ISO 9000 GUIDE
Management System Certification
-IRCA
and the Role Of Auditor Registration
-About
ISO 9000
-The Structure Of QS-9000
-AEROSPACE
-Environmental Management
Systems
-Information Security
Management Systems
Management System
Certification
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Introduction to Quality Management System |
study of the
development of international quality management standards shows that
they evolved from military standards following World War ll. Their
structure and content were influenced to a large extent by United
States Military Standards MIL-Q-9858, UK DEF Stan 05-20 series and
NATO quality standards (AQAP). In the 1770s, pressure from industry
to alleviate the burden of multiple assessment caused by many
differing supplier standards led to the development of a range of
national standards, such as BS 5750 in the UK and CSA Z299 in
Canada.
The British
Standards Institution published BS 5750 in 1979 which established a
recognized UK national standards. The International Organization for
Standardization, identifying an increasing global market for goods
and service and the need for international harmonization, formed a
technical committee (ISO TC 176) to draw up a series of
international quality management standards and, in 1987, ISO 9000
was published. This replaced BS 5750 in the UK and was published in
numerous countries around the world. The standard was further
revised in 1994.
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UK growth of quality management certification |
Quality
management certification in the UK was given impetus by the 1982
government white paper on quality standards and international
competitiveness, which identified a number of areas where British
business was falling behind. Alarm bells were ringing over growth in
trade deficit figures and the government looked for ways of
addressing the apparent shortcomings in British business and
industry.
Quality
management certification was identified as one response and a
National Quality Campaign was launched in 1983. Funding was made
available in the form of DTI grants for industry and certification
bodies to implement management systems. Major organization such as
the MoD, British rail and British telecom supported the initiative,
recognizing the advantage of a common standard applied within their
individual companies and imposed on suppliers.
Once this
process was under way, the certification industry grew rapidly, with
many organizations coming to regard certification as a necessary.
The annual rate of certificates issued peaked in 1994/95 when DTI
grants were withdrawn. Following this withdrawal of grants,
certification bodies become more competitive, responsive and
accountable.
As the
millennium approaches, the industry and the way it is perceived has
matured. Once regarded as complicated, bureaucratic and expensive,
certification is now seen as offering very real and tangible
benefits to all sections of business. Surveys show 'business
efficiency 'as the single most important reason for the introduction
of quality management disciplines and to again registration.
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The Infrastructure of Certification |
To provide
meaning certification services, a certification body must be able to
demonstrate competence and impartiality. For this reason,
certification bodies themselves are accredited in recognition that
they meet the internationally accepted standard (EN 45012) covering
integrity, independence and technical competence, and that their
assessors are capable of assessing companies against standards, such
as ISO 9000, to a consistent level.
To facilitate
this, countries have established national accreditation system for
certification bodies. The success of such system in the United
Kingdom and the Netherlands in particular, has encouraged many other
countries, including the United States and Japan, to set up and
administer similar systems. When a company gains certification from
a body which is it self accredited to a national system, it gives
customers confidence in the company's quality to deliver goods or
services to specified requirements, Certification thus becomes a
facilitator of trade. The certificate of registration is evidence of
a company's commitment to quality and, accreditation is the
statement of competence of the certification body.
Two EU
countries, the United Kingdom and the Netherlands, were the first to
establish credible and viable national system. Prior to August 1995,
the United Kingdom government sponsored the National Accreditation
Council for Certification Bodies (NACCB) as the UK's authoritative
body for certification matters. At the time, NACCB had accredited 48
certification bodies, employing more than 1,100 assessors. They, in
turn, had registered more than 44,000 companies against ISO 9000. In
August 1995, NACCB was replaced by the United Accreditation Service
(UKAS) which was established to combine the work of NACCB and the
National Measurement Accreditation Service (NAMAS), the
accreditation unit for laboratories and test houses. As
certification bodies have to operate in a multitude of different
business areas, a recognised accreditation body for each area they
offer certification in should accredit them. The list of business
areas they are accredited for it termed their scope.
The
international standard ISO 9000 has their requirement standards, ISO
9001, 9002 and 9003. Each part covers a range of activities, such as
design, manufacture, servicing and inspection (ISO 9001),
manufacture, servicing and inspection (ISO 9002) or inspection (ISO
9003), Within each of these areas, a business has its specific
activity described as their scope of registration. A potential buyer
considering a supplier because of its ISO 9000 certification should
ensure that the supplier's product or service is covered by the
scope of its certification of registration.
UKAS provides a
unified national accreditation service to bodies undertaking
certification of products, personnel and management systems
(including environmental management). and to laboratories performing
tests and calibrations. Any certification body in the world can seek
accreditation from UKAS. Acting under licence, it advises the
Secretary of States for Trade and Industry on the accreditation of
certification bodies and other related matters. UKAS is a company
limited by guarantee. Under a memorandum of understanding, the DTI
recognises the unique national role UKAS plays in the filed of
accreditation and allows it to provide accreditation in it own
right, without referrals or recommendations to the DTI, although
this is subject to strict compliance with national and international
standards. The accredited certification bodies are kept under
constant surveillance during the validity of their certificate. UKAS
use the by now familiar NACB logo incorporating the Royal Crown and
Tick.
