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The Concept
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What is quality? |
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In simple terms, quality is the ability to meet all the
expectations of the purchaser of goods or services. There is a more
technical definition in the International Standard ISO 8402 which
defines quality as: "The totality of features and characteristics of a
product or service that bear on its ability to satisfy stated or
implied needs." |
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Are ISO 9000 quality standards applicable irrespective of the
product's final technical characteristics? |
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Yes, but this is really a matter of perspective. To take an
extreme case, quality requirements will obviously not be the same for
a rubber band used in an office than for a seal which, if it fails,
might endanger the safety of air travelers. The ISO 9000 quality
requirements at assessment time will thus be different for the office
supply item than for an aircraft or automotive seal. 'Stated or
implied needs' are the key words in the official definition. |
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What do these 'key words' really cover? |
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Needs are variable factors. They depend on criteria specific to
each product or service, such as usability, safety, availability,
reliability, maintainability, economics and environmental
aspects. They are usually listed in contractual agreements between
supplier and customer. In other circumstances, these needs may be
implied. They must then be identified and defined to draw up a
specific quality standard. In the final analysis, quality is when a
supplier fully meets what his customer expects, at delivery time, once
and for all. |
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What prompted setting up ISO 9000 quality standards? |
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Prior to 1987, industries had to repeatedly justify their quality procedures
and methods to national and foreign customers - often at considerable
cost. With the development of international trade, the need for a
common set of universally accepted quality standards became
obvious. In early 1980 ISO set up international technical committees
to try to solve this problem. Their proposals were finalized, some
seven years later, and today form the nucleus of the ISO 9000 quality
management and assurance series. ISO 9000 standards in fact are a
worldwide compilation of the best quality practices on which everyone
has agreed. |
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What do standards have to do with competition? |
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Traditionally,
standards have been thought of not as a natural priority, but as a tolerated
requirement. Today that view is changing. With a global economy a reality,
industries are waking up to the importance of standards, their use, and their
misuse. Knowledge of the process by which standards are developed is also
gaining importance. This is especially true of quality standards. Quality is
one of few remaining fields where you can gain a distinct advantage over
your competition.
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The Implementation
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What is the role of ISO 9000 standards? |
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These standards set the basic rules for quality systems - from
concept to implementation - whatever the product or service. They are
a set of rules for manufacturing a product or
delivering a service. They should ensure that a supplier has the
capability to produce the required goods or services, ensure that what
they deliver fully meets the customer expectations. |
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With what activities are they concerned? |
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The primary standard deals with manufactured products. Subsidiary
standards provide guidelines relating to primary standards, to service
industries and specialized products, such as software. Guidelines are
also prepared for auditing procedures and competence of auditors. |
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What about the Malcolm Baldrige National Quality Award,
the Deming Prize, etc.? Aren't these programs equivalent,
or better, "standards" than the IS0 9000 series? |
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The answer to this question is simple: you can't hope to meet the
expectations of any of these programs if you aren't already implementing the
ISO 9000 standards in your company. These standards
provide the foundation on which you can build your quality management and
quality assurance systems so you can ultimately achieve a high level of
success. Moreover, the ISO 9000 series is the only system accepted
internationally.
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A substantial number of product-related standards already exist
throughout the world in a wide variety of countries and
industries. Are ISO 9000 standards scheduled to supersede them? |
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No. Most of these technical standards are applied to well-
identified end products. They set the requirements for these products
in terms of performance, size, safety, etc. It should be remembered
that ISO 9000 describes how to go about making sure that a given
supplier has the capability of meeting these specific standards and
delivering a good quality product or service . It does not guarantee,
however, that this supplier really delivers a product adequate for a
precise purpose.
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Can you explain this difference? |
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Quality cannot be evaluated in a vacuum. It must relate to a
standard specification. Requirements for a chemical product or process
differ widely from those for a refrigerator or for the services of a
hotel, a bank or an airline company. ISO 9000 standards are of a
practical nature to trade or industry; they are not just academic
rules. The end product is therefore taken into consideration in ISO
9000 assessments; but it may, nevertheless, still be necessary to review
it separately for its functionality, which depends on its final use in
a given environment. Product or service specific standards may then be
required for testing the final product.
