Quality management systems - Requirements (ISO 9001:2000)

Migrated from Progress Sheet (TC Comment) (2000-07-10): Revision of EN ISO 9001:1994, incorporating EN ISO 9002 and EN ISO 9003 ++ (CC/981112) ++ Resolution BT 59/1999 : · the relationship between EN ISO 9001: 2000 and modules ++ H, D and E - as defined in Council decision 93/465/EEC - shall be described in a ++ European foreword (an option preferred to an informative annex), in line with ++ the request of the mandate. This foreword is to be drafted by BT/WG 107, and is ++ to be circulated for comments to CEN member bodies in parallel with the enquiry on prEN ISO 9001:2000. (MCH 2000-01-20)

Qualitätsmanagementsysteme - Anforderungen (ISO 9001:2000)

Diese Internationale Norm legt Forderungen an ein Qualitätsmanagementsystem fest, wenn eine Organisation folgendes tun muß: a) ihre Fähigkeit zur ständigen Bereitstellung von Produkten darlegen, die den Forderungen der Kunden und den zutreffenden behördlichen Forderungen entsprechen, und b) die Kundenzufriedenheit durch wirksame Anwendung des Systems einschließlich der Prozesse zur ständigen Verbesserung und zur Verhinderung von Fehlern erreichen.

Systèmes de management de la qualité - Exigences (ISO 9001:2000)

Sistemi vodenja kakovosti – Zahteve (ISO 9001:2000)

General Information

Status
Withdrawn
Publication Date
14-Dec-2000
Withdrawal Date
14-Nov-2008
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
15-Nov-2008
Completion Date
15-Nov-2008

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 9001:2000
15-december-2000
1DGRPHãþD
SIST EN ISO 9001:1994/AC:1997:2007-04
Sistemi vodenja kakovosti – Zahteve (ISO 9001:2000)
Quality management systems - Requirements (ISO 9001:2000)
Qualitätsmanagementsysteme - Anforderungen (ISO 9001:2000)
Systemes de management de la qualité - Exigences (ISO 9001:200
Ta slovenski standard je istoveten z: EN ISO 9001:2000
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
SIST EN ISO 9001:2000 sl,en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 9001:2000
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SIST EN ISO 9001:2000
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SIST EN ISO 9001:2000
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SIST EN ISO 9001:2000
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SIST EN ISO 9001:2000
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SIST EN ISO 9001:2000
INTERNATIONAL ISO
STANDARD 9001
Third edition
2000-12-15
Quality management systems —
Requirements
Systèmes de management de la qualité — Exigences
Reference number
ISO 9001:2000(E)
© ISO 2000
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SIST EN ISO 9001:2000
ISO 9001:2000(E)
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© ISO 2000

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, elec-

tronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's mem-

ber body in the country of the requester.
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Printed in Switzerland
ii ISO 2000 – All rights reserved
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SIST EN ISO 9001:2000
ISO 9001:2000(E)
Contents Page

1 Scope ............................................................................................................................................................... 1

1.1 General .......................................................................................................................................................... 1

1.2 Application ..................................................................................................................................................... 1

2 Normative reference ......................................................................................................................................... 1

3 Terms and definitions ........................................................................................................................................ 1

4 Quality management system ............................................................................................................................ 2

4.1 General requirements .................................................................................................................................... 2

4.2 Documentation requirements ........................................................................................................................ 2

5 Management responsibility ............................................................................................................................... 3

5.1 Management commitment ............................................................................................................................. 3

5.2 Customer focus ............................................................................................................................................. 4

5.3 Quality policy ................................................................................................................................................. 4

5.4 Planning ......................................................................................................................................................... 4

5.5 Responsibility, authority and communication ................................................................................................ 4

5.6 Management review ...................................................................................................................................... 5

6 Resource management .................................................................................................................................... 5

6.1 Provision of resources ................................................................................................................................... 5

6.2 Human resources .......................................................................................................................................... 6

6.3 Infrastructure ................................................................................................................................................. 6

6.4 Work environment .......................................................................................................................................... 6

7 Product realization ............................................................................................................................................ 6

7.1 Planning of product realization ...................................................................................................................... 6

7.2 Customer-related processes ......................................................................................................................... 7

7.3 Design and development ............................................................................................................................... 8

7.4 Purchasing ..................................................................................................................................................... 9

7.5 Production and service provision ................................................................................................................. 10

7.6 Control of monitoring and measuring devices ............................................................................................. 11

8 Measurement, analysis and improvement ...................................................................................................... 11

8.1 General ........................................................................................................................................................ 11

8.2 Monitoring and measurement ...................................................................................................................... 11

8.3 Control of nonconforming product ............................................................................................................... 12

8.4 Analysis of data ........................................................................................................................................... 13

8.5 Improvement ................................................................................................................................................ 13

Annexes

A Correspondence between ISO 9001:2000 and ISO 14001:1996.................................................................... 15

B Correspondence between ISO 9001:2000 and ISO 9001:1994 .................................................................... 19

Bibliography........................................................................................................................................................... 23

ISO 2000 – All rights reserved iii
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SIST EN ISO 9001:2000
ISO 9001:2000(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO

member bodies). The work of preparing International Standards is normally carried out through ISO technical

committees. Each member body interested in a subject for which a technical committee has been established has

the right to be represented on that committee. International organizations, governmental and non-governmental, in

liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical

Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.

Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.

Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

International Standard ISO 9001 was prepared by Technical Committee ISO/TC 176, Quality management and

quality assurance, Subcommittee SC 2, Quality systems.

