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
- Status
- Withdrawn
- Publication Date
- 14-Dec-2000
- Withdrawal Date
- 14-Nov-2008
- Technical Committee
- CEN/SS F20 - Quality assurance
- Drafting Committee
- CEN/SS F20 - Quality assurance
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 15-Nov-2008
- Completion Date
- 15-Nov-2008
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Referred By
EN 60746-1:2003 - Expression of performance of electrochemical analyzers - Part 1: General - Effective Date
- 09-Feb-2026
- Referred By
EN 60746-2:2003 - Expression of performance of electrochemical analyzers - Part 2: pH value - Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 09-Feb-2026
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Frequently Asked Questions
EN ISO 9001:2000 is a standard published by the European Committee for Standardization (CEN). Its full title is "Quality management systems - Requirements (ISO 9001:2000)". This standard covers: 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)
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)
EN ISO 9001:2000 is classified under the following ICS (International Classification for Standards) categories: 03.100.70 - Management systems; 03.120.10 - Quality management and quality assurance. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 9001:2000 has the following relationships with other standards: It is inter standard links to EN ISO 9001:2008, EN 61400-3:2009, EN 61189-5:2006, EN 61189-2:2006, EN 61192-2:2003, EN 60895:2003, EN 60300-1:2003, EN 62326-1:2002, EN 61478:2001, EN 61811-50:2002, EN 60794-4-10:2007, EN 60746-1:2003, EN 60746-2:2003, EN 61496-1:2004, EN 61400-1:2005. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 9001:2000 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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 9001:2000(E)
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©
ii ISO 2000 – All rights reserved
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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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.
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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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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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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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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 of product realization
The organization shall plan and develop the processes needed for product realization. Planning of product realization
shall be consistent with the requirements of the other processes of the quality management system (see 4.1).
In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes, documents, and provide resources specific to the product;
c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria
for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements
(see 4.2.4).
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The output of this planning shall be in a form suitable for the organization's method of operations.
NOTE 1 A document specifying the processes of the quality management system (including the product realization processes)
and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.
NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
The organization shall determine
a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,
b) requirements not stated by the customer but necessary for specified or intended use, where known,
c) statutory and regulatory requirements related to the product, and
d) any additional requirements determined by the organization.
7.2.2 Review of requirements related to the product
The organization shall review the requirements related to the product. This review shall be conducted prior to the
organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts
or orders, acceptance of changes to contracts or orders) and shall ensure that
a) product requirements are defined,
b) contract or order requirements differing from those previously expressed are resolved, and
c) the organization has the ability to meet the defined requirements.
Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).
Where the customer provides no documented statement of requirement, the customer requirements shall be
confirmed by the organization before acceptance.
Where product requirements are changed, the organization shall ensure that relevant documents are amended and
that relevant personnel are made aware of the changed requirements.
NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover
relevant product information such as catalogues or advertising material.
7.2.3 Customer communication
The organization shall determine and implement effective arrangements for communicating with customers in
relation to
a) product information,
b) enquiries, contracts or order handling, including amendments, and
c) customer feedback, including customer complaints.
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ISO 9001:2000(E)
7.3 Design and development
7.3.1 Design and development planning
The organization shall plan and control the design and development of product.
During the design and development planning, the organization shall determine
a) the design and development stages,
b) the review, verification and v
...
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.
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
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
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
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.
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.
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
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
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
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.
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«.
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.
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 kljub različnemu two International Standards have different
namenu podobno strukturo, da bi bilo to v scopes, they have similar structures in order to
pomoč pri njuni uporabi. assist their application as a consistent pair.
ISO 9001 specificira zahteve za sistem vodenja ISO 9001 specifies requirements for a quality
kakovosti za uporabo znotraj organizacije, management system that can be used for internal
certificiranje ali pogodbene namene. Osredotoča application by organizations, or for certification, or
se na uspešnost sistema vodenja kakovosti pri for contractual purposes. It focuses on the
izpolnjevanju zahtev odjemalcev. effectiveness of the quality management system
in meeting customer requirements.
