by
Shirley Butchart and Debbie Manz
Based on Robert W. Peach (ed.), The ISO 9000
Handbook, Ceem Information Services, 1994.
Yonatan Reshef
School of Business
University of Alberta
Edmonton, Alberta
T6G 2R6 CANADA
General Background Information
- ISO 9000 are a series of standards set by the International Organization for
Standardization (ISO), they were first published in 1987. The Intentional Organization for
Standardization was founded in 1946 as part of a drive in Europe to develop a common set
of manufacturing, trade and communication standards. (The name ISO does not technically
stand for anything!) The American National Standards Institute (ANSI) is the U.S. member
body to ISO. Standards developed by the ISO are voluntarily adopted there are no legal
requirements to force countries to adopt them. The ISO develops standards in all
industries except those related to electrical and electronic engineering which are made by
the Geneva-based International Electrotechnical Commission (IEC).
- The standards are generic standards for quality management and
quality assurance, applicable to all types of companies, large and small and in all
sectors of the economy.
- There are five documents in the ISO 9000 series, and the series
are becoming an intentionally recognized common language for quality, facilitating global
trade.
- As of 1994, 74 countries had adopted the ISO 9000 series as a
national standard. In addition, government agencies around the world are beginning to use
the ISO 9000 series.
- ISO and IEC have provided their own clarification of terms that
are often used interchangeably as follows:
- Accreditation - procedure by
which an authoritative body gives formal recognition that a body or person is competent to
carry out specific tasks
- Certification - procedure by
which a third party gives written assurance that a product, process or service conforms to
specific requirements.
- Registration - procedure by
which a body indicates relevant characteristics of a product, process or service, or
particulars of a body or person, and then includes or registers the product, process or
service in a appropriate publicly available list.
The Role of ISO 9000 Series
- Quality Management: The ISO
9000 series standards provide guidance for suppliers of all types of products who want to
implement effective quality systems in their organizations or to improve their existing
quality system.
- Quality Assurance: The
standards also provide generic requirements against which a customer can evaluate the
adequacy of a supplier's quality system.
An overall aim of the series is to harmonize intentional trade by
supplying a set of standards with worldwide credibility and acceptance. For some firms,
registration in one of the series is a legal requirement to enter the regulated EC market.
The ISO 9000 Series and Standards
- The basic ISO 9000 series consists of five standards: ISO 900-1,
ISO 9001, ISO 9002, ISO 9003 and ISO 9004-1.
- The standards are of two categories: 9001, 9002, and 9003 are
conformance standards, used for external quality assurance in providing confidence to
customers that the firm's quality system will provide a satisfactory product or service.
- 9000-1 and 9004-1 are guidance standards, they are descriptive
documents, not prescriptive requirements, providing guidance to all organizations for
quality management purposes. The documents are used for internal quality assurance,
activities aimed at providing confidence to the management of an organization that the
intended quality is being achieved.
- The ISO series supports a definition of quality that includes;
"the totality of characteristics of an entity that bear on its ability to satisfy
stated or implied needs." Generally it is stated that quality in a product or service
refers to "fitness for use" or "fitness for purpose."
- The standards indicate that a quality system is "the
organizational structure, responsibilities, procedures, processes and resources needed to
implement quality management." The ISO 9000 series are based on the idea of building
quality into every aspect of the enterprise, with an integrated quality management system.
- Quality management is referred to as "ail activities of the
overall management function that determine the quality policy, objectives and
responsibilities and implement them by means such as quality planning, quality control,
quality assurance and quality improvement within the quality system."
- The series indicate that quality assurance includes Wall the
planned and systematic activities implemented within the quality system and demonstrated
as needed to provide adequate confidence that an entity will fulfill requirements for
quality." An entity can be a process, a product, an organization, a system, a person
or any combination of these. The purpose of the quality assurance system is to prevent
problems from occurring, detect them when they do occur, identify the cause, remedy the
cause, and prevent reoccurrence.
- Standards in the ISO 9000 series are not product standards. The
series does not include any technical requirements, these standards are considered
complementary to but not substitutes for distinct product technical requirements.
- ISO 9001, 9002, and 9003 standards require a company to document
what it does, do what it documents, review the process and change it when necessary. These
requirements do not constitute a full-fledge total quality management system; rather they
provide the building blocks for such a system.
- ISO 9001 Quality systems standards are for quality assurance in
design/development, production, installation and servicing. It is the most comprehensive
of the conformance standards. It includes all the elements in ISO 9002 and 9003. In
addition, it addresses the design, development and servicing capabilities not addressed in
the others.
- ISO 9002 Quality systems standards for quality assurance in
production, installation and servicing. It does not include the design function.
- ISO 9003 Quality systems standards for quality assurance in final
inspection and test is the least comprehensive of the conformance standards. It addresses
only the requirements for detection and control of problems during final inspection and
testing.
ISO 9000 Series Registration, Accreditation
Issues and Processes
- 1993 survey done by Deloitte and Touche of US and Canadian firms
indicated that for many firms the reason to seek registration was the European
requirements for exporting regulated products.
- A major decision for a firm seeking registration is the selection
of the registrar, firms look to choose a registrar based on reputation, country
affiliating and accreditation. Registration is considered a major marketing tool.
- The Standards Council of Canada (SCC) is the accreditation body
for Canada. That means that the SCC is the body in Canada that is qualified to accredit
Registrars. They do an assessment of any applicant registrar and registrars may be
Canadian or they may be from other countries.
- Registrars may be accredited by a number of authoritative bodies;
European, Canadian or American, as examples. These authoritative or accrediting bodies are
also called certifying bodies. They are authorized to provide registration certification
to consultants etc. A company applying for ISO 9000 series, is applying for registration
and in the fact certification from one of the arms distant accrediting bodies.
- Therefore, a firm may be assessed and registered by a Canadian
firm who is accredited by one of the authorizing bodies of one of the European countries
and by the SCC; in order to ensure international acceptance of their registration they are
likely to request the registration process be under the certifying responsibility of the
European country's authorizing body.
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