Sec 11 The ISO 9000 Family

THE ISO 9000 FAMILY
OF INTERNATIONAL STANDARDS
1
OVERVIEW
litary and nuclear power industry needs, and, to a lesser extent, for commercial an
oftware, processed materials, and services.
2
THE ISO 9000 FAMILY OF INTERNATIONAL STANDARDS
OVERVIEW
3
OVERVIEW
in one phrase: the globalization of business. Expressions such as the “post-indus
versity a permanent key factor

ew markets
4
OVERVIEW
establishing policy, setting objectives for quality, designing management systems
ed by simultaneous application of two kinds of standards:
5
OVERVIEW
03 are requirements standards. They are quality system models to be used for quali
are mandatory. ISO 9004 is an example of a guideline standard. Guideline standard
the ISO 9000 family standards are non-prescriptive in the sense that they describe
6
OVERVIEW
shall prepare a quality manual covering the requirements of this International Standard. T
Standard, including, to the extent applicable, documents of external origin such as standard
7
OVERVIEW
8
THE FACETS OF PRODUCT QUALITY
ndamental to the ISO 9000 family. Among these is the concept of the four facets o
ommercial and industrial uses, the national predecessor counterparts of ISO 9003
9
COMMONALITIES AND DISTINCTIONS BETWEEN QUALITY MANAGEMENT AND QUALITY ASSURAN
10
VISION 2000
strategies from that report are essential to any discussion of the ISO 9000 stan
continually meet the needs of the marketplace. These goals are universal accepta
de could be maintained only if the remarkable, rapid, worldwide success in replaci
f the withdrawal of prior national standards and adoption of the ISO 9000 standa
11
BEYOND VISION 2000
hould and could have more impact in guiding practitioners of quality management.
O 9000, ISO 9001, ISO 9004, and a proposed new document on quality management princ
12
QUALITY SYSTEM CERTIFICATION / REGISTRATION
two-party contract, where the providing organization (i.e., the supplier) is referr
rmal audit of a supplier organization to assess conformance to the appropriate qu
13
QUALITY SYSTEM CERTIFICATION / REGISTRATION
tiny by the accreditation body through audits that cover the registrar’s documente
14
ONFORMITY ASSESSMENT AND INTERNATIONAL TRADE
ganization must produce evidence of conformity in four areas:
products. Consequently, there are multiple incentives for large numbers of suppli
15
NDARDIZATION PROBLEMS AND OPPORTUNITIES FOR THE ISO 9000 FAMILY
rtainly applies in relation to the ISO 9000 family. As a preliminary to discussing
16
e 1960s the virtually universal perspective of business managers was “If it ain’t
nt. Continuous improvement is increasingly necessary for economic survival in the
es. This requires a “process” focus, which is reflected in the documentation and ma
17
“Say what you do.

Do what you say.”
short of the requirements in the ISO 9000 standards set in 1987 and revised in 19
18
it, meaningful requirements relating to statistical techniques (clause 4.20, Statis
oviders, etc.—have little knowledge or experience in statistical techniques.
ibilities on accreditation bodies. They have the responsibility to ensure that the
19
ial language versions shall be technically equivalent and structurally identical”
lation from one language to another always presents challenges when great accurac
any situations of use are encountered; the intended meaning of the standard is no
utually resolved at an early stage
20
pplier and the registrar has taken adequately into consideration the amount and n
roduct the customer receives is processed within the registered quality system, ev
21
processed within the registered quality system, even in situations where the suppl
22
n documentation so that, as a consequence, customers may be aware of this fact.
to be subcontractor operations. It does not matter whether the excluded portions
e intermediate state.
001. For such organizations, the cost of registration/certification by the usual t
23
RELATION OF ISO 9000 STANDARDS TO NATIONAL QUALITY AWARDS AND TO TQM
he Malcolm Baldrige National Quality Award (MBNQA) in the United States; and the E
success through customer satisfaction, and benefits to all members of the organiz
24
sales and marketing aspects that directly affect product quality. Thus, the scope
25
work for building a quality management system that will be effective and efficien
26

Sec 11 The ISO 9000 Family

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Sec 11 The ISO 9000 Family

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THE ISO 9000 FAMILY

oftware, processed materials, and services.

in one phrase: the globalization of business. Expressions such as the “post-indus

versity a permanent key factor

establishing policy, setting objectives for quality, designing management systems

ed by simultaneous application of two kinds of standards:

are mandatory. ISO 9004 is an example of a guideline standard. Guideline standard

de could be maintained only if the remarkable, rapid, worldwide success in replaci

rmal audit of a supplier organization to assess conformance to the appropriate qu

ganization must produce evidence of conformity in four areas:

rtainly applies in relation to the ISO 9000 family. As a preliminary to discussing

nt. Continuous improvement is increasingly necessary for economic survival in the

“Say what you do.

it, meaningful requirements relating to statistical techniques (clause 4.20, Statis

oviders, etc.—have little knowledge or experience in statistical techniques.

ial language versions shall be technically equivalent and structurally identical”

utually resolved at an early stage

n documentation so that, as a consequence, customers may be aware of this fact.

to be subcontractor operations. It does not matter whether the excluded portions

001. For such organizations, the cost of registration/certification by the usual t

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