EN ISO 16106:2020

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
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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 .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 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

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 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

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 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.
0.2 Quality management principles
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,
some examples of benefits associated with the principle and examples of typical actions to improve the
organization's performance when applying the principle.
The quality management principles are:
— customer focus;
— leadership;
— engagement of people;
— process approach;
— improvement;
— evidence-based decision making;
— relationship management.
0.3  Process approach
0.3.1  General
This 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
ISO 16106:2020(E)
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.
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.
viii © ISO 2020 – All rights reserved

ISO 16106:2020(E)
Figure 2 — Representation of the structure of this document in the PDCA cycle
The PDCA cycle can be briefly described as follows:
— Plan: establish the objectives of the system and its processes, and the resources needed to deliver
results in accordance with customers' requirements and the organization's policies and identify
and address risks and opportunities;
— Do: implement what was planned;
— Check: monitor and (where applicable) measure processes and the resulting products and services
against policies, objectives, requirements and planned activities, and report the results;
— Act: take actions to improve performance, as necessary.
0.3.3  Risk-based thinking
Risk-based thinking (see 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.
ISO 16106:2020(E)
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.
x © ISO 2020 – All rights reserved

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
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
[27]
UN Model Regulations .
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:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
ISO 16106:2020(E)
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
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
Note 1 to entry: A management system can address a single discipline or several disciplines.
Note 2 to entry: The system elements include the organization’s structure, roles and responsibilities, planning
and operation.
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.
2 © ISO 2020 – All rights reserved

ISO 16106:2020(E)
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
ability to apply knowledge and skills to achieve intended results
3.11
documented information
information required to be controlled and maintained by an organization (3.1) and the medium on
which it is contained
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).
ISO 16106:2020(E)
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.
...