EN ISO 15378:2017
(Main)Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
ISO 15378:2017 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 this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
NOTE 1 In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards.
In ISO 15378:2017 the term "if appropriate" is used several times. When a requirement is qualified by this phrase, it is deemed to be "appropriate" unless the organization can document a justification otherwise.
ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.
Primärpackmittel für Arzneimittel - Besondere Anforderungen für die Anwendung von ISO 9001:2015 entsprechend der Guten Herstellungspraxis (GMP) (ISO 15378:2017)
Diese Internationale Norm legt Anforderungen an ein Qualitätsmanagementsystem fest, wenn eine Organisation
a) ihre Fähigkeit darlegen muss, beständig Produkte und Dienstleistungen bereitstellen zu können, die die Anforderungen der Kunden und die zutreffenden gesetzlichen und behördlichen Anforderungen erfüllen, und
b) danach strebt, die Kundenzufriedenheit durch wirksame Anwendung des Systems zu erhöhen, ein-schließlich der Prozesse zur Verbesserung des Systems und der Zusicherung der Einhaltung von Anforderungen der Kunden und von zutreffenden gesetzlichen und behördlichen Anforderungen.
Alle in dieser Internationalen Norm festgelegten Anforderungen sind allgemeiner Natur und auf jede Organisation zutreffend, unabhängig von deren Art oder Größe oder von der Art der von ihr bereitgestellten Produkte und Dienstleistungen.
ANMERKUNG 1 In dieser Internationalen Norm bezieht sich die Benennung „Produkt“ bzw. „Dienstleistung“ nur auf solche Produkte und Dienstleistungen, die für einen Kunden vorgesehen sind oder von diesem gefordert werden.
ANMERKUNG 2 Gesetzliche und behördliche Anforderungen können auch als rechtliche Anforderungen bezeichnet werden.
Zusätzlich zu ISO 9001 legt dieses Dokument auf Primärpackmittel anwendbare Gute Herstellungspraxis (GMP)-Anforderungen für ein Qualitätsmanagementsystem fest, bei dem eine Organisation ihre Fähigkeit nachweisen muss, Primärpackmittel für Arzneimittel zu liefern, die stets den Anforderungen der Kunden, inklusive der gesetzlichen Bestimmungen und anwendbaren Internationalen Normen, entsprechen.
In diesem Dokument wird mehrfach der Begriff „falls angemessen“ verwendet. Wenn eine Anforderung auf diese Weise bezeichnet wird, wird sie als „angemessen“ betrachtet, solange die Organisation nicht eine anderweitige Begründung dokumentieren kann.
Dieses Dokument ist eine Anwendungsnorm für die Entwicklung, Herstellung und Lieferung von Primärpackmitteln für Arzneimittel.
Articles d'emballage primaire pour médicaments - Exigences particulières pour l'application de l'ISO 9001:2015 prenant en considération les Bonnes Pratiques de Fabrication (BPF) (ISO 15378:2017)
L'ISO 15378 :2017 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 15378 :2017 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.
NOTE 1 Dans l'ISO 15378 :2017, les termes «produit» ou «service» s'appliquent uniquement aux produits et services destinés à, ou exigés par, un client.
NOTE 2 L'expression «legal requirement» recouvre en anglais le concept, utilisé dans l'ISO 15378 :2017, d'exigence légale et réglementaire.
En complément de l'ISO 9001, le présent document spécifie les exigences des Bonnes Pratiques de Fabrication (BPF) applicables aux articles d'emballage primaire pour un système de management de la qualité lorsqu'un organisme doit démontrer son aptitude à fournir des articles d'emballage primaire pour médicaments satisfaisant en permanence aux exigences des clients, y compris les exigences réglementaires et les Normes internationales.
Dans le présent document, l'expression «si approprié» est utilisée plusieurs fois. Lorsqu'une exigence est qualifiée par cette expression, elle est réputée «appropriée» à moins que l'organisme ne puisse documenter une justification contraire.
Le présent document est une norme d'application destinée à la conception, à la fabrication et à la fourniture d'articles d'emballage primaire pour médicaments.