ISO 9004:2000 daje navodila na podlagi ISO 9004:2000 gives guidance on a wider
širšega obsega ciljev sistema vodenja kakovosti range of objectives of a quality management
kot ISO 9001, zlasti za nenehno izboljševanje system than does ISO 9001, particularly for the
celotnega delovanja in uspešnosti organizacije continual improvement of an organization's
kot tudi njene uspešnosti. ISO 9004:2000 se overall performance and efficiency, as well as
priporoča kot vodilo za organizacije, katerih its effectiveness. ISO 9004:2000 is
najvišje vodstvo želi v prizadevanju za nenehno recommended as a guide for organizations
izboljševanje delovanja preseči okvire zahtev whose top management wishes to move
ISO 9001. Vendar pa ni namenjen za beyond the requirements of ISO 9001, in
certificiranje ali uporabo v pogodbenih odnosih. pursuit of continual improvement of
performance. However, it is not intended for
certification or contractual use.
SIST EN ISO 9001 : 2000
0.4 Združljivost z drugimi sistemi vodenja 0.4 Compatibility with other management
systems
Ta mednarodni standard je usklajen z ISO This International Standard has been aligned
14001:1996 z namenom, da se poveča with ISO 14001:1996 in order to enhance the
združljivost obeh standardov v korist skupnosti compatibility of the two standards for the benefit
uporabnikov. of the user community.
Ta mednarodni standard ne vključuje zahtev, This International Standard does not include
specifičnih za druge sisteme vodenja, kot na requirements specific to other management
primer specifičnih zahtev za ravnanje z okoljem, systems, such as those particular to
varovanje zdravja in varnost pri delu, finančno environmental management, occupational health
vodenje ali obvladovanje tveganj. Kljub temu ta and safety management, financial management
mednarodni standard organizaciji omogoča, da or risk management. However, this International
uskladi ali združi svoj sistem vodenja kakovosti z Standard enables an organization to align or
zahtevami sorodnih sistemov vodenja. Da bi integrate its own quality management system with
organizacija vzpostavila sistem vodenja kakovosti, related management system requirements. It is
ki izpolnjuje zahteve tega mednarodnega possible for an organization to adapt its existing
standarda, lahko prilagodi svoj(-e) obstoječi(-e) management system(s) in order to establish a
sistem(-e) vodenja. quality management system that complies with
the requirements of this International Standard.
Sistemi vodenja kakovosti – Quality management systems –
Zahteve Requirements
1 Predmet standarda 1 Scope
1.1 Splošno 1.1 General
Ta mednarodni standard specificira zahteve za This International Standard specifies require-
sistem vodenja kakovosti. Uporablja se, kadar ments for a quality management system where
organizacija: an organization
a) mora dokazati svojo sposobnost, da a) needs to demonstrate its ability to consistently
dosledno dobavlja proizvode, ki izpolnjujejo provide product that meets customer and
zahteve odjemalcev in zahteve ustrezne applicable regulatory requirements, and
zakonodaje,
b) namerava izboljšati zadovoljstvo odjemalcev b) aims to enhance customer satisfaction
z učinkovito uporabo sistema, vključno s through the effective application of the
procesi za nenehno izboljševanje sistema in system, including processes for continual
zagotavljanje skladnosti z zahtevami odjemal- improvement of the system and the
cev in ustreznimi zahtevami regulative. assurance of conformity to customer and
applicable regulatory requirements.
OPOMBA: V tem mednarodnem standardu se izraz
NOTE In this International Standard, the term
»proizvod« nanaša samo na proizvod, ki je
»product« applies only to the product
namenjen odjemalcu ali ki ga odjemalec
intended for, or required by, a customer.
zahteva.
1.2 Uporaba 1.2 Application
Vse zahteve, specificirane v tem mednarodnem All the requirements of this International
standardu, so splošne in namenjene za Standard are generic and are intended to be
uporabo v vseh organizacijah, ne glede na applicable to all organizations, regardless of
vrsto in velikost ter priskrbljeni proizvod. type, size and product provided.
SIST EN ISO 9001 : 2000
Kjer se zahteva(-e) tega mednarodnega Where any requirement(s) of this International
standarda ne more(-jo) uporabiti zaradi narave Standard cannot be applied due to the nature of
organizacije in njenih proizvodov, se lahko an organization and its product, this can be
preuči možnost za njihovo opustitev. considered for an exclusion.
