EN ISO 9001:2015
(Main)Quality management systems - Requirements (ISO 9001:2015)
Quality management systems - Requirements (ISO 9001:2015)
ISO 9001:2015 specifies requirements for a quality management system when an organization:
a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
Qualitätsmanagementsysteme - Anforderungen (ISO 9001:2015)
Systèmes de management de la qualité - Exigences (ISO 9001:2015, Version corrigée 2015-09-15)
L'ISO 9001:2015 spécifie les exigences relatives au système de management de la qualité lorsqu'un organisme:
a) doit démontrer son aptitude à fournir constamment des produits et des services conformes aux exigences des clients et aux exigences légales et réglementaires applicables, et
b) vise à accroître la satisfaction de ses clients par l'application efficace du système, y compris les processus pour l'amélioration 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 9001:2015 sont génériques et prévues pour s'appliquer à tout organisme, quels que soient son type ou sa taille, ou les produits et services qu'il fournit.
Sistemi vodenja kakovosti - Zahteve (ISO 9001:2015)
Ta mednarodni standard določa zahteve za sistem vodenja kakovosti, kadar organizacija:
a) mora dokazati svojo zmožnost, da dosledno zagotavlja izdelke ali storitve, ki izpolnjujejo zahteve odjemalcev ter veljavne zahteve zakonodaje in regulative, in
b) želi izboljšati zadovoljstvo odjemalcev z uspešno uporabo sistema, vključno s procesi za izboljševanje sistema in z zagotavljanjem skladnosti z zahtevami odjemalcev ter veljavnimi zahtevami zakonodaje in regulative.
Vse zahteve tega mednarodnega standarda so splošne in naj bi veljale za vse organizacije ne glede na njihovo vrsto, velikost in izdelek ali storitev, ki ju zagotavljajo.
OPOMBA 1: Izraza "izdelek" ali "storitev" se v tem mednarodnem standardu nanašata samo na izdelke in storitve, ki so namenjeni odjemalcu oziroma ki jih odjemalec zahteva.
OPOMBA 2: Zahteve zakonodaje in regulative se lahko izrazijo kot zakonske zahteve.
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SLOVENSKI STANDARD
SIST EN ISO 9001:2015
01-oktober-2015
1DGRPHãþD
SIST EN ISO 9001:2008
SIST EN ISO 9001:2008/AC:2009
Sistemi vodenja kakovosti - Zahteve (ISO 9001:2015)
Quality management systems - Requirements (ISO 9001:2015)
Qualitätsmanagementsysteme - Anforderungen (ISO 9001:2015)
Systèmes de management de la qualité - Exigences (ISO 9001:2015)
Ta slovenski standard je istoveten z: EN ISO 9001:2015
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
SIST EN ISO 9001:2015 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 9001:2015
EN ISO 9001
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2015
EUROPÄISCHE NORM
ICS 03.120.10 Supersedes EN ISO 9001:2008
English Version
Quality management systems - Requirements (ISO
9001:2015)
Systèmes de management de la qualité - Exigences (ISO Qualitätsmanagementsysteme - Anforderungen (ISO
9001:2015) 9001:2015)This European Standard was approved by CEN on 14 September 2015.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC 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
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9001:2015 E
worldwide for CEN national Members.---------------------- Page: 3 ----------------------
SIST EN ISO 9001:2015
EN ISO 9001:2015 (E)
Contents Page
European foreword ....................................................................................................................................................... 3
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EN ISO 9001:2015 (E)
European foreword
This document (EN ISO 9001:2015) 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 March 2016, and conflicting national standards shall
be withdrawn at the latest by March 2016.Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.This document supersedes EN ISO 9001:2008.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.Endorsement notice
The text of ISO 9001:2015 has been approved by CEN as EN ISO 9001:2015 without any modification.
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SIST EN ISO 9001:2015
INTERNATIONAL ISO
STANDARD 9001
Fifth edition
2015-09-15
Quality management systems —
Requirements
Systèmes de management de la qualité — Exigences
Reference number
ISO 9001:2015(E)
ISO 2015
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SIST EN ISO 9001:2015
ISO 9001:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
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copyright@iso.org
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ii © ISO 2015 – All rights reserved
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SIST EN ISO 9001:2015
ISO 9001:2015(E)
Contents Page
Foreword ..........................................................................................................................................................................................................................................v
Introduction ................................................................................................................................................................................................................................vi
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 1
3 Terms and definitions ..................................................................................................................................................................................... 1
4 Context of the organization ....................................................................................................................................................................... 1
4.1 Understanding the organization and its context ....................................................................................................... 1
4.2 Understanding the needs and expectations of interested parties .............................................................. 2
4.3 Determining the scope of the quality management system ............................................................................. 2
4.4 Quality management system and its processes .......................................................................................................... 2
5 Leadership .................................................................................................................................................................................................................. 3
5.1 Leadership and commitment ..................................................................................................................................................... 3
5.1.1 General...................................................................................................................................................................................... 3
5.1.2 Customer focus .................................................................................................................................................................. 3
5.2 Policy ............................................................................................................................................................................................................... 4
5.2.1 Establishing the quality policy ............................................................................................................................. 4
5.2.2 Communicating the quality policy .................................................................................................................... 4
5.3 Organizational roles, responsibilities and authorities.......................................................................................... 4
6 Planning ......................................................................................................................................................................................................................... 4
6.1 Actions to address risks and opportunities ................................................................................................................... 4
6.2 Quality objectives and planning to achieve them ...................................................................................................... 5
6.3 Planning of changes ............................................................................................................................................................................ 5
7 Support ........................................................................................................................................................................................................................... 6
7.1 Resources ..................................................................................................................................................................................................... 6
7.1.1 General...................................................................................................................................................................................... 6
7.1.2 People ........................................................................................................................................................................................ 6
7.1.3 Infrastructure ..................................................................................................................................................................... 6
7.1.4 Environment for the operation of processes ........................................................................................... 6
7.1.5 Monitoring and measuring resources ........................................................................................................... 7
7.1.6 Organizational knowledge ....................................................................................................................................... 7
7.2 Competence ............................................................................................................................................................................................... 8
7.3 Awareness ................................................................................................................................................................................................... 8
7.4 Communication ...................................................................................................................................................................................... 8
7.5 Documented information ............................................................................................................................................................... 8
7.5.1 General...................................................................................................................................................................................... 8
7.5.2 Creating and updating ................................................................................................................................................. 9
7.5.3 Control of documented information ............................................................................................................... 9
8 Operation ..................................................................................................................................................................................................................... 9
8.1 Operational planning and control .......................................................................................................................................... 9
8.2 Requirements for products and services ......................................................................................................................10
8.2.1 Customer communication .....................................................................................................................................10
8.2.2 Determining the requirements for products and services .......................................................10
8.2.3 Review of the requirements for products and services ..............................................................10
8.2.4 Changes to requirements for products and services .....................................................................11
8.3 Design and development of products and services ..............................................................................................11
8.3.1 General...................................................................................................................................................................................11
8.3.2 Design and development planning ................................................................................................................11
8.3.3 Design and development inputs ......................................................................................................................11
8.3.4 Design and development controls .................................................................................................................12
8.3.5 Design and development outputs ..................................................................................................................12
8.3.6 Design and development changes .................. ................................................................................................12
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ISO 9001:2015(E)
8.4 Control of externally provided processes, products and services ...........................................................13
8.4.1 General...................................................................................................................................................................................13
8.4.2 Type and extent of control ....................................................................................................................................13
8.4.3 Information for external providers ...............................................................................................................13
8.5 Production and service provision ........................................................................................................................................14
8.5.1 Control of production and service provision ........................................................................................14
8.5.2 Identification and traceability ...........................................................................................................................14
8.5.3 Property belonging to customers or external providers ............................................................15
8.5.4 Preservation ......................................................................................................................................................................15
8.5.5 Post-delivery activities ............................................................................................................................................15
8.5.6 Control of changes .......................................................................................................................................................15
8.6 Release of products and services .........................................................................................................................................15
8.7 Control of nonconforming outputs .....................................................................................................................................16
9 Performance evaluation ............................................................................................................................................................................16
9.1 Monitoring, measurement, analysis and evaluation ............................................................................................16
9.1.1 General...................................................................................................................................................................................16
9.1.2 Customer satisfaction ...............................................................................................................................................17
9.1.3 Analysis and evaluation ..........................................................................................................................................17
9.2 Internal audit .........................................................................................................................................................................................17
9.3 Management review ........................................................................................................................................................................18
9.3.1 General...................................................................................................................................................................................18
9.3.2 Management review inputs .................................................................................................................................18
9.3.3 Management review outputs .............................................................................................................................18
10 Improvement .........................................................................................................................................................................................................19
10.1 General ........................................................................................................................................................................................................19
10.2 Nonconformity and corrective action ..............................................................................................................................19
10.3 Continual improvement ...............................................................................................................................................................19
Annex A (informative) Clarification of new structure, terminology and concepts ............................................21
Annex B (informative) Other International Standards on quality management and quality
management systems developed by ISO/TC 176 .............................................................................................................25
Bibliography .............................................................................................................................................................................................................................28
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SIST EN ISO 9001:2015
ISO 9001:2015(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.The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is Technical Committee ISO/TC 176, Quality management
and quality assurance, Subcommittee SC 2, Quality systems.This fifth edition cancels and replaces the fourth edition (ISO 9001:2008), which has been technically
revised, through the adoption of a revised clause sequence and the adaptation of the revised quality
management principles and of new concepts. It also cancels and replaces the Technical Corrigendum
ISO 9001:2008/Cor.1:2009.© ISO 2015 – All rights reserved v
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SIST EN ISO 9001:2015
ISO 9001:2015(E)
Introduction
0.1 General
The adoption of a quality management system is a strategic decision for an organization that can help
to improve its overall performance and provide a sound basis for sustainable development initiatives.
The potential benefits to an organization of implementing a quality management system based on this
International Standard are:a) the ability to consistently provide products and services that meet customer and applicable
statutory and regulatory requirements;b) facilitating opportunities to enhance customer satisfaction;
c) addressing risks and opportunities associated with its context and objectives;
d) the ability to demonstrate conformity to specified quality management system requirements.
