SIST EN ISO 29001:2020

SLOVENSKI STANDARD
01-september-2020
Nadomešča:
SIST-TS CEN ISO/TS 29001:2012
Petrokemična industrija ter industrija za predelavo nafte in zemeljskega plina -
Sektorsko specifični sistemi vodenja kakovosti - Zahteve za proizvodne in
storitvene organizacije (ISO 29001:2020)
Petroleum, petrochemical and natural gas industries - Sector-specific quality
management systems - Requirements for product and service supply organizations (ISO
29001:2020)
Erdöl-, petrochemische und Erdgasindustrie - Sektorspezifische
Qualitätsmangementsysteme - Anforderungen an Hersteller- und Serviceorganisationen
(ISO 29001:2020)
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 (ISO 29001:2020)
Ta slovenski standard je istoveten z: EN ISO 29001:2020
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
75.020 Pridobivanje in predelava Extraction and processing of
nafte in zemeljskega plina petroleum and natural gas
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 29001
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2020
EUROPÄISCHE NORM
ICS 03.100.70; 75.020 Supersedes CEN ISO/TS 29001:2011
English Version
Petroleum, petrochemical and natural gas industries -
Sector-specific quality management systems -
Requirements for product and service supply
organizations (ISO 29001:2020)
Industries du pétrole, de la pétrochimie et du gaz Erdöl-, petrochemische und Erdgasindustrie -
naturel - Systèmes de management de la qualité Sektorspezifische Qualitätsmangementsysteme -
spécifiques au secteur - Exigences pour les organismes Anforderungen an Hersteller- und
de fourniture de produits et de services (ISO Serviceorganisationen (ISO 29001:2020)
29001:2020)
This European Standard was approved by CEN on 26 April 2020.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 29001:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 29001:2020) has been prepared by Technical Committee ISO/TC 67 "Materials,
equipment and offshore structures for petroleum, petrochemical and natural gas industries" in
collaboration with Technical Committee CEN/TC 12 “Materials, equipment and offshore structures for
petroleum, petrochemical and natural gas industries” the secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2020, and conflicting national standards
shall be withdrawn at the latest by November 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN ISO/TS 29001:2011.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 29001:2020 has been approved by CEN as EN ISO 29001:2020 without any modification.

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
ISO 29001:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

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 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

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 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

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 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

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 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

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/ 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.
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
applicable statutory and regulatory requirements.
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.
NOTE 1 In this International Standard, the terms “product” or “service” only apply to products and services
intended for, or required by, a customer.
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
ISO 29001:2020(E)
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:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .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
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.
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,
(ii) needed for a stated purpose or task, and(iii) requiring specific action.
3.2 Competence
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]
2 © ISO 2020 – All rights reserved

ISO 29001:2020(E)
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.
The organization shall monitor and review information about these external and internal issues.
NOTE 1 Issues can include positive and negative factors or conditions for consideration.
NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal,
technological, competitive, market, cultural, social and economic environments, whether international,
national, regional or local.
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.
ISO 29001:2020(E)
4.2 Understanding the needs and expectations of interested parties
ISO 9001:2015, Quality management systems — Requirements
4.2  Understanding the needs and expectations of interested parties
Due to their effect or potential effect on the organization's ability to consistently provide products
and services that meet customer and applicable statutory and regulatory requirements, the
organization shall determine:
a) the interested parties that are relevant to the quality management system;
b) the requirements of these interested parties that are relevant to the quality management system.
The organization shall monitor and review information about these interested parties and their
relevant requirements.
The organization shall retain documented information that demonstrates the understanding of the
needs and expectations of interested parties as described in 4.2.
4.3 Determining the scope of the quality management system
ISO 9001:2015, Quality management systems — Requirements
4.3  Determining the scope of the quality management system
The organization shall determine the boundaries and applicability of the quality management system
to establish its scope.
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of
...