This third edition of ISO 9001 cancels and replaces the second edition (ISO 9001:1994) together with

ISO 9002:1994 and ISO 9003:1994. It constitutes a technical revision of these documents. Those organizations

which have used ISO 9002:1994 and ISO 9003:1994 in the past may use this International Standard by excluding

certain requirements in accordance with 1.2.

The title of ISO 9001 has been revised in this edition and no longer includes the term “Quality assurance”. This

reflects the fact that the quality management system requirements specified in this edition of ISO 9001, in addition to

quality assurance of product, also aim to enhance customer satisfaction.
Annexes A and B of this International Standard are for information only.
iv ISO 2000 – All rights reserved
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SIST EN ISO 9001:2000
ISO 9001:2000(E)
Introduction
0.1 General

The adoption of a quality management system should be a strategic decision of an organization. The design and

implementation of an organization's quality management system is influenced by varying needs, particular

objectives, the products provided, the processes employed and the size and structure of the organization. It is not the

intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity

of documentation.

The quality management system requirements specified in this International Standard are complementary to

requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated

requirement.

This International Standard can be used by internal and external parties, including certification bodies, to assess the

organization's ability to meet customer, regulatory and the organization's own requirements.

The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the

development of this International Standard.
0.2 Process approach

This International Standard promotes the adoption of a process approach when developing, implementing and

improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer

requirements.

For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using

resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a

process. Often the output from one process directly forms the input to the next.

The application of a system of processes within an organization, together with the identification and interactions of

these processes, and their management, can be referred to as the “process approach”.

An advantage of the process approach is the ongoing control that it provides over the linkage between the individual

processes within the system of processes, as well as over their combination and interaction.

When used within a quality management system, such an approach emphasizes the importance of

a) understanding and meeting requirements,
b) the need to consider processes in terms of added value,
c) obtaining results of process performance and effectiveness, and
d) continual improvement of processes based on objective measurement.

The model of a process-based quality management system shown in Figure 1 illustrates the process linkages

presented in clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as

inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as

to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the

requirements of this International Standard, but does not show processes at a detailed level.

ISO 2000 – All rights reserved v
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SIST EN ISO 9001:2000
ISO 9001:2000(E)

NOTE In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be briefly

described as follows.

Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and

the organization's policies.
Do: implement the processes.

Check: monitor and measure processes and product against policies, objectives and requirements for the product and report

the results.
Act: take actions to continually improve process performance.
Figure 1 — Model of a process-based quality management system
0.3 Relationship with ISO 9004

The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management

system standards which have been designed to complement each other, but can also be used independently.

Although the two International Standards have different scopes, they have similar structures in order to assist their

application as a consistent pair.

ISO 9001 specifies requirements for a quality management system that can be used for internal application by

organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality

management system in meeting customer requirements.
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SIST EN ISO 9001:2000
ISO 9001:2000(E)

ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001,

particularly for the continual improvement of an organization's overall performance and efficiency, as well as its

effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move

beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not

intended for certification or for contractual purposes.
0.4 Compatibility with other management systems

This International Standard has been aligned with ISO 14001:1996 in order to enhance the compatibility of the two

standards for the benefit of the user community.

This International Standard does not include requirements specific to other management systems, such as those

particular to environmental management, occupational health and safety management, financial management or risk

management. However, this International Standard enables an organization to align or integrate its own quality

management system with related management system requirements. It is possible for an organization to adapt its

existing management system(s) in order to establish a quality management system that complies with the

requirements of this International Standard.
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SIST EN ISO 9001:2000
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SIST EN ISO 9001:2000
INTERNATIONAL STANDARD ISO 9001:2000(E)
Quality management systems — Requirements
1 Scope
1.1 General

This International Standard specifies requirements for a quality management system where an organization

a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory

requirements, and

b) aims to enhance customer satisfaction through the effective application of the system, including processes for

continual improvement of the system and the assurance of conformity to customer and applicable regulatory

requirements.

NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a customer.

1.2 Application

All requirements of this International Standard are generic and are intended to be applicable to all organizations,

regardless of type, size and product provided.

Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and

its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these

exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or

responsibility, to provide product that meets customer and applicable regulatory requirements.

2 Normative reference

The following normative document contains provisions which, through reference in this text, constitute provisions of

this International Standard. For dated references, subsequent amendments to, or revisions of, any of these

publications do not apply. However, parties to agreements based on this International Standard are encouraged to

investigate the possibility of applying the most recent edition of the normative document indicated below. For undated

references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain

registers of currently valid International Standards.
ISO 9000:2000, Quality management systems — Fundamentals and vocabulary.
3 Terms and definitions

For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.

The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the

vocabulary currently used:
supplier organization customer
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SIST EN ISO 9001:2000
ISO 9001:2000(E)

The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this

International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”.

Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.

4 Quality management system
4.1 General requirements

The organization shall establish, document, implement and maintain a quality management system and continually

improve its effectiveness in accordance with the requirements of this International Standard.

The organization shall

a) identify the processes needed for the quality management system and their application throughout the

organization (see 1.2),
b) determine the sequence and interaction of these processes,

c) determine criteria and methods needed to ensure that both the operation and control of these processes are

effective,

d) ensure the availability of resources and information necessary to support the operation and monitoring of these

processes,
e) monitor, measure and analyse these processes, and

f) implement actions necessary to achieve planned results and continual improvement of these processes.

These processes shall be managed by the organization in accordance with the requirements of this International

Standard.

Where an organization chooses to outsource any process that affects product conformity with requirements, the

organization shall ensure control over such processes. Control of such outsourced processes shall be identified

within the quality management system.