Primarni embalažni materiali za zdravila - Posebne zahteve za uporabo ISO 9001:2015 v povezavi z dobro proizvodno prakso (DPP) (ISO 15378:2017)
Ta dokument, poleg standarda ISO 9001, določa zahteve za dobro proizvodno prakso, ki se uporabljajo za primarne embalažne materiale v sistemu vodenja kakovosti v primerih, ko mora organizacija izkazati svojo zmožnost dobave primarnih embalažnih materialov za zdravila, ki dosledno izpolnjujejo zahteve strank ter zakonodajne zahteve.
V tem dokumentu je večkrat uporabljen izraz »če je primerno«. Kadar je v zahtevi dodana fraza »če je primerno«, se šteje, da je zahtevo treba upoštevati, razen če lahko organizacija dokumentira drugo utemeljitev.
Ta dokument je aplikacijski standard za načrtovanje, izdelavo in dobavo primarnih embalažnih materialov za zdravila.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2018
1DGRPHãþD
SIST EN ISO 15378:2015
Primarni embalažni materiali za zdravila - Posebne zahteve za uporabo ISO
9001:2015 v povezavi z dobro proizvodno prakso (DPP) (ISO 15378:2017)
Primary packaging materials for medicinal products - Particular requirements for the
application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO
15378:2017)
Primärpackmittel für Arzneimittel - Besondere Anforderungen für die Anwendung von
ISO 9001:2015 entsprechend der Guten Herstellungspraxis (GMP) (ISO 15378:2017)
Articles d'emballage primaire pour médicaments - Exigences particulières pour
l'application de l'ISO 9001:2015 prenant en considération les Bonnes Pratiques de
Fabrication (BPF) (ISO 15378:2017)
Ta slovenski standard je istoveten z: EN ISO 15378:2017
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.040.01 Medicinska oprema na Medical equipment in general
splošno
55.040 0DWHULDOLLQSULSRPRþNL]D Packaging materials and
SDNLUDQMH accessories
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 15378
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2017
EUROPÄISCHE NORM
ICS 03.100.70; 11.040.01 Supersedes EN ISO 15378:2015
English Version
Primary packaging materials for medicinal products -
Particular requirements for the application of ISO
9001:2015, with reference to good manufacturing practice
(GMP) (ISO 15378:2017)
Articles d'emballage primaire pour médicaments - Primärpackmittel für Arzneimittel - Besondere
Exigences particulières pour l'application de l'ISO Anforderungen für die Anwendung von ISO 9001:2015
9001:2015 prenant en considération les Bonnes entsprechend der Guten Herstellungspraxis (GMP)
Pratiques de Fabrication (BPF) (ISO 15378:2017) (ISO 15378:2017)
This European Standard was approved by CEN on 13 October 2017.
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, Serbia, 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
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15378:2017 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 15378:2017) has been prepared by Technical Committee ISO/TC 76
“Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical
use”.
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 April 2018, and conflicting national standards shall be
withdrawn at the latest by April 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15378:2015.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 15378:2017 has been approved by CEN as EN ISO 15378:2017 without any modification.
INTERNATIONAL ISO
STANDARD 15378
Fourth edition
2017-09
Primary packaging materials for
medicinal products — Particular
requirements for the application of
ISO 9001:2015, with reference to good
manufacturing practice (GMP)
Articles d'emballage primaire pour médicaments — Exigences
particulières pour l'application de l'ISO 9001:2015 prenant en
considération les bonnes pratiques de fabrication (BPF)
Reference number
ISO 15378:2017(E)
©
ISO 2017
ISO 15378:2017(E)
© ISO 2017, 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
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
ISO 15378:2017(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
3.1 Terms related to organization. 2
3.2 Terms related to activity . 3
3.3 Terms related to system . 4
3.4 Terms related to requirement . 5
3.5 Terms related to process . 6
3.6 Terms related to results . 7
3.7 Terms related to data, information and document . 8
3.8 Terms related to action . 9
3.9 Terms related to characteristic .10
3.10 Terms related to determination .10
3.11 Terms relating to risk management .11
4 Context of the organization .12
4.1 Understanding the organization and its context .12
4.2 Understanding the needs and expectations of interested parties .12
4.3 Determining the scope of the quality management system .13
4.4 Quality management system and its processes .13
5 Leadership .14
5.1 Leadership and commitment .14
5.1.1 General.14
5.1.2 Customer focus .15
5.1.3 Customer audits.15
5.2 P olicy .15
5.3 Organizational roles, responsibilities and authorities.16
6 Planning .17
6.1 Actions to address risks and opportunities .17
6.2 Quality objectives and planning to achieve them .18
6.3 Planning of changes .19
7 Support .19
7.1 Resources .19
7.1.1 General.19
7.1.2 People .19
7.1.3 Infrastructure .20
7.1.4 Environment for the operation of processes .21
7.1.5 Monitoring and measuring resources .23
7.1.6 Organizational knowledge .24
7.2 Competence .24
7.2.1 General.24
7.2.2 GMP-training .24
7.3 Awareness .
...