This International Standard can be used by internal and external parties.It is not the intent of this International Standard to imply the need for:
— uniformity in the structure of different quality management systems;
— alignment of documentation to the clause structure of this International Standard;
— the use of the specific terminology of this International Standard within the organization.
The quality management system requirements specified in this International Standard are
complementary to requirements for products and services.This International Standard employs the process approach, which incorporates the Plan-Do-Check-Act
(PDCA) cycle and risk-based thinking.The process approach enables an organization to plan its processes and their interactions.
The PDCA cycle enables an organization to ensure that its processes are adequately resourced and
managed, and that opportunities for improvement are determined and acted on.Risk-based thinking enables an organization to determine the factors that could cause its processes and
its quality management system to deviate from the planned results, to put in place preventive controls
to minimize negative effects and to make maximum use of opportunities as they arise (see Clause A.4).
Consistently meeting requirements and addressing future needs and expectations poses a challenge
for organizations in an increasingly dynamic and complex environment. To achieve this objective, the
organization might find it necessary to adopt various forms of improvement in addition to correction
and continual improvement, such as breakthrough change, innovation and re-organization.
In this International Standard, the following verbal forms are used:— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement.
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SIST EN ISO 9001:2015
ISO 9001:2015(E)
0.2 Quality management principles
This International Standard is based on the quality management principles described in ISO 9000. The
descriptions include a statement of each principle, a rationale of why the principle is important for the
organization, some examples of benefits associated with the principle and examples of typical actions
to improve the organization’s performance when applying the principle.The quality management principles are:
— customer focus;
— leadership;
— engagement of people;
— process approach;
— improvement;
— evidence-based decision making;
— relationship management.
0.3 Process approach
0.3.1 General
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. Specific requirements considered essential to the
adoption of a process approach are included in 4.4.Understanding and managing interrelated processes as a system contributes to the organization’s
effectiveness and efficiency in achieving its intended results. This approach enables the organization
to control the interrelationships and interdependencies among the processes of the system, so that the
overall performance of the organization can be enhanced.The process approach involves the systematic definition and management of processes, and their
interactions, so as to achieve the intended results in accordance with the quality policy and strategic
direction of the organization. Management of the processes and the system as a whole can be achieved
using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking
advantage of opportunities and preventing undesirable results.The application of the process approach in a quality management system enables:
a) understanding and consistency in meeting requirements;
b) the consideration of processes in terms of added value;
c) the achievement of effective process performance;
d) improvement of processes based on evaluation of data and information.
Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The
monitoring and measuring check points, which are necessary for control, are specific to each process
and will vary depending on the related risks.© ISO 2015 – All rights reserved vii
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SIST EN ISO 9001:2015
ISO 9001:2015(E)
Figure 1 — Schematic representation of the elements of a single process
0.3.2 Plan-Do-Check-Act cycle
The PDCA cycle can be applied to all processes and to the quality management system as a whole.
Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle.
NOTE Numbers in brackets refer to the clauses in this International Standard.Figure 2 — Representation of the structure of this International Standard in the PDCA cycle
viii © ISO 2015 – All rights reserved---------------------- Page: 14 ----------------------
SIST EN ISO 9001:2015
ISO 9001:2015(E)
The PDCA cycle can be briefly described as follows:
— Plan: establish the objectives of the system and its processes, and the resources needed to deliver
results in accordance with customers’ requirements and the organization’s policies, and identify
and address risks and opportunities;— Do: implement what was planned;
— Check: monitor and (where applicable) measure processes and the resulting products and services
against policies, objectives, requirements and planned activities, and report the results;
— Act: take actions to improve performance, as necessary.0.3.3 Risk-based thinking
Risk-based thinking (see Clause A.4) is essential for achieving an effective quality management system.
The concept of risk-based thinking has been implicit in previous editions of this International Standard
including, for example, carrying out preventive action to eliminate potential nonconformities, analysing
any nonconformities that do occur, and taking action...
SLOVENSKI STANDARD
SIST EN ISO 9001:2015
01-oktober-2015
Nadomešča:
SIST EN ISO 9001:2008
SIST EN ISO 9001:2008/AC:2009
Sistemi vodenja kakovosti - Zahteve (ISO 9001:2015)
Quality management systems - Requirements (ISO 9001:2015)
Qualitätsmanagementsysteme - Anforderungen (ISO 9001:2015)
Systèmes de management de la qualité - Exigences (ISO 9001:2015)
Ta slovenski standard je istoveten z: EN ISO 9001:2015
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
SIST EN ISO 9001:2015 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 9001:2015
EN ISO 9001
EUROPÄISCHE NORM
EUROPEAN STANDARD
September 2015
NORME EUROPÉENNE
ICS 03.120.10 Ersatz für EN ISO 9001:2008
Deutsche Fassung
Qualitätsmanagementsysteme - Anforderungen (ISO
9001:2015)
Quality management systems - Requirements (ISO Systèmes de management de la qualité - Exigences (ISO
9001:2015) 9001:2015, Version corrigée 2015-09-15)Diese Europäische Norm wurde vom CEN am 14. September 2015 angenommen.
Die CEN-Mitglieder sind gehalten, die CEN/CENELEC-Geschäftsordnung zu erfüllen, in der die Bedingungen festgelegt sind, unter
denen dieser Europäischen Norm ohne jede Änderung der Status einer nationalen Norm zu geben ist. Auf dem letzten Stand
befindliche Listen dieser nationalen Normen mit ihren bibliographischen Angaben sind beim Management-Zentrum des CEN-
CENELEC oder bei jedem CEN-Mitglied auf Anfrage erhältlich.Diese Europäische Norm besteht in drei offiziellen Fassungen (Deutsch, Englisch, Französisch). Eine Fassung in einer anderen
Sprache, die von einem CEN-Mitglied in eigener Verantwortung durch Übersetzung in seine Landessprache gemacht und dem
Management-Zentrum mitgeteilt worden ist, hat den gleichen Status wie die offiziellen Fassungen.
CEN-Mitglieder sind die nationalen Normungsinstitute von Belgien, Bulgarien, Dänemark, Deutschland, der ehemaligen
jugoslawischen Republik Mazedonien, Estland, Finnland, Frankreich, Griechenland, Irland, Island, Italien, Kroatien, Lettland,
Litauen, Luxemburg, Malta, den Niederlanden, Norwegen, Österreich, Polen, Portugal, Rumänien, Schweden, der Schweiz, der
Slowakei, Slowenien, Spanien, der Tschechischen Republik, der Türkei, Ungarn, dem Vereinigten Königreich und Zypern.
EUROPÄISCHES KOMITEE FÜR NORMUNGEUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
CEN-CENELEC Management-Zentrum: Avenue Marnix 17, B-1000 Brüssel
© 2015 CEN Alle Rechte der Verwertung, gleich in welcher Form und in welchem Ref. Nr. EN ISO 9001:2015 D
Verfahren, sind weltweit den nationalen Mitgliedern von CENvorbehalten.
