Quality management systems - Requirements (ISO 9001:2008)

ISO 9001:2008 specifies requirements for a quality management system where an organization
needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
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 statutory and regulatory requirements.
All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of ISO 9001:2008 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 ISO 9001:2008 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 statutory and regulatory requirements.

Qualitätsmanagementsysteme - Anforderungen (ISO 9001:2008)

1.1   Allgemeines
Diese Internationale Norm legt Anforderungen an ein Qualitätsmanagementsystem fest, wenn eine Organisation
a)   ihre Fähigkeit zur ständigen Bereitstellung von Produkten darzulegen hat, die die Anforderungen der Kunden und die zutreffenden gesetzlichen und behördlichen Anforderungen erfüllen, und
b)   danach strebt, die Kundenzufriedenheit durch wirksame Anwendung des Systems zu erhöhen, ein-schließlich der Prozesse zur ständigen Verbesserung des Systems und der Zusicherung der Einhaltung der Anforderungen der Kunden und der zutreffenden gesetzlichen und behördlichen Anforderungen.
ANMERKUNG 1   In dieser Internationalen Norm bezieht sich die Benennung "Produkt" nur auf
a)   solche Produkte, die für einen Kunden vorgesehen sind oder von diesem gefordert werden,
b)   alle beabsichtigten Ergebnisse der Produktrealisierungsprozesse.
ANMERKUNG 2   Gesetzliche und behördliche Anforderungen können auch als rechtliche Anforderungen bezeichnet werden.
1.2   Anwendung
Alle in dieser Internationalen Norm festgelegten Anforderungen sind allgemeiner Natur und auf alle Organisa-tionen anwendbar, unabhängig von deren Art und Größe und von der Art der bereitgestellten Produkte.
Wenn sich aufgrund des Charakters einer Organisation und ihrer Produkte eine oder mehrere Anforderungen dieser Internationalen Norm nicht anwenden lassen, kann für diese ein Ausschluss in Betracht gezogen werden.
Wenn Ausschlüsse vorgenommen werden, ist das Beanspruchen der Konformität mit dieser Internationalen Norm nur zulässig, wenn die Ausschlüsse auf Anforderungen aus Abschnitt 7 beschränkt sind und derartige Ausschlüsse die Fähigkeit oder Verantwortung der Organisation zur Bereitstellung von Produkten, die den Kunden  und zutreffenden gesetzlichen und behördlichen Anforderungen entsprechen, nicht beeinträchtigen.

Systèmes de management de la qualité - Exigences (ISO 9001:2008)

L'ISO 9001:2008 spécifie les exigences relatives au système de management de la qualité lorsqu'un organisme
a besoin de démontrer son aptitude à fournir régulièrement un produit conforme aux exigences des clients et aux exigences légales et réglementaires applicables, et
vise à accroître la satisfaction de ses clients par l'application efficace du système, y compris les processus pour l'amélioration continue du système et l'assurance de la conformité aux exigences des clients et aux exigences légales et réglementaires applicables.
Toutes les exigences de l'ISO 9001:2008 sont génériques et prévues pour s'appliquer à tout organisme, quels que soient son type, sa taille et le produit fourni.
Quand une ou plusieurs exigences de l'ISO 9001:2008 ne peuvent pas être appliquées en raison de la nature d'un organisme et de son produit, leur exclusion peut être envisagée.
Lorsque des exclusions sont faites, les demandes de conformité à l'ISO 9001:2008 ne sont acceptables que si ces exclusions se limitent aux exigences de l'Article 7 et n'ont pas d'incidence sur l'aptitude ou la responsabilité des organismes à fournir un produit conforme aux exigences des clients et aux exigences légales et réglementaires applicables.

Sistemi vodenja kakovosti - Zahteve (ISO 9001:2008)

Ta mednarodni standard specificira zahteve za sistem vodenja kakovosti. Uporablja se, kadar organizacija:
a) mora dokazati svojo sposobnost, da dosledno dobavlja proizvode, ki izpolnjujejo zahteve odjemalcev in zahteve ustrezne zakonodaje in regulative, in
b) namerava izboljšati zadovoljstvo odjemalcev z učinkovito uporabo sistema, vključno s procesi za nenehno izboljševanje sistema in
zagotavljanje skladnosti z zahtevami odjemalcev in ustreznimi zahtevami zakonodaje in regulative.
OPOMBA 1: V tem mednarodnem standardu se izraz »proizvod« nanaša samo na
a) proizvod, ki je namenjen odjemalcu ali ki ga odjemalec zahteva,
b) vsak namerni izhod kot rezultat procesa realizacije proizvoda.
OPOMBA 2: Zahteve zakonodaje in regulative so lahko izražene kot pravne zahteve.