ba
S L O V E N S K I SIST EN ISO 15378
S T A N D A R D
januar 2018
Primarni embalažni materiali za zdravila – Posebne zahteve za uporabo
ISO 9001:2015 v povezavi z dobro proizvodno prakso (DPP) (ISO 5378:2017)
Primary packaging materials for medicinal products – Particular requirements for
the application of ISO 9001:2015, with reference to good manufacturing practice
(DPP) (ISO 15378:2017)
Articles d'emballage primaire pour médicaments - Exigences particulières pour
l'application de l'ISO 9001:2015 prenant en considération les Bonnes Pratiques de
Fabrication (BPF) (ISO 15378:2017)
Primärpackmittel für Arzneimittel – Besondere Anforderungen für die Anwendung
von ISO 9001:2015 entsprechend der Guten Herstellungspraxis (DPP)
(ISO 15378:2017)
Referenčna oznaka
ICS 03.120.10; 11.040.01; 55.040 SIST EN ISO 15378:2018 (sl)
Nadaljevanje na straneh II in III ter od 1 do 132
© 2023-04. Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
SIST EN ISO 15378 : 2018
NACIONALNI UVOD
Standard SIST EN ISO 15378 (sl, en), Primarni embalažni materiali za zdravila – Posebne zahteve za
uporabo ISO 9001:2015 v povezavi z dobro proizvodno prakso (DPP) (ISO 15378:2017), 2018, ima
status slovenskega standarda in je istoveten evropskemu standardu EN ISO 15378 (en), Primary
packaging materials for medicinal products – Particular requirements for the application of ISO
9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017), 2017.
Ta standard nadomešča SIST EN ISO 15378:2015
NACIONALNI PREDGOVOR
Evropski standard EN ISO 15378:2017 je pripravil tehnični odbor ISO/TC 76 Transfuzijski, infuzijski in
injekcijski pripomočki ter oprema za obdelavo krvi za uporabo v medicini in farmaciji. Slovenski standard
V primeru spora glede besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski
standard v angleškem jeziku. Slovensko-angleško izdajo standarda je pripravil SIST/TC VZK Vodenje
in zagotavljanje kakovosti.
Odločitev za privzem tega standarda je 26. oktobra 2017 sprejel tehnični odbor SIST/TC VZK Vodenje
in zagotavljanje kakovosti.
ZVEZA S STANDARDI
S privzemom tega evropskega standarda veljajo za omejeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen standarda, ki smo ga že sprejeli v nacionalno standardizacijo:
SIST EN ISO 9000:2015 (sl, en) Sistemi vodenja kakovosti – Osnove in slovar (ISO 9000:2015)
SIST EN ISO 9001:2015 (sl, en) Sistemi vodenja kakovosti – Zahteve (ISO 9001:2015)
SIST EN ISO 9004:2018 (sl, en) Vodenje kakovosti – Kakovost organizacije – Napotki za doseganje
trajne uspešnosti (ISO 9004:2018)
OSNOVA ZA IZDAJO STANDARDA
– privzem standarda EN ISO 15378:2017
PREDHODNA IZDAJA
– SIST EN ISO 15378:2015, Primarni embalažni materiali za zdravila – Posebne zahteve za uporabo
ISO 9001:2008 v povezavi z dobro proizvodno prakso (DPP) (ISO 15378:2015)
OPOMBE
Povsod, kjer se v besedilu standarda uporablja izraz ''evropski standard'' ali ''mednarodni
standard'', v SIST EN ISO 15378:2018 to pomeni ''slovenski standard''.