A distinction must therefore be made between assessing a company's ISO
9000-based quality system and standards, and certifying the final
product itself. |
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How is this achieved? |
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The ISO 9000 series standards enumerate the basic rules governing
quality systems. The manner in which these quality systems are
implemented must, however, be adapted to the actual production for which
a registration is sought. For instance, ISO 9000 rules state -
irrespective of the product manufactured - that testing equipment must
be regularly calibrated. This is the general rule. When a company is
assessed to determine whether it meets ISO 9000 standards for a given
final product, it is no longer enough to confirm that testing
equipment is regularly calibrated and how. To come back to our rubber
band vs. aviation seal analogy, the test operations take a different
dimension. It then becomes necessary to review what testing equipment
is used, whether it is appropriate for this type of product, what
calibration procedure is being used in regard to the product,
etc. This explains why ISO 9000 assessment teams always include people
who are familiar with a particular business or product line. |
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Are ISO 9000 standards compulsory? |
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Companies using ISO 9000 do so on a voluntary basis. Nobody is
compelled to use the ISO 9000 standards, except in those cases where
governments or regulatory authorities impose them for public security
reasons, or where they are called for in contractual terms . But, it
could also be argued that, as soon as there is a demand for them from
the market, they become virtually unavoidable. And this type of demand
is obviously growing worldwide at a rapid pace...
The ISO 9000 standards are not a goal by themselves. They could be
looked upon as a first step in the direction of the ultimate Total
Quality Concept already prevailing in certain countries. |
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The ISO 9000 Standard
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What ISO 9000 standards exist? |
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There are five basic standards in the series, from ISO 9000 to
ISO 9004. To avoid misunderstandings and misinterpretation, ISO
8402, which was mentioned earlier, gives precise and detailed
definitions of essential terms used in the quality area. |
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Are there any additional guidelines for the ISO 9000
series? |
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Yes. ISO 9004-2 was prepared as a guideline for service industries and ISO
9000-3 deals with software. In addition, there is the ISO 10011 series
on various aspects of auditing quality systems. There
are also documents on guidelines for implementing ISO 9001, 9002, and
9003; project management; process industries; configuration management;
quality plans; quality manuals; economics of quality; and continuous
improvement. Of course, there is the vocabulary document ISO 8402
that defines the terminology contained in the ISO 9000 series.
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What does the first standard in the series involve? |
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ISO 9000: "Guidelines for Selection and Use
of Quality Management and Assurance Standards" assists in obtaining an
understanding of what the ISO 9000 series really is about, for both
supplier and customer. ISO 9000 elaborates on the general philosophy
of quality systems standards, their characteristics, the existing
types, where and when they are best used, and describes what elements
quality assurance models should incorporate. If ISO 9000 is the
to the quality systems, ISO 9004 is the set of which makes it possible to customize quality standards and
make them conform to real life situations. ISO 9004 is the basic
element in the building up process of a quality system suited to
specific situations. It is the tool for internal quality management
purposes. |
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What does ISO 9004 include? |
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It's a comprehensive basket of quality objectives from which
everyone picks what his activities require. No one needs all of the
list in ISO 9004, because requirements or production processes are not
the same from one company, or industry, to another. There is, of course,
always a minimal list of topics which must be part of any system to
deserve the quality label. Topics covered in ISO 9004 cover 20
different chapters, all very much detailed. |
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This is quite a comprehensive program. |
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Yes. Again, not everything in these 20 chapters applies to every
product or service situation. But where they pertain, there is no
doubt that these are universally recognized quality requirements. Once
an ISO quality management and quality assurance system has been
customized, it can then be assessed by a customer or by an independent
body. One of the elements the assessor looks at is, of course, whether
the basic - and indispensable - quality elements are present in this
system. |
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Are ISO 9000 standards regularly revised? |
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All ISO standards are reviewed every five years. |
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The ISO 9001 to 9003 Standards
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To what do the other standards - 9001 to 9003 - correspond to? |
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These three ISO models are 9001, 9002 and 9003 quality assurance
systems - the basic requirements for a supplier's quality management
system. They are the standards against which the quality management
system will be assessed.
ISO 9001 covers the areas of design and development, production,
installation and servicing of products or services.
ISO 9002 is limited to quality management in production and
installation. Both include contract review, document control,
purchasing, process control, handling, storage, packaging and
delivery, training and internal quality audits.
ISO 9003 covers quality assurance obligations of the supplier in the
areas of final inspection and testing, assessment and registration
procedures. |
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Who is responsible for checking that a supplier conforms
to quality standards? |
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Obviously, the primary responsibility is with the customer.
However, to avoid multiple assessments, there is a growing trend to
entrust this function to specialized organizations. These may be
Member bodies of ISO or other ISO-recognized third party bodies, such
as independent companies recognized by national standards
organizations in each country. |
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What does it mean to be registered to ISO
9001, 9002, or 9003 standards.
