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 —
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Emballages pour marchandises dangereuses, grands récipients vrac
(GRV) et grands emballages — Lignes directrices pour l'application
(standards.iteh.ai)
de l'ISO 9001

ISO 16106:2020
https://standards.iteh.ai/catalog/standards/sist/f8df7a5c-3374-4924-bb44-
ec7d92d06df5/iso-16106-2020

Reference number
ISO 16106:2020(E)

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ISO 16106:2020(E)


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ISO 16106:2020
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 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
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6.1 Actions to address risks and opportunities.................................................................................................................... 8
6.2 (standards.iteh.ai)
Quality objectives and planning to achieve them....................................................................................................... 8
6.3 Planning of changes............................................................................................................................................................................. 9
7 Support............................................................................................................................................................................................................................
ISO 16106:2020 9
7.1 Resources...................................................................................................................................................................................................... 9
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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

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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
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10.1 General......................................................................................................................................................................................................... 23
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10.2 Nonconformity and corrective action............................................................................................................................... 23
10.3 Continual improvement................................................................................................................................................................ 24
Annex A (informative) Clarification of new structure, ISO 16106:2020 terminology and concepts.............................................25
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Annex B (informative) Other International Standards on quality management and quality
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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

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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
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World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www​.iso​.org/​
iso/​foreword​.html. (standards.iteh.ai)
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 16106:2020
ISO/TC 122). https://standards.iteh.ai/catalog/standards/sist/f8df7a5c-3374-4924-bb44-
ec7d92d06df5/iso-16106-2020
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.

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Introduction
0.1   General
The United Nations Recommendations on the Transport of Dangerous Goods[27] (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
(ADR)[28];
— the Regulations Concerning the International Carriage of Dangerous Goods by Rail (RID)[29];
— the International Civil Aviation Organization’s Technical Instructions for the Safe Transport of
Dangerous Goods by Air (ICAO TI)[30];
— the International Maritime Dangerous Goods Code (IMDG)[31].
The application of this document should take into account the requirements of these international
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agreements and the national legislation for the transport of dangerous goods.

(standards.iteh.ai)
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 seriesISO 16106:2020
from “quality assurance programmes” (1987 edition),
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over “quality systems” (1994 edition) to “quality management systems” (2000 edition), is not reflected
in the UN Model Regulations and the international ec7d92d06df5/iso-16106-2020
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.

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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 thinking enables an organization to determine the factors that can 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 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 can find it necessary to adopt various forms of improvement in addition to correction and
continual improvement, such as breakthrough change, innovation and re-organization.
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0.2   Quality management principles
(standards.iteh.ai)
This document 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,
ISO 16106:2020
some examples of benefits associated with the principle and examples of typical actions to improve the
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organization's performance when applying the principle.
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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 document 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

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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.

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ISO 16106:2020
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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 document.

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Figure 2 — Representation of the structure of this document in the PDCA cycle
(standards.iteh.ai)
The PDCA cycle can be briefly described as follows:
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— Plan: establishhttps://standards.iteh.ai/catalog/standards/sist/f8df7a5c-3374-4924-bb44-
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
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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 A.4) is essential for achieving an effective quality management system.
The concept of risk-based thinking was implicit in the previous editions of this document including,
for example, carrying out preventive action to eliminate potential nonconformities, analysing any
nonconformities that do occur, and taking action to prevent recurrence that is appropriate for the
effects of the nonconformity.
To conform to the requirements of this document, an organization needs to plan and implement
actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis
for increasing the effectiveness of the quality management system, achieving improved results and
preventing negative effects.
Opportunities can arise as a result of a situation favourable to achieving an intended result, for
example, a set of circumstances that allow the organization to attract customers, develop new products
and services, reduce waste or improve productivity. Actions to address opportunities can also include
consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have
positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not
all positive effects of risk result in opportunities.

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0.4   Relationship with other management system standards

This document applies the framework developed by ISO to improve alignment among its International
Standards for management systems (see A.1).
This document enables an organization to use the process approach, coupled with the PDCA cycle and
risk-based thinking, to align or integrate its quality management system with the requirements of
other management system standards.
This document relates to ISO 9000 and ISO 9004 as follows:
— ISO 9000 provides essential background for the proper understanding and implementation of this
document;
— ISO 9004 provides guidance for organizations that choose to progress beyond the requirements of
this document.
Annex B provides details of other International Standards on quality management and quality
management systems that have been developed by ISO/TC 176.
Sector-specific quality management system standards based on the requirements of this document
have been developed for a number of sectors. Some of these standards specify additional quality
management system requirements, while others are limited to providing guidance to the application of
this document within a particular sector.