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
II
SIST EN 61140 : 2016
Ta nacionalni dokument je istoveten EN ISO 15378:2017 in je objavljen z dovoljenjem
CEN-CENELEC
Avenue Marnix 17
1000 Bruselj
Belgija
This national document is identical with EN ISO 15378:2017 and is published with the permission
of
CEN-CEMELEC
Avenue Marnix 17
1000 Bruxelles
Belgium
III
SIST EN ISO 15378 : 2018
(prazna stran)
IV
EVROPSKI STANDARD EN ISO 15378
EUROPEAN STANDARD
NORME EUROPÉENNE
oktober 2017
EUROPÄISCHE NORM
ICS 03.120.10; 11.040.01; 55.040 Nadomešča EN ISO 15378:2015
Slovenska izdaja
Primarni embalažni materiali za zdravila – Posebne zahteve za
uporabo ISO 9001:2015 v povezavi z dobro proizvodno prakso (DPP)
(ISO 15378:2017)
Primary packaging materials for Articles d'emballage primaire pour Primärpackmittel für Arzneimittel –
medicinal products – Particular médicaments – Exigences Besondere Anforderungen für die
requirements for the application of particulières pour l'application de Anwendung von ISO 9001:2015
ISO 9001:2015, with reference to l'ISO 9001:2015 prenant en entsprechend der Guten
good manufacturing practice considération les Bonnes Herstellungspraxis (DPP) (ISO
(DPP) (ISO 15378:2017) Pratiques de Fabrication (BPF) 15378:2017)
(ISO 15378:2017)
Ta evropski standard je CEN sprejel dne 13. oktobra 2017.
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 zahtevo na voljo pri Upravnem
centru CEN-CENELEC ali članih CEN.
Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). 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, Srbije, Španije, Švedske, Švice, Turčije in
Združenega kraljestva.
CEN
Evropski komite za standardizacijo
European Committee for Standardization
Comité Européen de Normalisation
Europäisches Komitee für Normung
Upravni center CEN-CENELEC: Avenue Marnix 17, B-1000 Bruselj
© 2017 CEN Vse pravice do izkoriščanja v kakršnikoli obliki in na kakršenkoli Ref. št. EN ISO 15378:2017 E
način imajo nacionalni člani CEN.
SIST EN ISO 15378 : 2018
Evropski predgovor European foreword
Ta dokument (EN ISO 15378:2017) je pripravil This document (EN ISO 15378:2017) has
tehnični odbor ISO/TC 76 "Transfuzijski, been prepared by Technical Committee
infuzijski in injekcijski pripomočki ter oprema ISO/TC 76 “Transfusion, infusion and
za obdelavo krvi za uporabo v medicini in injection, and blood processing equipment for
farmaciji". medical and pharmaceutical use”.
Ta evropski standard mora z objavo This European Standard shall be given the
istovetnega besedila ali z razglasitvijo dobiti status of a national standard, either by
status nacionalnega standarda najpozneje do publication of an identical text or by
aprila 2018, nacionalne standarde, ki so v endorsement, at the latest by April 2018, and
nasprotju s tem standardom, pa je treba conflicting national standards shall be
umakniti najpozneje do aprila 2018. withdrawn at the latest by April 2018.
Opozoriti je treba na možnost, da je nekaj Attention is drawn to the possibility that some
elementov tega dokumenta lahko predmet of the elements of this document may be the
patentnih pravic. CEN ne prevzema subject of patent rights. CEN shall not be held
odgovornosti za identifikacijo katerihkoli ali responsible for identifying any or all such
vseh takih patentnih pravic. patent rights.
Ta dokument nadomešča standard EN ISO This document supersedes EN ISO
15378:2015. 15378:2015.
V skladu z notranjimi pravili CEN-CENELEC According to the CEN-CENELEC Internal
morajo ta evropski standard prevzeti Regulations, the national standards
nacionalne organizacije za standarde organizations of the following countries are
naslednjih držav: Avstrije, Belgije, Bolgarije, bound to implement this European Standard:
Cipra, Češke republike, Danske, Estonije, Austria, Belgium, Bulgaria, Croatia, Cyprus,
Finske, Francije, Grčije, Hrvaške, Irske, Czech Republic, Denmark, Estonia, Finland,
Islandije, Italije, Latvije, Litve, Luksemburga, Former Yugoslav Republic of Macedonia,
Madžarske, Malte, Nekdanje jugoslovanske France, Germany, Greece, Hungary, Iceland,
republike Makedonije, Nemčije, Nizozemske, Ireland, Italy, Latvia, Lithuania, Luxembourg,
Norveške, Poljske, Portugalske, Romunije, Malta, Netherlands, Norway, Poland,
Slovaške, Slovenije, Srbije, Španije, Švedske, Portugal, Romania, Serbia, Slovakia,
Švice, Turčije in Združenega kraljestva. Slovenia, Spain, Sweden, Switzerland, Turkey
and the United Kingdom.
