SIST EN ISO 16106:2020
(Main)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)
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)
EN-ISO 16106 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.$0$0It is applicable to an organization that) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements; 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.
Verpackungen zur Beförderung gefährlicher Güter - Gefahrgutverpackungen, Großpackmittel (IBC) und Großverpackungen - Leitfaden für die Anwendung der 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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 16106:2020
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
SIST EN ISO 16106:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 16106:2020
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SIST EN ISO 16106:2020
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.
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SIST EN ISO 16106:2020
EN ISO 16106:2020 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 16106:2020
EN ISO 16106:2020 (E)
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.
3
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SIST EN ISO 16106:2020
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SIST EN ISO 16106:2020
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
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SIST EN ISO 16106:2020
ISO 16106:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
---------------------- Page: 8 ----------------------
SIST EN ISO 16106:2020
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 .13
8.2.3 Review of the requirements for products and services .14
8.2.4 Changes to requirements for products and services .14
8.3 Design and development of products and services .14
8.3.1 General.14
8.3.2 Design and development planning .14
8.3.3 Design and development inputs .15
8.3.4 Design and development controls .15
8.3.5 Design and development outputs .16
8.3.6 Design and development changes . .16
© ISO 2020 – All rights reserved iii
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SIST EN ISO 16106:2020
ISO 16106:2020(E)
8.4 Control of externally provided processes, products and services .16
8.4.1 General.16
8.4.2 Type and extent of control .17
8.4.3 Information for external providers .17
8.5 Production and service provision .18
8.5.1 Control of production and service provision .18
8.5.2 Identification and traceability .18
8.5.3 Property belonging to customers or external providers .18
8.5.4 Preservation .19
8.5.5 Post-delivery activities .19
8.5.6 Control of changes .19
8.6 Release of products and services .19
8.7 Control of nonconforming outputs .20
9 Performance evaluation .20
9.1 Monitoring, measurement, analysis and evaluation .20
9.1.1 General.20
9.1.2 Customer satisfaction .21
9.1.3 Analysis and evaluation .21
9.2 Internal audit .22
9.3 Management review .22
9.3.1 General.22
9.3.2 Management review inputs .22
9.3.3 Management review outputs .23
10 Improvement .23
10.1 General .23
10.2 Nonconformity and corrective action .23
10.3 Continual improvement .24
Annex A (informative) Clarification of new structure, terminology and concepts .25
Annex B (informative) Other International Standards on quality management and quality
management systems developed by ISO/TC 176 .29
Annex C (informative) Packaging specification data .32
Annex D (informative) IBC specification data .38
Annex E (informative) Large packaging (LP) specification data .42
Annex F (informative) Notes to the packaging specifications of Annexes C, D and E .44
Annex G (informative) Items and elements of verification, controls, monitoring and validation .45
Annex H (informative) Examples of typical frequencies for the verification of conformity
with design and performance requirements .50
Bibliography .53
iv © ISO 2020 – All rights reserved
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SIST EN ISO 16106:2020
ISO 16106:2020(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 of the voluntary nature of standards, 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 www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 122, Packaging, Subcommittee SC 3,
Performance requirements and tests for means of packaging, packages and unit loads (as required by
ISO/TC 122).
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
This second edition cancels and replaces the first edition (ISO 16106:2006), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— ISO 9001:2015 has been integrated;
— the sector-specific requirements on quality management systems for transport packages for
dangerous goods into ISO 9001:2015 have been revised;
— new Annexes E and F have been created;
— editorial changes have been made.
© ISO 2020 – All rights reserved v
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SIST EN ISO 16106:2020
ISO 16106:2020(E)
Introduction
0.1 General
[27]
The United Nations Recommendations on the Transport of Dangerous Goods (referred to in this
document as the UN Model Regulations) require the application of a quality assurance programme
for the manufacture and testing of packagings, IBCs and large packagings that satisfies the competent
authority in order to ensure that each manufactured packaging, IBC and large packaging meets the
requirements.
The UN Model Regulations are given legal entity by the provision of a series of international modal
agreements and national legislation for the transport of dangerous goods. These international
agreements include:
— the European Agreement Concerning the International Carriage of Dangerous Goods by Road
[28]
(ADR) ;
[29]
— the Regulations Concerning the International Carriage of Dangerous Goods by Rail (RID) ;
— the International Civil Aviation Organization’s Technical Instructions for the Safe Transport of
[30]
Dangerous Goods by Air (ICAO TI) ;
[31]
— the International Maritime Dangerous Goods Code (IMDG) .
The application of this document should take into account the requirements of these international
agreements and the national legislation for the transport of dangerous goods.
In conjunction with ISO 9001, this document gives guidance on a system for applying quality processes
and assurance to the production of dangerous goods packagings, IBCs and large packagings.
