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ISO 9000 specifies requirements for a Quality
Management System overseeing the production of a product or service. It is
not a standard for ensuring a product or service is of quality; rather, it
attests to the process of production, and how it will be managed and
reviewed.
ISO 9000 was originally created by the British Standard Institute as BS
5750. The standard is now maintained by ISO (the
International Organization for Standardization) and administered by
accreditation and certification bodies.
It is widely accepted, although a perception, rightly or wrongly, of high
price and effort has led to many companies using alternatives such as IC9700, or IC9200, both of which are
issued by the International Charter.
Some countries accepted ISO 9000 as their national standard. (e.g. IR
9000 in Iran). History
In WWII, England had a serious problem with the bombs that came
out of munitions plants. In an attempt to resolve the problem, ministry of
the defense inspectors placed in plants of munitions. To supply to the
government, a company had that to write above of the procedure making its
product, to have the procedure inspected for ministry and to assure its workers
it followed these procedures. This, and the similar problems in the excess of
the industries nuclear and being able of the generation the following decades,
were symptoms of the fast technological advance in manufacturing. The advances
in science had been introduced in the technology and thence in manufacturing
correctly too much fast to be controlled. Moreover, the controlling had been
seen while too much frequent basing decisions in the reports of better paper
that in understanding what it was happening in the wooden floor of the plant. In
1959, United States the
developed requirements of the program of the quality, MIL-Q-985å, a quality
standard it military attainment, detailing what the suppliers had had that to
make to obtain conformance. Per 1962, NASA
had developed similarly requirements of the system of quality for its suppliers.
In 1968, NATO adopted the specifications of
AQAP (procedures allies of the quality assurance) for the attainment of the
equipment of NATO. The idea of the quality assurance spread beyond the Armed
Forces. In 1966, the government of the Joined Kingdom lead to the first national
campaign for the quality and the trustworthiness with the slogan "quality is all
business." In 1969, central
electricity that generates the plate (Joined Kingdom) and [[hydro] of
Ontario] (Canada) developed standards of the quality assurance for suppliers. By
this time, the suppliers were evaluated by all the number of its customers. It
was recognized extensively that this age an effort duplication very
despotically. In 1969, a BRITISH report of the committee in the subject
recommended that the methods of the suppliers must be evaluated of meeting to a
generic standard of the quality assurance. In 1971, institute
British standard published the first BRITISH standard for the quality
assurance, BS 9000, that it was developed for the industry of the electronics.
In 1974, the BSI published BS 5179, "guidelines for the quality assurance". The
end to dislocate burden of the inspection of the customer, the quality assurance
was guaranteed by the supplier with the inspection third-party. With 1970s, the
BSI organized meetings with industry to adjust a common standard. The result was
BS 5750 in 1979. The bodies of the industry key agree to leave to fall its
proper standards and to use them preferably. The purpose of BS 5750 was to
supply a common contractual original, demonstrating that the industrial
production was controlled.
Revisions
The standard has evolved over several revisions.
- The initial 1987 version, ISO
9000:1987, originally issued as BS 5750, focused on quality control via
retroactive checking and corrective actions. This version was strongly
influenced by the existing US Department of Defence Military Standards
("MILSPECS") on manufacturing, and so was well-suited to the demands of a
rigorous, stable, factory-floor manufacturing process.
- The 1994 version, ISO 9000:1994,
emphasized quality
assurance via preventive actions, and required evidence of compliance with
documented procedures. Unfortunately, companies tended to implement its
requirements by creating shelf-loads of procedure manuals, and becoming burdened
with an ISO bureaucracy. Adapting and improving processes could be particularly
difficult in this kind of environment.
- The 2000 version, ISO 9000:2000,
introduced the concept of process effectiveness via process performance metrics,
and so reduced the emphasis on having documented procedures if clear evidence
could be presented to show that the process was working well. Expectations of
continuous process improvement and tracking customer
satisfaction were made explicit at this revision.
Certification
ISO does not itself certify organizations.
Many countries have formed accreditation bodies to authorize certification
bodies, which audit organizations applying for ISO 9001 compliance
certification. * note * It is not possible to be certified to ISO 9000.
Although commonly referred to ISO 9000:2000 certification, the actual standard
to which an organization's quality management can be certified is ISO 9001:2000.
Both the accreditation bodies and the certification bodies charge fees for their
services. The various accreditation bodies have mutual agreements with each
other to ensure that certificates issued by one of the accredited certification
bodies (CB) is world-wide accepted.
The applying organization is assessed based on an extensive sample of its
sites, functions, products, services, and processes and a list of problems
("action requests" or "non-compliances") made known to management. If there are
no major problems on this list, the certification body will issue an ISO 9001
certificate (see note above) for each geographical site it has visited once it
receives a satisfactory improvement plan from the management showing how any
problems will be resolved.
An ISO certificate is not a once-and-for-all award, but must be renewed at
regular intervals recommended by the certification body — usually around 3
years.
Auditing
Two types of auditing are required by the standard: auditing by the external
certification body and audits by internal staff trained for this process. The
aim is a continual process of assessment, leading to corrective and preventive
actions, is maintained throughout the scope of the certified organization. It is
considered healthier for internal auditors to audit outside their usual
management line, so as to bring a degree of independence to their
judgements.
