AS/NZS ISO 9001:2016

ISO 9001:2015
AS/NZS ISO 9001:2016

Australian/New Zealand Standard™

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Quality management systems—

Requirements
 AS/NZS ISO 9001:2016
This Joint Australian/New Zealand Standard was prepared by Joint Technical
Committee QR-008, Quality Systems. It was approved on behalf of the Council of
Standards Australia on 22 February 2016 and on behalf of the Council of Standards
New Zealand on 16 February 2016.
This Standard was published on 26 February 2016.

The following are represented on Committee QR-008:

Association of Accredited Certification Bodies

Australian Industry Group
Australian Institute of Petroleum
Australian Organisation for Quality
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Australian Prudential Regulation Authority

Consumers Federation of Australia
Engineers Australia
Griffith University, Qld
Housing NSW
ISACA
Joint Accreditation System of Australia and New Zealand
Master Builders Australia
Materials Australia
New Zealand Organisation for Quality
Royal Australian Chemical Institute
University of Canterbury, New Zealand
University of Technology Sydney
University of Wollongong

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This Standard was issued in draft form for comment as DR AS/NZS ISO 9001:2015.
 AS/NZS ISO 9001:2016

Australian/New Zealand Standard™

This is a free 11 page sample. Access the full version online.

Quality management systems—

Requirements

Originated in Australia as AS 3901—1987/ISO 9001:1990, AS 3902—1987/ISO 9002:1990

and AS 3903—1987/ISO 9003:1990.
Originated in New Zealand as NZS 5601:1987, NZS 5602:1987 and NZS 5603:1987.
Previous edition AS/NZS ISO 9001:2008.
Fifth edition 2016.

COPYRIGHT
© Standards Australia Limited/Standards New Zealand
All rights are reserved. No part of this work may be reproduced or copied in any form or by
any means, electronic or mechanical, including photocopying, without the written
permission of the publisher, unless otherwise permitted under the Copyright Act 1968
(Australia) or the Copyright Act 1994 (New Zealand).
Jointly published by SAI Global Limited under licence from Standards Australia Limited,
GPO Box 476, Sydney, NSW 2001 and by Standards New Zealand, Private Bag 2439,
Wellington 6140.

ISBN 978 1 76035 422 0

 AS/NZS ISO 9001:2016 ii

PREFACE

This Standard was prepared by the Joint Standards Australia/Standards New Zealand Committee
QR-008, Quality Systems, to supersede AS/NZS ISO 9001:2008.
The objective of this Standard is to specify requirements for a quality management system. All the
requirements are generic and are intended to be applicable to any organization, regardless of its type
or size, or the products and services it provides.
This Standard is identical with, and has been reproduced from ISO 9001:2015, Quality management
systems—Requirements.
As this Standard is reproduced from an International Standard, the following applies:
(a) In the source text ‘this International Standard’ should read ‘this Australian/New Zealand
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Standard’.
(b) A full point substitutes for a comma when referring to a decimal marker.
References to International Standards should be replaced by references to Australian or
Australian/New Zealand Standards, as follows:
Reference to International Standard Australian/New Zealand Standard
ISO AS/NZS ISO
9000 Quality management 9000 Quality management
systems⎯Fundamentals and vocabulary systems⎯Fundamentals and vocabulary
The term ‘informative’ has been used in this Standard to define the application of the Annexes to
which it applies. An ‘informative’ Annex is only for information and guidance.
 ISO 9001:2015(E)

AS/NZS ISO 9001:2016 iii

Contents Page

CONTENTS
Foreword .......................................................................................................................................................................................................................................... v
Introduction vi
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 1
3 Terms and definitions ..................................................................................................................................................................................... 1
4 Context of the organization ....................................................................................................................................................................... 1
4.1 Understanding the organization and its context ....................................................................................................... 1
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 .......................................................................................................... 2
5 Leadership .................................................................................................................................................................................................................. 3
5.1 Leadership and commitment ..................................................................................................................................................... 3
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5.1.1 General...................................................................................................................................................................................... 3
5.1.2 Customer focus .................................................................................................................................................................. 3
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......................................................................................................................................................................................................................... 4
6.1 Actions to address risks and opportunities ................................................................................................................... 4
6.2 Quality objectives and planning to achieve them...................................................................................................... 5
6.3 Planning of changes ............................................................................................................................................................................ 5
7 Support ........................................................................................................................................................................................................................... 6
7.1 Resources..................................................................................................................................................................................................... 6
7.1.1 General...................................................................................................................................................................................... 6
7.1.2 People ........................................................................................................................................................................................ 6
7.1.3 Infrastructure ..................................................................................................................................................................... 6
7.1.4 Environment for the operation of processes ........................................................................................... 6
7.1.5 Monitoring and measuring resources ........................................................................................................... 7
7.1.6 Organizational knowledge....................................................................................................................................... 7
7.2 Competence ............................................................................................................................................................................................... 8
7.3 Awareness ................................................................................................................................................................................................... 8
7.4 Communication ...................................................................................................................................................................................... 8
7.5 Documented information............................................................................................................................................................... 8
7.5.1 General...................................................................................................................................................................................... 8
7.5.2 Creating and updating ................................................................................................................................................. 9
7.5.3 Control of documented information ............................................................................................................... 9
8 Operation ..................................................................................................................................................................................................................... 9
8.1 Operational planning and control .......................................................................................................................................... 9
8.2 Requirements for products and services ...................................................................................................................... 10
8.2.1 Customer communication..................................................................................................................................... 10
8.2.2 Determining the requirements for products and services ....................................................... 10
8.2.3 Review of the requirements for products and services .............................................................. 10
8.2.4 Changes to requirements for products and services ..................................................................... 11
8.3 Design and development of products and services .............................................................................................. 11
8.3.1 General................................................................................................................................................................................... 11
8.3.2 Design and development planning................................................................................................................ 11
8.3.3 Design and development inputs ...................................................................................................................... 11
8.3.4 Design and development controls ................................................................................................................. 12
8.3.5 Design and development outputs .................................................................................................................. 12
8.3.6 Design and development changes.................................................................................................................. 12