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(standards.iteh.ai)
ISO 16106:2020
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INTERNATIONAL STANDARD ISO 16106:2020(E)

Transport packages for dangerous goods — Dangerous

goods packagings, intermediate bulk containers (IBCs)
and large packagings — Guidelines for the application of
ISO 9001

1 Scope
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
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processes for improvement of the system and the assurance of conformity to customer and
(standards.iteh.ai)
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 ISO 16106:2020
and services it provides.
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NOTE In this document, the termsec7d92d06df5/iso-16106-2020
“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].

2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000, Quality management systems — Fundamentals and vocabulary

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 9000 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://​w ww​.iso​.org/​obp
— IEC Electropedia: available at http://​w ww​.electropedia​.org/​

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3.1
organization
person or group of people that has its own functions with responsibilities, authorities and relationships
to achieve its objectives (3.8)
Note 1 to entry: The concept of organization includes, but is not limited to, sole-trader, company, corporation, firm,
enterprise, authority, partnership, charity or institution, or part or combination thereof, whether incorporated
or not, public or private.

3.2
interested party
stakeholder
person or organization (3.1) that can affect, be affected by, or perceive itself to be affected by a decision
or activity
3.3
requirement
need or expectation that is stated, generally implied or obligatory
Note 1 to entry: “Generally implied” means that it is custom or common practice for the organization and
interested parties that the need or expectation under consideration is implied.

Note 2 to entry: A specified requirement is one that is stated, e.g. in documented information.

3.4
management system
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set of interrelated or interacting elements of an organization (3.1) to establish policies (3.7) and
objectives (3.8) and processes (3.12) to achieve those objectives
(standards.iteh.ai)
Note 1 to entry: A management system can address a single discipline or several disciplines.
ISO 16106:2020
Note 2 to entry: The system elements include the organization’s structure, roles and responsibilities, planning
and operation.
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ec7d92d06df5/iso-16106-2020
Note 3 to entry: The scope of a management system can include the whole of the organization, specific and
identified functions of the organization, specific and identified sections of the organization, or one or more
functions across a group of organizations.

3.5
top management
person or group of people who directs and controls an organization (3.1) at the highest level
Note 1 to entry: Top management has the power to delegate authority and provide resources within the
organization.

Note 2 to entry: If the scope of the management system (3.4) covers only part of an organization, then top
management refers to those who direct and control that part of the organization.

3.6
effectiveness
extent to which planned activities are realized and planned results achieved
3.7
policy
intentions and direction of an organization (3.1), as formally expressed by its top management (3.5)
3.8
objective
result to be achieved
Note 1 to entry: An objective can be strategic, tactical, or operational.

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Note 2 to entry: Objectives can relate to different disciplines (such as financial, health and safety, and
environmental goals) and can apply at different levels (such as strategic, organization-wide, project, product and
process (3.12)).

Note 3 to entry: An objective can be expressed in other ways, e.g. as an intended outcome, a purpose, an
operational criterion, as a quality objective, or by the use of other words with similar meaning (e.g. aim, goal, or
target).

Note 4 to entry: In the context of quality management systems, quality objectives are set by the organization,
consistent with the quality policy, to achieve specific results.

3.9
risk
effect of uncertainty
Note 1 to entry: An effect is a deviation from the expected — positive or negative.

Note 2 to entry: Uncertainty is the state, even partial, of deficiency of information related to, understanding or
knowledge of, an event, its consequence, or likelihood.

Note 3 to entry: Risk is often characterized by reference to potential “events” (as defined in ISO Guide 73) and
“consequences” (as defined in ISO Guide 73), or a combination of these.

Note 4 to entry: Risk is often expressed in terms of a combination of the consequences of an event (including
changes in circumstances) and the associated “likelihood” (as defined in ISO Guide 73) of occurrence.

