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
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de management de PREVIEW
la qualité spécifiques au secteur — Exigences pour
les organismes de fourniture de produits et de services
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ISO 29001:2020
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Reference number
ISO 29001:2020(E)

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ISO 29001:2020(E)


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ISO 29001:2020
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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
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6.1 Actions to address risks and opportunities.................................................................................................................... 8
6.2 (standards.iteh.ai)
Quality objectives and planning to achieve them.................................................................................................... 10
6.3 Planning of changes.......................................................................................................................................................................... 10
7 Support.........................................................................................................................................................................................................................
ISO 29001:2020 11
7.1 Resources................................................................................................................................................................................................... 11
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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

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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
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10.1 General......................................................................................................................................................................................................... 34
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10.2 Nonconformity and corrective action............................................................................................................................... 34
10.3 Continual improvement................................................................................................................................................................ 35
Annex A (informative) Clarification of new structure, ISO 29001:2020 terminology and concepts.............................................36
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Annex B (informative) Other International Standards on quality management and quality
4c06f5d2fbd8/iso-29001-2020
management systems developed by ISO/TC 176..............................................................................................................41
Annex C (informative) Risk and opportunity management and conformity assessment
processes....................................................................................................................................................................................................................45
Bibliography.............................................................................................................................................................................................................................. 51

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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www​.iso​.org/​directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www​.iso​.org/​patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
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World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www​.iso​.org/​
iso/​foreword​.html. (standards.iteh.ai)
This document was prepared by Technical Committee ISO/TC  67, Materials, equipment and offshore
structures for petroleum, petrochemical and ISOnatural gas industries, in collaboration with the European
29001:2020
Committee for Standardization (CEN) Technical Committee CEN/TC 12, Materials, equipment and
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offshore structures for petroleum, petrochemical and natural gas industries, in accordance with the
4c06f5d2fbd8/iso-29001-2020
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.

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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.
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It is not the intent of this International Standard to imply the need for:
—
(standards.iteh.ai)
uniformity in the structure of different quality management systems;
— alignment of documentation to the clause structure of this International Standard;
ISO 29001:2020
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— the use of the specific terminology of 4c06f5d2fbd8/iso-29001-2020
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).

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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
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This International Standard is based on the quality management principles described in ISO 9000.
(standards.iteh.ai)
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 ISO 29001:2020 when applying the principle.
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The quality management principles are:
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— customer focus;
— leadership;
— engagement of people;
— process approach;
— improvement;
— evidence-based decision making;
— relationship management.

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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:
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a) understanding and consistency in meeting requirements;
b) (standards.iteh.ai)
the consideration of processes in terms of added value;
c) the achievement of effective process performance; ISO 29001:2020
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d) improvement of processes based on evaluation of data and information.
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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

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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.

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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.

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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

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ISO 9001:2015, Quality management(standards.iteh.ai)
systems — Requirements
0.4   Relationship with other management system standards
ISO 29001:2020
This International Standard applies the framework developed by ISO to improve alignment among
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its International Standards for management systems (see Clause A.1).
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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.

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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/​public.

This document also relates to ISO/TS 9002 Quality management systems — Guidelines for the application
of ISO 9001:2015. ISO/TS 9002 provides guidance on the intent of the requirements in ISO 9001:2015,
with examples of possible steps an organization can take to meet the requirements. It does not add to,
subtract from, or in any way modify those requirements.
Matrices showing the correlation between the clauses of this edition of this document and the previous
edition (ISO/TS  29001:2010) and other international and industry standards dealing with quality
management systems requirements can be found on the ISO/TC  67 open access web site at https://​
committee​.iso​.org/​tc67.

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(standards.iteh.ai)
ISO 29001:2020
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ISO 29001:2020
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INTERNATIONAL STANDARD ISO 29001:2020(E)

Petroleum, petrochemical and natural gas industries —

Sector-specific quality management systems —
Requirements for product and service supply
organizations

1 Scope

ISO 9001:2015, Quality management systems — Requirements

1   Scope
This International Standard specifies requirements for a quality management system when an
organization:
a) needs to demonstrate its ability to consistently provide products and services that meet
customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including
processes for improvement of the system and the assurance of conformity to customer and
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applicable statutory and regulatory requirements.
(standards.iteh.ai)
All the requirements of this International Standard are generic and are intended to be applicable to
any organization, regardless of its type or size, or the products and services it provides.
ISO 29001:2020
NOTE 1 In this International Standard, the terms “product” or “service” only apply to products and services
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intended for, or required by, a customer. 4c06f5d2fbd8/iso-29001-2020
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.

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.

2 Normative references

ISO 9001:2015, Quality management systems — Requirements

2   Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2015, Quality management systems — Fundamentals and vocabulary

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3 Terms and definitions

ISO 9001:2015, Quality management systems — Requirements

3   Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.

For the purposes of this document, the terms and definitions given in ISO  9000:2015 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://​w ww​.iso​.org/​obp
— IEC Electropedia: available at http://​w ww​.electropedia​.org/​
3.1
quality specification level
QSL
level defining the extent of control activities, typically including testing, inspection, verification and
validation, undertaken by the provider to demonstrate conformance with requirements based on the
determination of operational risk and/or obligations
Note 1 to entry: Similar product- or service-specific terms can be used in technical standards to establish the
iTeh STANDARD PREVIEW
extent of control activities for defined levels of product or service risk, e.g. quality specification level (QSL) in API
Spec 6D, product specification level (PSL) in API Spec 6A and API Spec 17D, and exposure level in ISO 19900.
(standards.iteh.ai)
Note 2 to entry: Product or service risk is related to criticality. In this context, 'critical' is defined as that deemed
by the organization, product or service specification, or customer as (i) mandatory, indispensable or essential,
ISO 29001:2020
(ii) needed for a stated purpose or task, and(iii) requiring specific action.
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3.2 Competence
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3.2.1
competence catalogue
hierarchical structured list of the competences required to perform a task
[SOURCE: ISO/TS 17969:2017, 3.3, modified – 'any task' has been changed to 'a task' and 'competency'
and 'competencies' have been changed to 'competence' and 'competences'.]
3.2.2
competence profile
skills and behaviour, each specified at a level of proficiency, required to perform a role or activity in line
with the associated risk or opportunity
[SOURCE: ISO/TS 17969:2017, 3.4, modified – 'the role' has been changed to 'a role', 'competency' has
been changed to 'competence' and 'or opportunity' has been added.]
3.2.3
proficiency level
level of ability and behaviour attributes within a specific skill
[SOURCE: ISO/TS 17969:2017, 3.8]

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3.3
inspection and test plan
tabular presentation of a quality plan, typically used for process or product applications, to define
the specific sequence of operational activities, instructions, acceptance criteria, information to be
maintained and retained, and associated provider, customer and independent conformity assessment
activities
Note 1 to entry: Inspection and test plans may be presented as a single document or as a series of interdependent
or supporting documents.

Note  2  to entry:  ISO 10005 can be used to inform the development of inspection and test plans for specific
processes and products.

4 Context of the organization

4.1 Understanding the organization and its context

ISO 9001:2015, Quality management systems — Requirements

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

NOTE 2 Understanding the external context ISO 29001:2020

can be facilitated by considering issues arising from legal,
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technological, competitive, market, cultural, social and economic environments, whether international,
national, regional or local. 4c06f5d2fbd8/iso-29001-2020

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

The organization shall retain documented information that demonstrates the understanding of its
context as described in 4.1 including considerations of Note 1 to Note 3.

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