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Very few individuals -- including, in my experience,
the ISO administrators in Geneva and at the national body levels
(ANSI here in the U.S.) -- know the origins of ISO 9001. The following
excerpt from Chapter 17 of Optimizing Quality in Electronics Assembly:
A Heretical Approach that I co-authored with Frank B. Whitehall
of Edinburgh, Scotland may be of some help with the historical
aspect:
"The origins of ISO 9000 lie in British defence
procurement, which likely explains the inspection-oriented nature
of the system.
In 1968, the British Ministry of Technology the government
body that, at the time, handled defence materiel specifications
and procurement produced one of the most innovative quality system
specifications in modern military standards history. Known as
AvP92, it purported to cover the entire spectrum of the contractor's
operation from design to delivery.
Particularly with respect to design quality, it has
never been surpassed. Although it turned out to be relatively
short-lived, AvP92 set the precedent for evaluating suppliers
by quality management processes as well as actual product. AvP92 was replaced in 1973 by the DEF STAN 05/20 series issued by the department now known as the Ministry of Defence (MoD). DEF STAN 05/21 covered the design, production and service of hardware functions. This new standard was broadly equivalent to the 1969 NATO quality management specifications known as AQAP. For reasons unknown today, the United States
(which, as the most influential NATO member at the
time, undoubtedly exercised considerable influence over the AQAP
contents) never invoked AQAP specifications for American defense
contractors. MIL-Q-9858 (later MIL-Q- 9858A) was introduced in
its place. The conflict in standards between NATO and the U.S.
Department of Defense caused considerable resentment among European
defense contractors who found themselves required to follow several
divergent sets of standards.
The ultimate consequence of the DoD decision, however,
was that American industry would be caught unprepared when Western
Europe chose to harmonize on quality management standards strongly
related to the NATO and MoD requirements. In 1979, the British Standards Institution (BSI) issued a standard (BS 5750) for quality management procedures. Under BS 5750, much like under AvP92 and AQAP, supplier quality would be judged not just by the dependability of the product (or, eventually, service) but also by its
official quality assurance systems, the formal documentation
of those systems and the correlation between documented procedures
and actual practices. The reasoning behind the new standard was still apparent in the Introduction to the 1987 version of BS 5750: "Most organizations ó industrial, commercial or governmental ó produce a product or service intended to satisfy a user's needs or requirements. Such requirements are often incorporated in 'specifications'. However, technical specifications may not in themselves guarantee that a customer's requirements will be consistently met, if there happen to be any deficiencies in the
specifications or in the organizational system to
design and produce the product or service.
Consequently, this has led to the development of
quality system standards and guidelines that complement relevant
product or service requirements given in the technical specifications.
The series of International Standards (ISO 9000 to ISO 9004 inclusive)
embodies a rationalization of the many and various national approaches
in this sphere."
Although this rationale contains serious logical
and operational flaws that will be discussed in Chapter 17, it
does provide clear insight into the original reason for development
of an international quality management standard. BS 5750 was initially seen as a toothless curiosity by the defense contracting community where rigorous adherence to customer-mandated processes and record-keeping was as important as actual product performance in satisfying contracts. However, defense contractors are often owned by
general-purpose conglomerates which also have substantial
holdings in civilian industry. To those conglomerates, even a
diluted military approach to quality management was better than
none at all. Combined with urging by the British government to
support the scheme, United Kingdom companies saw real incentive
to participate in BS 5750. BS 5750 began as a self-regulatory system. Customers would issue contracts requiring compliance with BS 5750 provisions and suppliers were expected to honor those requirements. Thus, suppliers followed the guidelines set out by the BSI and judged whether they were in compliance.
Customers could inspect vendor operations to assure
the accuracy of vendors' self assessments but no formal regulatory
body existed.
At the same time, BSI offered a third party assessment
service for use where suppliers or customers wanted an "official"
certificate.
Inevitably, some companies graded themselves as BS
5750 compliant even though their actual procedures violated significant
requirements. This caused customers seeking BS 5750-compliant
suppliers to conduct audits of each new supplier. Some of those
major corporate customers reaudited suppliers at regular intervals.