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SIST EN ISO 9001:2015
EN ISO 9001:2015 (D)
Inhalt
Seite
Europäisches Vorwort .......................................................................................................................................................... 4
Vorwort ...................................................................................................................................................................................... 5
Einleitung .................................................................................................................................................................................. 6
1 Anwendungsbereich ............................................................................................................................................. 11
2 Normative Verweisungen ................................................................................................................................... 11
3 Begriffe ...................................................................................................................................................................... 11
4 Kontext der Organisation ................................................................................................................................... 11
4.1 Verstehen der Organisation und ihres Kontextes ..................................................................................... 11
4.2 Verstehen der Erfordernisse und Erwartungen interessierter Parteien ......................................... 12
4.3 Festlegen des Anwendungsbereichs des Qualitätsmanagementsystems ......................................... 12
4.4 Qualitätsmanagementsystem und seine Prozesse .................................................................................... 12
5 Führung ..................................................................................................................................................................... 13
5.1 Führung und Verpflichtung................................................................................................................................ 13
5.1.1 Allgemeines ............................................................................................................................................................. 13
5.1.2 Kundenorientierung ............................................................................................................................................. 14
5.2 Politik ......................................................................................................................................................................... 14
5.2.1 Festlegung der Qualitätspolitik ........................................................................................................................ 14
5.2.2 Bekanntmachung der Qualitätspolitik .......................................................................................................... 14
5.3 Rollen, Verantwortlichkeiten und Befugnisse in der Organisation .................................................... 14
6 Planung ...................................................................................................................................................................... 15
6.1 Maßnahmen zum Umgang mit Risiken und Chancen ............................................................................... 15
6.2 Qualitätsziele und Planung zu deren Erreichung ...................................................................................... 15
6.3 Planung von Änderungen ................................................................................................................................... 16
7 Unterstützung ......................................................................................................................................................... 16
7.1 Ressourcen ............................................................................................................................................................... 16
7.1.1 Allgemeines ............................................................................................................................................................. 16
7.1.2 Personen ................................................................................................................................................................... 16
7.1.3 Infrastruktur ........................................................................................................................................................... 17
7.1.4 Prozessumgebung ................................................................................................................................................. 17
7.1.5 Ressourcen zur Überwachung und Messung ............................................................................................... 17
7.1.6 Wissen der Organisation ..................................................................................................................................... 18
7.2 Kompetenz ............................................................................................................................................................... 18
7.3 Bewusstsein ............................................................................................................................................................. 18
7.4 Kommunikation ..................................................................................................................................................... 19
7.5 Dokumentierte Information .............................................................................................................................. 19
7.5.1 Allgemeines ............................................................................................................................................................. 19
7.5.2 Erstellen und Aktualisieren ............................................................................................................................... 19
7.5.3 Lenkung dokumentierter Information .......................................................................................................... 20
8 Betrieb ....................................................................................................................................................................... 20
8.1 Betriebliche Planung und Steuerung ............................................................................................................. 20
8.2 Anforderungen an Produkte und Dienstleistungen.................................................................................. 21
8.2.1 Kommunikation mit den Kunden .................................................................................................................... 21
8.2.2 Bestimmen von Anforderungen für Produkte und Dienstleistungen ................................................ 21
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8.2.3 Überprüfung der Anforderungen für Produkte und Dienstleistungen ............................................. 21
8.2.4 Änderungen von Anforderungen an Produkte und Dienstleistungen ............................................... 22
8.3 Entwicklung von Produkten und Dienstleistungen .................................................................................. 22
8.3.1 Allgemeines ............................................................................................................................................................. 22
8.3.2 Entwicklungsplanung .......................................................................................................................................... 22
8.3.3 Entwicklungseingaben ........................................................................................................................................ 23
8.3.4 Steuerungsmaßnahmen für die Entwicklung ............................................................................................. 23
8.3.5 Entwicklungsergebnisse ..................................................................................................................................... 23
8.3.6 Entwicklungsänderungen .................................................................................................................................. 24
8.4 Steuerung von extern bereitgestellten Prozessen, Produkten und Dienstleistungen ................. 24
8.4.1 Allgemeines ............................................................................................................................................................. 24
8.4.2 Art und Umfang der Steuerung ......................................................................................................................... 24
8.4.3 Informationen für externe Anbieter .............................................................................................................. 25
8.5 Produktion und Dienstleistungserbringung ............................................................................................... 25
8.5.1 Steuerung der Produktion und der Dienstleistungserbringung .......................................................... 25
8.5.2 Kennzeichnung und Rückverfolgbarkeit ...................................................................................................... 26
8.5.3 Eigentum der Kunden oder der externen Anbieter .................................................................................. 26
8.5.4 Erhaltung .................................................................................................................................................................. 26
8.5.5 Tätigkeiten nach der Lieferung ........................................................................................................................ 27
8.5.6 Überwachung von Änderungen ........................................................................................................................ 27
8.6 Freigabe von Produkten und Dienstleistungen ......................................................................................... 27
8.7 Steuerung nichtkonformer Ergebnisse ......................................................................................................... 27
9 Bewertung der Leistung ...................................................................................................................................... 28
9.1 Überwachung, Messung, Analyse und Bewertung ..................................................................................... 28
9.1.1 Allgemeines ............................................................................................................................................................. 28
9.1.2 Kundenzufriedenheit ........................................................................................................................................... 28
9.1.3 Analyse und Bewertung ...................................................................................................................................... 29
9.2 Internes Audit ......................................................................................................................................................... 29
9.3 Managementbewertung ...................................................................................................................................... 30
9.3.1 Allgemeines ............................................................................................................................................................. 30
9.3.2 Eingaben für die Managementbewertung .................................................................................................... 30
9.3.3 Ergebnisse der Managementbewertung ....................................................................................................... 30
10 Verbesserung .......................................................................................................................................................... 31
10.1 Allgemeines ............................................................................................................................................................. 31
10.2 Nichtkonformität und Korrekturmaßnahmen ........................................................................................... 31
10.3 Fortlaufende Verbesserung ............................................................................................................................... 32
Anhang A (informativ) Erläuterung der neuen Struktur, Terminologie und Konzepte ............................ 33
Anhang B (informativ) Andere Internationale Normen des ISO/TC 176 zu Qualitätsmanagement
und Qualitätsmanagementsystemen ............................................................................................................. 37
Literaturhinweise................................................................................................................................................................. 41
---------------------- Page: 5 ----------------------SIST EN ISO 9001:2015
EN ISO 9001:2015 (D)
Europäisches Vorwort
Dieses Dokument (EN ISO 9001:2015) wurde vom Technischen Komitee ISO/TC 176 „Quality management
and quality assurance“ erarbeitet.Diese Europäische Norm muss den Status einer nationalen Norm erhalten, entweder durch Veröffentlichung
eines identischen Textes oder durch Anerkennung bis März 2016, und etwaige entgegenstehende nationale
Normen müssen bis März 2016 zurückgezogen werden.Es wird auf die Möglichkeit hingewiesen, dass einige Elemente dieses Dokuments Patentrechte berühren
können. CEN [und/oder CENELEC] sind nicht dafür verantwortlich, einige oder alle diesbezüglichen
Patentrechte zu identifizieren.Dieses Dokument ersetzt EN ISO 9001:2008.
Dieses Dokument wurde unter einem Mandat erarbeitet, das die Europäische Kommission und die
Europäische Freihandelszone dem CEN erteilt haben, und unterstützt grundlegende Anforderungen der EU-
Richtlinien.Entsprechend der CEN-CENELEC-Geschäftsordnung sind die nationalen Normungsinstitute der folgenden
Länder gehalten, diese Europäische Norm zu übernehmen: Belgien, Bulgarien, Dänemark, Deutschland, die
ehemalige jugoslawische Republik Mazedonien, Estland, Finnland, Frankreich, Griechenland, Irland, Island,
Italien, Kroatien, Lettland, Litauen, Luxemburg, Malta, Niederlande, Norwegen, Österreich, Polen, Portugal,
Rumänien, Schweden, Schweiz, Slowakei, Slowenien, Spanien, Tschechische Republik, Türkei, Ungarn,
Vereinigtes Königreich und Zypern.Anerkennungsnotiz
Der Text von ISO 9001:2015 wurde vom CEN als EN ISO 9001:2015 ohne irgendeine Abänderung genehmigt.
---------------------- Page: 6 ----------------------SIST EN ISO 9001:2015
EN ISO 9001:2015 (D)
Vorwort
ISO (die Internationale Organisation für Normung) ist eine weltweite Vereinigung von Nationalen
Normungsorganisationen (ISO-Mitgliedsorganisationen). Die Erstellung von Internationalen Normen wird
normalerweise von ISO Technischen Komitees durchgeführt. Jede Mitgliedsorganisation, die Interesse an
einem Thema hat, für welches ein Technisches Komitee gegründet wurde, hat das Recht, in diesem Komitee
vertreten zu sein. Internationale Organisationen, staatlich und nicht-staatlich, in Liaison mit ISO, nehmen
ebenfalls an der Arbeit teil. ISO arbeitet eng mit der Internationalen Elektrotechnischen Kommission (IEC)
bei allen elektrotechnischen Themen zusammen.Die Verfahren, die bei der Entwicklung dieses Dokuments angewendet wurden und die für die weitere Pflege
vorgesehen sind, werden in den ISO/IEC-Direktiven, Teil 1 beschrieben. Im Besonderen sollten die für die
verschiedenen ISO-Dokumentenarten notwendigen Annahmekriterien beachtet werden. Dieses Dokument
wurde in Übereinstimmung mit den Gestaltungsregeln der ISO/IEC-Direktiven, Teil 2 erarbeitet (siehe
www.iso.org/directives).Es wird auf die Möglichkeit hingewiesen, dass einige Elemente dieses Dokuments Patentrechte berühren
können. ISO ist nicht dafür verantwortlich, einige oder alle diesbezüglichen Patentrechte zu identifizieren.
Details zu allen während der Entwicklung des Dokuments identifizierten Patentrechten finden sich in der
Einleitung und/oder in der ISO-Liste der empfangenen Patenterklärungen (siehe www.iso.org/patents).
Jeder in diesem Dokument verwendete Handelsname wird als Information zum Nutzen der Anwender
angegeben und stellt keine Anerkennung dar.Eine Erläuterung der Bedeutung ISO-spezifischer Benennungen und Ausdrücke, die sich auf
Konformitätsbewertung beziehen, sowie Informationen über die Beachtung der WTO-Grundsätze zu
technischen Handelshemmnissen (TBT, en: Technical Barriers to Trade) durch ISO enthält der folgende Link:
www.iso.org/iso/foreword.html.Das für dieses Dokument verantwortliche Komitee ist ISO/TC 176 „Quality management and quality
assurance“, Subcommittee SC 2, Quality systems.Diese fünfte Ausgabe der ISO 9001 ersetzt die vierte Ausgabe (ISO 9001:2008), welche fachlich überarbeitet
wurde, durch die Umsetzung einer überarbeiteten Abschnittsreihenfolge und die Einführung der
überarbeiteten Grundsätze des Qualitätsmanagements und neuer Begriffe. Sie ersetzt auch die Berichtigung
ISO 9001:2008/ Cor.1:2009.---------------------- Page: 7 ----------------------
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Einleitung
0.1 Allgemeines
Die Einführung eines Qualitätsmanagementsystems ist eine strategische Entscheidung einer Organisation,
die helfen kann, ihre Gesamtleistung zu steigern und eine gute Basis für nachhaltige Entwicklungsinitiativen
bereitstellt.Die potentiellen Vorteile für eine Organisation, die sich aus der Umsetzung eines Qualitätsmanagement-
systems basierend auf dieser Internationalen Norm ergeben, sind folgende:a) die Fähigkeit, beständig Produkte und Dienstleistungen zu liefern, die die Kundenanforderungen und
zutreffende gesetzliche und behördliche Anforderungen erfüllen;b) das Eröffnen von Chancen zur Erhöhung der Kundenzufriedenheit;
c) die Behandlung von Risiken und Chancen im Zusammenhang mit ihrem Kontext und ihren Zielen; und
d) die Fähigkeit, Konformität mit festgelegten Anforderungen des Qualitätsmanagementsystems
nachzuweisen.Diese Internationale Norm kann von internen und externen Parteien angewendet werden.
Es ist nicht die Absicht dieser Internationalen Norm, die Notwendigkeit zu unterstellen für:
— die Vereinheitlichung der Struktur unterschiedlicher Qualitätsmanagementsysteme;
— die Angleichung der Dokumentation an die Gliederung dieser Internationalen Norm;
— die Verwendung der speziellen Terminologie dieser Internationalen Norm innerhalb der Organisation.
Die in dieser Internationalen Norm festgelegten Anforderungen an ein Qualitätsmanagementsystem
ergänzen die Anforderungen an Produkte und Dienstleistungen.Diese Internationale Norm wendet den prozessorientierten Ansatz an, der das Planen-Durchführen-Prüfen-
Handeln-Modell (PDCA, en: Plan-Do-Check-Act) sowie risikobasiertes Denken umfasst.