General Information

Status
Withdrawn
Publication Date
14-Nov-2008
Withdrawal Date
14-Sep-2015
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
15-Sep-2015

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sistemi vodenja kakovosti - Zahteve (ISO 9001:2008)Qualitätsmanagementsysteme - Anforderungen (ISO 9001:2008)Systèmes de management de la qualité - Exigences (ISO 9001:2008)Quality management systems - Requirements (ISO 9001:2008)03.120.10Vodenje in zagotavljanje kakovostiQuality management and quality assuranceICS:Ta slovenski standard je istoveten z:EN ISO 9001:2008SIST EN ISO 9001:2008en01-december-2008SIST EN ISO 9001:2008SLOVENSKI

STANDARDSIST EN ISO 9001:20001DGRPHãþD
SIST EN ISO 9001:2008

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 9001November 2008ICS 03.120.10Supersedes EN ISO 9001:2000

English VersionQuality management systems - Requirements (ISO 9001:2008)Systèmes de management de la qualité - Exigences (ISO9001:2008)Qualitätsmanagementsysteme - Anforderungen (ISO9001:2008)This European Standard was approved by CEN on 8 November 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36

B-1050 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 9001:2008: ESIST EN ISO 9001:2008

EN ISO 9001:2008 (E) 2 Contents Page Foreword ..............................................................................................................................................................3

SIST EN ISO 9001:2008

EN ISO 9001:2008 (E) 3 Foreword This document (EN ISO 9001:2008) has been prepared by Technical Committee ISO/TC 176 "Quality management and quality assurance". This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2009, and conflicting national standards shall be withdrawn at the latest by May 2009. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 9001:2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 9001:2008 has been approved by CEN as EN ISO 9001:2008 without any modification.

SIST EN ISO 9001:2008
SIST EN ISO 9001:2008

INTERNATIONALSTANDARDISO9001Fourth edition2008-11-15Reference numberISO9001:2008(E)© ISO2008Quality management systems— RequirementsSystèmes de management de la qualité— Exigences

SIST EN ISO 9001:2008

ISO9001:2008(E)ii© ISO2008–All rights reservedPDF disclaimerThis PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shallnot be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. Indownloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariataccepts no liability in this area.Adobe is a trademark of Adobe Systems Incorporated.Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creationparameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In theunlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

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©ISO2008 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below orISO's member body in the country of the requester.ISO copyright officeCase postale 56  CH-1211 Geneva 20Tel.+ 41 22 749 01 11Fax+ 41 22 749 09 47E-mailcopyright@iso.orgWebwww.iso.orgPublished in SwitzerlandSIST EN ISO 9001:2008

ISO9001:2008(E)© ISO2008–All rights reservediiiContents Page1Scope .................................................................................................................................................... 11.1General ................................................................................................................................................. 11.2Application ........................................................................................................................................... 12Normative references .......................................................................................................................... 13Terms and definitions .......................................................................................................................... 14Quality management system .............................................................................................................. 24.1General requirements ......................................................................................................................... 24.2Documentation requirements ............................................................................................................ 25Management responsibility ................................................................................................................ 35.1Management commitment .................................................................................................................. 35.2Customer focus ................................................................................................................................... 45.3Quality policy ....................................................................................................................................... 45.4Planning ............................................................................................................................................... 45.5Responsibility, authority and communication .................................................................................. 45.6Management review ............................................................................................................................ 56Resource management ....................................................................................................................... 66.1Provision of resources ........................................................................................................................ 66.2Human resources ................................................................................................................................ 66.3Infrastructure ....................................................................................................................................... 66.4Work environment ............................................................................................................................... 67Product realization ............................................................................................................................... 77.1Planning of product realization .......................................................................................................... 77.2Customer-related processes .............................................................................................................. 77.3Design and development .................................................................................................................... 87.4Purchasing ........................................................................................................................................... 97.5Production and service provision .................................................................................................... 107.6Control of monitoring and measuring equipment .......................................................................... 118Measurement, analysis and improvement ....................................................................................... 128.1General ............................................................................................................................................... 128.2Monitoring and measurement .......................................................................................................... 128.3Control of nonconforming product .................................................................................................. 138.4Analysis of data ................................................................................................................................. 138.5Improvement ...................................................................................................................................... 14AnnexA(informative)Correspondence between ISO9001:2008 and ISO14001:2004 ....................... 15AnnexB(informative)Changes between ISO9001:2000 and ISO9001:2008 ....................................... 20Bibliography ............................................................................................................................................... 26SIST EN ISO 9001:2008

