EN ISO 9001:2000
(Main)Quality management systems - Requirements (ISO 9001:2000)
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
Relations
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
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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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
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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.
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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.
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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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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
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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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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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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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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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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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
II
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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
Centralni sekretariat: Rue de Stassart 36, B-1050 Bruselj
© 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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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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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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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
3.
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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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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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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