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by Ashok M. Thakkar

ISO 9000’s prescription for quality management systems was developed with the expectation that it would standardize such systems globally while providing consistent quality in goods and services. Unfortunately, although the standard has become a global one, it certainly hasn’t succeeded in ensuring consistent quality. This article attempts to pinpoint the causes that contribute to this problem--and emphasize that ISO 9001 is definitely capable of producing the desired results.

Registration ROI

Worldwide, ISO 9001 registrations have exceeded the half-million mark. Great Britain, which is only slightly bigger than California, is home to more than 70,000 organizations registered to ISO 9001, compared to the United States’ 50,000. But Britain’s 40-percent registration lead hasn’t necessarily enabled it to produce significantly better products and services than those of the United States. Developing countries such as India and China each have in excess of 10,000 organizations registered to ISO 9001. Although they’ve seen significant increases in their exports, much of this can be attributed to nonstandard-related policies and other developments. These countries haven’t necessarily earned adequate returns on investment from registering to ISO 9001.

Thus, the question is, “Does ISO 9001 really help to improve quality?” The answer is a definite “Yes, but…” This “but” refers to the quality of a registered organization’s QMS. Consider the following questions:

Have you developed a QMS that satisfies the intent, not just the letter, of ISO 9001?

Is your QMS aligned with your strategic goals or is it a parallel management system creating nonvalue-added bureaucratic burden?

Does the system make sense to you or have you established it because, in somebody’s opinion, ISO 9001 “requires” you to do it?

Is it driven by top management or just the quality manager?

Does your external auditor perform a tough and demanding surveillance audit, or does he or she simply go through the motions without prodding you toward continual improvement?

A sizable minority, if not a majority, would respond unfavorably to these questions. The fact that ISO 9001 continues to spread, albeit at a much slower pace, is due largely to marketplace pressure. However, at this juncture, after half a million registrations, the standard’s survival depends upon it evolving into a cultural phenomenon driven by internal needs rather than external pressure. Unfortunately, examples of this are few and far between. Assuming this current trend continues, it won’t be long before ISO 9001 registrations show negative growth.

Five main groups compete in the game of implementing and maintaining ISO 9001 quality management systems. They include:

Organizations that develop, implement and maintain the QMS in accordance with the standard

Registrars accredited and authorized to issue certificates that legitimize organizations’ ISO 9001 compliance

The Registrar Accreditation Board, which is the nonprofit governing body that oversees registrars, their auditors and the organizations

ISO 9001 training providers

Consultants who assist organizations in understanding, developing, implementing and maintaining their QMSs. (Note that consultants can be internal or external.)

Let’s examine the role of each of these players in turn.

Registered organizations

Many organizations implement ISO 9001 because they must. And, due to their leaders’ sketchy experience dealing with QMSs, not many of those companies understand ISO 9001’s considerable effect on them. This is why they often join the game reluctantly or maintain their QMSs as extra burdens. In many cases, the QMS remains the quality manager’s program. This is also why an alarming number of organizations have either decided to drop, or are seriously considering dropping, ISO 9001:1994 registration instead of upgrading to ISO 9001:2000. In most cases, the management representative is relegated to the role of “necessary evil” rather than the important facilitator that he or she should be.

It’s not this article’s intent to point an accusatory finger at executives. This group is fairly willing to provide proper resources and support to the QMS process. However, many internal and external consultants falsely assume that executives wouldn’t be interested anyway and, thus, don’t bother involving them. Consultants design the QMS based on minimal, rather than adequate, executive participation, which marginalizes the system from the beginning. It’s also true that the ivory tower occupants haven’t been trained to think of quality as a strategic issue. For the most part, they’re unaware of the important role a QMS can play in their organization’s survival and growth.


Close to 80 registrars compete for clients in the United States. As with any other group, this one consists of members who vary in ability. The variation, unfortunately, is significantly greater than what can be tolerated. This is an alarming reality.

As if this weren’t bad enough, variation exists among auditors from the same registrar. Auditors’ training appears to be ineffective in an unusually large number of cases. Although ISO 9001:2000 requires organizations to verify effectiveness of training, registrars are apparently exempt from verifying the effectiveness of their own auditors’ training.


The Registrar Accreditation Board

Pleading inadequate resources, the U.S. RAB hasn’t adequately monitored registrars, their auditors and the organizations that are consequently registered. As a result, many marginal and even noncompliant QMSs are recommended for registration. Such marginalization undermines the standard’s credibility and encourages organizations to abandon this very important approach to business and product/service excellence.

Add to this the issue of registrars that offer a comprehensive package of consulting and registration services. Although this practice is frowned upon on paper, it’s happening, and the RAB largely ignores what amounts to a travesty of basic certification integrity.