ISO9001:2008(E)iv© ISO2008–All rights reservedForewordISO (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 ISOtechnical committees. Each member body interested in a subject for which a technical committee has beenestablished has the right to be represented on that committee. International organizations, governmental andnon-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the InternationalElectrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part2.The main task of technical committees is to prepare International Standards. Draft International Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as anInternational 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 document may be the subject of patentrights. ISO shall not be held responsible for identifying any or all such patent rights.ISO9001 was prepared by Technical Committee ISO/TC176, Quality management and quality assurance,Subcommittee SC2, Quality systems.This fourth edition cancels and replaces the third edition (ISO9001:2000), which has been amended to clarifypoints in the text and to enhance compatibility with ISO14001:2004.Details of the changes between the third edition and this fourth edition are given in AnnexB.SIST EN ISO 9001:2008

ISO9001:2008(E)© ISO2008–All rights reservedvIntroduction0.1GeneralThe adoption of a quality management system should be a strategic decision of an organization. The designand implementation of an organization's quality management system is influenced bya)its organizational environment, changes in that environment, and the risks associated with thatenvironment,b)its varying needs,c)its particular objectives,d)the products it provides,e)the processes it employs,f)its size and organizational structure.It is not the intent of this International Standard to imply uniformity in the structure of quality managementsystems or uniformity of documentation.The quality management system requirements specified in this International Standard are complementary torequirements for products. Information marked “NOTE” is for guidance in understanding or clarifying theassociated requirement.This International Standard can be used by internal and external parties, including certification bodies, toassess the organization's ability to meet customer, statutory and regulatory requirements applicable to theproduct, and the organization's own requirements.The quality management principles stated in ISO9000 and ISO9004 have been taken into consideration duringthe development of this International Standard.0.2Process approachThis International Standard promotes the adoption of a process approach when developing, implementing andimproving the effectiveness of a quality management system, to enhance customer satisfaction by meetingcustomer requirements.For an organization to function effectively, it has to determine and manage numerous linked activities. Anactivity or set of activities using resources, and managed in order to enable the transformation of inputs intooutputs, 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 interactionsof these processes, and their management to produce the desired outcome, can be referred to as the “processapproach”.An advantage of the process approach is the ongoing control that it provides over the linkage between theindividual 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 ofa)understanding and meeting requirements,b)the need to consider processes in terms of added value,SIST EN ISO 9001:2008

ISO9001:2008(E)vi© ISO2008–All rights reservedc)obtaining results of process performance and effectiveness, andd)continual improvement of processes based on objective measurement.The model of a process-based quality management system shown in Figure1 illustrates the process linkagespresented in Clauses4 to 8. This illustration shows that customers play a significant role in definingrequirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating tocustomer perception as to whether the organization has met the customer requirements. The model shown inFigure1 covers all the requirements of this International Standard, but does not show processes at a detailedlevel.NOTEIn addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can bebriefly described as follows.Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and theorganization's policies.Do: implement the processes.Check: monitor and measure processes and product against policies, objectives and requirements for the product andreport the results.Act: take actions to continually improve process performance.Figure1—Model of a process-based quality management systemSIST EN ISO 9001:2008

ISO9001:2008(E)© ISO2008–All rights reservedvii0.3Relationship with ISO9004ISO9001 and ISO9004 are quality management system standards which have been designed to complementeach other, but can also be used independently.ISO9001 specifies requirements for a quality management system that can be used for internal application byorganizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the qualitymanagement system in meeting customer requirements.At the time of publication of this International Standard, ISO9004 is under revision. The revised edition ofISO9004 will provide guidance to management for achieving sustained success for any organization in acomplex, demanding, and ever changing, environment. ISO9004 provides a wider focus on qualitymanagement than ISO9001; it addresses the needs and expectations of all interested parties and theirsatisfaction, by the systematic and continual improvement of the organization’s performance. However, it is notintended for certification, regulatory or contractual use.0.4Compatibility with other management systemsDuring the development of this International Standard, due consideration was given to the provisions ofISO14001:2004 to enhance the compatibility of the two standards for the benefit of the user community.AnnexA shows the correspondence between ISO9001:2008 and ISO14001:2004.This International Standard does not include requirements specific to other management systems, such asthose particular to environmental management, occupational health and safety management, financialmanagement or risk management. However, this International Standard enables an organization to align orintegrate its own quality management system with related management system requirements. It is possible foran organization to adapt its existing management system(s) in order to establish a quality management systemthat complies with the requirements of this International Standard.SIST EN ISO 9001:2008