Customers who emphasized supplier process more than product dependability
began urging establishment of a national body to carry out audits
and issue approvals. In 1984, the British government's Department of Trade and Industry gave BSI authority to regulate certification companies through a subsidiary organization called the National Accreditation Council for Certification
Bodies (NACCB). Though the NACCB now part of the
United Kingdom Accreditation Service (UKAS) in itself did not
prevent self-assessment, its creation in reality marked the demise
of the two-party (i.e., customer and supplier) certification system.
The transition resulted from wording of BS 5750: Part 0: Section 0.1: 1987. "Assessments of a supplier's quality system are utilized prior to a contract to determine the supplier's ability
to satisfy the requirements of ISO 9001, ISO 9002
or ISO 9003 and, when appropriate, supplementary requirements.
In many cases, assessments are performed directly by the purchaser.
By agreement between purchaser and supplier, pre-contract assessment
may be delegated to an organization independent of both contracting
parties. The number or the extent of assessments can be minimized
by using ISO 9001, ISO 9002 or ISO 9003 and by recognizing previous
assessments carried out in accordance with these International
Standards by the purchaser or by an agreed independent assessing
organization."
The "agreed independent assessing organization(s)"
were for-hire certification companies that sold their services
to both customers and suppliers. Customers who lacked sufficient
staff to audit suppliers could enlist these independent auditing
bodies. Obversely, suppliers seeking accreditation carrying more
weight than their own claims of compliance could also retain the
same auditing bodies to vouch for their systems. The appeal of third party certification to customers was very great. Rather than bearing the burden of auditing suppliers, the customers could pass along the costs to suppliers. Some suppliers also welcomed the shift in emphasis to third party certification since that certification greatly
reduced the time spent in their facilities by various
customer representatives. But for those companies that had not
been subjected to frequent customer audits, the cost of BS 5750
compliance rose significantly as it became necessary to pay for
third party auditing. Moreover, the potential for abuse by the
certification bodies was enormous and not all such organizations
resisted the temptation to squeeze payments from supplier companies
in exchange for certification.
BSI's close ties to ISO ensured that BS 5750 came
to the attention of the international standards body. At the same
time, movement towards uniformity of industrial and social standards
throughout the European Community ensured that leaders of other
European countries found BS 5750 highly attractive. In 1987, a
quality management format identical to BS5750 was adopted by the
International Organization for Standardization under the designation
ISO 9000.
ISO 9000 was strongly promoted by most governments
in the European Community. (Germany was the most resistant but
eventually enlisted as well.). That was not the case in the U.S.,
where federal interest was focused on the newly-created (and government-run)
Malcolm Baldrige National Quality Award. Consequently, for its
first five years of existence, ISO9000 was almost exclusively
a European standard generically known as EN29000 although each
country tended to have its own national designation (as, for example,
the U.K. which retained the BS 5750 label).
Only in recent years have national designations been
largely replaced by reference to the EN series." (Optimizing Quality in Electronics Assembly: A Heretical Approach by James Allen Smith and Frank B. Whitehall; copyright 1997, McGraw-Hill
Professional Publishing)
Regarding the relationship between ISO 9000 and quality,
Whitehall and I spent several hundred pages explaining the limited
ability of ISO9000 (or, for that matter, QS 9000) to improve quality.
The first part of the exercise required development
of what Deming would call an "operational" definition
of quality. (Or, more accurately, the first part of the exercise
required defining the meaning of an "operational definition"
before we could even work on development of that definition.)
Since this is not a topic that lends itself to concise presentation, forgive me if I say only that the current ASQC approach to quality -- i.e., quality is what the customer says it is, not what the providing entity says it is -- does not meet the requirements laid out by Deming for an
operational definition. Once the real, objective
meaning of quality is specified, the arguments favouring ISO9000
and QS 9000 collapse (except the obvious supporting factor that
many unenlightened companies impose ISO/QS certification as a
supplier requirement).
Jim Allen Smith |