Der prozessorientierte Ansatz ermöglicht einer Organisation, ihre Prozesse und deren Wechselwirkungen zu
planen.Das PDCA-Modell ermöglicht einer Organisation sicherzustellen, dass angemessene Ressourcen für ihre
Prozesse zur Verfügung stehen, die Prozesse gesteuert werden und dass Chancen zur Verbesserung
bestimmt werden und auf diese reagiert wird.Risikobasiertes Denken ermöglicht einer Organisation, diejenigen Faktoren zu bestimmen, die bewirken
könnten, dass ihre Prozesse und ihr Qualitätsmanagementsystem von den geplanten Ergebnissen
abweichen, vorbeugende Maßnahmen zur Steuerung umzusetzen, um negative Auswirkungen zu
minimieren und den maximalen Nutzen aus sich bietenden Möglichkeiten zu ziehen (siehe Abschnitt A.4).
Die beständige Erfüllung der Anforderungen und die Berücksichtigung zukünftiger Erfordernisse und
Erwartungen stellen eine Herausforderung für Organisationen in einer zunehmend dynamischen und
komplexen Umgebung dar. Zum Erreichen dieses Ziels kann es für die Organisation notwendig sein,
---------------------- Page: 8 ----------------------SIST EN ISO 9001:2015
EN ISO 9001:2015 (D)
zusätzlich zur Korrektur und fortlaufenden Verbesserung, verschiedene Formen der Verbesserung, z. B.
bahnbrechende Veränderung, Innovation und Neuorganisation, einzuführen.In dieser Internationalen Norm werden die folgenden Verbformen verwendet:
— „muss“ gibt eine Anforderung an;
— „sollte“ gibt eine Empfehlung an;
— „darf“ gibt eine Zulässigkeit an;
— „kann“ gibt eine Möglichkeit oder ein Vermögen an.
Als „ANMERKUNG“ gekennzeichnete Informationen dienen als Anleitung zum Verständnis oder zur
Erläuterung der zugehörigen Anforderung.0.2 Grundsätze des Qualitätsmanagements
Diese Internationale Norm basiert auf den in ISO 9000 beschriebenen Grundsätzen des Qualitäts-
managements. Die Beschreibungen beinhalten eine Aussage zu jedem Grundsatz, eine Begründung, warum
der Grundsatz für die Organisation wichtig ist, einige Beispiele für mit den Grundsätzen verbundene Vorteile
und Beispiele für typische Maßnahmen zur Steigerung der Leistung der Organisation bei Anwendung der
Grundsätze.Die Grundsätze des Qualitätsmanagements sind folgende:
— Kundenorientierung;
— Führung;
— Einbeziehung von Personen;
— prozessorientierter Ansatz;
— Verbesserung;
— faktengestützte Entscheidungsfindung;
— Beziehungsmanagement.
0.3 Prozessorientierter Ansatz
0.3.1 Allgemeines
Diese Internationale Norm fördert die Umsetzung eines prozessorientierten Ansatzes bei der Entwicklung,
Verwirklichung und Verbesserung der Wirksamkeit eines Qualitätsmanagementsystems, um die
Kundenzufriedenheit durch Erfüllen der Kundenanforderungen zu erhöhen. Spezifische Anforderungen, die
für die Umsetzung eines prozessorientierten Ansatzes von wesentlicher Bedeutung sind, sind in 4.4
enthalten.Das Verstehen und Steuern zusammenhängender Prozesse als ein System trägt zur Wirksamkeit und
Effizienz einer Organisation beim Erreichen ihrer beabsichtigten Ergebnisse bei. Dieser Ansatz ermöglicht
der Organisation, die Zusammenhänge und Wechselbeziehungen von Prozessen des Systems so zu steuern,
dass die Gesamtleistung der Organisation verbessert werden kann.---------------------- Page: 9 ----------------------
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Der prozessorientierte Ansatz umfasst die systematische Festlegung und Steuerung von Prozessen und
deren Wechselwirkungen, so dass die angestrebten Ergebnisse mit der Qualitätspolitik und der
strategischen Ausrichtung der Organisation übereinstimmen. Die Steuerung der Prozesse und des Systems
als Ganzes kann durch den PDCA-Zyklus (siehe 0.3.2) erreicht werden, dessen Hauptaugenmerk auf
risikobasiertem Denken (siehe 0.3.3) liegt, um Chancen zu nutzen und unerwünschte Ergebnisse zu
verhindern.Die Anwendung des prozessorientierten Ansatzes in einem Qualitätsmanagementsystem ermöglicht
Folgendes:a) Verstehen der Anforderungen und deren fortlaufende Einhaltung;
b) Betrachtung der Prozesse im Hinblick auf Wertschöpfung;
c) Erreichen einer wirksamen Prozessleistung;
d) Verbesserung von Prozessen basierend auf der Bewertung von Daten und Informationen.
Bild 1 zeigt eine schematische Darstellung eines Prozesses und zeigt die Wechselwirkungen seiner Elemente.
Die für die Steuerung benötigten Kontrollpunkte zur Überwachung und Messung sind für jeden Prozess
spezifisch und ändern sich in Abhängigkeit von den damit zusammenhängenden Risiken.
Bild 1 — Schematische Darstellung der Elemente eines Einzelprozesses0.3.2 „Planen-Durchführen-Prüfen-Handeln“-Zyklus
Auf alle Prozesse und auf das Qualitätsmanagementsystem als Ganzes kann der „Planen-Durchführen-
Prüfen-Handeln“-Zyklus (PDCA) angewendet werden. Bild 2 veranschaulicht, wie die Abschnitte 4 bis 10 in
den PDCA-Zyklus eingebunden werden können.---------------------- Page: 10 ----------------------
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ANMERKUNG Die Zahlen in Klammern beziehen sich auf die Abschnitte in dieser Internationalen Norm.
Bild 2 — Darstellung der Struktur dieser Norm im PDCA-ZyklusDer PDCA-Zyklus kann kurz wie folgt beschrieben werden:
— Planen: Festlegen von Zielen des Systems und der Teilprozesse und Festlegen von Ressourcen, die zum
Erzielen von Ergebnissen in Übereinstimmung mit den Kundenanforderungen und den Politiken der
Organisation notwendig sind, sowie Ermitteln und Behandeln von Risiken und Chancen;
— Durchführen: Umsetzen des Geplanten;— Prüfen: Überwachen und (sofern zutreffend) Messen von Prozessen und den daraus resultierenden
Produkten und Dienstleistungen im Hinblick auf Politiken, Ziele, Anforderungen und geplante
Tätigkeiten, sowie Berichterstattung über die Ergebnisse;— Handeln: Ergreifen von Maßnahmen zur Verbesserung der Leistung, soweit notwendig.
0.3.3 Risikobasiertes DenkenRisikobasiertes Denken (siehe Abschnitt A.4) ist zum Erreichen eines wirksamen Qualitätsmanagement-
systems unerlässlich. Das Konzept des risikobasierten Denkens war bereits in früheren Ausgaben dieser
Internationalen Norm enthalten, z. B. mit der Umsetzung von Vorbeugungsmaßnahmen zur Abschaffung von
möglichen Nichtkonformitäten, der Analyse jeglicher auftretender Nichtkonformitäten und dem Ergreifen
von Maßnahmen zum Verhindern des Wiederauftretens, die den Auswirkungen der Nichtkonformität
angemessen sind.---------------------- Page: 11 ----------------------
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EN ISO 9001:2015 (D)
Die Erfüllung der Anforderungen dieser Internationalen Norm verlangt von der Organisation, dass sie
Maßnahmen plant und umsetzt, mit denen Risiken und Chancen behandelt werden. Die Behandlung von
sowohl Risiken als auch Chancen bildet eine Grundlage für die Steigerung der Wirksamkeit des
Qualitätsmanagementsystems, für das Erreichen verbesserter Ergebnisse und für das Vermeiden von
negativen Auswirkungen.Chancen können sich infolge einer Situation ergeben, die sich günstig auf das Erreichen eines beabsichtigten
Ergebnisses auswirkt, z. B. eine Reihe von Umständen, die es der Organisation ermöglicht Kunden zu
gewinnen, neue Produkte und Dienstleistungen zu entwickeln, Abfälle zu verringern oder die Produktivität
zu verbessern. Maßnahmen zur Behandlung von Chancen können außerdem die Betrachtung zugehöriger
Risiken einschließen. Risiko ist die Auswirkung von Ungewissheiten, und jede dieser Ungewissheiten kann
positive oder negative Auswirkungen besitzen. Eine positive Abweichung, die aus einem Risiko hervorgeht,
kann eine Chance liefern, wobei jedoch nicht alle positiven Auswirkungen eines Risikos in Chancen
resultieren.0.4 Zu
...