.viiiSIST EN ISO 9001:2008

INTERNATIONAL STANDARDISO9001:2008(E)© ISO2008–All rights reserved1Quality management systems— Requirements1Scope1.1GeneralThis International Standard specifies requirements for a quality management system where an organizationa)needs to demonstrate its ability to consistently provide product that meets customer and applicablestatutory and regulatory requirements, andb)aims to enhance customer satisfaction through the effective application of the system, including processesfor continual improvement of the system and the assurance of conformity to customer and applicablestatutory and regulatory requirements.NOTE1In this International Standard, the term “product” only applies toa)product intended for, or required by, a customer,b)any intended output resulting from the product realization processes.NOTE2Statutory and regulatory requirements can be expressed as legal requirements.1.2ApplicationAll requirements of this International Standard are generic and are intended to be applicable to allorganizations, regardless of type, size and product provided.Where any requirement(s) of this International Standard cannot be applied due to the nature of an organizationand its product, this can be considered for exclusion.Where exclusions are made, claims of conformity to this International Standard are not acceptable unless theseexclusions are limited to requirements within Clause7, and such exclusions do not affect the organization'sability, or responsibility, to provide product that meets customer and applicable statutory and regulatoryrequirements.2Normative referencesThe following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenced document(including any amendments) applies.ISO9000:2005, Quality management systems— Fundamentals and vocabulary3Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO9000 apply.Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean“service”.SIST EN ISO 9001:2008

ISO9001:2008(E)2© ISO2008–All rights reserved4Quality management system4.1General requirementsThe organization shall establish, document, implement and maintain a quality management system andcontinually improve its effectiveness in accordance with the requirements of this International Standard.The organization shalla)determine the processes needed for the quality management system and their application throughout theorganization (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 processesare effective,d)ensure the availability of resources and information necessary to support the operation and monitoring ofthese processes,e)monitor, measure where applicable, and analyse these processes, andf)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 thisInternational Standard.Where an organization chooses to outsource any process that affects product conformity to requirements, theorganization shall ensure control over such processes. The type and extent of control to be applied to theseoutsourced processes shall be defined within the quality management system.NOTE1Processes needed for the quality management system referred to above include processes for managementactivities, provision of resources, product realization, measurement, analysis and improvement.NOTE2An “outsourced process” is a process that the organization needs for its quality management system and whichthe organization chooses to have performed by an external party.NOTE3Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformityto all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourcedprocess can be influenced by factors such asa)the potential impact of the outsourced process on the organization's capability to provide product that conforms torequirements,b)the degree to which the control for the process is shared,c)the capability of achieving the necessary control through the application of 7.4.4.2Documentation requirements4.2.1GeneralThe quality management system documentation shall includea)documented statements of a quality policy and quality objectives,b)a quality manual,c)documented procedures and records required by this International Standard, andd)documents, including records, determined by the organization to be necessary to ensure the effectiveplanning, operation and control of its processes.SIST EN ISO 9001:2008

ISO9001:2008(E)© ISO2008–All rights reserved3NOTE1Where the term “documented procedure” appears within this International Standard, this means that theprocedure is established, documented, implemented and maintained. A single document may address the requirements forone or more procedures. A requirement for a documented procedure may be covered by more than one document.NOTE2The extent of the quality management system documentation can differ from one organization to another due toa)the size of organization and type of activities,b)the complexity of processes and their interactions, andc)the competence of personnel.NOTE3The documentation can be in any form or type of medium.4.2.2Quality manualThe organization shall establish and maintain a quality manual that includesa)the scope of the quality management system, including details of and justification for any exclusions(see1.2),b)the documented procedures established for the quality management system, or reference to them, andc)a description of the interaction between the processes of the quality management system.4.2.3Control of documentsDocuments required by the quality management system shall be controlled. Records are a special type ofdocument and shall be controlled according to the requirements given in 4.2.4.A documented procedure shall be established to define the controls neededa)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 determined by the organization to be necessary for the planningand operation of the quality management system are identified and their distribution controlled, andg)to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they areretained for any purpose.4.2.4Control of recordsRecords established to provide evidence of conformity to requirements and of the effective operation of thequality management system shall be controlled.The organization shall establish a documented procedure to define the controls needed for the identification,storage, protection, retrieval, retention and disposition of records.Records shall remain legible, readily identifiable and retrievable.5Management responsibility5.1Management commitmentTop management shall provide evidence of its commitment to the development and implementation of thequality management system and continually improving its effectiveness bySIST EN ISO 9001:2008

ISO9001:2008(E)4© ISO2008–All rights reserveda)communicating to the organization the importance of meeting customer as well as statutory and regulatoryrequirements,b)establishing the quality policy,c)ensuring that quality objectives are established,d)conducting management reviews, ande)ensuring the availability of resources.5.2Customer focusTop management shall ensure that customer requirements are determined and are met with the aim ofenhancing customer satisfaction (see7.2.1 and 8.2.1).5.3Quality policyTop management shall ensure that the quality policya)is appropriate to the purpose of the organization,b)includes a commitment to comply with requirements and continually improve the effectiveness of the qualitymanagement system,c)provides a framework for establishing and reviewing quality objectives,d)is communicated and understood within the organization, ande)is reviewed for continuing suitability.5.4Planning5.4.1Quality objectivesTop management shall ensure that quality objectives, including those needed to meet requirements for product[see7.1a)], are established at relevant functions and levels within the organization. The quality objectives shallbe measurable and consistent with the quality policy.5.4.2Quality management system planningTop management shall ensure thata)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, andb)the integrity of the quality management system is maintained when changes to the quality managementsystem are planned and implemented.5.5Responsibility, authority and communication5.5.1Responsibility and authorityTop management shall ensure that responsibilities and authorities are defined and communicated within theorganization.SIST EN ISO 9001:2008