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 ISO 9001:2015(E)
AS/NZS ISO 9001:2016 iv
Page

8.4 Control of externally provided processes, products and services ........................................................... 13

8.4.1 General................................................................................................................................................................................... 13
8.4.2 Type and extent of control.................................................................................................................................... 13
8.4.3 Information for external providers............................................................................................................... 13
8.5 Production and service provision........................................................................................................................................ 14
8.5.1 Control of production and service provision........................................................................................ 14
8.5.2 Identification and traceability ........................................................................................................................... 14
8.5.3 Property belonging to customers or external providers............................................................ 15
8.5.4 Preservation...................................................................................................................................................................... 15
8.5.5 Post-delivery activities ............................................................................................................................................ 15
8.5.6 Control of changes ....................................................................................................................................................... 15
8.6 Release of products and services ......................................................................................................................................... 15
8.7 Control of nonconforming outputs ..................................................................................................................................... 16
9 Performance evaluation ............................................................................................................................................................................16
9.1 Monitoring, measurement, analysis and evaluation ............................................................................................ 16
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9.1.1 General................................................................................................................................................................................... 16
9.1.2 Customer satisfaction ............................................................................................................................................... 17
9.1.3 Analysis and evaluation .......................................................................................................................................... 17
9.2 Internal audit ......................................................................................................................................................................................... 17
9.3 Management review ........................................................................................................................................................................ 18
9.3.1 General................................................................................................................................................................................... 18
9.3.2 Management review inputs ................................................................................................................................. 18
9.3.3 Management review outputs ............................................................................................................................. 18
10 Improvement .........................................................................................................................................................................................................19
10.1 General ........................................................................................................................................................................................................ 19
10.2 Nonconformity and corrective action .............................................................................................................................. 19
10.3 Continual improvement ............................................................................................................................................................... 19
Annex A (informative) Clarification of new structure, terminology and concepts ............................................21
Annex B (informative) Other International Standards on quality management and quality
management systems developed by ISO/TC 176 .............................................................................................................25
Bibliography ............................................................................................................................................................................................................................. 28

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 ISO 9001:2015(E)
AS/NZS ISO 9001:2016 v

Introduction
INTRODUCTION
0.1 General
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
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;
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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.

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 AS/NZS ISO 9001:2016 vi ISO 9001:2015(E)


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.
The quality management principles are:
— customer focus;
— leadership;
— engagement of people;
— process approach;
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— 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 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.

© ISO 2015 – All rights reserved  vii

 ISO 9001:2015(E)
AS/NZS ISO 9001:2016 vii

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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 International Standard.

Figure 2 — Representation of the structure of this International Standard in the PDCA cycle

viii  © ISO 2015 – All rights reserved

 AS/NZS ISO 9001:2016 viii ISO 9001:2015(E)


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 Clause A.4) is essential for achieving an effective quality management system.
The concept of risk-based thinking has been implicit in previous editions of this International Standard
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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 International Standard, 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.
0.4   Relationship with other management system standards
This International Standard applies the framework developed by ISO to improve alignment among its
International Standards for management systems (see Clause A.1).
This International Standard 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 International Standard relates to ISO 9000 and ISO 9004 as follows:
— ISO 9000 Quality management systems — Fundamentals and vocabulary provides essential
background for the proper understanding and implementation of this International Standard;
— ISO 9004 Managing for the sustained success of an organization — A quality management approach
provides guidance for organizations that choose to progress beyond the requirements of this
International Standard.
Annex B provides details of other International Standards on quality management and quality
management systems that have been developed by ISO/TC 176.
This International Standard does not include requirements specific to other management systems,
such as those for environmental management, occupational health and safety management, or
financial management.
Sector-specific quality management system standards based on the requirements of this International
Standard 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 International Standard within the particular sector.

© ISO 2015 – All rights reserved 

 ISO 9001:2015(E)
AS/NZS ISO 9001:2016 ix


A matrix showing the correlation between the clauses of this edition of this International Standard and
the previous edition (ISO 9001:2008) can be found on the ISO/TC 176/SC 2 open access web site at:
www.iso.org/tc176/sc02/public.
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