Petroleum, petrochemical and natural gas industries -- Sector-specific quality management systems -- Requirements for product and service supply organizations

This document defines quality management system requirements for product and service supply organizations to the petroleum, petrochemical and natural gas industries. This document is written as a supplement to ISO 9001:2015. The supplementary requirements and guidance to ISO 9001:2015 have been developed to manage supply chain risks and opportunities associated with the petroleum, petrochemical and natural gas industries and to provide a framework for aligning requirements with complementary standards employed within the industries.

Industries du pétrole, de la pétrochimie et du gaz naturel -- Systèmes de management de la qualité spécifiques au secteur -- Exigences pour les organismes de fourniture de produits et de services

General Information

Status
Published
Publication Date
12-May-2020
Current Stage
6060 - International Standard published
Start Date
13-May-2020
Ref Project

RELATIONS

Buy Standard

Standard
ISO 29001:2020 - Petroleum, petrochemical and natural gas industries -- Sector-specific quality management systems -- Requirements for product and service supply organizations
English language
53 pages
sale 15% off
Preview
sale 15% off
Preview
Standard
ISO 29001:2020 - Petroleum, petrochemical and natural gas industries -- Sector-specific quality management systems -- Requirements for product and service supply organizations
English language
53 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (sample)

INTERNATIONAL ISO
STANDARD 29001
First edition
2020-05
Petroleum, petrochemical and natural
gas industries — Sector-specific
quality management systems —
Requirements for product and service
supply organizations
Industries du pétrole, de la pétrochimie et du gaz naturel — Systèmes
de management de la qualité spécifiques au secteur — Exigences pour
les organismes de fourniture de produits et de services
Reference number
ISO 29001:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO 29001:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 29001:2020(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Context of the organization ....................................................................................................................................................................... 3

4.1 Understanding the organization and its context ....................................................................................................... 3

4.2 Understanding the needs and expectations of interested parties .............................................................. 4

4.3 Determining the scope of the quality management system ............................................................................. 4

4.4 Quality management system and its processes .......................................................................................................... 5

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.......................................................................................... 8

6 Planning ......................................................................................................................................................................................................................... 8

6.1 Actions to address risks and opportunities ................................................................................................................... 8

6.2 Quality objectives and planning to achieve them ...................................................................................................10

6.3 Planning of changes .........................................................................................................................................................................10

7 Support ........................................................................................................................................................................................................................11

7.1 Resources ..................................................................................................................................................................................................11

7.1.1 General...................................................................................................................................................................................11

7.1.2 People .....................................................................................................................................................................................11

7.1.3 Infrastructure ..................................................................................................................................................................11

7.1.4 Environment for the operation of processes ........................................................................................12

7.1.5 Monitoring and measuring resources ........................................................................................................13

7.1.6 Organizational knowledge ....................................................................................................................................14

7.2 Competence ............................................................................................................................................................................................14

7.3 Awareness ................................................................................................................................................................................................15

7.4 Communication ...................................................................................................................................................................................15

7.5 Documented information ............................................................................................................................................................16

7.5.1 General...................................................................................................................................................................................16

7.5.2 Creating and updating ..............................................................................................................................................16

7.5.3 Control of documented information ............................................................................................................17

8 Operation ..................................................................................................................................................................................................................18

8.1 Operational planning and control .......................................................................................................................................18

8.2 Requirements for products and services ......................................................................................................................19

8.2.1 Customer communication .....................................................................................................................................19

8.2.2 Determining the requirements for products and services .......................................................19

8.2.3 Review of the requirements for products and services ..............................................................20

8.2.4 Changes to requirements for products and services .....................................................................20

8.3 Design and development of products and services ..............................................................................................21

8.3.1 General...................................................................................................................................................................................21

8.3.2 Design and development planning ................................................................................................................21

8.3.3 Design and development inputs ......................................................................................................................22

8.3.4 Design and development controls .................................................................................................................22

8.3.5 Design and development outputs ..................................................................................................................23

8.3.6 Design and development changes .................. ................................................................................................23

© ISO 2020 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 29001:2020(E)

8.4 Control of externally provided processes, products and services ...........................................................24

8.4.1 General...................................................................................................................................................................................24

8.4.2 Type and extent of control ....................................................................................................................................24

8.4.3 Information for external providers ...............................................................................................................25

