Transport packages for dangerous goods - Dangerous goods packagings, intermediate bulk containers (IBCs) and large packagings - Guidelines for the application of ISO 9001 (ISO 16106:2020)

This document gives guidance on the application of a quality management system in the manufacture, measuring and monitoring of design type approved dangerous goods packaging, intermediate bulk containers (IBCs) and large packaging.
This document does not include guidance specific to other management systems, such as those for environmental management, occupational health and safety management, or financial management.
It is applicable to an organization that:
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 guidance in this document is generic and intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
NOTE       In this document, the terms "product" or "service" only apply to products and services intended for, or required by, a customer.
It does not apply to design type testing, for which reference is made to 6.1.5, 6.3.5, 6.5.6 and 6.6.5 of the UN Model Regulations[27].

Verpackungen zur Beförderung gefährlicher Güter - Gefahrgutverpackungen, Großpackmittel (IBC) und Großverpackungen - Leitfaden für die Anwendung von ISO 9001 (ISO 16106:2020)

Dieses Dokument bietet eine Anleitung zur Anwendung des Qualitätsmanagementsystems für die Herstellung, Messung und Überwachung zugelassener Bauarten von Verpackungen, Großpackmitteln (IBC) und Großverpackungen für gefährliche Güter.
Dieses Dokument enthält keine spezifische Anleitung zu anderen Managementsystemen, z. B. Umweltmanagement, Arbeitsschutzmanagement oder Finanzmanagement.
Es gilt für eine Organisation, die
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, einschließlich der Prozesse zur Verbesserung des Systems und der Zusicherung der Einhaltung von Anforderungen der Kunden und von zutreffenden gesetzlichen und behördlichen Anforderungen.
Alle Anleitungen in diesem Dokument sind allgemeiner Natur und auf jede Organisation zutreffend, unabhängig von deren Art oder Größe oder von der Art der von ihr bereitgestellten Produkte und Dienst-leistungen.
ANMERKUNG   In diesem Dokument bezieht sich die Benennung „Produkt“ bzw. „Dienstleistung“ nur auf solche Produkte und Dienstleistungen, die für einen Kunden vorgesehen sind oder von diesem gefordert werden.
Es ist nicht für die Bauartprüfung anzuwenden, auf die unter 6.1.5, 6.3.5, 6.5.6 und 6.6.5 der UN Empfehlungen verwiesen wird [27].

Emballages de transport pour marchandises dangereuses - Emballages pour marchandises dangereuses, grands récipients vrac (GRV) et grands emballages - Lignes directrices pour l'application de l'ISO 9001 (ISO 16106:2020)

Le présent document fournit des recommandations relatives à l'application d'un système de management de la qualité dans la production, la mesure et la surveillance du modèle type approuvé pour les emballages, les grands récipients vrac (GRV) et les grands emballages pour marchandises dangereuses.
Le présent document ne comporte pas de recommandations spécifiques à d'autres systèmes de management, tels que le management environnemental, le management de la santé et de la sécurité au travail ou la gestion financière.
Il s'applique à tout organisme qui:
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 recommandations du présent document 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       Dans le présent document, les termes «produit» ou «service» s'appliquent uniquement aux produits et services destinés à, ou exigés par, un client.
Elle ne s'applique pas aux essais de modèle type, au sujet desquels il est fait référence aux paragraphes 6.1.5, 6.3.5, 6.5.6 et 6.6.5 du Règlement type de l'ONU[27].

Transportna embalaža za nevarno blago - Embalaža za nevarno blago, vsebniki IBC in večja embalaža - Smernice za uporabo standarda ISO 9001 (ISO 16106:2020)

General Information

Status
Published
Publication Date
18-Feb-2020
Withdrawal Date
30-Aug-2020
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
19-Feb-2020
Completion Date
19-Feb-2020

