations, such as the US Underwriters Laboratories (UL), the British Standards Institution (BSI), Lloyds Register, and several others, are “accredited” by the appropriate National Accreditation service, which entitles them to assess companies and other organisations, and to issue certificates to confirm that their quality systems meet the requirements of the standard. The justification given for third party assessment is that it removes the need for every customer to perform his own assessment of all of his suppliers.

The supplier’s registration indicates to all of his customers that his quality system complies with the standard, and he is relieved of the burden of being subjected to separate assessments by all of his customers, who might furthermore have varying requirements.

The other main difference is that IS09000 is applied to every kind of product and service, and by every kind of purchasing organisation. Today, schools and colleges, consultancy practices, local government departments, and window cleaners, in addition to large companies in every industrial sector, are being forced by their customers to become registered or are deciding that registration is necessary for future business success.

Does ISO9000 Improve Quality?

ISO9000 does not specifically address the quality of products and services. It describes, in very general and rather vague terms, the “system” that should be in place to assure quality. In principle, there is nothing in the standard to prevent an organisation from producing poor quality goods or services, so long as procedures are followed and problems are documented. Obviously an organisation with an effective quality system would normally be more likely to take corrective action and to improve processes and service, than would one which is disorganised. However, the fact of certification cannot be taken as assurance of quality. It is often stated that registered organisations can, and sometimes do, produce “well-documented rubbish”. An alarming number of purchasing and quality managers, in industry and in the public sector, seem to be unaware of this fundamental limitation of the standard.

The effort and expense that must be expended to obtain and maintain registration tend to engender the attitude that optimal standards of quality have been achieved. The publicity that typically goes with initial registration supports this. The objectives of the organisation, and particularly of the staff directly involved in the registration process, are directed at the maintenance of procedures and at audits to ensure that people work to them. It becomes more important to work to procedures than to develop better ways of working.

ISO9000 and Total Quality Management

Total quality management (TQM) is the approach that was pioneered by teachers such as W.E. Deming and K. Ishikawa, and initially applied in Japan in the late 1950’s. TQM requires that every person in the business becomes committed to a never-ending drive to improve quality. The drive must be led by top management, and must be vigorously supported by intensive training, the application of statistical methods to reduce variation, and motivation for all to contribute. TQM links quality to productivity, and it was the prime mover behind the Japanese post-war industrial revolution. It is fundamental to the survival of any modern manufacturing company competing in world markets. Such businesses set standards for quality, both internally and from their suppliers, far in excess of the requirements of ISO9000. These requirements relate to the actual quality of the products and services, and to continuous improvement. Much less emphasis is placed on the “system”.

Third party assessment is at the heart of the ISO9000 approach. However, the TQM philosophy demands close partnership between purchasers and suppliers. A matter as essential as quality cannot safely be left to be assessed by third parties, who are unlikely to have the appropriate specialist knowledge, and who cannot be members of the joint purchaser-supplier team. This principle applies whether the supply is of complex engineering products or of relatively simple services, or of anything between. Furthermore, as explained above, the actual quality of the product or service is not included in the assessment.

Defenders of ISO9000 say that the TQM approach is too severe for most organisations, and that ISO9000 can provide a “foundation” for a total quality effort. However, the foremost teachers of modern quality management all argue against this view. They point out that any organisation can adopt the TQM philosophy, and that it will lead to benefits that are far greater than those generated by registration, and at much lower costs. David Hutchins, the leading teacher of quality management in the UK, states in his book “Achieve Total Quality” that “Eventually, those industries that manage to survive and the governments of the countries that have been taken down this blind alley will live to regret that they did not think all this through before it was too late”. Juran, Deming and Ishikawa all expressed similar views. It is interesting that the ISO9000 approach is so widely applied despite the teaching of the pioneers of modern quality.

The Controversy

Since its inception, ISO9000 has generated considerable controversy. Small organisations are questioning the value of the exercise, as they do not see how the expensive process of preparing documentation and undergoing registration improves the quality of their products and services, and large organisations are also querying the benefits in relation to the high costs of compliance and questionable effectiveness. The evidence is, however, variable. Some organisations have generated real improvements as a result of certification, and many consultants and certification bodies provide good service in quality improvement.

As remarked above, the leading teachers of quality management all argue against the “systems” approach to quality, and the world’s leading companies do not rely on it. So why is the approach so widely used? The answer is partly cultural and partly coercion.