8.5 Production and service provision ........................................................................................................................................26

8.5.1 Control of production and service provision ........................................................................................26

8.5.2 Identification and traceability ...........................................................................................................................27

8.5.3 Property belonging to customers or external providers ............................................................27

8.5.4 Preservation ......................................................................................................................................................................27

8.5.5 Post-delivery activities ............................................................................................................................................28

8.5.6 Control of changes .......................................................................................................................................................28

8.6 Release of products and services .........................................................................................................................................29

8.7 Control of nonconforming outputs .....................................................................................................................................29

9 Performance evaluation ............................................................................................................................................................................30

9.1 Monitoring, measurement, analysis and evaluation ............................................................................................30

9.1.1 General...................................................................................................................................................................................30

9.1.2 Customer satisfaction ...............................................................................................................................................30

9.1.3 Analysis and evaluation ..........................................................................................................................................31

9.2 Internal audit .........................................................................................................................................................................................32

9.3 Management review ........................................................................................................................................................................32

9.3.1 General...................................................................................................................................................................................32

9.3.2 Management review inputs .................................................................................................................................33

9.3.3 Management review outputs .............................................................................................................................33

10 Improvement .........................................................................................................................................................................................................34

10.1 General ........................................................................................................................................................................................................34

10.2 Nonconformity and corrective action ..............................................................................................................................34

10.3 Continual improvement ...............................................................................................................................................................35

Annex A (informative) Clarification of new structure, terminology and concepts ............................................36

Annex B (informative) Other International Standards on quality management and quality

management systems developed by ISO/TC 176 .............................................................................................................41

Annex C (informative) Risk and opportunity management and conformity assessment

processes ...................................................................................................................................................................................................................45

Bibliography .............................................................................................................................................................................................................................51

iv © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 29001:2020(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 67, Materials, equipment and offshore

structures for petroleum, petrochemical and natural gas industries, in collaboration with the European

Committee for Standardization (CEN) Technical Committee CEN/TC 12, Materials, equipment and

offshore structures for petroleum, petrochemical and natural gas industries, in accordance with the

Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This first edition cancels and replaces ISO/TS 29001:2010, which has been technically revised. The

main changes compared to the previous edition are as follows:
— alignment with ISO 9001:2015.

The boxed text is reproduced from ISO 9001:2015 unaltered and in its entirety. The petroleum,

petrochemical and natural gas industry sector-specific supplemental requirements and guidance are

provided outside the boxed text.

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.
© ISO 2020 – All rights reserved v
---------------------- Page: 5 ----------------------
ISO 29001:2020(E)
Introduction
0.1 General
ISO 9001:2015, Quality management systems — Requirements
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;

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).
vi © ISO 2020 – All rights reserved
---------------------- Page: 6 ----------------------
ISO 29001:2020(E)

Consistently meeting requirements and addressing future needs and expectations poses a challenge

for organizations in an increasingly dynamic and complex environment. To achieve this objective, the

organization might find it necessary to adopt various forms of improvement in addition to correction

and continual improvement, such as breakthrough change, innovation and re-organization.

In this International Standard, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.

Information marked as “NOTE” is for guidance in understanding or clarifying the associated

requirement.
0.2 Quality management principles
ISO 9001:2015, Quality management systems — Requirements
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;
— improvement;
— evidence-based decision making;
— relationship management.
© ISO 2020 – All rights reserved vii
---------------------- Page: 7 ----------------------
ISO 29001:2020(E)
0.3 Process approach
0.3.1 General
ISO 9001:2015, Quality management systems — Requirements
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.
Figure 1 — Schematic representation of the elements of a single process
viii © ISO 2020 – All rights reserved
---------------------- Page: 8 ----------------------
ISO 29001:2020(E)
0.3.2 Plan-Do-Check-Act cycle
ISO 9001:2015, Quality management systems — Requirements
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

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.
© ISO 2020 – All rights reserved ix
---------------------- Page: 9 ----------------------
ISO 29001:2020(E)
0.3.3 Risk-based thinking
ISO 9001:2015, Quality management systems — Requirements
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 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
ISO 9001:2015, Quality management systems — Requirements
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.
x © ISO 2020 – All rights reserved
---------------------- Page: 10 ----------------------
ISO 29001:2020(E)

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.

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/
...