S L O V E N S K I SIST EN ISO 9001
S T A N D A R D
oktober 2015
Sistemi vodenja kakovosti – Zahteve (ISO 9001:2015)
Quality management systems – Requirements (ISO 9001:2015)
Systèmes de management de la qualité – Exigences (ISO 9001:2015)
Qualitätsmanagementsysteme – Anforderungen (ISO 9001:2015)
Referenčna oznaka
ICS 03.120.10 SIST EN ISO 9001:2015 (sl, en)
Nadaljevanje na straneh II in III ter od 1 do 53
© 2015-11. Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------SIST EN ISO 9001 : 2015
NACIONALNI UVOD
Standard SIST EN ISO 9001 (sl, en), Sistemi vodenja kakovosti – Zahteve, 2015, ima status
slovenskega standarda in je istoveten evropskemu standardu EN ISO 9001, Quality management
systems – Requirements (ISO 9001:2015), 2015.NACIONALNI PREDGOVOR
Mednarodni standard ISO 9001:2015 je pripravil tehnični pododbor Mednarodne organizacije za
standardizacijo ISO/TC 176/SC 2 Sistemi kakovosti. Slovenski standard SIST EN ISO 9001:2015 je
prevod angleškega besedila evropskega standarda EN ISO 9001:2015, ki je istoveten mednarodnemu
standardu; k dokumentu je dodan evropski predgovor. 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 27. oktobra 2015 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 9000:2015 (sl,en) Sistemi vodenja kakovosti – Osnove in slovar
SIST EN ISO 9004:2009 (sl,en) Vodenje za trajno uspešnost organizacije – Pristop z vodenjem
kakovosti (ISO 9004:2009)SIST ISO 10001:2008 (en) Vodenje kakovosti – Zadovoljstvo odjemalcev – Smernice za
kodeks ravnanja organizacijSIST ISO 10002:2014 (en) Vodenje kakovosti – Zadovoljstvo odjemalcev – Smernice za
ravnanje s pritožbami v organizacijahSIST ISO 10003:2008 (en) Vodenje kakovosti – Zadovoljstvo odjemalcev – Smernice za
reševanje nesoglasij z odjemalci s pomočjo drugih organizacijSIST ISO 10004:2012 (sl,en) Vodenje kakovosti – Zadovoljstvo odjemalcev – Smernice za
nadzorovanje in merjenjeSIST ISO 10005:2005 (sl,en) Sistemi vodenja kakovosti – Smernice za plane kakovosti
SIST ISO 10006:2004 (sl,en) Sistemi vodenja kakovosti – Smernice za vodenje kakovosti
projektovSIST ISO 10007:2004 (en) Sistemi vodenja kakovosti – Smernice za vodenje konfiguracij
SIST ISO 10008:2013 (en) Vodenje kakovosti – Zadovoljstvo odjemalcev – Smernice za
elektronsko poslovanje med organizacijami in potrošnikiSIST EN ISO 10012:2003 (sl,en) Sistemi vodenja meritev – Zahteve za procese merjenja in
merilno opremo (ISO 10012:2003)SIST ISO/TR 10013:2002 (sl,en) Smernice za dokumentacijo sistema vodenja kakovosti
SIST ISO 10014:2006 (sl,en) Vodenje kakovosti – Smernice za doseganje finančnih in
ekonomskih koristiSIST ISO 10015:2002 (en) Vodenje kakovosti – Smernice za usposabljanje
SIST ISO/TR 10017:2003 (en) Napotki za statistične metode v zvezi z ISO 9001:2000
---------------------- Page: 2 ----------------------SIST EN ISO 9001 : 2015
SIST ISO 10018:2012 (sl,en) Vodenje kakovosti – Smernice za vključevanje in kompetence
zaposlenihSIST ISO 10019:2005 (en) Smernice za izbiro svetovalcev za sisteme vodenja kakovosti in
uporabo njihovih storitevSIST EN ISO 14001:2005 (sl,en) Sistemi ravnanja z okoljem – Zahteve z navodili za uporabo
(ISO 14001:2004)SIST EN ISO 19011:2011 (sl,en) Smernice za presojanje sistemov vodenja (ISO 19011:2011)
SIST ISO 31000:2011 (sl,en) Obvladovanje tveganja – Načela in smerniceSIST EN 60300-1:2014 (en) Vodenje zagotovljivosti – 1. del: Navodilo za vodenje in izvedbo
(IEC 60300-1:2014)SIST EN 61160:2007 (en) Pregled zasnove (IEC 61160:2005)
PREDHODNA IZDAJA
– SIST EN ISO 9001:2008 (sl,en)
OSNOVA ZA IZDAJO STANDARDA
– Privzem standarda EN ISO 9001:2015.
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz “evropski” ali “mednarodni” standard, v SIST
EN ISO 9001:2015 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 9001:2015 (sl,en) prevedeno kot “snovanje in
razvoj”.– V standardu SIST EN ISO 9001:2015 je izraz “PDCA cycle” preveden kot “cikel PDCA”. V
nekaterih drugih standardih, povezanih s kakovostjo, se uporablja tudi izraz “krog PDCA”.
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.– Ta nacionalni dokument je istoveten EN ISO 9001:2015 in je objavljen z dovoljenjem
CEN-CENELECUpravni center
Avenue Marnix 17
B-1000 Bruselj
This national document is identical with EN ISO 9001:2015 and is published with the
permission ofCEN-CENELEC
Management Centre
Avenue Marnix 17
B -1000 Brussels
III
---------------------- Page: 3 ----------------------
SIST EN ISO 9001 : 2015
(Prazna stran)
---------------------- Page: 4 ----------------------
EVROPSKI STANDARD EN ISO 9001
EUROPEAN STANDARD
EUROPÄISCHE NORM
NORME EUROPÉENNE september 2015
ICS: 03.120.10 Nadomešča EN ISO 9001:2008
Slovenska izdaja
Sistemi vodenja kakovosti – Zahteve
(ISO 9001:2015)
Quality management systems Systèmes de management de Qualitätsmanagementsysteme –
– Requirements la qualité – Exigences Anforderungen(ISO 9001:2015) (ISO 9001:2015) (ISO 9001:2015)
Ta evropski standard je CEN sprejel dne 14. septembra 2015.
Člani CEN morajo izpolnjevati določila notranjih predpisov CEN/CENELEC, s katerimi 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 Upravnem
centru CEN-CENELEC ali članih CEN.Ta evropski standard obstaja v treh uradnih izdajah (nemški, angleški in francoski). Izdaje v drugih
jezikih, ki jih člani CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri Upravnem centru
CEN-CENELEC, veljajo kot uradne izdaje.Člani CEN so nacionalni organi za standarde Avstrije, Belgije, Bolgarije, Cipra, Češke republike,
Danske, Estonije, Finske, Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Latvije, Litve,
Luksemburga, Madžarske, Malte, Nekdanje jugoslovanske republike Makedonije, Nemčije,
Nizozemske, Norveške, Poljske, Portugalske, Romunije, Slovaške, Slovenije, Španije, Švedske,
Švice, Turčije in Združenega kraljestva.CEN
Evropski komite za standardizacijo
European Committee for Standardization
Europäisches Komitee für Normung
Comité Européen de Normalisation
Upravni center CEN-CENELEC: Avenue Marnix 17, B-1000 Bruselj
© 2015 CEN Lastnice avtorskih pravic so vse države članice CEN Ref. št. EN ISO 9001:2015 E
---------------------- Page: 5 ----------------------SIST EN ISO 9001 : 2015
Predgovor k evropskemu standardu
Ta dokument (EN ISO 9001:2015) 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 marca 2016, nacionalne standarde, ki so v nasprotju s tem standardom, pa
je treba umakniti najpozneje do marca 2016.Opozoriti je treba na možnost, da je lahko nekaj elementov tega dokumenta predmet patentnih pravic.
CEN [in/ali CENELEC] ne prevzema odgovornosti za identifikacijo katerihkoli ali vseh takih patentnih
pravic.Ta dokument nadomešča EN ISO 9001:2008.
Ta dokument je bil pripravljen v okviru mandata, ki sta ga Evropska komisija in Evropsko združenje za
prosto trgovino dodelila CEN in podpira bistvene zahteve Direktiv EU.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, Hrvaške, Irske, Islandije, Italije, Latvije, Litve,
Luksemburga, Madžarske, Malte, Nekdanje jugoslovanske republike Makedonije, Nemčije,
Nizozemske, Norveške, Poljske, Portugalske, Romunije, Slovaške, Slovenije, Španije, Švedske,
Švice, Turčije in Združenega kraljestva.Razglasitvena objava
Besedilo ISO 9001:2015 je CEN odobril kot EN ISO 9001:2015 brez kakršnihkoli sprememb.