NOTE Processes needed for the quality management system referred to above should include processes for management

activities, provision of resources, product realization and measurement.
4.2 Documentation requirements
4.2.1 General
The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures required by this International Standard,

d) documents needed by the organization to ensure the effective planning, operation and control of its processes,

and
e) records required by this International Standard (see 4.2.4).

NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is

established, documented, implemented and maintained.
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SIST EN ISO 9001:2000
ISO 9001:2000(E)

NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to

a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.
NOTE 3 The documentation can be in any form or type of medium.
4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes

a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),

b) the documented procedures established for the quality management system, or reference to them, and

c) a description of the interaction between the processes of the quality management system.

4.2.3 Control of documents

Documents required by the quality management system shall be controlled. Records are a special type of document

and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,

c) to ensure that changes and the current revision status of documents are identified,

d) to ensure that relevant versions of applicable documents are available at points of use,

e) to ensure that documents remain legible and readily identifiable,

f) to ensure that documents of external origin are identified and their distribution controlled, and

g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are

retained for any purpose.
4.2.4 Control of records

Records shall be established and maintained to provide evidence of conformity to requirements and of the effective

operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A

documented procedure shall be established to define the controls needed for the identification, storage, protection,

retrieval, retention time and disposition of records.
5 Management responsibility
5.1 Management commitment

Top management shall provide evidence of its commitment to the development and implementation of the quality

management system and continually improving its effectiveness by

a) communicating to the organization the importance of meeting customer as well as statutory and regulatory

requirements,
b) establishing the quality policy,
c) ensuring that quality objectives are established,
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SIST EN ISO 9001:2000
ISO 9001:2000(E)
d) conducting management reviews, and
e) ensuring the availability of resources.
5.2 Customer focus

Top management shall ensure that customer requirements are determined and are met with the aim of enhancing

customer satisfaction (see 7.2.1 and 8.2.1).
5.3 Quality policy
Top management shall ensure that the quality policy
a) is appropriate to the purpose of the organization,

b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality

management system,
c) provides a framework for establishing and reviewing quality objectives,
d) is communicated and understood within the organization, and
e) is reviewed for continuing suitability.
5.4 Planning
5.4.1 Quality objectives

Top management shall ensure that quality objectives, including those needed to meet requirements for product [see

7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be

measurable and consistent with the quality policy.
5.4.2 Quality management system planning
Top management shall ensure that

a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as

well as the quality objectives, and

b) the integrity of the quality management system is maintained when changes to the quality management system

are planned and implemented.
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority

Top management shall ensure that responsibilities and authorities are defined and communicated within the

organization.
5.5.2 Management representative

Top management shall appoint a member of management who, irrespective of other responsibilities, shall have

responsibility and authority that includes

a) ensuring that processes needed for the quality management system are established, implemented and

maintained,
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SIST EN ISO 9001:2000
ISO 9001:2000(E)

b) reporting to top management on the performance of the quality management system and any need for

improvement, and

c) ensuring the promotion of awareness of customer requirements throughout the organization.

NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the

quality management system.
5.5.3 Internal communication

Top management shall ensure that appropriate communication processes are established within the organization

and that communication takes place regarding the effectiveness of the quality management system.

5.6 Management review
5.6.1 General

Top management shall review the organization's quality management system, at planned intervals, to ensure its

continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement

and the need for changes to the quality management system, including the quality policy and quality objectives.

Records from management reviews shall be maintained (see 4.2.4).
5.6.2 Review input
The input to management review shall include information on
a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and
g) recommendations for improvement.
5.6.3 Review output

The output from the management review shall include any decisions and actions related to

a) improvement of the effectiveness of the quality management system and its processes,

b) improvement of product related to customer requirements, and
c) resource needs.
6 Resource management
6.1 Provision of resources
The organization shall determine and provide the resources needed

a) to implement and maintain the quality management system and continually improve its effectiveness, and

b) to enhance customer satisfaction by meeting customer requirements.
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SIST EN ISO 9001:2000
ISO 9001:2000(E)
6.2 Human resources
6.2.1 General

Personnel performing work affecting product quality shall be competent on the basis of appropriate education,

training, skills and experience.
6.2.2 Competence, awareness and training
The organization shall

a) determine the necessary competence for personnel performing work affecting product quality,

b) provide training or take other actions to satisfy these needs,
c) evaluate the effectiveness of the actions taken,

d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to

the achievement of the quality objectives, and

e) maintain appropriate records of education, training, skills and experience (see 4.2.4).

6.3 Infrastructure

The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product

requirements. Infrastructure includes, as applicable
a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport or communication).
6.4 Work environment

The organization shall determine and manage the work environment needed to achieve conformity to product

requirements.
7 Product realization
7.1 Planning
...

SLOVENSKI SIST EN ISO 9001
STANDARD
december 2000
Sistemi vodenja kakovosti – Zahteve (ISO 9001:2000)
(istoveten EN ISO 9001:2000)
Quality management systems – Requirements (ISO 9001:2000)
Systèmes de management de la qualité – Exigences (ISO 9001:2000)
Qualitätsmanagementsysteme – Anforderungen (ISO 9001:2000)
Referenčna oznaka
ICS 01.120.10 SIST EN ISO 9001:2000 (sl, en)
Nadaljevanje na strani II in od 2 do 50

© 2004-09. Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 9001 : 2000
NACIONALNI UVOD

Standard SIST EN ISO 9001 (sl,en), Sistemi vodenja kakovosti - Zahteve, 2000, ima status

slovenskega standarda in je istoveten evropskemu standardu EN ISO 9001, Quality management

systems - Requirements (ISO 9001:2000), 2000.
NACIONALNI PREDGOVOR

Mednarodni standard ISO 9001:2000 je pripravil tehnični odbor Mednarodne organizacije za

standardizacijo ISO/TC 176 Vodenje in zagotavljanje kakovosti. Slovenski standard SIST EN ISO

9001:2000 je prevod angleškega besedila evropskega standarda EN ISO 9001:2000, ki je istoveten

mednarodnemu standardu, dodan je evropski predgovor k dokumentu. V primeru spora glede besedila

slovenskega prevoda v tem standardu je odločilen izvirni evropski standard v angleškem jeziku.