The change in terminology in the ISO 9000 series from “quality assurance programmes” (1987 edition),
over “quality systems” (1994 edition) to “quality management systems” (2000 edition), is not reflected
in the UN Model Regulations and the international agreements referred to in the bibliography of this
document. The former term “quality assurance programme” is still used there. Furthermore, the term
“testing”, which was used in the 1994 edition of the ISO 9000 series in the context of product inspection
and testing was replaced by “measurement and monitoring” in the 2000 edition. For the purposes of this
document, the latest terminology is used, in accordance with ISO 9000. This difference in terminology
should not deter users from using this document.
This document is based on Revision 19 of the UN Model Regulations.
This document is an application standard for transport packages for dangerous goods, which contains
the text of ISO 9001:2015.
For an explanation of how this document was prepared, see Annex A.
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
document 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 document can be used by internal and external parties.
vi © ISO 2020 – All rights reserved
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SIST EN ISO 16106:2020
ISO 16106:2020(E)
It is not the intent of this document to prescribe:
— uniformity in the structure of different quality management systems;
— alignment of documentation to the clause structure of this document;
— the use of the specific terminology of this document within the organization.
The quality management system requirements specified in this document are complementary to
requirements for products and services.
This document 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 thi
...
SLOVENSKI STANDARD
oSIST prEN ISO 16106:2018
01-oktober-2018
7UDQVSRUWQDHPEDODåD]DQHYDUQHVQRYL(PEDODåD]DQHYDUQHVQRYLYVHEQLNL,%&
LQYHþMDHPEDODåD6PHUQLFH]DXSRUDERVWDQGDUGD,62 ,62',6
Transport packages for dangerous goods - Dangerous goods packagings, intermediate
bulk containers (IBCs) and large packagings - Guidelines for the application of ISO 9001
(ISO/DIS 16106:2018)
Verpackungen zur Beförderung gefährlicher Güter - Gefahrgutverpackungen,
Großpackmittel (IBC) und Großverpackungen - Leitfaden für die Anwendung der ISO
9001 (ISO/DIS 16106:2018)
Emballages de transport pour marchandises dangereuses - Emballages pour
marchandises dangereuses, grands récipients vrac (GRV) et grands emballages -
Directives pour l'application de l'ISO 9001 (ISO/DIS 16106:2018)
Ta slovenski standard je istoveten z: prEN ISO 16106
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
oSIST prEN ISO 16106:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 16106:2018
---------------------- Page: 2 ----------------------
oSIST prEN ISO 16106:2018
DRAFT INTERNATIONAL STANDARD
ISO/DIS 16106
ISO/TC 122/SC 3 Secretariat: BSI
Voting begins on: Voting terminates on:
2018-07-30 2018-10-22
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 — Directives pour l'application de l'ISO 9001
ICS: 55.020; 13.300
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
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 16106:2018(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 2018
---------------------- Page: 3 ----------------------
oSIST prEN ISO 16106:2018
ISO/DIS 16106:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
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 2018 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 16106:2018
ISO/DIS 16106:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Context of the organization . 2
4.1 Understanding the organization and its context . 2
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 . 3
5 Leadership . 3
5.1 Leadership and commitment . 3
5.1.1 General. 3
5.1.2 Customer focus . 4
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 . 5
6.1 Actions to address risks and opportunities . 5
6.2 Quality objectives and planning to achieve them . 5
6.3 Planning of changes . 6
7 Support . 6
7.1 Resources . 6
7.1.1 General. 6
7.1.2 People . 6
7.1.3 Infrastructure . 7
7.1.4 Environment for the operation of processes . 7
7.1.5 Monitoring and measuring resources . 7
7.1.6 Organizational knowledge . 8
7.2 Competence . 8
7.3 Awareness . 8
7.4 Communication . 9
7.5 Documented information . 9
7.5.1 General. 9
7.5.2 Creating and updating . 9
7.5.3 Control of documented information . 9
8 Operation .10
8.1 Operational planning and control .10
8.2 Requirements for products and services .10
8.2.1 Customer communication .10
8.2.2 Determining the requirements for products and services .11
8.2.3 Review of the requirements for products and services .11
8.2.4 Changes to requirements for products and services .11
8.3 Design and development of products and services .12
8.3.1 General.12
8.3.2 Design and development planning .12
8.3.3 Design and development inputs .12
8.3.4 Design and development controls .12
8.3.5 Design and development outputs .13
8.3.6 Design and development changes . .13
© ISO 2018 – All rights reserved iii
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oSIST prEN ISO 16106:2018
ISO/DIS 16106:2018(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 .14
8.4.3 Information for external providers .14
8.5 Production and service provision .15
8.5.1 Control of production and service provision .15
8.5.2 Identification and traceability .15
8.5.3 Property belonging to customers or external providers .16
8.5.4 Preservation .16
8.5.5 Post-delivery activities .16
8.5.6 Control of changes .16
8.6 Release of products and services .16
8.7 Control of nonconforming outputs .17
9 Performance evaluation .17
9.1 Monitoring, measurement, analysis and evaluation .17
9.1.1 General.17
9.1.2 Customer satisfaction .18
9.1.3 Analysis and evaluation .18
9.2 Internal audit .19
9.3 Management review .19
9.3.1 General.19
9.3.2 Management review inputs .20
9.3.3 Management review outputs .20
10 Improvement .20
10.1 General .20
10.2 Nonconformity and corrective action .21
10.3 Continual improvement .21
Annex A (informative) Clarification of new structure, terminology and concepts .22
Annex B (informative) Other International Standards on quality management and quality
management systems developed by ISO/TC 176 .26
Annex C (normative) Packaging specifications data .29
Annex D (normative) IBC specifications data .35
Annex E (normative) Large packaging (LP) specification data .39
Annex F (informative) Notes to the packaging specifications of annex C, D and E .41
Annex G (normative) Items and elements of verification, controls, monitoring and validation .42
Annex H (informative) Examples of typical frequencies for the verification of conformity
with design and performance requirements .47
Bibliography .50
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oSIST prEN ISO 16106:2018
ISO/DIS 16106:2018(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 voluntary nature of standards, 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.