---------------------- Page: 6 ----------------------SIST EN ISO 9001 : 2015
Vsebina Stran Contents Page
Predgovor ................................................................ 6 Foreword ........................................................... 6
Uvod ........................................................................ 7 Introduction ........................................................ 7
1 Področje uporabe ...................................... 14 1 Scope ....................................................14
2 Zveze s standardi ...................................... 14 2 Normative references ............................14
3 Izrazi in definicije........................................ 14 3 Terms and definitions ............................14
4 Kontekst organizacije ............................... 14 4 Context of the organization ...................14
4.1 Razumevanje organizacije in 4.1 Understanding the organizationnjenega konteksta ..................................... 14 and its context .......................................14
4.2 Razumevanje potreb in pričakovanj 4.2 Understanding the needszainteresiranih strani ................................. 15 and expectations of interested parties ..15
4.3 Opredeljevanje področja uporabe 4.3 Determining the scope of the qualitysistema vodenja kakovosti ........................ 15 management system .............................15
4.4 Sistem vodenja kakovosti in njegovi 4.4 Quality management systemprocesi ........................................................ 16 and its processes ..................................16
5 Voditeljstvo ................................................. 17 5 Leadership ............................................17
5.1 Voditeljstvo in zavezanost......................... 17 5.1 Leadership and commitment.................17
5.1.1 Splošno ...................................................... 17 5.1.1 General .................................................17
5.1.2 Osredotočenost na odjemalce.................. 18 5.1.2 Customer focus .....................................18
5.2 Politika ........................................................ 18 5.2 Policy .....................................................18
5.2.1 Vzpostavljanje politike kakovosti .............. 18 5.2.1 Establishing the quality policy ...............18
5.2.2 Komuniciranje o politiki kakovosti ............. 18 5.2.2 Communicating the quality policy .........18
5.3 Organizacijske vloge, odgovornosti 5.3 Organizational roles, responsibilities
in pooblastila .............................................. 18 and authorities ......................................18
6 Planiranje ................................................... 19 6 Planning ................................................19
6.1 Ukrepi za obravnavanje tveganj in 6.1 Actions to address riskspriložnosti ................................................... 19 and opportunities ..................................19
6.2 Cilji kakovosti in planiranje za 6.2 Quality objectives and planningnjihovo doseganje ..................................... 20 to achieve them .....................................20
6.3 Planiranje sprememb ................................ 20 6.3 Planning of changes .............................20
7 Podpora ...................................................... 21 7 Support ..................................................21
7.1 Viri ............................................................... 21 7.1 Resources .............................................21
7.1.1 Splošno ...................................................... 21 7.1.1 General .................................................21
7.1.2 Ljudje .......................................................... 21 7.1.2 People ...................................................21
7.1.3 Infrastruktura .............................................. 21 7.1.3 Infrastructure .........................................21
7.1.4 Okolje za delovanje 7.1.4 Environment for the operationprocesov ..................................................... 21 of processes ..........................................21
7.1.5 Viri nadzorovanja in merjenja ................... 22 7.1.5 Monitoring and measuring resources ...22
7.1.6 Organizacijsko znanje .............................. 23 7.1.6 Organizational knowledge .....................23
7.2 Kompetentnost .......................................... 23 7.2 Competence ..........................................23
7.3 Ozaveščenost ............................................ 23 7.3 Awareness ............................................23
7.4 Komuniciranje ............................................ 24 7.4 Communication ....................................24
7.5 Dokumentirane informacije ....................... 24 7.5 Documented information .......................24
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7.5.1 Splošno ...................................................... 24 7.5.1 General .................................................24
7.5.2 Ustvarjanje in posodabljanje ..................... 24 7.5.2 Creating and updating ...........................24
7.5.3 Obvladovanje dokumentiranih 7.5.3 Control of documentedinformacij .................................................... 25 information ............................................25
8 Delovanje ................................................... 25 8 Operation ..............................................25
8.1 Planiranje in obvladovanje delovanja ....... 25 8.1 Operational planning and control ..........25
8.2 Zahteve za izdelke 8.2 Requirements for productsin storitve .................................................... 26 and services ..........................................26
8.2.1 Komuniciranje z odjemalci ........................ 26 8.2.1 Customer communication .....................26
8.2.2 Opredeljevanje zahtev za izdelke in 8.2.2 Determining the requirementsstoritve ........................................................ 26 for products and services ......................26
8.2.3 Pregled zahtev za izdelke 8.2.3 Review of requirements forin storitve .................................................... 27 products and services ...........................27
8.2.4 Spremembe zahtev za izdelke in 8.2.4 Changes to requirementsstoritve ........................................................ 27 for products and services ......................27
8.3 Snovanje in razvoj izdelkov 8.3 Design and developmentin storitev .................................................... 28 of products and services .......................28
8.3.1 Splošno ...................................................... 28 8.3.1 General .................................................28
8.3.2 Planiranje snovanja in razvoja .................. 28 8.3.2 Design and development planning .......28
8.3.3 Vhodi snovanja in razvoja ......................... 28 8.3.3 Design and development inputs ...........28
8.3.4 Ukrepi za obvladovanje snovanja in 8.3.4 Design and developmentrazvoja ........................................................ 29 controls ..................................................29
8.3.5 Izhodi snovanja in razvoja......................... 29 8.3.5 Design and development outputs .........29
8.3.6 Spremembe snovanja in razvoja .............. 30 8.3.6 Design and development changes .......30
8.4 Obvladovanje procesov, izdelkov in 8.4 Control of externally providedstoritev zunanjih ponudnikov .................... 30 processes, products and services ........30
8.4.1 Splošno ...................................................... 30 8.4.1 General .................................................30
8.4.2 Vrsta in obseg obvladovanja .................... 31 8.4.2 Type and extent of control ....................31
8.4.3 Informacije za zunanje ponudnike ............ 31 8.4.3 Information for external providers .........31
8.5 Proizvodnja in izvedba storitev ................. 32 8.5 Production and service provision ..........32
8.5.1 Obvladovanje proizvodnje in izvedbe 8.5.1 Control of productionstoritev ........................................................ 32 and service provision ............................32
8.5.2 Identifikacija in sledljivost .......................... 33 8.5.2 Identification and traceability.................33
8.5.3 Lastnina odjemalcev in zunanjih 8.5.3 Property belonging to customersponudnikov ................................................. 33 or external providers .............................33
8.5.4 Ohranitev .................................................... 33 8.5.4 Preservation ..........................................33
8.5.5 Aktivnosti po dostavi .................................. 33 8.5.5 Post-delivery activities .........................33
8.5.6 Obvladovanje sprememb .......................... 34 8.5.6 Control of changes ................................34
8.6 Sprostitev izdelkov in storitev ................... 34 8.6 Release of products and services ........34
8.7 Obvladovanje neskladnih izhodov ........... 34 8.7 Control of nonconforming outputs .........34
9 Vrednotenje izvedbe ................................ 35 9 Performance evaluation ........................35
9.1 Nadzorovanje, merjenje, analiziranje 9.1 Monitoring, measurement,in vrednotenje ............................................ 35 analysis and evaluation .........................35
9.1.1 Splošno ...................................................... 35 9.1.1 General .................................................35
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9.1.2 Zadovoljstvo odjemalcev........................... 36 9.1.2 Customer satisfaction ...........................36
9.1.3 Analiziranje in vrednotenje ........................ 36 9.1.3 Analysis and evaluation .......................36
9.2 Notranja presoja ........................................ 36 9.2 Internal audit .........................................36
9.3 Vodstveni pregled ...................................... 37 9.3 Management review ..............................37
9.3.1 Splošno ...................................................... 37 9.3.1 General .................................................37
9.3.2 Vhodi vodstvenega pregleda .................... 37 9.3.2 Management review inputs ...................37
9.3.3 Izhodi vodstvenega pregleda.................... 38 9.3.3 Management review outputs .................38
10 Izboljševanje .............................................. 38 10 Improvement .........................................38
10.1 Splošno ...................................................... 38 10.1 General .................................................38
10.2 Neskladnost in korektivni ukrepi ............... 38 10.2 Nonconformity and corrective action ....38
10.3 Nenehno izboljševanje .............................. 39 10.3 Continual improvement ........................39
Dodatek A (informativni): Pojasnilo o Annex A (informative): Clarification ofnovi strukturi, terminologiji in new structure, terminology and
pojmih ......................................................... 40 concepts ................................................40
Dodatek B (informativni): Drugi mednarodni Annex B (informative): Other International
standardi o vodenju kakovosti in Standards on quality managementsistemih vodenja kakovosti, ki jih je and quality management systems
razvil ISO/TC 176 ...................................... 46 developed by ISO/TC 176 .....................46
Literatura ............................................................... 52 Bibliography .....................................................52
---------------------- Page: 9 ----------------------SIST EN ISO 9001 : 2015
Predgovor Foreword
Mednarodna organizacija za standardizacijo ISO (the International Organization for
(ISO) 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 ga zanima področje, za katero je bil normally carried out through ISO technical
ustanovljen tehnični odbor, ima pravico biti committees. Each member body interested in a
zastopan v tem odboru. Pri delu sodelujejo tudi subject for which a technical committee has been
mednarodne vladne in nevladne organizacije, established has the right to be represented on
povezane z ISO. V vseh zadevah, ki so that committee. International organizations,
povezane s standardizacijo na področju governmental and non-governmental, in liaison
elektrotehnike, ISO tesno sodeluje z with ISO, also take part in the work. ISOMednarodno elektrotehniško komisijo (IEC). collaborates closely with the International
Electrotechnical Commission (IEC) on all mattersof electrotechnical standardization.
Postopki, uporabljeni pri razvoju tega The procedures used to develop this document
dokumenta, in postopki, predvideni za njegovo and those intended for its further maintenance
nadaljnje vzdrževanje, so opisani v Direktivah are described in the ISO/IEC Directives, Part 1.
ISO/IEC, 1. del. Posebna pozornost naj se In particular the different approval criteria
nameni različnim kriterijem odobritve, potrebnim needed for the different types of ISO
za različne vrste dokumentov ISO. Ta documents should be noted. This documentdokument je bil pripravljen v skladu z was drafted in accordance with the editorial
uredniškimi pravili Direktiv ISO/IEC, 2. del (glej rules of the ISO/IEC Directives, Part 2 (see
www.iso.org/directives). www.iso.org/directives).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. Details
pravic. Podrobnosti o morebitnih patentnih of any patent rights identified during the
pravicah, identificiranih med pripravo tega development of the document will be in the
dokumenta, bodo navedene v uvodu in/ali na Introduction and/or on the ISO list of patent
seznamu patentnih izjav, ki jih je prejela declarations received (see www.iso.org/patents).
organizacija ISO (glej www.iso.org/patents).Morebitna trgovska imena, uporabljena v tem Any trade name used in this document is
dokumentu, so informacije za uporabnike in ne information given for the convenience of users
pomenijo podpore blagovni znamki. and does not constitute an endorsement.Za razlago pomena specifičnih pojmov in izrazov For an explanation on the meaning of ISO specific
ISO, povezanih z ugotavljanjem skladnosti, ter terms and expressions related to conformity
informacij o tem, kako ISO spoštuje načela assessment, as well as information about ISO's
Mednarodne trgovinske organizacije (WTO) v adherence to the World Trade Organization (WTO)
Tehničnih ovirah pri trgovanju (TBT), glej naslednji principles in the Technical Barriers to Trade (TBT)
naslov URL: www.iso.org/foreword.html. see the following URL: www.iso.org/foreword.html.
Za ta dokument je odgovoren tehnični odbor The committee responsible for this document is
ISO/TC 176 Vodenje in zagotavljanje kakovosti, Technical Committee ISO/TC 176, Quality
pododbor SC2 Sistemi kakovosti. management and quality assurance,Subcommittee SC 2, Quality systems.
Ta peta izdaja standarda razveljavlja in This fifth edition cancels and replaces the fourth
nadomešča četrto izdajo (ISO 9001:2008), ki je edition (ISO 9001:2008), which has been techni-
bila tehnično revidirana s tem, da je sprejeto cally revised, through the adoption of a revised
spremenjeno zaporedje točk, da so prirejena clause sequence and the adaptation of the
popravljena načela vodenja kakovosti in novi revised quality management principles and of new
pojmi. Ta izdaja tudi razveljavlja in nadomešča concepts. It also cancels and replaces the
tehnični popravek ISO 9001:2008/Cor.1:2009. Technical Corrigendum ISO 9001:2008/Cor.1:2009.