DRAFT INTERNATIONAL STANDARD
ISO/DIS 29001
ISO/TC 67 Secretariat: NEN
Voting begins on: Voting terminates on:
2018-02-21 2018-05-16
Petroleum, petrochemical and natural gas industries —
Sector-specific quality management systems —
Requirements for product and service supply
organizations

Industries du pétrole, de la pétrochimie et du gaz naturel — Systèmes de management de la qualité

spécifiques au secteur — Exigences pour les organismes de fourniture de produits et de services

ICS: 03.100.70; 75.020
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 29001:2018(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2018
---------------------- Page: 1 ----------------------
ISO/DIS 29001:2018(E) ISO/DIS 29001:2017(E)

8 Operation ......................................................................................................................................................... 25

8.1 Operational planning and control .......................................................................................................... 25

8.2 Requirements for products and services ............................................................................................. 26

8.2.1 Customer communication ......................................................................................................................... 26

8.2.2 Determining the requirements for products and services ............................................................ 26

8.2.3 Review of the requirements for products and services .................................................................. 26

8.2.4 Changes to requirements for products and services ....................................................................... 27

8.3 Design and development of products and services .......................................................................... 27

8.3.1 General ............................................................................................................................................................. 27

8.3.2 Design and development planning ......................................................................................................... 27

8.3.3 Design and development inputs .............................................................................................................. 28

8.3.4 Design and development controls .......................................................................................................... 28

8.3.5 Design and development outputs ........................................................................................................... 29

8.3.6 Design and development changes .......................................................................................................... 29

8.4 Control of externally provided processes, products and services .............................................. 29

8.4.1 General ............................................................................................................................................................. 29

8.4.2 Type and extent of control ........................................................................................................................ 30

8.4.3 Information for external providers ....................................................................................................... 30

8.5 Production and service provision .......................................................................................................... 31

8.5.1 Control of production and service provision ...................................................................................... 31

8.5.2 Identification and traceability ................................................................................................................. 32

8.5.3 Property belonging to customers or external providers ............................................................... 32

8.5.4 Preservation ................................................................................................................................................... 32

8.5.5 Post-delivery activities ............................................................................................................................... 33

8.5.6 Control of changes ........................................................................................................................................ 33

8.6 Release of products and services ............................................................................................................ 33

8.7 Control of nonconforming outputs ......................................................................................................... 34

9 Performance evaluation ............................................................................................................................. 34

9.1 Monitoring, measurement, analysis and evaluation ....................................................................... 34

9.1.1 General ............................................................................................................................................................. 34

9.1.2 Customer satisfaction.................................................................................................................................. 35

9.1.3 Analysis and evaluation ............................................................................................................................. 35

9.2 Internal audit ................................................................................................................................................. 36

9.3 Management review .................................................................................................................................... 36

9.3.1 General ............................................................................................................................................................. 36

9.3.2 Management review inputs....................................................................................................................... 36

9.3.3 Management review outputs .................................................................................................................... 37

10 Improvement.................................................................................................................................................. 37

10.1 General ............................................................................................................................................................. 37

10.2 Nonconformity and corrective action ................................................................................................... 38

10.3 Continual improvement ............................................................................................................................. 38

Annex A (informative) Clarification of new structure, terminology and concepts ............................ 39

COPYRIGHT PROTECTED DOCUMENT

A.1 Structure and terminology ........................................................................................................................ 39

A.2 Products and services ................................................................................................................................. 40

© ISO 2018

A.3 Understanding the needs and expectations of interested parties .............................................. 40

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

A.4 Risk-based thinking ..................................................................................................................................... 40

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

A.5 Applicability ................................................................................................................................................... 41

below or ISO’s member body in the country of the requester.