ISO9001:2008(E)© ISO2008–All rights reserved55.5.2Management representativeTop management shall appoint a member of the organization's management who, irrespective of otherresponsibilities, shall have responsibility and authority that includesa)ensuring that processes needed for the quality management system are established, implemented andmaintained,b)reporting to top management on the performance of the quality management system and any need forimprovement, andc)ensuring the promotion of awareness of customer requirements throughout the organization.NOTEThe responsibility of a management representative can include liaison with external parties on matters relating tothe quality management system.5.5.3Internal communicationTop management shall ensure that appropriate communication processes are established within theorganization and that communication takes place regarding the effectiveness of the quality managementsystem.5.6Management review5.6.1GeneralTop management shall review the organization's quality management system, at planned intervals, to ensure itscontinuing suitability, adequacy and effectiveness. This review shall include assessing opportunities forimprovement and the need for changes to the quality management system, including the quality policy andquality objectives.Records from management reviews shall be maintained (see 4.2.4).5.6.2Review inputThe input to management review shall include information ona)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, andg)recommendations for improvement.5.6.3Review outputThe output from the management review shall include any decisions and actions related toa)improvement of the effectiveness of the quality management system and its processes,b)improvement of product related to customer requirements, andc)resource needs.SIST EN ISO 9001:2008

ISO9001:2008(E)6© ISO2008–All rights reserved6Resource management6.1Provision of resourcesThe organization shall determine and provide the resources neededa)to implement and maintain the quality management system and continually improve its effectiveness, andb)to enhance customer satisfaction by meeting customer require

...

SLOVENSKI SIST EN ISO 9001
STANDARD
december 2008
Sistemi vodenja kakovosti – Zahteve (ISO 9001:2008)
Quality management systems – Requirements (ISO 9001:2008)
Systèmes de management de la qualité – Exigences (ISO 9001:2008)
Qualitätsmanagementsysteme – Anforderungen (ISO 9001:2008)
Referenčna oznaka
ICS 03.120.10 SIST EN ISO 9001:2008 (sl, en)
Nadaljevanje na straneh II in od 1 do 61

© 2008-12. Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 9001 : 2008
NACIONALNI UVOD

Standard SIST EN ISO 9001 (sl, en), Sistemi vodenja kakovosti – Zahteve, 2008, ima status

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

systems – Requirements (ISO 9001:2000), 2008.
NACIONALNI PREDGOVOR

Mednarodni standard ISO 9001:2008 je pripravil tehnični odbor Mednarodne organizacije za

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

9001:2008 je prevod angleškega besedila evropskega standarda EN ISO 9001:2008, 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 in dne 17. oktobra 2008 potrdil za izdajo 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:
SIST EN ISO 9000:2005 (sl,en) Sistemi vodenja kakovosti – Osnove in slovar

SIST EN ISO 9004:2004 (sl,en) Sistemi vodenja kakovosti – Smernice za izboljšanje delovanja

SIST EN ISO 14001:2005 (sl,en) Sistemi ravnanja z okoljem – Zahteve z navodili za uporabo

PREDHODNA IZDAJA
– SIST EN ISO 9001:2000 (sl,en)
OSNOVA ZA IZDAJO STANDARDA
– Privzem standarda EN ISO 9001:2008
OPOMBE

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

EN ISO 9001:2008 to pomeni “slovenski” standard.

– 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 9001:2008 (sl,en) prevedeno kot “snovanje in razvoj”.

– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.

– Ta nacionalni dokument je istoveten EN ISO 9001:2008 in je objavljen z dovoljenjem

CEN
Rue de Stassart, 36
1050 Bruxelles
Belgija

– This national document is identical with EN ISO 9001:2008 and is published with the permission of

CEN
Rue de Stassart, 36
1050 Bruxelles
Belgium
---------------------- Page: 2 ----------------------
EVROPSKI STANDARD EN ISO 9001:2008
EUROPEAN STANDARD
EUROPÄISCHE NORM
NORME EUROPÉENNE november 2008
ICS: 03.120.10 Nadomešča EN ISO 9001:2000
Slovenska izdaja
Sistemi vodenja kakovosti ─ Zahteve
(ISO 9001:2008)

Quality management systems Systèmes de management de Qualitätsmanagementsysteme –

– Requirements la qualité – Exigences Anforderungen
(ISO 9001:2008) (ISO 9001:2008) (ISO 9001:2008)
Ta evropski standard je CEN sprejel dne 8. novembra 2008.