---------------------- Page: 10 ----------------------SIST EN ISO 9001 : 2015
Uvod Introduction
0.1 Splošno 0.1 General
Privzem sistema vodenja kakovosti je strateška The adoption of a quality management system
odločitev organizacije, ki ji lahko pomaga is a strategic decision for an organization that
izboljšati celotno izvajanje in daje trdno podlago can help to improve its overall performance and
pobudam za trajnostni razvoj. provide a sound basis for sustainabledevelopment initiatives.
Koristi, ki jih ima lahko organizacija od izvajanja The potential benefits to an organization of
sistema vodenja kakovosti na podlagi tega implementing a quality management system
mednarodnega standarda, so: based on this International Standard are:a) zmožnost, da dosledno zagotavlja izdelke a) the ability to consistently provide products
in storitve, ki izpolnjujejo zahteve and services that meet customer andodjemalcev ter veljavne zahteve applicable statutory and regulatory
zakonodaje in regulative; requirements;
b) dajanje priložnosti za povečanje b) facilitating opportunities to enhance
zadovoljstva odjemalcev; customer satisfaction;
c) obravnavanje tveganj in priložnosti, c) addressing risks and opportunities
povezanih z njenim kontekstom in cilji; associated with its context and objectives;
d) zmožnost, da dokaže izpolnjevanje d) the ability to demonstrate conformity to
skladnosti s specificiranimi zahtevami specified quality management systemsistema vodenja kakovosti. requirements.
Ta mednarodni standard lahko uporabljajo This International Standard can be used by
strani znotraj in zunaj organizacije. internal and external parties.Ta mednarodni standard nima namena It is not the intent of this International Standard
nakazovati potrebe po: to imply the need for:– enotni zgradbi različnih sistemov vodenja – uniformity in the structure of different
kakovosti; quality management systems;– uskladitvi dokumentacije s strukturo točk – alignment of documentation to the clause
tega mednarodnega standarda;structure of this International Standard;
– the use of the specific terminology of this
– uporabi specifične terminologije tega
International Standard within the
mednarodnega standarda v organizaciji.
organization.
Zahteve sistema vodenja kakovosti, določene v The quality management system requirements
tem mednarodnem standardu, dopolnjujejo specified in this International Standard are
zahteve za izdelke in storitve. complementary to requirements for productsand services.
Ta mednarodni standard uporablja procesni This International Standard employs the
pristop, ki vključuje cikel "planiraj-izvedi-preveri- process approach, which incorporates the Plan-
ukrepaj" (PDCA) in razmišljanje na podlagi Do-Check-Act (PDCA) cycle and risk-based
tveganja. thinking.Procesni pristop pomaga organizaciji planirati The process approach enables an organization
njene procese in njihovo interakcijo. to plan its processes and their interactions.
Cikel PDCA pomaga organizaciji zagotavljati, The PDCA cycle enables an organization to
da svoje procese podpre z ustreznimi viri in jih ensure that its processes are adequately
vodi ter da identificira priložnosti za izboljšanje resourced and managed, and that opportunities
in ustrezno ukrepa. for improvement are identified and acted on.---------------------- Page: 11 ----------------------
SIST EN ISO 9001 : 2015
Razmišljanje na podlagi tveganja pomaga Risk-based thinking enables an organization to
organizaciji opredeliti dejavnike, ki bi lahko determine the factors that could cause its
povzročili odstopanje njenih procesov in processes and its quality management system
njenega sistema vodenja kakovosti od to deviate from the planned results, to put in
planiranih rezultatov, sprejeti preventivne place preventive controls to minimize negative
ukrepe za zmanjšanje negativnih vplivov ter kar effects and to make maximum use of
najbolje izkoristiti priložnosti, ko se ponudijo opportunities as they arise (see Clause A.4).
(glej točko A.4).Dosledno izpolnjevanje zahtev ter obravnavanje Consistently meeting requirements and
prihodnjih potreb in pričakovanj v vse bolj addressing future needs and expectations
dinamičnem in kompleksnem okolju poses a challenge for organizat...
SLOVENSKI STANDARD
oSIST prEN ISO 9001:2014
01-september-2014
Sistemi vodenja kakovosti - Zahteve
Quality management systems - Requirements
Qualitätsmanagementsysteme - Anforderungen
Systèmes de management de la qualité - Exigences
Ta slovenski standard je istoveten z: prEN ISO 9001
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
oSIST prEN ISO 9001:2014 en,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------oSIST prEN ISO 9001:2014
---------------------- Page: 2 ----------------------
oSIST prEN ISO 9001:2014
DRAFT INTERNATIONAL STANDARD
ISO/DIS 9001
ISO/TC 176/SC 2 Secretariat: BSI
Voting begins on: Voting terminates on:
2014-07-10 2014-10-10
Quality management systems — Requirements
Systèmes de management de la qualité — Exigences
ICS: 03.120.10
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO andTHIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 9001:2014(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2014
---------------------- Page: 3 ----------------------
oSIST prEN ISO 9001:2014
ISO/DIS 9001:2014(E)
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as
permitted under the applicable laws of the user’s country, neither this ISO draft nor any extract
from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means,
electronic, photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s
member body in the country of the requester.ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2014 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 9001:2014
60 Contents Page
61 Foreword ............................................................................................................................................................. 5
62 Introduction ......................................................................................................................................................... 6
63 0.1 General .......................................................................................................................................................... 6
64 0.2 The ISO standards for quality management .............................................................................................. 6
65 0.4 Plan-Do-Check-Act cycle ............................................................................................................................. 8
66 0.5 “Risk-based thinking” .................................................................................................................................. 9
67 0.6 Compatibility with other management system standards ....................................................................... 9
68 1 Scope .................................................................................................................................................... 11
69 2 Normative references .......................................................................................................................... 12
70 3 Terms and definitions ......................................................................................................................... 12
71 4 Context of the organization ................................................................................................................ 25
72 4.1 Understanding the organization and its context .............................................................................. 25
73 4.2 Understanding the needs and expectations of interested parties ................................................. 25
74 4.3 Determining the scope of the quality management system ........................................................... 25
75 4.4 Quality management system and its processes .............................................................................. 26
76 5 Leadership ........................................................................................................................................... 26
77 5.1 Leadership and commitment ............................................................................................................. 26
78 5.2 Quality policy ....................................................................................................................................... 27
79 5.3 Organizational roles, responsibilities and authorities .................................................................... 28
80 6 Planning for the quality management system .................................................................................. 28
81 6.1 Actions to address risks and opportunities ..................................................................................... 28
82 6.2 Quality objectives and planning to achieve them ............................................................................ 29
83 6.3 Planning of changes ........................................................................................................................... 29
84 7 Support ................................................................................................................................................. 30
85 7.1 Resources ............................................................................................................................................ 30
86 7.1.1 General ................................................................................................................................................. 30
87 7.1.2 People ................................................................................................................................................... 30
88 7.1.3 Infrastructure ....................................................................................................................................... 30
89 7.1.4 Environment for the operation of processes.................................................................................... 30
90 7.1.5 Monitoring and measuring resources ............................................................................................... 30
91 7.1.6 Organizational knowledge .................................................................................................................. 31
92 7.2 Competence ......................................................................................................................................... 31
93 7.3 Awareness ............................................................................................................................................ 31
94 7.4 Communication ................................................................................................................................... 32
95 7.5 Documented information .................................................................................................................... 32
96 7.5.1 General ................................................................................................................................................. 32
97 7.5.2 Creating and updating ........................................................................................................................ 32
98 8 Operation .............................................................................................................................................. 33
99 8.1 Operational planning and control ...................................................................................................... 33
100 8.2 Determination of requirements for products and services ............................................................. 33
101 8.2.1 Customer communication .................................................................................................................. 33
102 8.2.2 Determination of requirements related to products and services ................................................. 34
103 8.2.3 Review of requirements related to products and services ............................................................. 34
104 8.3 Design and development of products and services ........................................................................ 34
105 8.3.1 General ................................................................................................................................................. 34
106 8.3.2 Design and development planning .................................................................................................... 35
107 8.3.3 Design and development Inputs ........................................................................................................ 35
108 8.3.4 Design and development controls ..................................................................................................... 35
© ISO 2014 – All rights reserved 3 ISO/TC 176/SC2/WG24/N111---------------------- Page: 5 ----------------------
oSIST prEN ISO 9001:2014
109 8.3.5 Design and development outputs ...................................................................................................... 36
110 8.3.6 Design and development changes .................................................................................................... 36
111 8.4 Control of externally provided products and services .................................................................... 36
112 8.4.1 General ................................................................................................................................................. 36
113 8.4.2 Type and extent of control of external provision ............................................................................. 36
114 8.4.3 Information for external providers ..................................................................................................... 37
115 8.5 Production and service provision ..................................................................................................... 37
116 8.5.1 Control of production and service provision ................................................................................... 37
117 8.5.2 Identification and traceability ............................................................................................................. 38
118 8.5.3 Property belonging to customers or external providers ................................................................. 38
119 8.5.4 Preservation ......................................................................................................................................... 38
120 8.5.5 Post-delivery activities ........................................................................................................................ 38
121 8.5.6 Control of changes .............................................................................................................................. 39
122 8.6 Release of products and services ..................................................................................................... 39
123 8.7 Control of nonconforming process outputs, products and services ............................................ 39
124 9 Performance evaluation ...................................................................................................................... 40
125 9.1 Monitoring, measurement, analysis and evaluation ........................................................................ 40
126 9.1.1 General ................................................................................................................................................. 40
127 9.1.2 Customer satisfaction ......................................................................................................................... 40
128 9.1.3 Analysis and evaluation ...................................................................................................................... 40
129 9.2 Internal audit ........................................................................................................................................ 41
130 9.3 Management review ............................................................................................................................ 41
131 10 Improvement ........................................................................................................................................ 42
132 10.1 General ................................................................................................................................................. 42
133 10.2 Nonconformity and corrective action ................................................................................................ 42
134 10.3 Continual improvement ...................................................................................................................... 43
135 Annex A (informative) Clarification of new structure, terminology and concepts ................................... 44
136 Annex B (informative) Quality management principles .............................................................................. 47
137 Annex C (informative) The ISO 10000 portfolio of quality management standards ................................. 49
138 Bibliography ...................................................................................................................................................... 52
139140
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oSIST prEN ISO 9001:2014
141 Foreword
142 ISO (the International Organization for Standardization) is a worldwide federation of national standards
143 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
144 through ISO technical committees. Each member body interested in a subject for which a technical
145 committee has been established has the right to be represented on that committee. International
146 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
147 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
148 electrotechnical standardization.149 The procedures used to develop this document and those intended for its further maintenance are
150 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
151 different types of ISO documents should be noted. This document was drafted in accordance with the
152 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
153 Attention is drawn to the possibility that some of the elements of this document may be the subject of
154 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
155 any patent rights identified during the development of the document will be in the Introduction and/or
156 on the ISO list of patent declarations received (see www.iso.org/patents).157 Any trade name used in this document is information given for the convenience of users and does not
158 constitute an endorsement.159 For an explanation on the meaning of ISO specific terms and expressions related to conformity
160 assessment, as well as information about ISO's adherence to the WTO principles in the Technical
161 Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
162 The committee responsible for this document is Technical Committee ISO/TC 176, Quality
163 management and quality assurance, Subcommittee SC2, Quality systems.th th
164 This 5 edition of ISO 9001 cancels and replaces the 4 edition (ISO 9001:2008). This new edition
165 represents a technical revision compared to the earlier edition, through the adoption of a revised
166 clause sequence, the adaptation of the revised "quality management principles" and of new concepts.