Slovensko-angleško izdajo standarda je pripravil SIST/TC VZK Vodenje in zagotavljanje kakovosti.

ZVEZE S STANDARDI

S privzemom tega evropskega standarda, ki je istoveten mednarodnemu standardu, veljajo za

omejeni namen referenčnih standardov vsi standardi, navedeni v izvirniku, razen standardov, ki so že

sprejeti v nacionalno standardizacijo:
ISO 9000:2000 (en) Sistemi vodenja kakovosti – Osnove in slovar
ISO 9004:2000 (en) Sistemi vodenja kakovosti – Smernice za izboljšanje delovanja

SIST EN ISO 14001:1997(sl,en) Sistemi ravnanja z okoljem – Razčlenitev z navodili za uporabo

PREDHODNA IZDAJA
– SIST ISO 9001:1995 (sl,en)
OSNOVA ZA IZDAJO STANDARDA
– Privzem standarda EN ISO 9001:2000.
OPOMBE

– Povsod, kjer se v besedilu standarda uporablja izraz “evropski” ali “mednarodni” standard, v SIST

EN ISO 9001:2000 to pomeni “slovenski” standard. Nacionalni uvod in nacionalni predgovor nista

sestavni del standarda.

– V povezavi s kakovostjo prevajamo izraz “management” kot “vodenje”, v povezavi z drugimi pojmi

pa npr. kot “ravnanje” z okoljem, “obvladovanje” tveganja itd. Če gre za skupino ljudi, ki vodi

organizacijo, prevajamo “management” kot “vodstvo”.

– Povsod, kjer se v angleškem besedilu uporablja izraz “design and development”, je to v slovenskem

besedilu standarda SIST EN ISO 9001:2000 (sl,en) prevedeno kot “načrtovanje in razvoj”.

– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.

– Ta nacionalni dokument je istoveten EN ISO 9001:2000 in je objavljen z dovoljenjem

CEN
Rue de Stassart, 36
1050 Bruxelles
Belgija

– This national document is identical with EN ISO 9001:2000 and is published with the permission of

CEN
Rue de Stassart, 36
1050 Bruxelles
Belgium
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EVROPSKI STANDARD EN ISO 9001:2000
EUROPEAN STANDARD
EUROPÄISCHE NORM
NORME EUROPÉENNE december 2000
ICS: 00.012 10 Nadomešča EN ISO 9001:1994, EN ISO 9002:1994
in EN ISO 9003:1994
Slovenska izdaja
Sistemi vodenja kakovosti - Zahteve
(ISO 9001:2000)

Quality management systems Systèmes de management de Qualitätsmanagementsysteme –

- Requirements la qualité – Exigences Anforderungen
(ISO 9001:2000) (ISO 9001:2000) (ISO 9001:2000)
Ta evropski standard je CEN sprejel dne 2000-12-15.

Članice CEN morajo izpolnjevati določila poslovnika CEN/CENELEC, s katerim je predpisano, da

mora biti ta standard brez kakršnihkoli sprememb sprejet kot nacionalni standard. Seznami

najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki so na voljo pri centralnem

sekretariatu ali članicah CEN.

Ta evropski standard obstaja v treh uradnih izdajah (nemški, angleški in francoski). Izdaje v drugih

jezikih, ki jih članice CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri centralnem

sekretariatu CEN, veljajo kot uradne izdaje.

Članice CEN so nacionalne ustanove za standardizacijo Avstrije, Belgije, Češke republike, Danske,

Finske, Francije, Grčije, Irske, Islandije, Italije, Luksemburga, Nemčije, Nizozemske, Norveške,

Portugalske, Španije, Švedske, Švice in Združenega kraljestva.
CEN
Evropski komite za standardizacijo
European Committee for Standardization
Europäisches Komitee für Normung
Comité Européen de Normalisation
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© 2000. Lastnice avtorskih pravic so vse države članice CEN Ref. št. EN ISO 9001:2000 E

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SIST EN ISO 9001 : 2000
Predgovor

Besedilo mednarodnega standarda ISO 9001:2000 je pripravil tehnični odbor ISO/TC 176 »Vodenje

kakovosti in zagotavljanje kakovosti«, pododbor SC2 »Sistemi kakovosti«. Prenos tega standarda v

evropski standard je ob pomoči delovne skupine strokovnega sveta CEN/BT WG107 vodil Centralni

sekretariat CEN.

Ta evropski standard nadomešča EN ISO 9001:1994, EN ISO 9002:1994 in EN ISO 9003:1994.

Ta evropski standard mora dobiti status nacionalnega standarda z objavo istovetnega besedila ali z

razglasitvijo najpozneje do junija 2001, nacionalne standarde, ki so v nasprotju s tem standardom, pa

je treba umakniti najpozneje do junija 2001.

OPOMBA: Spodnje navedbe so posebej namenjene organizacijam, ki so zaradi označevanja svojih izdelkov z znakom CE

in podeljevanja tega znaka drugim strankam, vpletenim v proces, dolžne upoštevati določila evropskih direktiv

»novega pristopa«.

