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Table of Contents
                            National foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
	4.1 Understanding the organization and its context
	4.2 Understanding the needs and expectations of interested parties
	4.3 Determining the scope of the quality management system
	4.4 Quality management system and its processes
5 Leadership
	5.1 Leadership and commitment
		5.1.1 General
		5.1.2 Customer focus
	5.2 Policy
		5.2.1 Establishing the quality policy
		5.2.2 Communicating the quality policy
	5.3 Organizational roles, responsibilities and authorities
6 Planning
	6.1 Actions to address risks and opportunities
	6.2 Quality objectives and planning to achieve them
	6.3 Planning of changes
7 Support
	7.1 Resources
		7.1.1 General
		7.1.2 People
		7.1.3 Infrastructure
		7.1.4 Environment for the operation of processes
		7.1.5 Monitoring and measuring resources
		7.1.6 Organizational knowledge
	7.2 Competence
	7.3 Awareness
	7.4 Communication
	7.5 Documented information
		7.5.1 General
		7.5.2 Creating and updating
		7.5.3 Control of documented information
8 Operation
	8.1 Operational planning and control
	8.2 Requirements for products and services
		8.2.1 Customer communication
		8.2.2 Determining the requirements for products and services
		8.2.3 Review of the requirements for products and services
		8.2.4 Changes to requirements for products and services
	8.3 Design and development of products and services
		8.3.1 General
		8.3.2 Design and development planning
		8.3.3 Design and development inputs
		8.3.4 Design and development controls
		8.3.5 Design and development outputs
		8.3.6 Design and development changes
	8.4 Control of externally provided processes, products and services
		8.4.1 General
		8.4.2 Type and extent of control
		8.4.3 Information for external providers
	8.5 Production and service provision
		8.5.1 Control of production and service provision
		8.5.2 Identification and traceability
		8.5.3 Property belonging to customers or external providers
		8.5.4 Preservation
		8.5.5 Post-delivery activities
		8.5.6 Control of changes
	8.6 Release of products and services
	8.7 Control of nonconforming outputs
9 Performance evaluation
	9.1 Monitoring, measurement, analysis and evaluation
		9.1.1 General
		9.1.2 Customer satisfaction
		9.1.3 Analysis and evaluation
	9.2 Internal audit
	9.3 Management review
		9.3.1 General
		9.3.2 Management review inputs
		9.3.3 Management review outputs
10 Improvement
	10.1 General
	10.2 Nonconformity and corrective action
	10.3 Continual improvement
Document Text Contents
Page 1

BSI Standards Publication

WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06

Quality management systems — Guidelines
for the application of ISO 9001:2015

PD ISO/TS 9002:2016

Page 2

National foreword

This Published Document is the UK implementation of ISO/TS 9002:2016.

The UK participation in its preparation was entrusted to
Technical Committee QS/1, Quality management and quality
assurance procedures.

A list of organizations represented on this committee can be obtained on
request to its secretary.

This publication does not purport to include all the necessary provisions
of a contract. Users are responsible for its correct application.

© The British Standards Institution 2016
Published by BSI Standards Limited 2016

ISBN 978 0 580 91749 3

ICS 03.120.10

Compliance with a British Standard cannot confer immunity from
legal obligations.

This Published Document was published under the authority of the
Standards Policy and Strategy Committee on 30 November 2016.

Amendments/corrigenda issued since publication

Date Text affected


Page 29

ISO/TS 9002:2016(E)

action when processes, products and services do not meet agreed specifications. These persons should
understand what the implications are if there are nonconformities in the quality management system
(e.g. rework, scrap, customer dissatisfaction, legal implications). Depending on the nature of the work
that the persons perform, the actions for creating awareness can vary.

The organization should ensure that the persons of the organization understand how they contribute
to the effectiveness of the quality management system, by performing work processes that achieve
conforming outputs, which in turn helps customer satisfaction.

The organization can create awareness in many ways, such as:

a) clarifying what is expected (e.g. visual tools such as pictures of acceptable and unacceptable
products and services);

b) communicating clear requirements for products and services;

c) designing processes to clearly segregate nonconforming outputs;

d) communicating clearly how to handle complaints and the internal escalation steps in the case of
nonconforming outputs.