The RAB’s method for qualifying lead auditors has resulted in keeping more qualified people out while ushering in marginally qualified individuals. The board’s chief concern, presumably, is overseeing auditors. If such a requirement isn’t in the RAB’s charter, it should be. In the absence of monitoring by the RAB, the registrar is expected to send its management personnel to monitor its own auditors. In such cases of self-monitoring, where “the fox is asked to guard the chicken coop,” weak enforcement is almost inevitable.

Auditors have also noted the striking difference between how Britain’s RBA and the United States’ RAB monitor their auditors. Those auditing under the British RBA registration scheme are far more likely to be monitored by an independent observer than auditors working under the U.S. RAB scheme. In fact, several auditors have confirmed that, while working under the U.S. RAB, they’ve never been monitored by an independent observer.

Moreover, no mechanism exists for monitoring and correcting auditors’ behavior during audits. Occasionally, some auditors do come across as arrogant or downright wrong. In such cases, clients fearing reprisal prefer to keep quiet, although this sours them on the process as a whole. In the end, ISO 9001’s reputation and validity suffers more than just the registrar’s reputation.

Unavoidable conflict of interest is another issue: The audited organization is also the client that pays the auditor’s bills. The latter’s commercial interests collide head on with his or her responsibilities as an ethical auditor. Some can walk this fine line carefully and successfully, but an alarming number don’t. It’s another example of how marginal QMSs get recommended for registration. When these systems fail to produce desired results, ISO 9001 is blamed, not the auditors.

ISO 9001 training providers

Training providers, the fourth group of players, are divided into two broad categories: private companies and educational institutions such as universities. The former usually do a respectable job of conducting training, but the same can’t be said for universities. I’ve come across quite a few ISO 9001 instructors whose knowledge of an ISO 9001 QMS is purely academic. In my opinion, this is akin to an instructor who teaches swimming without ever having jumped into the water.


The ISO 9001 standard is a strategic exercise. It’s designed to effect a cultural change in an organization so that everyone breathes and thinks quality in every business process. When a consultant fails to understand this basic premise and instead concentrates on mere compliance to the letter of the law, a marginally compliant system is born. The consultant has an obligation to understand the standard, the basics of various business processes and the relationship between the two.

A marginal system produces marginal results and loses credibility in the eyes of executives, whose commitment, involvement and provision of resources ultimately support a successful QMS. Systems that fail to impress executives are delegated to lower levels of management for maintenance, where they become bureaucratic burdens rather than strategic business tools.

What should be done?

The American Society for Quality and ANSI-RAB must promote ISO 9001 as a strategic business tool worthy of being discussed in executive suites and boardrooms.

ASQ must develop consultant certification criteria to weed out marginal advisors.

Special courses must be offered to corporate executives that explain ISO 9001:2000’s strategic importance and suggest implementation strategies. These courses should be specific about top managers’ roles.

Training providers must possess certain basic qualifications--including practical experience--before leading others in QMS development.

A certification program for management representatives must be established. Additionally, more stringent guidelines must be developed concerning management representatives’ positions and authority in organizations, along with criteria for verifying that top management effectively supports management representatives.

Minimum basic qualifications must be established for auditors from different registrars.

Auditor training must include standardized information in business processes.

Registrars must measure the effectiveness of auditor training and practice continual improvement in their auditing methodologies.

A committee of registrar representatives, working with RAB, must develop criteria and a methodology for measuring and monitoring auditor performance. A parallel system must be developed to verify the auditor’s effectiveness.

Registrars must monitor auditor performance more closely. If an auditor consistently produces “zero defect” audits, such trends should be investigated and corrected. It’s impossible to create a flawless QMS.

Renewed emphasis must be placed on surveillance visits. Annual surveillance audits should be increased to a semiannual cycle.

Proof of continual improvement must be demanded during each surveillance visit, and major discrepancies should be considered if the QMS fails to produce continual improvement on significant business measures.

RAB must develop a system of monitoring auditors’ behavior during audits. Clients should have the means to report on auditors’ unprofessional or unethical behavior easily and without fear of reprisal.

RAB must evaluate its system of qualifying auditors so that it effectively filters out marginal performers and attracts more qualified individuals.

Every auditor must be observed in action by an independent observer at least once every three years. A detailed report must be kept on file.

RAB must monitor registrars’ conflicts of interest more effectively.

RAB must prohibit registrars from offering cash incentives to consultants for referral.

RAB must prevent registrars from offering a “guarantee of registration.”

RAB must induce registrars to establish a more transparent as well as effective system for handling and resolving clients’ grievances against auditors.

RAB must be more proactive in combating registrar violations.

About the author

Ashok M. Thakkar is president and CEO of the Roswell, Georgia-based consulting firm ITTI LLC. Since he assumed company leadership in June 1993, ITTI has helped 112 clients in four countries and three languages register to various ISO standards. Thakkar has worked with more than eight leading registrars and 60 different auditors internationally. A provisional auditor for eight years, in January 2001 he returned his card to RAB due to the reasons identified in this article. Letters to the editor about this article can be e-mailed to letters@qualitydigest.com.