Izdaja EN ISO 9001:2000 vsebuje zahtevke za Odločbo Sveta 93/465/EGS z dne 22. julija 1993 o modulih

za različne faze ugotavljanja skladnosti in o pravilih za označevanje ter uporabo znaka CE za skladnost, ki

so namenjeni uporabi v direktivah o tehnični harmonizaciji. Pomembno je opozoriti na dejstvo, da se lahko

moduli iz posameznih direktiv o tehnični harmonizaciji v nekaterih pogledih razlikujejo od tistih, ki so opisani

v Direktivi Sveta 93/465/EGS. V vseh primerih pa je pravno zavezujoča priloga ustrezne(-ih) direktive

(direktiv). Načela, ki so opisana v tem predgovoru, veljajo ne glede na te razlike.

Trije moduli iz odločbe Sveta, tj. moduli D, E in H, zahtevajo, da »mora proizvajalec uporabljati

odobren sistem kakovosti«. Sistemi kakovosti iz teh modulov obsegajo naslednja področja:

- nadzor in preskušanje končnega proizvoda (modul E),
- proizvodnja, končni nadzor in preskušanje (modul G),
- načrtovanje/razvoj in nadzor končnega proizvoda ter preskušanje (modul H).

Odločba Sveta 93/465/EGS natančno navaja, da skladnost s harmoniziranimi standardi EN 29001, EN

29002 ali EN 29003 potrjuje domnevo o skladnosti z ustreznimi zahtevami iz modulov D, E in H.

Evropski standardi EN 29001, EN 29002 in EN 29003 so bili najprej nadomeščeni z EN ISO 9001:1994,

EN ISO 9002:1994 in EN ISO 9003:1994, danes pa so vsi trije nadomeščeni z EN ISO 9001:2000.

Kadar želijo organizacije vzpostaviti sisteme vodenja kakovosti v skladu z moduli D, E ali H, lahko

uporabijo EN ISO 9001:2000. Pri doseganju skladnosti z moduli D, E ali H lahko organizacije

posamezne zahteve opustijo.

Zahteve iz 7. točke evropskega standarda EN ISO 9001:2000 v zvezi z razlikami med moduli D, E in H

se lahko opustijo, domneva o skladnosti pa kljub temu velja.
Modul E Modul D Modul H
Dovoljene opustitve Dovoljene opustitve Dovoljene opustitve
Točka 7.1: Planiranje realizacije proizvoda
Točka 7.3: Načrtovanje Niso dovoljene
Točka 7.2.3: Komuniciranje z odjemalci
in razvoj opustitve
Točka 7.3: Načrtovanje in razvoj
Točka 7.4: Nabava
Točka 7.5.1: Obvladovanje proizvodnje in izvedbe
storitev
Točka 7.5.2: Validacija procesov za proizvodnjo in
izvedbo storitev
Točka 7.5.3: Identifikacija in sledljivost

Poudariti je treba, da v modulih D, E in H ni točno določenih zahtev, ki se nanašajo na koncepta »zadovoljstvo odjemalcev« in

»nenehno izboljševanje«. Posledično neskladnost z zahtevami EN ISO 9001:2000, ki se jasno navezujejo na te koncepte, ne

kršijo domneve o skladnosti z ustreznim modulom.
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SIST EN ISO 9001 : 2000

Opozoriti je treba, da v primerih, ko so opustitve iz točke 1.2 standarda EN ISO 9001:2000

presežene, sklicevanje na skladnost z EN ISO 9001:2000 ni dovoljeno.

V skladu z notranjimi predpisi CEN/CENELEC morajo ta evropski standard obvezno uvesti nacionalne

organizacije za standarde naslednjih držav: Avstrije, Belgije, Češke republike, Danske, Finske,

Francije, Grčije, Irske, Islandije, Italije, Luksemburga, Nemčije, Nizozemske, Norveške, Portugalske,

Španije, Švedske, Švice in Združenega kraljestva.
Razglasitvena objava

Besedilo mednarodnega standarda ISO 9001:2000 je CEN odobril kot evropski standard brez

kakršnihkoli sprememb.

OPOMBA: Normativna sklicevanja na mednarodne standarde so podana v dodatku ZA (normativni).

Mednarodna organizacija za standardizacijo (ISO) je svetovna zveza nacionalnih organov za

standarde (članov ISO). Mednarodne standarde ponavadi pripravljajo tehnični odbori ISO. Vsak član,

ki želi delovati na določenem področju, za katero je bil ustanovljen tehnični odbor, ima pravico biti

zastopan v tem odboru. Pri delu sodelujejo tudi vladne in nevladne mednarodne organizacije,

povezane z ISO. V vseh zadevah, ki so povezane s standardizacijo na področju elektrotehnike, ISO

tesno sodeluje z Mednarodno elektrotehniško komisijo (IEC).

Osnutki mednarodnih standardov so pripravljeni v skladu s pravili, podanimi v 3. delu Direktiv ISO/IEC.

Osnutki mednarodnih standardov, ki jih sprejmejo tehnični odbori, se pošljejo vsem članom v

glasovanje. Za objavo mednarodnega standarda je treba pridobiti soglasje najmanj 75

odstotkov članov, ki se udeležijo glasovanja.

Opozoriti je treba na možnost, da so lahko nekateri elementi tega mednarodnega standarda predmet

patentnih pravic. ISO ne prevzema odgovornosti za identifikacijo katerihkoli ali vseh takih patentnih

pravic.

Mednarodni standard ISO 9001 je pripravil tehnični odbor ISO/TC 176 Vodenje in zagotavljanje

kakovosti, pododbor SC2 Sistemi kakovosti.