167168 NOTE TO THIS TEXT (which will not be included in the published International Standard):
169170 This text has been prepared using the “high-level structure” (i.e. clause sequence, common text and terminology)
171 provided in Annex SL, Appendix 2 of the ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2013. This is
172 intended to enhance alignment among ISO’s management system standards, and to facilitate their
173 implementation for organizations that need to meet the requirements of two or more such standards
174 simultaneously.175
176 The clause sequence of ISO 9001:2008 has been changed to be consistent with “Annex SL”. The text of Annex
177 SL is highlighted in the main body of the text (clauses 1 to 10) by the use of blue font. This is only to facilitate
178 analysis and will not be incorporated in the final version of ISO 9001.179
180 This new harmonized approach allows for the addition of discipline-specific (in this case quality-specific) text
181 which has been applied by including the following:182
183 a) specific quality management system requirements considered essential to meet the scope of the ISO
184 9001 standard;185 b) text to reflect the use of the Quality Management Principles that form the basis for ISO’s quality
186 management system standards;187 c) requirements and notes to clarify and ensure consistent interpretation and implementation of the
188 common text in the context of a quality management system.© ISO 2014 – All rights reserved 5 ISO/TC 176/SC2/WG24/N111
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oSIST prEN ISO 9001:2014
189 Introduction
190 0.1 General
191 The adoption of a quality management system ought to be a strategic decision for an organization. A
192 robust quality management system can help an organization to improve its overall performance and
193 forms an integral component of sustainable development initiatives. The design and implementation of
194 an organization's quality management system is influenced by the context of the organisation and the
195 changes in that context, particularly with respect to:196 a) its specific objectives;
197 b) the risks associated with its context and objectives;
198 c) the needs and expectations of its customers and other relevant interested parties;
199 d) the products and services it provides;200 e) the complexity of processes it employs and their interactions;
201 f) the competence of persons within or working on behalf of the organization;
202 g) its size and organizational structure.203 The context of an organization can include internal factors such as organizational culture, and external
204 factors such as the socio-economic conditions under which it operates; consequently all the
205 requirements of this International Standard are generic but the ways in which they are applied can
206 differ from one organization to another. Accordingly, it is not the intent of this International Standard to
207 imply the need for uniformity in the structure of different quality management systems, or uniformity of
208 documentation to align to the clause structure of this International Standard, or to impose specific
209 terminology to be used within the organization.210 The quality management system requirements specified in this International Standard are
211 complementary to requirements for products and services.212 Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.
213 This International Standard can be used by internal and external parties, to assess the organization's
214 ability to consistently meet customer, statutory and regulatory requirements applicable to the products
215 and services it provides, the organization's own requirements and its aim to enhance customer
216 satisfaction.217 0.2 The ISO standards for quality management
218 This International Standard is one of the three core standards in the ISO portfolio of quality
219 management system standards.220
221 • ISO 9000 Quality management systems — Fundamentals and vocabulary provides an essential
222 background for the proper understanding and implementation of this International Standard. The
223 quality management principles described in detail in ISO 9000 were developed by ISO/TC 176,
224 and have been taken into consideration during the development of this International Standard.
225 These principles are not requirements in themselves, but they form the foundation of the
226 requirements specified by this International Standard. An outline of the quality management
227 principles is included in an Annex B to this International Standard.© ISO 2014 – All rights reserved 6 ISO/TC 176/SC2/WG24/N111
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228 • ISO 9001 (this International Standard) specifies requirements aimed primarily at giving confidence
229 in the products and services provided by an organization and thereby improving customer
230 satisfaction (see clause 1 Scope). Its proper implementation can also be expected to bring other
231 organizational benefits such as improved internal communication, better understanding and
232 control of the organization’s processes, and reduction in defects and waste.233
234 • ISO 9004 Managing for the sustained success of an organization - A quality management
235 approach provides guidance for organizations that choose to progress beyond the requirements of
236 this International Standard to address a broader range of topics that can lead to continual
237 improvement of the organization's overall performance. ISO 9004 includes guidance on a self-
238 assessment methodology for an organization to be able to evaluate the level of maturity of its
239 quality management system.240
241 Other standards that have been developed to support the implementation of a quality management
242 system include those in the ISO 10000 number range. These include guidelines on customer
243 satisfaction, quality plans, quality management in projects, configuration management, measurement
244 processes and measuring equipment, documentation, financial and economic benefits of quality
245 management, training, statistical techniques, the involvement and competence of people, selection of
246 quality management system consultants and auditing of management systems. These standards are
247 described further in Annex C of this International Standard.248 0.3 Process approach
249 Consistent and predictable results are achieved more effectively and efficiently when activities are
250 understood and managed as interrelated processes that function as a coherent system. This
251 International Standard promotes the adoption of a process approach when developing, implementing
252 and improving the effectiveness of a quality management system, to enhance customer satisfaction by
253 meeting customer requirements. Clause 4.4 of this International Standard includes specific
254 requirements considered essential to the adoption of a process approach.255 The process approach applies systematic definition and management of processes and their
256 interactions so as to achieve the intended results in accordance with the quality policy and strategic
257 direction of the organization. Management of the processes and the system as a whole can be
258 achieved using a “Plan-Do-Check-Act” (PDCA) methodology (see 0.4) with an overall focus on “Risk-
259 based thinking" aimed at preventing undesirable outcomes (see 0.5).260 When used within a quality management system, the process approach ensures:
261 a) understanding and consistently meeting requirements;
262 b) consideration of processes in terms of added value;
263 c) the achievement of effective process performance;
264 d) improvement of processes based on evaluation of data and information.
265 Figure 1 illustrates the process linkages between clauses 4 to 10 of this International Standard. This
266 shows that customers play a significant role in defining the input requirements that the organization
267 needs to meet at all stages of its quality management system. In addition, the needs and expectations
268 of other relevant interested parties can also play a role in defining those requirements. Monitoring of
269 customer satisfaction requires the evaluation of information relating to customer perceptions as to
270 whether the organization has met these requirements.271 The schematic model shown in Figure 1 covers all the requirements of this International Standard, but
272 does not show the individual processes at a detailed level. Each of these processes, and the system
273 as a whole, can be managed using the PDCA methodology described in clause 0.4 of this
274 International Standard.275
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276
277 Figure 1 - Model of a process-based quality management system, showing the links to the
278 clauses of this International Standard279
280 0.4 Plan-Do-Check-Act cycle
281 The methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes and to the
282 quality management system as a whole. The clauses of this International Standard broadly follow the
283 PDCA cycle which can be briefly described as follows:284
285 Plan: establish the objectives of the system and its component processes, and the resources
286 needed to deliver results in accordance with customers’ requirements and the organization’s
287 policies.288 Do: implement what was planned.
289 Check: monitor and (where applicable) measure processes and the resulting products and
290 services against policies, objectives and requirements, and report the results.
291 Act: take actions to improve process performance, as necessary.292 Figure 2 shows schematically how a single process within the quality management system can be
293 managed using the PDCA cycle.294
295
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oSIST prEN ISO 9001:2014
296
297 Figure 2 - Schematic representation of a single process within the system
298
299 0.5 “Risk-based thinking”
300 Risk is the effect of uncertainty on an expected result and the concept of risk-based thinking has
301 always been implicit in ISO 9001. This International Standard makes risk-based thinking more explicit
302 and incorporates it in requirements for the establishment, implementation, maintenance and continual
303 improvement of the quality management system. Organizations can choose to develop a more
304 extensive risk-based approach than is required by this International Standard, and ISO 31000
305 provides guidelines on formal risk management which can be appropriate in certain organizational
306 contexts.307
308 Not all the processes of the quality management system represent the same level of risk in terms of
309 the organization’s ability to meet its objectives, and the consequences of process, product, service or
310 system nonconformities are not the same for all organizations. For some organizations, the
311 consequences of delivering nonconforming products and services can result in minor inconvenience to
312 the customer; for others, the consequences can be far-reaching and fatal. “Risk-based thinking”
313 therefore means considering risk qualitatively (and, depending on the organization’s context,
314 quantitatively) when defining the rigour and degree of formality needed to plan and control the quality
315 management system, as well as its component processes and activities.316
317 0.6 Compatibility with other management system standards
318 This International Standard has adopted the “high-level structure” (i.e. clause sequence, common text
319 and common terminology) developed by ISO to improve alignment among...
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