Razglasitvena objava Endorsement notice
Besedilo mednarodnega standarda ISO The text of ISO 15378:2017 has been
15378:2017 je CEN odobril kot evropski approved by CEN as EN ISO 15378:2017
standard EN ISO 15378:2017 brez without any modification.
kakršnihkoli sprememb.
SIST EN ISO 15378 : 2018
VSEBINA Stran CONTENTS Page
Evropski predgovor . 2 European foreword . 2
Predgovor . 6 Foreword . . 6
Uvod . 8 Introduction . 8
1 Področje uporabe . 18 1 Scope .18
2 Zveze s standardi . 19 2 Normative references .19
3 Izrazi in definicije . 19 3 Terms and definitions .19
3.1 Izrazi v zvezi z organizacijo . 20 3.1 Terms related to organization .20
3.2 Izrazi v zvezi z aktivnostjo . 21 3.2 Terms related to activity .21
3.3 Izrazi v zvezi s sistemom . 23 3.3 Terms related to system .23
3.4 Izrazi v zvezi z zahtevami . 24 3.4 Terms related to requirement .24
3.5 Izrazi v zvezi s procesi . 25 3.5 Terms related to process .25
3.6 Izrazi v zvezi z rezultati . 27 3.6 Terms related to results .27
3.7 Izrazi v zvezi s podatki, informacijami in 3.7 Terms related to data, information and
dokumenti . 28 document .28
3.8 Izrazi v zvezi z ukrepi . 30 3.8 Terms related to action .30
3.9 Izrazi v zvezi s karakteristikami . 31 3.9 Terms related to characteristic .31
3.10 Izrazi v zvezi z opredeljevanjem . 31 3.10 Terms related to determination .31
3.11 Izrazi v zvezi z obvladovanjem 3.11 Terms relating to risk management .32
tveganja . 32
4 Kontekst organizacije . 33 4 Context of the organization .33
4.1 Razumevanje organizacije in njenega 4.1 Understanding the organization and its
konteksta . 33 context .33
4.2 Razumevanje potreb in pričakovanj 4.2 Understanding the needs and expectations
zainteresiranih strani . 34 of interested parties .34
4.3 Opredeljevanje področja uporabe sistema 4.3 Determining the scope of the quality
vodenja kakovosti . 34 management system .34
4.4 Sistem vodenja kakovosti in njegovi 4.4 Quality management system and its
procesi . 35 processes .35
5 Voditeljstvo . 36 5 Leadership .36
5.1 Voditeljstvo in zavezanost . 36 5.1 Leadership and commitment .36
5.1.1 Splošno . 36 5.1.1 General .36
5.1.2 Osredotočenost na odjemalce . 37 5.1.2 Customer focus .37
5.1.3 Presoje odjemalcev . 38 5.1.3 Customer audits .38
5.2 Politika . 38 5.2 Policy .38
5.3 Vloge, odgovornosti in pooblastila 5.3 Organizational roles, responsibilities and
organizacije . 39 authorities .39
6 Planiranje . 40 6 Planning .40
6.1 Ukrepi za obravnavanje tveganj in 6.1 Actions to address risks and
priložnosti . 40 opportunities .40
6.2 Cilji kakovosti in planiranje za njihovo 6.2 Quality objectives and planning to
doseganje . 41 achieve them .41
6.3 Planiranje sprememb . 42 6.3 Planning of changes .42
SIST EN ISO 15378 : 2018
7 Podpora . 43 7 Support .43
7.1 Viri . 43 7.1 Resources .43
7.1.1 Splošno . 43 7.1.1 General .43
7.1.2 Ljudje . 43 7.1.2 People .43
7.1.3 Infrastruktura . 43 7.1.3 Inf
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