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, Bolgarije, Cipra, Češke

republike, Danske, Estonije, Finske, Francije, Grčije, Irske, Islandije, Italije, Latvije, Litve,

Luksemburga, Madžarske, Malte, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Romunije,

Slovaške, Slovenije, 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

© 2008. Lastnice avtorskih pravic so vse države članice CEN Ref. št. EN ISO 9001:2008 E

---------------------- Page: 3 ----------------------
SIST EN ISO 9001 : 2008
Predgovor

Ta dokument (EN ISO 9001:2008) je pripravil tehnični odbor ISO/TC 176 »Vodenje in zagotavljanje

kakovosti«.

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

razglasitvijo najpozneje do maja 2009, nacionalne standarde, ki so v nasprotju s tem standardom, pa

je treba umakniti najpozneje do maja 2009.

Opozoriti je treba na možnost, da je lahko nekaj elementov tega dokumenta predmet patentnih pravic.

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

Ta dokument nadomešča EN ISO 9001:2000.

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

organizacije za standarde naslednjih držav: Avstrije, Belgije, Bolgarije, Cipra, Češke republike,

Danske, Estonije, Finske, Francije, Grčije, Irske, Islandije, Italije, Latvije, Litve, Luksemburga,

Madžarske, Malte, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Romunije, Slovaške,

Slovenije, Španije, Švedske, Švice in Združenega kraljestva.
Razglasitvena objava

Besedilo ISO 9001:2008 je CEN odobril kot EN ISO 9001:2008 brez kakršnihkoli sprememb.

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SIST EN ISO 9001 : 2008
Vsebina Contents

Predgovor.............................................................. 4 Foreword...........................................................4

0 Uvod..............................................................4 0 Introduction................................................4

0.1 Splošno.........................................................4 0.1 General......................................................4

0.2 Procesni pristop............................................5 0.2 Process approach......................................5

0.3 Razmerje do ISO 9004................................. 7 0.3 Relationship with ISO 9004 .......................7

0.4 Združljivost z drugimi sistemi 0.4 Compatibility with other management

vodenja.......................................................... 7 systems ......................................................7

1 Predmet standarda.......................................9 1 Scope.........................................................9

1.1 Splošno.........................................................9 1.1 General......................................................9

1.2 Uporaba........................................................9 1.2 Application.................................................9

2 Zveza z drugimi standardi ............................ 9 2 Normative reference..................................9

3 Izrazi in definicije......................................... 10 3 Terms and definitions ..............................10

4 Sistem vodenja kakovosti...........................10 4 Quality management system...................10

4.1 Splošne zahteve.........................................10 4.1 General requirements..............................10

4.2 Zahteve glede dokumentacije....................11 4.2 Documentation requirements..................11

5 Odgovornost vodstva..................................13 5 Management responsibility......................13

5.1 Zavezanost vodstva....................................13 5.1 Management commitment.......................13

5.2 Osredotočenost na odjemalce ................... 13 5.2 Customer focus.......................................13

5.3 Politika kakovosti........................................13 5.3 Quality policy ...........................................13

5.4 Planiranje....................................................13 5.4 Planning...................................................13

5.5 Odgovornosti, pooblastila in 5.5 Responsibility, authority and

komuniciranje.............................................. 14 communication ........................................14

5.6 Vodstveni pregled.......................................15 5.6 Management review ................................15

6 Vodenje virov..............................................15 6 Resource management ...........................15

6.1 Priskrba virov..............................................15 6.1 Provision of resources.............................15

6.2 Človeški viri ................................................. 16 6.2 Human resources....................................16

6.3 Infrastruktura...............................................16 6.3 Infrastructure ...........................................16

6.4 Delovno okolje............................................16 6.4 Work environment ...................................16

7 Realizacija proizvoda..................................17 7 Product realization...................................17

7.1 Planiranje realizacije proizvoda.................. 17 7.1 Planning of product realization ................17

7.2 Procesi, povezani z odjemalci.................... 17 7.2 Customer-related processes...................17

7.3 Snovanje in razvoj.......................................19 7.3 Design and development.........................19

7.4 Nabava........................................................21 7.4 Purchasing...............................................21

7.5 Proizvodnja in izvedba storitev................... 22 7.5 Production and service provision ............22

7.6 Obvladovanje nadzorne in merilne 7.6 Control of monitoring and measuring

opreme ........................................................ 23 equipment................................................23

8 Merjenje, analize in 8 Measurement, analysis and

izboljševanje................................................ 24 improvement............................................24

8.1 Splošno.......................................................24 8.1 General....................................................24

8.2 Nadzorovanje in merjenje...........................25 8.2 Monitoring and measurement..................25

8.3 Obvladovanje neskladnih proizvodov ........ 26 8.3 Control of nonconforming product...........26

8.4 Analiza podatkov.........................................27 8.4 Analysis of data .......................................27

8.5 Izboljševanje...............................................27 8.5 Improvement................................................27

Dodatek A............................................................ 30 Annex A ...............................................................31

Dodatek B............................................................ 40 Annex B ...............................................................41

Bibliografija.......................................................... 60 Bibliography .........................................................61

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SIST EN ISO 9001 : 2008
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

pravili, podanimi v Direktivah ISO/IEC, 2. del. accordance with the rules given in the ISO/IEC

Directives, Part 2.