Sklicevanje na skladnost s tem mednarodnim Where exclusions are made, claims of
standardom v primeru opustitev ni sprejemljivo, conformity to this International Standard are not
razen če so te opustitve omejene na zahteve acceptable unless these exclusions are limited
znotraj točke 7 in ne vplivajo na sposobnost ali to requirements within clause 7, and such
odgovornost organizacije, da priskrbi proizvod, exclusions do not affect the organization’s
ki izpolnjuje zahteve odjemalcev in ustrezne ability, or responsibility, to provide product that
zahteve regulative. fulfils customer and applicable regulatory
requirements.
2 Zveza z drugimi standardi 2 Normative reference
Spodaj navedeni standard vsebuje določila, ki s The following normative document contains
sklicevanjem v tem besedilu tvorijo določila provisions which, through reference in this text,
tega mednarodnega standarda. Pri datiranem constitute provisions of this International
sklicevanju se ne upoštevajo poznejši dodatki Standard. For dated references, subsequent
ali popravki teh dokumentov. Vendar se amendments to, or revisions of, any of these
strankam, ki sklenejo dogovore, zasnovane na publications do not apply. However, parties to
tem mednarodnem standardu, priporoča, naj agreements based on this International
raziščejo možnost uporabe najnovejše izdaje Standard are encouraged to investigate the
spodaj navedenega standarda. Člani ISO in possibility of applying the most recent edition of
IEC vzdržujejo register veljavnih mednarodnih the normative document indicated below.
standardov. Members of ISO and IEC maintain registers of
currently valid International Standards.
ISO 9000:2000, Sistemi vodenja kakovosti – Osnove ISO 9000:2000, Quality management systems -
in slovar Fundamentals and vocabulary.
3 Izrazi in definicije 3 Terms and definitions
V tem mednarodnem standardu se uporabljajo For the purposes of this International Standard,
izrazi in definicije, ki so podani v standardu ISO the terms and definitions given in ISO 9000
9000. apply.
Da bi se odrazilo trenutno uporabljano izrazje, The following terms, used in this edition of ISO
so bili v tej izdaji ISO 9001 spremenjeni 9001 to describe the supply chain, have been
naslednji izrazi, ki opisujejo nabavno verigo: changed to reflect the vocabulary currently used:
dobavitelj organizacija odjemalec supplier organization customer
Izraz »organizacija« nadomešča predhodno The term »organization« replaces the term
uporabljan izraz »dobavitelj« in se nanaša na »supplier« used in ISO 9001:1994, and refers
enoto, v kateri se uporablja ta mednarodni to the unit to which this International Standard
standard. Prav tako izraz »dobavitelj« sedaj applies. Also, the term »supplier« now replaces
nadomešča izraz »podpogodbenik«. the term »subcontractor«.
Kjerkoli se v besedilu tega mednarodnega Throughout the text of this International
standarda pojavi izraz »proizvod«, lahko ta Standard, wherever the term »product« occurs,
izraz pomeni tudi »storitev«. it can also mean »service«.
SIST EN ISO 9001 : 2000
4 Sistem vodenja kakovosti 4 Quality management system
4.1 Splošne zahteve 4.1 General requirements
Organizacija mora vzpostaviti, dokumentirati, The organization shall establish, document,
izvajati in vzdrževati sistem vodenja kakovosti implement and maintain a quality management
ter nenehno izboljševati njegovo uspešnost v system and continually improve its
skladu z zahtevami tega mednarodnega effectiveness in accordance with the
standarda. requirements of this International Standard.
Pri izvajanju sistema vodenja kakovosti mora To implement the quality management system,
organizacija: the organization shall
a) identificirati procese, potrebne za sistem a) identify the processes needed for the
vodenja kakovosti, in njihovo uporabo v quality management system and their
celotni organizaciji (glej 1.2), application throughout the organization (see
1.2),
b) določiti zaporedje in medsebojne vplive teh b) determine the sequence and interaction of
procesov, these processes,
c) določiti kriterije in metode, potrebne za c) determine criteria and methods needed to
zagotovitev tako uspešnega delovanja kot ensure that both the operation and control
tudi uspešnega obvladovanja teh procesov, of these processes are effective,
d) zagotoviti, da so na voljo viri in informacije, d) ensure the availability of resources and
potrebne za podporo delovanja in information necessary to support the
nadzorovanja teh procesov, operation and monitoring of these
processes,
e) nadzorovati, meriti in analizirati te procese, e) monitor, measure and analyse these
processes, and
f) izvajati ukrepe, potrebne za doseganje
f) implement actions necessary to achieve
planiranih rezultatov in za nenehno
planned results and continual improvement
izboljševanje teh procesov.
of these processes.