Ta tretja izdaja ISO 9001 razveljavlja in nadomešča drugo izdajo (ISO 9001:1994) skupaj z ISO

9002:1994 in ISO 9003:1994 in predstavlja strokovno recenzijo teh dokumentov. Organizacije, ki so v

preteklosti uporabljale ISO 9002:1994 in ISO 9003:1994, smejo uporabljati ta mednarodni standard z

možnostjo izločitve določenih zahtev skladno s točko 1.2.

Naslov ISO 9001 je v tej izdaji popravljen in ne vključuje več izraza “zagotavljanje kakovosti”. To

ponazarja dejstvo, da so zahteve sistema vodenja kakovosti, določene v tej izdaji ISO 9001, poleg

zagotavljanja kakovosti proizvoda usmerjene tudi k povečanju zadovoljstva odjemalcev.

Dodatka A in B tega mednarodnega standarda sta podana zgolj informativno.
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SIST EN ISO 9001 : 2000
Vsebina Contents

Predgovor ......................................................... 6 Foreword............................................................6

0 Uvod .............................................................. 7 0 Introduction.....................................................7

0.1 Splošno....................................................... 7 0.1 General........................................................7

0.2 Procesni pristop.......................................... 7 0.2 Process approach .......................................7

0.3 Razmerje do ISO 9004............................... 9 0.3 Relationship with ISO 9004.........................9

0.4 Združljivost z drugimi sistemi 0.4 Compatibility with other management

vodenja..................................................... 10 systems .....................................................10

1 Predmet standarda...................................... 10 1 Scope ...........................................................10

1.1 Splošno.....................................................10 1.1 General......................................................10

1.2 Uporaba.................................................... 10 1.2 Application.................................................10

2 Zveza z drugimi standardi ........................... 11 2 Normative reference.....................................11

3 Izrazi in definicije ......................................... 11 3 Terms and definitions...................................11

4 Sistem vodenja kakovosti............................ 12 4 Quality management system........................12

4.1 Splošne zahteve....................................... 12 4.1 General requirements ...............................12

4.2 Zahteve glede dokumentacije .................. 13 4.2 Documentation requirements....................13

5 Odgovornost vodstva................................... 14 5 Management responsibility ..........................14

5.1 Zavezanost vodstva.................................. 14 5.1 Management commitment.........................14

5.2 Osredotočenost na odjemalce.................. 15 5.2 Customer focus .........................................15

5.3 Politika kakovosti...................................... 15 5.3 Quality policy.............................................15

5.4 Planiranje..................................................15 5.4 Planning ....................................................15

5.5 Odgovornosti, pooblastila in 5.5 Responsibility, authority and

komuniciranje ........................................... 16 communication..........................................16

5.6 Vodstveni pregled..................................... 16 5.6 Management review..................................16

6 Vodenje virov............................................... 17 6 Resource management................................17

6.1 Priskrba virov............................................ 17 6.1 Provision of resources...............................17

6.2 Človeški viri .............................................. 17 6.2 Human resources......................................17

6.3 Infrastruktura ............................................ 18 6.3 Infrastructure .............................................18

6.4 Delovno okolje.......................................... 18 6.4 Work environment .....................................18

7 Realizacija proizvoda................................... 18 7 Product realization .......................................18

7.1 Planiranje realizacije proizvoda................ 18 7.1 Planning of product realization..................18

7.2 Procesi, povezani z odjemalci.................. 19 7.2 Customer-related processes.....................19

7.3 Načrtovanje in razvoj… ............................ 20 7.3 Design and development ..........................20

7.4 Nabava ..................................................... 22 7.4 Purchasing ................................................22

7.5 Proizvodnja in izvedba storitev................. 23 7.5 Production and service provision ..............23

7.6 Obvladovanje nadzornih in merilnih 7.6 Control of monitoring and measuring

naprav ...................................................... 25 devices ......................................................25

8 Merjenje, analize in izboljševanje................ 26 8 Measurement, analysis and improvement...26

8.1 Splošno.....................................................26 8.1 General......................................................26

8.2 Nadzorovanje in merjenje......................... 26 8.2 Monitoring and measurement ...................26

8.3 Obvladovanje neskladnih proizvodov....... 28 8.3 Control of nonconforming product.............28

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SIST EN ISO 9001 : 2000

8.4 Analiza podatkov ...................................... 28 8.4 Analysis of data.........................................28

8.5 Izboljševanje............................................. 29 8.5 Improvement .............................................29

Dodatek A: Primerjava med ISO 9001:2000 Annex A: Correspondence between

in ISO 14001:1996 ....................................... 31 ISO 9001:2000 and ISO 14001:1996 ...........33

Dodatek B: Primerjava med ISO 9001:1994 Annex B: Correspondence between

in ISO 9001:2000 ......................................... 39 ISO 9001:2000 and ISO 9001:1994 .............41

Dodatek ZA..................................................... 47 Annex ZA.........................................................48

Bibliografija ..................................................... 49 Bibliography.....................................................50

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SIST EN ISO 9001 : 2000
Predgovor Foreword

ISO (Mednarodna organizacija za standardizacijo) ISO (The International Organization for

je svetovna zveza nacionalnih organov za Standardization) is a worldwide federation of

standarde (članov ISO). Mednarodne standarde national standards bodies (ISO member bodies).

ponavadi pripravljajo tehnični odbori ISO. Vsak The work of preparing International Standards is

član, ki želi delovati na določenem področju, za normally carried out through ISO technical

katero je bil ustanovljen tehnični odbor, ima committees. Each member body interested in a

pravico biti zastopan v tem odboru. Pri delu subject for which a technical committee has been

sodelujejo mednarodne vladne in nevladne established has the right to be represented on

organizacije, povezane z ISO. V vseh zadevah, that committee. International organizations,

ki so povezane s standardizacijo na področju governmental and non-governmental, in liaison

elektrotehnike, ISO tesno sodeluje z with ISO, also take part in the work. ISO

Mednarodno elektrotehniško komisijo (IEC). collaborates closely with the International

Electrotechnical Commission (IEC) on all matters
of electrotechnical standardization.