Under the 1994 standard, the auditing process could be adequately addressed
by performing "compliance auditing":
- Tell me what you do (describe the business process)
- Show me where it says that (reference the procedure manuals)
- Prove that that is what happened (exhibit evidence in documented
records)
Under the 2000 standard, the auditor performs a similar function but is
required to make more value judgements on what is effective, rather than
adhering safely to the formalism of what is prescribed.
ISO 9000 document suite
ISO 9000 is composed of the following sections:
- ISO 9000 covers the basic language.
- ISO 9001 is intended for use in organizations who do design,
development, installation and servicing of their product. It discusses how to
meet customer needs effectively. This is the only implementation for which
third-party auditors may grant certifications. The latest version is :2000.
- ISO 9002 is nearly identical to 9001, except it does not incorporate
design and development. In ISO 9000:2000, this was replaced by ISO 9001:2000.
- ISO 9003 is intended for organizations whose processes are almost
exclusive to inspection and testing of final products. In ISO 9000:2000, this
was replaced by ISO 9001:2000.
- ISO 9004 covers continual mprovement. This gives you advice on what
you should (or could) do to achieve ISO 9001 compliance and customer
satisfaction.
There are over 20 different members of the ISO 9000 family, most of them not
explicitly referred to as "ISO 900x". For example, parts of the 10,000 range are
also considered part of the 9000 family: ISO 10007:1995 discusses how to
maintain a large system while changing individual components.
To the casual reader, it is usually sufficient to understand that when an
organization claims to be "ISO 9000 compliant", it means they conform to one of
the specifications of ISO 9001:2000. (Note that certification to ISO 9001:1994,
or ISO 9002:1994 or ISO 9003:1994 was not valid after 14 December 2003.)
The ISO website and documentation give more detail on what each specification
entails. Many have seemingly subtle variations.
Industry-specific interpretations
As the paragraphs and clauses of the ISO 9001 standard have always been very
generalized and abstract, they have to be carefully interpreted to make sense
within a particular organization. Developing software is not like
making cheese or offering counseling services, yet the ISO
9001 guidelines can potentially be applied to each of these industries.
Over time, various industry sectors have wanted to standardize their
interpretations of the guidelines within their own marketplace.
- The TICK-IT standard is an interpretation of ISO 9000 produced by the
UK Board of Trade to suit the processes of the information technology industry,
especially software development.
- AS 9000 is the Aerospace Basic Quality System Standard, an
interpretation developed by major aerospace manufacturers. The current version
is AS 9100.
- QS 9000 is an interpretation agreed upon by major automotive
manufacturers (GM, Ford, Chrysler). It includes techniques such as FMEA and APQP.
- ISO/TS 16949:2002 is an interpretation agreed upon by major
automotive manufacturers (American and European manufacturers); the latest
version is based on ISO 9001:2000. The emphasis on a process approach is
stronger than in ISO 9001:2000 as well automotive industry specific
requirements.
- 'TL 9000' is the Telecom Quality Management and Measurement System
Standard, an interpretation developed by the telecom consortium, QuEST Forum (http://www.questforum.org) . The current
version is 3.5 and unlike ISO 9001 or the above sector standards, TL 9000
includes standardized product measurements that can be benchmarked.
Criticisms of ISO 9000
Criticisms of ISO 9000 generally concern inappropriate misapplication or
extension of its use in companies, and the effect this can have on organizational culture. While the
critisicm focuses on the standard, the problems typically arise from a failure
of organisations to understand the underlying philosophy and the fact that the
standard describes a systematic approach. Benefits will be difficult to achieve
where incomplete or incoherent implementations of ISO 9001 - based quality
management systems prevail.
- BS 5750 was designed to show that production was controlled. It in no way
addresses process or performance improvement. Processes, technology and customer
demands are ever-changing, but useful changes can be blocked for being
non-compliant. Whereas the work of W. Edwards Deming focuses on awareness
of processes, thus harnessing workers' creativity, ISO 9000 can create a culture
of ritualizing processes — including creative ones — thus suppressing it.
- "When all you have is a hammer, every problem looks like a nail." It
may not be appropriate to apply a process such as ISO 9000 to a field requiring
creativity, such as software engineering, which is more
analogous to designing factories than to operating a factory. ISO 9000 is
sometimes used as an excuse for inappropriate Taylorisation.
- Bad managers still manage at arm's length, using paper reports rather than
knowing what is happening on the factory floor. ISO 9000 can reinforce this
behaviour. Instead of being seen as an opportunity to improve things, audits
often become quite confrontational in structure.
- Many companies only register to ISO 9000 because they are forced to by the
marketplace — whether or not ISO 9000 is in fact appropriate to their business.
These problems were particularly pronounced with the ISO 9000:1994 revision.
The 2000 revision was in part an attempt to address such criticisms.
There are few or no objective metrics showing any effectiveness for ISO 9000.
In 1997, two people took the BSI to the Advertising Standards Authority
for claiming in an advertisement that ISO 9001 "improves productivity ...
almost always gives an immediate result in terms of productivity and efficiency,
and that means cost reductions ... pays for itself ... Staff morale is better
because they understand what is expected of them and each other," whilst
being unable to produce any objective metrics to substantiate these assertions.
The complaint was upheld.
In Japan, amidst complaints of ISO 9000 undermining world-class thinking, Toyota abandoned the standard in 2000, moving back to their in-house Toyota
Production System.
Related standards
ISO 14000 exists to ensure
that the manufacture of a product has the lowest possible environmental
ramifications. Like ISO 9000, it pertains to how a product is produced, rather
than how it is designed.
External links
Critical links
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