Organizacija mora voditi te procese skladno z
These processes shall be managed by the the
zahtevami tega mednarodnega standarda.
organization in accordance with the
requirements of this International Standard.
V primeru, da se organizacija odloči predati Where an organization chooses to outsource
zunanjim izvajalcem v izvajanje katerikoli proces,
any process that affects product conformity with
ki vpliva na skladnost proizvoda z zahtevami, requirements, the organization shall ensure
mora organizacija zagotoviti obvladovanje teh
control over such processes. Control of such
procesov. Obvladovanje teh procesov mora biti outsourced processes shall be identified within
vključeno v sistem vodenja kakovosti.
the quality management system.
OPOMBA: Procesi, potrebni za sistem vodenja
NOTE Processes needed for quality management
kakovosti, na katere se sklicuje gornje
system reffered to above should include
besedilo, naj vključujejo procese za
processes for management activities,
vodstvene aktivnosti, priskrbo virov, provision of resources, product realization
realizacijo proizvoda in merjenje. and measurement.
SIST EN ISO 9001 : 2000
4.2 Zahteve glede dokumentacije 4.2 Documentation requirements
4.2.1 Splošno 4.2.1 General
Dokumentacija sistema vodenja kakovosti mora The quality management system documentation
vključevati: shall include
a) dokumentirane izjave o politiki kakovosti in a) documented statements of a quality policy
ciljih kakovosti, and quality objectives,
b) poslovnik kakovosti, b) a quality manual,
c) dokumentirane postopke, ki jih zahteva ta c) documented procedures required by this
mednarodni standard, International Standard,
d) dokumente, ki jih organizacija potrebuje, da d) documents needed by the organization to
bi zagotovila uspešno planiranje, delovanje ensure the effective planning, operation and
in obvladovanje njenih procesov, control of its processes, and
e) zapise, ki jih zahteva ta mednarodni e) records required by this International
standard (glej 4.2.4). Standard (see 4.2.4).
OPOMBA 1: Kjer se v tem mednarodnem standardu NOTE 1 Where the term »documented procedure«
pojavlja izraz »dokumentiran postopek«, to appears within this International Standard,
pomeni, da je postopek vzpostavljen, this means that the procedure is
dokumentiran, da se izvaja in vzdržuje.
established, documented, implemented and
maintained.
OPOMBA 2: Obseg dokumentacije sistema vodenja NOTE 2 The extent of the quality management
kakovosti se lahko razlikuje od ene do druge system documentation can differ from one
organizacije zaradi: organization to another due to
a) velikosti organizacije in vrste aktivnosti,
a) the size of the organization and type of
activities,
b) kompleksnosti procesov in njihovih b) the complexity of processes and their
medsebojnih vplivov, interactions, and
c) kompetentnosti osebja. c) the competence of personnel.
OPOMBA 3: Dokumentacija je lahko v kakršnikoli obliki NOTE 3 The documentation can be in any form or
ali v kateremkoli mediju.
type of medium.
4.2.2 Poslovnik kakovosti 4.2.2 Quality manual
Organizacija mora izdelati in vzdrževati The organization shall establish and maintain a
poslovnik kakovosti, ki vključuje: quality manual that includes
a) predmet sistema vodenja kakovosti, a) the scope of the quality management
vključno z razlogi in s podrobnostmi glede system, including details of and justification
morebitnih opustitev (glej 1.2), for any exclusions (see 1.2),
b) dokumentirane postopke, vzpostavljene za
b) the documented procedures established for
sistem vodenja kakovosti, ali sklicevanje
the quality management system, or
nanje,
reference to them, and
c) opis medsebojnega vpliva procesov
c) a description of the interaction of the
sistema vodenja kakovosti. processes of the quality management
system.
SIST EN ISO 9001 : 2000
4.2.3 Obvladovanje dokumentov 4.2.3 Control of documents
Dokumente, ki jih zahteva sistem vodenja Documents required by the quality
kakovosti, je treba obvladovati. Zapisi so management system shall be controlled.
posebna vrsta dokumentov in jih je treba Records are a special type of document and
obvladovati v skladu z zahtevami, podanimi v shall be controlled according to the
4.2.4. requirements given in 4.2.4.
Vzpostaviti je treba dokumentiran postopek,
...
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