A.6 Documented information .......................................................................................................................... 41

ISO copyright office

A.7 Organizational knowledge ........................................................................................................................ 42

CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva, Switzerland

A.8 Control of externally provided processes, products and services .............................................. 42

Tel. +41 22 749 01 11
Annex B (informative) Other International Standards on quality management and
Fax +41 22 749 09 47
copyright@iso.org

quality management systems developed by ISO/TC 176 ............................................................... 43

www.iso.org
Published in Switzerland
© ISO 2017 – All rights reserved 3
ii © ISO 2018 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/DIS 29001:2018(E)
Contents

Foreword ........................................................................................................................................................................... 5

Introduction ..................................................................................................................................................................... 6

0.0 Field of application ......................................................................................................................................... 6

0.1 General ................................................................................................................................................................ 6

0.2 Quality management principles ................................................................................................................. 7

0.3 Process approach............................................................................................................................................. 7

0.3.1 General ................................................................................................................................................................ 7

0.3.2 Plan-Do-Check-Act cycle ................................................................................................................................ 8

0.3.3 Risk-based thinking ........................................................................................................................................ 9

0.4 Relationship with other management system standards .............................................................. 10

1 Scope ................................................................................................................................................................. 11

2 Normative references ................................................................................................................................. 11

3 Terms and definitions ................................................................................................................................. 11

4 Context of the organization ....................................................................................................................... 14

4.1 Understanding the organization and its context ............................................................................... 14

4.2 Understanding the needs and expectations of interested parties .............................................. 14

4.3 Determining the scope of the quality management system .......................................................... 14

4.4 Quality management system and its processes ................................................................................. 15

5 Leadership....................................................................................................................................................... 16

5.1 Leadership and commitment ................................................................................................................... 16

5.1.1 General ............................................................................................................................................................. 16

5.1.2 Customer focus .............................................................................................................................................. 16

5.2 Policy ................................................................................................................................................................. 17

5.2.1 Establishing the quality policy ................................................................................................................. 17

5.2.2 Communicating the quality policy .......................................................................................................... 17

5.3 Organizational roles, responsibilities and authorities ................................................................... 17

6 Planning ........................................................................................................................................................... 18

6.1 Actions to address risks and opportunities ........................................................................................ 18

6.2 Quality objectives and planning to achieve them ............................................................................. 19

6.3 Planning of changes ..................................................................................................................................... 19

7 Support ............................................................................................................................................................. 20

7.1 Resources ........................................................................................................................................................ 20

7.1.1 General ............................................................................................................................................................. 20

7.1.2 People ............................................................................................................................................................... 20

7.1.3 Infrastructure ................................................................................................................................................ 20

7.1.4 Environment for the operation of processes ...................................................................................... 21

7.1.5 Monitoring and measuring resources ................................................................................................... 21

7.1.6 Organizational knowledge ........................................................................................................................ 22

7.2 Competence .................................................................................................................................................... 22

7.3 Awareness ....................................................................................................................................................... 23

7.4 Communication ............................................................................................................................................. 23

7.5 Documented information .......................................................................................................................... 24

7.5.1 General ............................................................................................................................................................. 24

7.5.2 Creating and updating................................................................................................................................. 24

7.5.3 Control of documented information ...................................................................................................... 24

© ISO 2018 – All rights reserved 2
---------------------- Page: 3 ----------------------
ISO/DIS 29001:2018(E)

8 Operation ......................................................................................................................................................... 25

8.1 Operational planning and control .......................................................................................................... 25

8.2 Requirements for products and services ............................................................................................. 26

8.2.1 Customer communication ......................................................................................................................... 26

8.2.2 Determining the requirements for products and services ............................................................ 26

8.2.3 Review of the requirements for products and services .................................................................. 26

8.2.4 Changes to requirements for products and services ....................................................................... 27

8.3 Design and development of products and services .......................................................................... 27

8.3.1 General ............................................................................................................................................................. 27

8.3.2 Design and development planning ......................................................................................................... 27

8.3.3 Design and development inputs .............................................................................................................. 28

8.3.4 Design and development controls .......................................................................................................... 28

8.3.5 Design and development outputs ........................................................................................................... 29

8.3.6 Design and development changes .......................................................................................................... 29

8.4 Control of externally provided processes, products and services .............................................. 29

8.4.1 General ............................................................................................................................................................. 29

8.4.2 Type and extent of control ........................................................................................................................ 30

8.4.3 Information for external providers ....................................................................................................... 30

8.5 Production and service provision .......................................................................................................... 31

8.5.1 Control of production and service provision ...................................................................................... 31

8.5.2 Identification and traceability ................................................................................................................. 32

8.5.3 Property belonging to customers or external providers ............................................................... 32

8.5.4 Preservation ................................................................................................................................................... 32

8.5.5 Post-delivery activities ............................................................................................................................... 33

8.5.6 Control of changes ........................................................................................................................................ 33

8.6 Release of products and services ............................................................................................................ 33