The cultural pressure derives from the tendency to believe that people perform better when told what to do, rather than when they are given freedom and the necessary skills and motivation to determine the best ways to perform their work. This belief stems from the concept of scientific management, as described earlier.

The coercion to apply the standards comes from several directions. For example, the UK Treasury guidelines to public purchasing bodies states that they should “consider carefully registered suppliers in preference to non- registered ones”. In practice, many agencies simply exclude non- registered suppliers, or demand that bidders for contracts must be registered. All contractors and their subcontractors supplying the UK Ministry of Defence must be registered, since the MoD decided to drop its own assessments in favour of the third party approach. Several large companies adopt the same policy. (The US “big 3” automakers have developed QS9000, a variant of ISO9000, and have made it mandatory for their suppliers to be registered to it. It is notable that their Japanese competitors have not gone down this path!). European Community policy for public purchasing is not explicit on ISO9000, and of course there are no such conditions regarding commercial trade, but this has not prevented registration providers in the USA from advertising that ISO9000 is “a condition for doing business in Europe”.

The UK government Department of Trade and Industry claims that the standard is voluntary, and that it has been developed by industry to meet their own needs. This is simply untrue. Registration is often as voluntary as a donation to the Mafia. The standard has not been “written by industry”, but by people with vested interests who sit on standards-writing committees, which in practice have unfettered power to “standardise” methods which directly contradict the essential lessons of the modern quality and productivity revolution, as well as those of the New Management.

It is notable that the journals of the main Western professional institutions for quality assurance, the American Society for Quality and the UK Institute for Quality Assurance, have become almost totally devoted to ISO9000 and related topics.

The Solution

The only rational solution to the situation that has been allowed to develop is to dismantle the structures that have been built around the standard, and to remove all aspects of compulsion, whether stated or implied. The standard should be used only as a guide to what should be included in a minimal quality system. The systems for accreditation and registration should be abandoned. Companies and other suppliers should be encouraged to set up and audit their own quality systems, and purchasers should be free to set standards for quality of goods and services they buy. Of course any organisation should be free to seek external advice and auditing if they wish. However, purchasing organisations, particularly in the public sector, must not discriminate against suppliers on the grounds of who audits their quality systems, but only on their quality management and performance.

Finally, the severe limitations of the standard, in relation to modern concepts and practices of total quality, must be recognised and emphasised. Its application has no doubt led to some local improvements, but at great overall cost, and negative overall effect.

Therefore the major agencies involved, particularly government purchasing departments and the institutions that represent the professional interests of people in the quality assurance field, should proclaim the deficiencies and should support the application of the quality methods that are used by the world’s leading companies and economies.

© P.D.T. O’Connor 1998

Check out his writings on engineering, quality, and other topics here.

Coalition Royal Navy budget cuts

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2 Responses to ISO 9000: Help or Hoax?

  1. Anonymous says:

    Dear ISOWatch

    You will enjoy another last gasp of the ISo bandwagon in Quality Digest this week.

    I posted a link to your site, but this hasn’t made the author very happy.

    Oh dear.

  2. ISOwatcher says:

    Sadly – and as usual – all these authors have vested interests in the ISO compliance business. Most notably Reg Blake of BSI Group America Inc. has to promote his employer’s business:

    Mark Ames is president of AQS Management Systems Inc.
    Reg Blake is vice president of corporate development and regulatory affairs for BSI Group America Inc.
    Michael J. Caruso is vice president of certification for UL DQS Inc.
    Phil Heinle is the owner of Quality Consulting.”

    Any lab that has been inspected knows the comments about the ISO not being massively bureaucratic and petty just aren’t true. These statements are wishful thinking to fool clients. ISO 9001 may be easy relative to the lab standards, but I still disbelieve the comments.

    Changing to more reasonable registrars isn’t an option for labs; UKAS holds the inspection monopoly.

    Perhaps one day many management consultants will develop the vision to think beyond compliance and help clients establish genuinely beneficial systems. Most people outside the inspection cartel suffer when quality is redefined as compliance. The cartel cannot permit truly innovative thinking without damaging its powers of coercion. If creativity were allowed, the hangers-on in consultancy and academia could potentially free themselves from the enforcement cartel that presently leaves the business carcasses for them to pick over.

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