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Of all the questions about the ISO 9000 series, this is probably the one that
causes the most concern. Increasingly, European and other foreign
customers expect U.S. companies to have their quality systems registered
to ISO 9001, 9002, or 9003. This generally involves having an accredited
independent third party conduct an on-site audit of your company's
operations against the requirements of the appropriate standard. Upon
successful completion of this audit, your company will receive a registration
certificate that identifies your quality system as being in compliance with
ISO 9001, 9002, or 9003. Your company will also be listed in a register
maintained by the accredited third-party registration organization. You may
publicize your registration and use the third-party registrar's certification
mark and the accreditation body's mark on your advertising, letterheads,
and other publicity materials (but not on your products).
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What is ISO Technical Committee 176? |
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ISO Technical Committee 176 handles standardization in the field of generic
quality management, which includes quality systems, quality assurance,
and generic supporting technologies, including standards for the selection
and use of these standards.
The work of ISO Technical Committee 176 is familiar. ISO 9000-9004
are the premier
sources of quality system standards and are perhaps the single most
significant quality system standards ever developed. Their effects are felt
around the world. As market shares shrink and as quality becomes
competitive leverage, access to the means by which these documents are
developed is more important than ever.
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A guide to registrations
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What are the required steps to obtain registration? |
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Eight steps to ISO 9000 registration:
- Evaluation of existing quality procedures against the requirements
of the ISO 9001-9003 standards
- Identification of corrective action needed to conform with ISO 9000
series standards
- Preparation of a quality assurance program
- Definition, documentation and implementation of new procedures
- Preparation of a quality manual
- Pre-assessment meeting with registrar to analyze quality manual
- Actual assessment visit
- Registration
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Are the staff of these registration bodies also assessed for
their qualifications? |
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Definitely. They have to meet very severe rules set out in the
relevant ISO standards (10000 series) on auditing quality systems. The
assessing teams must always include persons
specialized in the industry or service being assessed. |
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What about proprietary information? |
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Confidentiality is a very critical problem, particularly when
auditors visit the plant and have access to confidential information
Published information only gives two details:
- to which ISO 9000 standard a company is registered; and
- and for which product or service. No other data is disclosed.
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Does registration to ISO 9000 automatically extend to other
plants of a company making the same product or offering the same
service? |
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No. A registration is only valid for the plant, or site, that has
been assessed. If a company manufactures the same product in another
plant elsewhere, this plant must be assessed separately. |
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Is the assessment procedure by an independent organization
compulsory? |
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No. But obviously such an assessment carries more weight to
customers than a mere announcement on the part of a supplier that he
conforms with the ISO quality standards. An assessment may also be
legally imposed or required by contract. |
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Can a company just follow the ISO 9000 procedures and tell its
customers it does, without ever trying to get a formal ISO 9000
registration?
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Yes. Nothing prevents this. If such a claim is sufficient for its
market; but with the current trend for quality certification, it might
not be sufficient. |
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Is there a protection against false claims of ISO registration? |
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This question raises a number of points. First, ISO does not
distribute registrations; these are given by specific organizations as
I have mentioned. No registration claim is legally valid unless
backed up by a certificate from a recognized registrar. Second, any
company can claim to follow ISO 9000 rules. In the first case, the
assessing organization can take legal action in its own right against
false claims. In the second case, action may be taken in the event of
a false claim through legislation on unfair trading practices, false
claims and/or unfair competition. |
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If my company is not registered as complying with IS0
9000 quality system standards, does it mean that we will
not be able to sell our products globally? |
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ISO 9000 registration is not a legal requirement for access to foreign
markets, but it can be beneficial. In the European Union (EU), for many
regulated products, ISO 9000 registration is an alternative for product
certification, not an absolute requirement. In fact, as cited in most EU
legislation, quality system registration is neither mandatory--there are other
paths to product certification--nor is it a stand-alone procedure.
Manufacturer compliance with either EN 29002 or 29003 is usually
combined with product type testing at the design stage for full certification to
EU legal requirements. Manufacturers interested in the European markets
need to review relevant EU product safety directives available from the U.S.
Department of Commerce for specifics applicable to their product area.
Outside of regulated product areas, the importance of ISO 9000 registration
as a competitive market tool varies from sector to sector. For instance, in
some sectors, European companies may require suppliers to attest that
they have an approved quality system in place as a condition for purchase.
This could be specified in any business contract. ISO 9000 registration may
also serve as a means of differentiating "classes" of suppliers, particularly in
high-tech areas, where high product reliability is crucial. In other words, if
two suppliers are competing for the same contract, the one with ISO 9000
registration may have a competitive edge with some buyers. Sector and
product areas where purchasers are more likely to generate pressure for
ISO 9000 registration include aerospace, autos, electronic components,
measuring and testing instruments, and so on. ISO 9000 registration may
also be a competitive factor in product areas where safety or liability are
concerns.
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