The Netherlands
also has its own national accreditation council, Raad voor
Accreditate (RvA), which receives government support and industry
sponsorship and industry sponsorship. AvA consists of a board of
government draw from various groups such as industry, consumers,
accredited certification bodies, the government and scientists. The
Board formulates accreditation criteria while a small executive
committee, drawn from the Board, decides whether accreditation
should be granted to a certification body, with approval and
rejection taking place on the basis of an assessment report.
Accreditation is granted for a two year period and a certificate is
issued by RvA as a mark of approval. After two years a new
assessment takes place and the certificates is issued. RvA has
151accredited certification bodies at the time of writing.
In June 1991,
the United become one of the first non-European country to set up an
accreditation body, it is referred to as the Joint American
Accreditation Body for Registrars of Quality System or ANSI/ RAB. Of
the 30 recognised accreditation bodies around the world, 23 are full
members of the International Accreditation Forum (IAF). As well as
the three mentioned above, these include Australia and New Zealand,
Japan, South Africa, Canada, China, 10 more European countries and
others from all over the world.
Of the countries
recognising ISO 9000 as the standards for quality management system
around the world, more than half are developing countries such as
Brazil, Chile, China, Columbia, the Czech Republic, Nigeria,
Slovakia, Slovenia, Bangladesh, Vietnam etc. In many of these
countries, the national standards body also carries out quality
systems certification and registration although no formal national
accreditation system exists. In almost all the developing countries
listed in the ISO Directory, foreign certification bodies such as
National Quality Assurance (NQA) of the United Kingdom, Det Norsk
Veritas Quality Assurance of Norway, SGS International Certification
Service of Switzerland and TuV Cert of Germany, Also provide quality
systems certification and registration. All these certification
bodies and some operate in multi-national markets.
There are a
number of organisations, some international and some operating in a
single country, that promote the mutual recognition of accreditation
bodies and perform other functions relating to the industry.
The European
Co-operation of Accreditation (EA) is a joint operation of
multi-national accreditation in Europe. Its main objective is to
establish a multi-national agreement between its members on the
basis of mutual confidence. Some 17 European countries have signed
the EA memorandum of understanding. IAF is a form of national
accreditation bodies and 17 of its members have signed a
multilateral mutual recognition agreement.
IQNet is a long
established group of certification bodies, made up primarily of
national standards bodies and other no profit making organizations.
The members of this network recognise each other as certification
bodies providing certification service in line with the European
standards and recommendations from the IAF.
The Association
of British Certification Bodies (ABCB) is the UK's trade association
for third party certification bodies. It was founded in 1984 in
response to a Department of Trade & Industry Proposal that
certification bodies should associate together to provide a
collective input to the national accreditation body. The ABCB become
a limited company in 1996 and is recognised by the government, UKAS
and other national and international organisations as the sole UK
trade association representing certification bodies. It is a member
of UKAS and is represented on various committees, including the UKAS
Policy Advisory Committee, British Standards Committees and
International committees. The ABCB played a major part in the
implementation of the 39 EAC scopes, acknowledging members'
interests. Its work continuously promotes accredited certification
and the interests of certification bodies.
The Independent
International Organization for Certification (IIOC) is made up of
seven international certification bodies. IIOC members have signed a
memorandum of understanding negating the need for multiple
assessment and working to improve the reputation of ISO 9000
certification as a benchmark for quality worldwide.
ITQS is a group
of certification bodies, which deals purely with assessment
certification of quality systems in the information technology
sector and, as such, is the only sectorial group of bodies. ITQS is
a multi-lateral, mutual recognition agreement for the information
technology sector that is approved by the European Committees for
information Technology and Communication Testing and Certification (ECTIC)
and the European Organisation for Testing and Certification (EOTC).
A company certified by one ITQS member becomes registered with ITQS
and receives an annex from them attesting that the certificate is
recognised by the other members.
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The International Organisation for Standardisation (ISO) |
The
International Organisation for Standardization (ISO is a worldwide
federation of national standards bodies. The scope of ISO covers
standardization in all fields except electrical and electronic
engineering which are the responsibilities of the International
Electro technical Communication (IEC). Together, ISO and IEC from
the world's largest non-government system for voluntary industrial
and technical collaboration at an international level. ISO's
technical work is published in the from of international standards
or guides. ISO/IEC Guides, drawn up by ISO/CASCO- the ISO committee
on conformity assessment, provide guidelines and standards on the
operation of accreditation bodies, certification bodies and other
related activities.
However, the
ISO/IEC Guides are not the only documents in the world that contain
type of requirements. In 1986, the European Commission initiated the
development of the EN 45000 series of standards. Since then, the use
of standards has been considered as a means to support the new
policy in the field of conformity assessment that was set out in the
resolution on the global approach to conformity assessment.
Standardisation bodies within European responsible for developing
standards for conformity assessment are Committee European D'
normalisation (CEN) and Committee European D nonmalisation Electro
Technic (CENELEC). Theses standards being to the EN 45000 series and
are developed with the aim to harmonise the criteria for conformity
assessment.
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