Communication of all kinds is important to ensure awareness and can include regular review meetings,
customer and external provider meetings, gathering feedback and ensuring this feedback is made
known to relevant persons.

7.4 Communication

The intent of this subclause is to ensure that the organization establishes the internal and external
communications that are needed and which are relevant to the quality management system.

The organization should determine on what it needs to communicate. This might be different for
internal and external parties. For example, the organization could communicate about the status of
the quality management system with persons of the organization, but communicate with external
providers about new terms and conditions on purchase orders.

The organization should determine those relevant internal and external parties with whom they
need to communicate, to ensure the effective operation of the quality management system. This can
include relevant persons within the organization at all levels and relevant interested parties (such as
customers, external providers used to source products and services, or regulatory bodies).

Different communication methods are often required for different situations. More formal
communication, such as reports, specifications, invoices or service level agreements, might be
required for external relevant interested parties. For internal communication, methods such as daily
contact, regular department meetings, briefing sessions, email or an intranet may be used. More
formal methods such as written reports or job specifications could also be required for internal
communication, depending on the nature of the information and how critical the issues are that need to
be communicated.

The organization should also determine who will communicate. This will depend on the nature of the
communication and with whom the organization is communicating. For example, top management
might communicate with persons of the organization while the owner of the purchasing process might
communicate with external providers.

To be effective, the organization’s communication processes should provide it and its persons with
the ability to:

— transmit and receive information quickly and to act on it;

— build trust amongst each other;

— transmit the importance of customer satisfaction, process performance, etc.;

© ISO 2016 – All rights reserved 19

PD ISO/TS 9002:2016

Page 30

ISO/TS 9002:2016(E)

— identify opportunities for improvement.

7.5 Documented information

7.5.1 General

The intent of this subclause is to ensure that the organization controls the documented information
needed for conformity to ISO 9001, as well as the documented information that it has determined is
needed for the effectiveness of its quality management system (see ISO 9001:2015, 4.4.2[28]).

When ISO 9001 refers to “maintain documented information”, this means ensuring that information is
kept up-to-date, e.g. the information contained in documented procedures, manuals, forms and check-
lists, information that could be stored in the cloud and downloaded to a smartphone or other electronic
device, and other documented information (such as the quality policy and quality objectives).

When ISO 9001 refers to “retain documented information”, this means ensuring that information that
is used to provide evidence about whether or not a requirement has been fulfilled is protected against
any deterioration or unauthorized change (that should not occur, unless an agreed correction has
to be made).

In general, ISO 9001 is not prescriptive in terms of the extent of documented information needed. This
will vary from organization to organization depending on the size and complexity of the operations
and processes; customer, statutory and regulatory requirements; and the competence of the persons
involved. For example, documented information needed for a small bakery will be simpler and less
extensive than that needed by an automotive parts manufacturer which has very specific customer
(statutory and regulatory) requirements, including documented information of external origin, to be
incorporated into the system.

7.5.2 Creating and updating

The intent of this subclause is to ensure that, when the organization creates and updates documented
information, the appropriate identification, format and media is used, and it is reviewed and approved.

Documented information should include an identification and description. There are many methods for
this, such as defining a title, date, author, or reference number (or a combination of two or more of these
methods) that an organization can use to determine information and its status.

The organization should establish the format for the documented information. The organization can
use hard copy, electronic or both to provide documented information. Consideration should also be
given to what software version will be used since it is possible that not all users will have access to the
same version. Some organizations might need to consider providing the documented information in
more than one language, based on the culture of the organization.

The organization should have established methods for the review and approval of its documented
information, e.g. having an identified person with the authority to approve the document information.

7.5.3 Control of documented information The intent of this subclause is to ensure that documented information is available in a suitable
medium whenever needed, and that it is adequately protected.

Having decided on what documented information is needed for the quality management system, the
organization should ensure it is available for all relevant areas, departments, process owners etc.
Consideration should also be given to providing relevant documented information to relevant external
interested parties when products and services are sourced externally. The documented information
should also be in a form that is suitable for intended use, for example a written service level agreement
for an external service provider, or process parameter information in electronic format that can be
downloaded at the process interface.

20 © ISO 2016 – All rights reserved

PD ISO/TS 9002:2016

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