Mednarodni standardi so pripravljeni v skladu s International Standards are drafted in accordance

pravili, podanimi v Direktivah ISO/IEC, 3. del. with the rules given in the ISO/IEC Directives, Part

Osnutki mednarodnih standardov, ki jih Draft International Standards adopted by the

sprejmejo tehnični odbori, se pošljejo vsem technical committees are circulated to the

članom v glasovanje. Za objavo mednarodnega member bodies for voting. Publication as an

standarda je treba pridobiti soglasje najmanj 75 International Standard requires approval by at

odstotkov članov, ki se udeležijo glasovanja. least 75 % of the member bodies casting a vote.

Opozoriti je treba na možnost, da je lahko nekaj Attention is drawn to the possibility that some of

elementov tega mednarodnega standarda the elements of this International Standard may

predmet patentnih pravic. ISO ne prevzema be the subject of patent rights. ISO shall not be

odgovornosti za identifikacijo katerihkoli ali vseh held responsible for identifying any or all such

takih patentnih pravic. patent rights.

Mednarodni standard ISO 9001 je pripravil International Standard ISO 9001 was prepared by

tehnični odbor ISO/TC 176 Vodenje in Technical Committee ISO/TC 176, Quality
zagotavljanje kakovosti, pododbor SC2 Sistemi management and quality assurance,
kakovosti. Subcommittee SC 2, Quality systems.

Ta tretja izdaja ISO 9001 razveljavlja in This third edition of ISO 9001 cancels and

nadomešča drugo izdajo (ISO 9001:1994) hkrati replaces the second edition (ISO 9001:1994)

z ISO 9002:1994 in ISO 9003:1994. Predstavlja together with ISO 9002:1994 and ISO 9003:1994.

strokovno revizijo teh dokumentov. Organizacije, It constitutes a technical revision of these

ki so v preteklosti uporabljale ISO 9002:1994 in documents. Those organizations which have used

ISO 9003:1994, lahko uporabljajo ta mednarodni ISO 9002:1994 and ISO 9003:1994 in the past

standard tako, da opustijo določene zahteve v may use this International Standard by excluding

skladu s točko 1.2. certain requirements in accordance with 1.2.

Naslov ISO 9001 je bil popravljen in ne vsebuje The title of ISO 9001 has been revised in this

več izraza »Zagotavljanje kakovosti«. To odraža edition and no longer includes the term »Ouality

dejstvo, da je namen zahtev za sistem vodenja Assurance«. This reflects the fact that the quality

kakovosti, specificiranih v tej izdaji ISO 9001, management system requirements specified in

poleg zagotavljanja kakovosti proizvoda tudi this edition of ISO 9001, in addition to quality

povečevanje zadovoljstva odjemalcev. assurance of product, also aim to enhance
customer satisfaction.

Dodatka A in B tega mednarodnega standarda Annexes A and B of this International Standard

sta podana samo informativno. are for information only.
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SIST EN ISO 9001 : 2000
0 Uvod 0 Introduction
0.1 Splošno 0.1 General

Privzem sistema vodenja kakovosti naj bo The adoption of a quality management system

strateška odločitev organizacije. Na načrtovanje should be a strategic decision of the

in izvajanje sistema vodenja kakovosti organization. The design and implementation of

organizacije vplivajo spreminjajoče se potrebe, an organization's quality management system is

posebni cilji, ponujeni proizvodi, izvajani procesi influenced by varying needs, particular

ter velikost in struktura organizacije. Ni namen objectives, the products provided, the

tega mednarodnega standarda, da bi zahteval processes employed and the size and structure

enotno strukturo sistemov vodenja kakovosti ali of the organization. It is not the intent of this

poenotenost dokumentacije. International Standard to imply uniformity in the
structure of quality management systems or
uniformity of documentation.
Zahteve za sistem vodenja kakovosti, The quality management system requirements

specificirane v tem mednarodnem standardu, specified in this International Standard are

so dopolnilo zahtevam za proizvode. Besedilo, complementary to requirements for products.

označeno z »OPOMBA«, predstavlja napotek Information marked »NOTE« is for guidance in

pri razumevanju ali razjasnitvi zahtev. understanding or clarifying the associated

requirement.

Ta mednarodni standard lahko uporabljajo This International Standard can be used by

notranje ali zunanje stranke, vključno s internal and external parties, including

certifikacijskimi organi, za ocenjevanje certification bodies, to assess the

sposobnosti organizacije glede izpolnjevanja organization's ability to meet customer,

zahtev odjemalcev, regulative ali zahtev, ki si regulatory and the organization's own

jih postavi organizacija sama. requirements.

Pri razvoju tega mednarodnega standarda so The quality management principles stated in

bila upoštevana načela vodenja kakovosti, ISO 9000 and ISO 9004 have been taken into

pojasnjena v ISO 9000 in ISO 9004. consideration during development of this
International Standard.
0.2 Procesni pristop 0.2 Process approach
Ta mednarodni standard spodbuja privzem This International Standard promotes the

procesnega pristopa pri razvijanju, izvajanju in adoption of a process approach when

izboljševanju uspešnosti sistema vodenja developing, implementing and improving the

kakovosti z namenom, da bi se z izpolnjevanjem effectiveness of a quality management system,

zahtev odjemalcev povečalo njihovo zadovoljstvo. to enhance customer satisfacion by meeting

customer requirements.