Glavna naloga tehničnih odborov je priprava The main task of technical committees is to

mednarodnih standardov. Osnutki mednarodnih prepare International Standards. Draft

standardov, ki jih sprejmejo tehnični odbori, se International Standards adopted by the technical

pošljejo vsem članom v glasovanje. Za objavo committees are circulated to the member bodies

mednarodnega standarda je treba pridobiti for voting. Publication as an International

soglasje najmanj 75 odstotkov članov, ki se Standard requires approval by at least 75 % of the

udeležijo glasovanja. 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 dokumenta predmet patentnih the elements of this document may be the subject

pravic. ISO ne prevzema odgovornosti za of patent rights. ISO shall not be held responsible

identifikacijo katerihkoli ali vseh takih patentnih for identifying any or all such patent rights.

pravic.

ISO 9001 je pripravil tehnični odbor ISO/TC 176 ISO 9001 was prepared by Technical Committee

Vodenje in zagotavljanje kakovosti, pododbor ISO/TC 176, Quality management and quality

SC2 Sistemi kakovosti. assurance, Subcommittee SC 2, Quality systems.

Ta četrta izdaja razveljavlja in nadomešča tretjo This fourth edition cancels and replaces the

izdajo (ISO 9001:2000), ki je bila dopolnjena z third edition (ISO 9001:2000), which has been

namenom večje razumljivosti besedila in amended to clarify points in the text and to

povečanja usklajenosti z ISO 14001:2004. enhance compatibility with ISO 14001:2004.

Podrobnosti o spremembah med tretjo izdajo in Details of the changes between the third edition

to četrto izdajo so podane v dodatku B. and this fourth edition are given in Annex B.

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 an

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

organizacije vplivajo: an organization's quality management system is
influenced by:

a) njeno organizacijsko okolje, spremembe v a) its organizational environment, changes in

tem okolju in tveganja v povezavi s tem that environment, and the risks associated

okoljem, with that environment,
---------------------- Page: 6 ----------------------
SIST EN ISO 9001 : 2008
b) njene spreminjajoče se potrebe, b) its varying needs,
c) njeni posebni cilji, c) its particular objectives,
d) proizvodi, ki jih ponuja, d) the products it provides,
e) procesi, ki jih izvaja, e) the processes it employs,

f) njena velikost in organizacijska struktura. f) its size and organizational structure.

Namen tega mednarodnega standarda ni, da bi It is not the intent of this International Standard

zahteval enotno strukturo sistemov vodenja to imply uniformity in the structure of quality

kakovosti ali poenotenost dokumentacije. 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, comple-mentary 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 certification

certifikacijskimi organi, za ocenjevanje bodies, to assess the organization's ability to meet

sposobnosti organizacije glede izpolnjevanja customer, statutory and regulatory requirements

zahtev odjemalcev, zakonodaje in regulative, ki applicable to the product, and the organization's

se nanašajo na proizvod, in zahtev, ki si jih own requirements.
postavi organizacija sama.

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 the 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 effectiveness of a quality management system,

izpolnjevanjem zahtev odjemalcev povečalo to enhance customer satisfacion by meeting

njihovo zadovoljstvo. customer requirements.

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

opredeliti in voditi številne povezane aktivnosti. has to determine and manage numerous

Aktivnost ali skupek aktivnosti, ki uporabljajo linked activities. An activity or set of activities

vire in ki se vodijo z namenom, da omogočijo using resources, and managed in order to

spremembo vhodov v izhode, se lahko enable the transformation of inputs into

obravnava kot proces. Izhod enega procesa outputs, can be considered as a process.

pogosto tvori vhod v drugi proces. Often the output from one process 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 z namenom ustvariti and interactions of these processes, and their

želeni rezultat, lahko poimenujemo “procesni management to produce the desired outcome,

pristop“. can be referred to as the “process approach“.