This document was prepared by Technical Committee ISO/TC 122, Packaging, Subcommittee SC 3,
Performance requirements and tests for means of packaging, packages and unit loads (as required by ISO/
TC 122).
This second edition cancels and replaces the firstedition (ISO 16106:2006), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— the integration of ISO 9001:2015;
— the revision of the sector-specific requirements on quality management systems for transport
packages for dangerous goods into ISO 9001:2015
— the inclusion of Annex E " Large packaging specification";
— the inclusion of Annex F "Notes on annexes C to E";
— editorial changes.
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oSIST prEN ISO 16106:2018
ISO/DIS 16106:2018(E)
Introduction
0.1 General
This International Standard gives guidance for the application of the quality management system to
the manufacture, measuring and monitoring of design type approved dangerous goods packagings,
Intermediate Bulk Containers (IBCs) and large packagings.
[1]
The United Nations Recommendations on the Transport of Dangerous Goods (referred to in this
International Standard as the UN Model Regulations) require the application of a quality assurance
programme for the manufacture and testing of packagings, IBCs and large packagings that satisfies the
competent authority in order to ensure that each manufactured packaging, IBC and large packaging
meets the requirements.
The UN Model Regulations are given legal entity by the provision of a series of international modal
agreements and national legislation for the transport of dangerous goods. These international
agreements include
— the European Agreement Concerning the International Carriage of Dangerous Goods by Road
[2]
(ADR);
[3]
— the Regulations Concerning the International Carriage of Dangerous Goods by Rail (RID);
— the International Civil Aviation Organization’s Technical Instructions for the Safe Transport of
[4]
Dangerous Goods by Air (ICAO TI);
[5]
— the International Maritime Dangerous Goods Code (IMDG).
The application of this International Standard will need to take into account the requirements of these
international agreements and the national legislation for the transport of dangerous goods.
Compliance with this International Standard does not replace the agreement of competent authorities
with quality assurance programmes. In conjunction with ISO 9001, this International Standard
specifies a system for applying quality processes and assurance to the production of dangerous goods
packagings, IBCs and large packagings.
The change in terminology in the ISO 9000- series from “quality assurance programmes” (1987
edition), over “quality systems” (1994 edition) to “quality management systems” (2000 edition),
is not reflected in the UN Model Regulations and the international agreements referred to in the
bibliography of this International Standard. The former term “quality assurance programme” is still
used there. Furthermore, the term “testing”, which was used in the 1994 edition of the ISO 9000- series
in the context of product inspection and testing has been replaced by “measurement and monitoring”
in the 2000 edition. For the purposes of this International Standard, the latest terminology is used
in accordance with ISO 9000. This difference in terminology should not deter users from using this
International Standard.
This International Standard is based on Revision 19 of the UN Model Regulations.
This International Standard is an application standard for transport packages for dangerous goods,
which contains the text of ISO 9001:2015.
The conventions for the layout of this International Standard are the following.
— Those clauses, subclauses or annexes that are quoted directly and unchanged from ISO 9001:2015
and ISO 9000:2015 (under clause 3 terms and definitions) are in black text.
— Additional GMP related requirements and recommendations as well as terms and definitions
relevant to the manufacturer of primary packaging materials are in blue text.
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.
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oSIST prEN ISO 16106:2018
ISO/DIS 16106:2018(E)
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.
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.
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oSIST prEN ISO 16106:2018
ISO/DIS 16106:2018(E)
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 involv
...
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