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SLOVENSKI STANDARD
01-junij-2020
Nadomešča:
SIST EN ISO 16106:2006
Transportna embalaža za nevarno blago - Embalaža za nevarno blago, vsebniki
IBC in večja embalaža - Smernice za uporabo standarda ISO 9001 (ISO 16106:2020)
Transport packages for dangerous goods - Dangerous goods packagings, intermediate
bulk containers (IBCs) and large packagings - Guidelines for the application of ISO 9001
(ISO 16106:2020)
Verpackungen zur Beförderung gefährlicher Güter - Gefahrgutverpackungen,
Großpackmittel (IBC) und Großverpackungen - Leitfaden für die Anwendung der ISO
9001 (ISO 16106:2020)
Emballages de transport pour marchandises dangereuses - Emballages pour
marchandises dangereuses, grands récipients vrac (GRV) et grands emballages -
Lignes directrices pour l'application de l'ISO 9001 (ISO 16106:2020)
Ta slovenski standard je istoveten z: EN ISO 16106:2020
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
13.300 Varstvo pred nevarnimi Protection against dangerous
izdelki goods
55.180.99 Drugi standardi v zvezi z Other standards related to
distribucijo blaga s prevozom freight distribution of goods
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 16106
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2020
EUROPÄISCHE NORM
ICS 13.300; 55.020 Supersedes EN ISO 16106:2006
English Version
Transport packages for dangerous goods - Dangerous
goods packagings, intermediate bulk containers (IBCs) and
large packagings - Guidelines for the application of ISO
9001 (ISO 16106:2020)
Emballages de transport pour marchandises Verpackungen zur Beförderung gefährlicher Güter -
dangereuses - Emballages pour marchandises Gefahrgutverpackungen, Großpackmittel (IBC) und
dangereuses, grands récipients vrac (GRV) et grands Großverpackungen - Leitfaden für die Anwendung der
emballages - Lignes directrices pour l'application de ISO 9001 (ISO 16106:2020)
l'ISO 9001 (ISO 16106:2020)
This European Standard was approved by CEN on 8 February 2020.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, 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: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16106:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 16106:2020) has been prepared by Technical Committee ISO/TC 122
"Packaging" in collaboration with Technical Committee CEN/TC 261 “Packaging” the secretariat of
which is held by AFNOR.
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 August 2020, and conflicting national standards shall
be withdrawn at the latest by August 2020.
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 16106:2006.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 16106:2020 has been approved by CEN as EN ISO 16106:2020 without any modification.

INTERNATIONAL ISO
STANDARD 16106
Second edition
2020-02
Transport packages for dangerous
goods — Dangerous goods packagings,
intermediate bulk containers (IBCs)
and large packagings — Guidelines for
the application of ISO 9001
Emballages de transport pour marchandises dangereuses —
Emballages pour marchandises dangereuses, grands récipients vrac
(GRV) et grands emballages — Lignes directrices pour l'application
de l'ISO 9001
Reference number
ISO 16106:2020(E)
©
ISO 2020
ISO 16106:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

ISO 16106:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Context of the organization . 5
4.1 Understanding the organization and its context . 5
4.2 Understanding the needs and expectations of interested parties . 5
4.3 Determining the scope of the quality management system . 5
4.4 Quality management system and its processes . 6
5 Leadership . 6
5.1 Leadership and commitment . 6
5.1.1 General. 6
5.1.2 Customer focus . 7
5.2 Policy . 7
5.2.1 Establishing the quality policy . 7
5.2.2 Communicating the quality policy . 7
5.3 Organizational roles, responsibilities and authorities. 7
6 Planning . 8
6.1 Actions to address risks and opportunities . 8
6.2 Quality objectives and planning to achieve them . 8
6.3 Planning of changes . 9
7 Support . 9
7.1 Resources . 9
7.1.1 General. 9
7.1.2 People . 9
7.1.3 Infrastructure . 9
7.1.4 Environment for the operation of processes .10
7.1.5 Monitoring and measuring resources .10
7.1.6 Organizational knowledge .10
7.2 Competence .11
7.3 Awareness .11
7.4 Communication .11
7.5 Documented information .12
7.5.1 General.12
7.5.2 Creating and updating .12
7.5.3 Control of documented information .12
8 Operation .13
8.1 Operational planning and control .13
8.2 Requirements for products and services .13
8.2.1 Customer communication .13
8.2.2 Determining the requirements for products and services .
...

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