8.7 Control of nonconforming outputs ......................................................................................................... 34

9 Performance evaluation ............................................................................................................................. 34

9.1 Monitoring, measurement, analysis and evaluation ....................................................................... 34

9.1.1 General ............................................................................................................................................................. 34

9.1.2 Customer satisfaction.................................................................................................................................. 35

9.1.3 Analysis and evaluation ............................................................................................................................. 35

9.2 Internal audit ................................................................................................................................................. 36

9.3 Management review .................................................................................................................................... 36

9.3.1 General ............................................................................................................................................................. 36

9.3.2 Management review inputs....................................................................................................................... 36

9.3.3 Management review outputs .................................................................................................................... 37

10 Improvement.................................................................................................................................................. 37

10.1 General ............................................................................................................................................................. 37

10.2 Nonconformity and corrective action ................................................................................................... 38

10.3 Continual improvement ............................................................................................................................. 38

Annex A (informative) Clarification of new structure, terminology and concepts ............................ 39

A.1 Structure and terminology ........................................................................................................................ 39

A.2 Products and services ................................................................................................................................. 40

A.3 Understanding the needs and expectations of interested parties .............................................. 40

A.4 Risk-based thinking ..................................................................................................................................... 40

A.5 Applicability ................................................................................................................................................... 41

A.6 Documented information .......................................................................................................................... 41

A.7 Organizational knowledge ........................................................................................................................ 42

A.8 Control of externally provided processes, products and services .............................................. 42

Annex B (informative) Other International Standards on quality management and

quality management systems developed by ISO/TC 176 ............................................................... 43

© ISO 2018 – All rights reserved 3
---------------------- Page: 4 ----------------------
ISO/DIS 29001:2018(E)

Annex C (informative) Risk management and conformity assessment processes ............................ 47

C.1 General ............................................................................................................................................................. 47

C.2 Risk classification principles .................................................................................................................... 47

C.3 Risk management and conformity assessment process ................................................................. 48

C.3.1 Customer's scope and context .................................................................................................................. 48

C.3.2 Undertaking risk assessment ................................................................................................................... 48

C.3.3 Determination of control and verification requirements .............................................................. 49

C.4 Control of externally provided processes, products and services .............................................. 49

C.4.1 Scope of externally provided activity .................................................................................................... 49

C.4.2 Potential provider capability assessment ........................................................................................... 50

C.4.3 Conformity assessment requirements for external providers .................................................... 50

C.4.4 Control of external providers during execution of scope .............................................................. 50

Appendix 1 – Examples of conformity assessment activities ...................................................................... 51

Bibliography ................................................................................................................................................................. 53

© ISO 2018 – All rights reserved 4
---------------------- Page: 5 ----------------------
ISO/DIS 29001:2018(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national

standards bodies (ISO member bodies). The work of preparing International Standards is

normally carried out through ISO technical committees. Each member body interested in a

subject for which a technical committee has been established has the right to be represented on

that committee. International organizations, governmental and non-governmental, in liaison

with ISO, also take part in the work. ISO collaborates closely with the International

Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance

are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria

needed for the different types of ISO documents should be noted. This document was drafted in

accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see
www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the

subject of patent rights. ISO shall not be held responsible for identifying any or all such patent

rights. Details of any patent rights identified during the development of the document will be in

the Introduction and/or on the ISO list of patent declarations received (see
www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and

does not constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO's adherence to the World Trade Organization

(WTO) principles in the Technical Barriers to Trade (TBT) see the following URL:
www.iso.org/iso/foreword.html.

The committee responsible for this document is Technical Committee ISO/TC 67, Materials,

equipment and offshore structures for petroleum, petrochemical and natural gas industries.

This fourth edition cancels and replaces the third edition (ISO/TS 29001:2010), of which it

constitutes a major revision in order to align with ISO 9001:2015.
© ISO 2018 – All rights reserved 5
---------------------- Page: 6 ----------------------
ISO/DIS 29001:2018(E)
Introduction
0.0 Field of application

This International Standard defines quality management system requirements for product and

service supply organizations for the petroleum, petrochemical and natural gas industries.

This International Standard is written as a supplement to ISO 9001:2015. The supplementary

requirements and guidance to ISO 9001:2015 have been developed to manage risks associated

with the petroleum,
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.