Da bi organizacija delovala uspešno, mora For an organization to function effectively, it has

identificirati in voditi številne povezane to identify and manage numerous linked

aktivnosti. Aktivnost, ki uporablja vire in ki jo activities. An activity using resources, and

vodimo z namenom, da omogoči spremembo managed in order to enable the transformation

vhodov v izhode, lahko obravnavamo kot of inputs into outputs, can be considered as a

proces. Izhod enega procesa pogosto tvori process. Often the output from one process

vhod v drugi proces. directly forms the input to the next.

Uporabo sistema procesov znotraj organizacije, The application of a system of processes within

vključno z njihovo identifikacijo, medsebojnimi an organization, together with the identification

vplivi in njihovim vodenjem, lahko poimenujemo and interactions of these processes, and their

»procesni pristop«. management, can be referred to as the
»process approach«.
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SIST EN ISO 9001 : 2000

Prednost procesnega pristopa je v tem, da An advantage of the process aproach is the

omogoča nenehni nadzor nad povezavami med ongoing control that it provides over the linkage

posameznimi procesi znotraj sistema procesov between the individual processes within the

kot tudi nad njihovimi kombinacijami in system of processes, as well as over their

medsebojnimi vplivi. combination and interaction.

Pri uporabi znotraj sistema vodenja kakovosti When used within a quality management

tak pristop poudari pomen: system, such an approach emphasizes the
importance of

a) razumevanja in izpolnjevanja zahtev, a) understanding and meeting requirements,

b) potrebe po obravnavanju procesov z vidika b) the need to consider processes in terms of

dodane vrednosti, added value,

c) pridobivanja rezultatov delovanja in c) obtaining results of process performance

uspešnosti procesov, and effectiveness, and

d) nenehnega izboljševanja procesov na d) continual improvement of processes based

osnovi objektivnih merjenj. on objective measurement.

Slika 1 prikazuje model sistema vodenja kakovosti, The model of a process-based quality

ki je osnovan na procesih. Model ponazarja management system shown in Figure 1

procesne povezave, kot so predstavljene v točkah illustrates the process linkages presented in

od 4 do 8. Slika prikazuje, da imajo odjemalci clauses 4 to 8. This illustration shows that

pomembno vlogo pri določanju vhodnih zahtev. customers play a significant role in defining

Spremljanje zadovoljstva odjemalca zahteva requirements as inputs. Monitoring of customer

ocenjevanje njegovega zaznavanja, ali je satisfaction requires the evaluation relating to

organizacija izpolnila njegove zahteve. Model, customer perception as to whether the organi-

prikazan na sliki 1, pokriva vse zahteve tega zation has met the customer requirements. The

mednarodnega standarda, vendar ne prikazuje model shown in Figure 1 covers all the

procesov podrobneje. requirements of this International Standard, but
does not show processes at a detailed level.

OPOMBA: Poleg zgoraj opisanega se lahko pri vseh NOTE In addition, the methodology known as

procesih uporabi metodologija, poznana kot “Plan-Do-Check-Act” (PDCA) can be applied

“Planiraj-Izvedi-Preveri-Ukrepaj” (PDCA). to all processes. PDCA can be briefly

PDCA lahko na kratko opišemo na spodaj described as follows.

navedeni način.

Planiraj : Vzpostavi cilje in procese, potrebne za Plan: establish the objectives and processes

doseganje rezultatov, v skladu z zahtevami necessary to deliver results in accordance

odjemalcev in načeli organizacije. with customer requirements and the
organization’s policies.
Izvedi: Izvajaj procese. Do: implement the processes.

Preveri: Nadzoruj in meri procese in proizvod glede Check: monitor and measure processes and product

načel, ciljev in zahtev za proizvod ter poročaj against policies, objectives and
o rezultatih. requirements for the product and report the
results.

Ukrepaj: Ukrepaj tako, da se delovanje procesa Act: take actions to continually improve process

nenehno izboljšuje. performance.
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SIST EN ISO 9001 : 2000
Nenehno izboljševanje Continual improvement of the
Nenehno izboljševanje Continual improvement of the
sistema vodenja kakovosti
quality management system
sistema vodenja kakovosti
quality management system
Odgovornost Management
Management
Odgovornost
vodstva responsibility
vodstva responsibility
Odjemalec Odjemalec
Customer Customer
Merjenje,
Measurement
Merjenje,
Measurement
Resource
Vodenje virov analize in Zadovoljstvo Resource
analysis and
Vodenje virov analize in Satisfaction
analysis and
management
izboljševanje management
improvement
izboljševanje
improvement
Vhod Izhod
Realizacija
Input Output
Realizacija Product
Zahteve Proizvod
Product
proizvoda Requirements Product
proizvoda realization
realization
Legenda Key

Aktivnosti, ki dodajajo vrednost Value adding activities

Tok informacij Information flow

Slika 1: Model sistema vodenja kakovosti, Figure 1: Model of a process-based quality

osnovan na procesih management system
0.3 Razmerje do ISO 9004 0.3 Relationship with ISO 9004

Ta izdaja ISO 9001 in ISO 9004 je bila razvita The present editions of ISO 9001 and ISO 9004

kot skladni par standardov za sistem vodenja have been developed as a consistent pair of

kakovosti, ki sta bila zasnovana tako, da drug quality management system standards which

drugega dopolnjujeta, vendar pa se lahko have designed to complement each other, but

uporabljata tudi samostojno. Ta dva can also be used independently. Although the
mednarodna standarda imata
...

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