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

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SIST EN ISO 9001 : 2008

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 The model of a process-based quality
kakovosti, ki je osnovan na procesih. Model management system shown in Figure 1

ponazarja procesne povezave, kot so illustrates the process linkages presented in

predstavljene v točkah od 4 do 8. Slika clauses 4 to 8. This illustration shows that

prikazuje, da imajo odjemalci pomembno vlogo customers play a significant role in defining

pri določanju vhodnih zahtev. Spremljanje requirements as inputs. Monitoring of customer

zadovoljstva odjemalca zahteva ocenjevanje satisfaction requires the evaluation of

informacij o njegovem zaznavanju, ali je information relating to customer perception as

organizacija izpolnila njegove zahteve. Model, to whether the organization has met the

prikazan na sliki 1, pokriva vse zahteve tega customer requirements. The model shown in

mednarodnega standarda, vendar ne prikazuje Figure 1 covers all the requirements of this

procesov podrobneje. 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). PDCA to all processes. PDCA can be briefly

lahko na kratko opišemo na spodaj navedeni described as follows.
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 requirements

o rezultatih. 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 : 2008
Nenehno izboljševanje
Continual improvement of the
Nenehno izboljševanje
Continual improvement of the
sistema vodenja kakovosti quality management system
sistema vodenja kakovosti quality management system
Management
Odgovornost
Management
Odgovornost
vodstva responsibility
responsibility
vodstva
Odjemalec Odjemalec Customer Customer
Measurement
Merjenje,
Measurement
Merjenje,
Resource
Resource
Vodenje virov analize in Zadovoljstvo analysis and
Satisfaction
analysis and
Vodenje virov analize in
management
management
izboljševanje improvement
improvement
izboljševanje
Vhod Izhod
Realizacija Input Output
Product
Realizacija
Zahteve Proizvod Product
Requirements Product
proizvoda
realization
proizvoda
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
ISO 9001 in ISO 9004 sta standarda za sistem ISO 9001 and ISO 9004 are quality

vodenja kakovosti, ki sta bila razvita tako, da management system standards which have

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

uporabljata tudi samostojno. can also be used independently.

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.

V času izdaje tega mednarodnega standarda je At the time of publication of this International

bil ISO 9004 v postopku prenove. Prenovljena Standard, ISO 9004 is under revision. The revised

izdaja ISO 9004 bo podajala navodila vodstvom edition of ISO 9004 will provide guidance to

katerekoli organizacije v kompleksnem, management for achieving sustained success for

zahtevnem in nenehno spreminjajočem se okolju any organization in a complex, demanding, and

za doseganje trajnega uspeha. ISO 9004 podaja ever changing, environment. ISO 9004 provides a

širši pogled na vodenje kakovosti kot ISO 9001; wider focus on quality management than

usmerja se na potrebe in pričakovanja vseh ISO 9001; it addresses the needs and

zainteresiranih strani in njihovega zadovoljstva s expectations of all interested parties and their

sistematičnim in nenehnim izboljševanjem satisfaction, by the systematic and continual

delovanja organizacije. Vendar pa ni namenjen improvement of the organization’s performance.

za certificiranje ali uporabo v zakonodaji ali However, it is not intended for certification,

pogodbenih odnosih. regulatory or contractual use.

0.4 Združljivost z drugimi sistemi vodenja 0.4 Compatibility with other management

systems

Pri pripravi tega mednarodnega standarda je During the development of this International

bila pozornost namenjena določilom Standard, due consideration was given to the

ISO 14001:2004, da bi v korist uporabnikov provisions of ISO 14001:2004 to enhance the

dosegli usklajenost obeh standardov. Dodatek compatibility of the two standards for the benefit of

A prikazuje primerjavo med ISO 9001:2008 in the user community. Annex A shows the

ISO 14001:2004. correspondence between ISO 9001:2008 and
ISO 14001:2004.
---------------------- Page: 9 ----------------------
SIST EN ISO 9001 : 2008

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.
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SIST EN ISO 9001 : 2008
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
dosledno dobavlja proizvode, ki consistently provide product that meets
izpolnjujejo zahteve odjemalcev in zahteve customer and applicable statutory and
ustrezne zakonodaje in regulative, in regulatory requirements, and

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 improvement of the system and the
odjemalcev in ustreznimi zahtevami assurance of conformity to customer and
zakonodaje in regulative. applicable statutory and regulatory
requirements.

OPOMBA 1: V tem mednarodnem standardu se izraz NOTE 1 In this International Standard, the term

»proizvod« nanaša samo na »product« only applies to
a) proizvod, ki je namenjen odjemalcu a) product intended for, or required by, a
ali ki ga odjemalec zahteva, customer
b) vsak namerni izhod kot rezultat b) any intended output resulting from
procesa realizacije proizvoda. product realization processes.

OPOMBA 2: Zahteve zakonodaje in regulative so lahko NOTE 2 Statutory and regulatory requirements can

izražene kot pravne zahteve. be expressed as legal requirements.
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.

Kjer se zahteva(-e) tega mednarodnega Where any requirement(s) of this International

standarda ne more(-jo) uporabiti za
...

Questions, Comments and Discussion

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