3.10
competence iTeh STANDARD PREVIEW
ability to apply knowledge and skills to achieve intended results
(standards.iteh.ai)
3.11
documented information ISO 16106:2020
information required to be controlled and maintained by an organization (3.1) and the medium on
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which it is contained ec7d92d06df5/iso-16106-2020
Note 1 to entry: Documented information can be in any format and media, and from any source.

Note 2 to entry: Documented information can refer to:

— the management system (3.4), including related processes (3.12);

— information created in order for the organization to operate (documentation);

— evidence of results achieved (records).

3.12
process
set of interrelated or interacting activities which transforms inputs into outputs
3.13
performance
measurable result
Note 1 to entry: Performance can relate either to quantitative or qualitative findings.

Note 2 to entry: Performance can relate to managing activities, processes (3.12), products (including services),
systems or organizations (3.1).

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3.14
outsource (verb)
make an arrangement where an external organization (3.1) performs part of an organization’s function
or process (3.12)
Note 1 to entry: An external organization is outside the scope of the management system (3.4), although the
outsourced function or process is within the scope.

3.15
monitoring
determining the status of a system, a process (3.12) or an activity
Note 1 to entry: To determine the status, there can be a need to check, supervise or critically observe.

3.16
measurement
process (3.12) to determine a value
3.17
audit
systematic, independent and documented process (3.12) for obtaining audit evidence and evaluating it
objectively to determine the extent to which the audit criteria are fulfilled
Note 1 to entry: An audit can be an internal audit (first party) or an external audit (second party or third party),
and it can be a combined audit (combining two or more disciplines).

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Note 2 to entry: An internal audit is conducted by the organization itself, or by an external party on its behalf.

Note 3 to entry: “Audit evidence” and “audit(standards.iteh.ai)

criteria” are defined in ISO 19011.

3.18
conformity ISO 16106:2020
fulfilment of a requirement (3.3)
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ec7d92d06df5/iso-16106-2020
3.19
nonconformity
non-fulfilment of a requirement (3.3)
3.20
corrective action
action to eliminate the cause(s) of a nonconformity (3.19) and to prevent recurrence
3.21
continual improvement
recurring activity to enhance performance (3.13)
3.22
competent authority
any national regulatory body or authority designated, or otherwise recognized as such, for any purpose
in connection with the international agreements
Note 1 to entry: International agreements are referred to in the Bibliography.

3.23
design type approved packaging
IBC
large packaging
dangerous goods packaging that has been tested and approved in accordance with:
— 6.1.5, 6.3.5, 6.5.6 and 6.6.5 of the UN Model Regulations; or
— national regulations

4  © ISO 2020 – All rights reserved

 ISO 16106:2020(E)


Note 1 to entry: The modal agreements are referred to in the Bibliography.

4 Context of the organization

4.1 Understanding the organization and its context

The organization should determine external and internal issues that are relevant to its purpose
and its strategic direction and that affect its ability to achieve the intended result(s) of its quality
management system.
The organization should monitor and review information about these external and internal issues.
NOTE 1 Issues can include positive and negative factors or conditions for consideration.

NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal,
technological, competitive, market, cultural, social and economic environments, whether international, national,
regional or local.

NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture,
knowledge and performance of the organization.

4.2 Understanding the needs and expectations of interested parties

Due to their effect, or potential effect, on the organization's ability to consistently provide products and
services that meet customer and applicable statutory and regulatory requirements, the organization
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should determine:
a)
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the interested parties that are relevant to the quality management system;
b) the requirements of these interested ISO parties that are relevant to the quality management system.
16106:2020
https://standards.iteh.ai/catalog/standards/sist/f8df7a5c-3374-4924-bb44-
The organization should monitor and review information about these interested parties and their
ec7d92d06df5/iso-16106-2020
relevant requirements.

4.3 Determining the scope of the quality management system

The organization should determine the boundaries and applicability of the quality management system
to establish its scope.
When determining this scope, the organization should consider:
a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of the organization.
The organization should apply all the requirements of this document if they are applicable within the
determined scope of its quality management system.
The scope of the organization's quality management system should be available and be maintained
as documented information. The scope should state the types of products and services covered, and
provide justification for any requirement of this document that the organization determines is not
applicable to the scope of its quality management system.
Conformity to this document may only be claimed if the requirements determined as not being
applicable do not affect the organization's ability or responsibility to ensure the conformity of its
products and services and the enhancement of customer satisfaction.

© ISO 2020 – All rights reserved  5