CEN ISO/TS 29001:2011

SLOVENSKI STANDARD
01-januar-2012
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Petroleum, petrochemical and natural gas industries - Sector-specific quality
management systems - Requirements for product and service supply organizations
(ISO/TS 29001:2010)
Erdöl-, petrochemische und Erdgasindustrie - Sektorspezifische
Qualitätsmanagementsysteme - Anforderungen an Hersteller- und Serviceorganisationen
(ISO/TS 29001:2010)
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/TS 29001:2010)
Ta slovenski standard je istoveten z: CEN ISO/TS 29001:2011
ICS:
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.

TECHNICAL SPECIFICATION
CEN ISO/TS 29001
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
February 2011
ICS 03.120.10; 75.020
English Version
Petroleum, petrochemical and natural gas industries - Sector-
specific quality management systems - Requirements for
product and service supply organizations (ISO/TS 29001:2010)
Industries du pétrole, de la pétrochimie et du gaz naturel - Erdöl-, petrochemische und Erdgasindustrie -
Systèmes de management de la qualité spécifiques au Sektorspezifische Qualitätsmanagementsysteme -
secteur - Exigences pour les organismes de fourniture de Anforderungen an Hersteller- und Serviceorganisationen
produits et de services (ISO/TS 29001:2010) (ISO/TS 29001:2010)
This Technical Specification (CEN/TS) was approved by CEN on 27 December 2010 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available
promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)
until the final decision about the possible conversion of the CEN/TS into an EN is reached.

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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 29001:2011: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
The text of ISO/TS 29001:2010 has been prepared by Technical Committee ISO/TC 67 “Materials, equipment
and offshore structures for petroleum, petrochemical and natural gas industries” of the International
Organization for Standardization (ISO) and has been taken over as CEN ISO/TS 29001:2011 by Technical
Committee CEN/TC 12 “Materials, equipment and offshore structures for petroleum, petrochemical and
natural gas industries” the secretariat of which is held by AFNOR.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this Technical Specification: 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, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO/TS 29001:2010 has been approved by CEN as a CEN ISO/TS 29001:2011 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 29001
Third edition
2010-06-01
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/TS 29001:2010(E)
©
ISO 2010
ISO/TS 29001:2010(E)
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ii © ISO 2010 – All rights reserved

ISO/TS 29001:2010(E)
Contents Page
Foreword .vi
Introduction.vii
0.1 General .vii
0.2 Process approach .viii
0.3 Relationship with ISO 9004.ix
0.4 Compatibility with other management systems.x
0.5 Goal of this Technical Specification.x
1 Scope.1
1.1 General .1
1.1.1 Field of Application — Supplemental.1
1.2 Application .2
1.2.1 Application — Supplemental.2
2 Normative references.2
3 Terms and definitions .2
3.1 Terms and definitions for the petroleum, petrochemical and natural gas industries.3
4 Quality management system.4
4.1 General requirements .4
4.1.1 Outsourced processes and/or services — Supplemental.4
4.2 Documentation requirements.5
4.2.1 General .5
4.2.2 Quality manual.5
4.2.2.1 Quality manual — Supplemental.5
4.2.3 Control of documents .6
4.2.3.1 Control of documents — Supplemental .6
4.2.3.2 Control of document changes — Supplemental .6
4.2.4 Control of records .6
4.2.4.1 Control of records — Supplemental .7
5 Management responsibility .7
5.1 Management commitment .7
5.2 Customer focus .7
5.3 Quality policy .8
5.3.1 Quality policy — Supplemental.8
5.4 Planning.8
5.4.1 Quality objectives.8
5.4.2 Quality management system planning.8
5.5 Responsibility, authority and communication .9
5.5.1 Responsibility and authority .9
5.5.2 Management representative.9
5.5.3 Internal communication.9
5.6 Management review .10
5.6.1 General .10
5.6.1.1 General — Supplemental .10
5.6.2 Review input .10
5.6.3 Review output.11
6 Resource management.11
6.1 Provision of resources.11
6.2 Human resources .11
6.2.1 General .11
6.2.2 Competence, training and awareness.12
ISO/TS 29001:2010(E)
6.2.2.1 Training — Supplemental.12
6.3 Infrastructure.12
6.4 Work environment .13
7 Product realization.13
7.1 Planning of product realization.13
7.1.1 Planning of product realization — Supplemental.13
7.2 Customer-related processes .14
7.2.1 Determination of requirements related to the product .14
7.2.2 Review of requirements related to the product .14
7.2.2.1 Review of requirements related to the product — Supplemental .14
7.2.3 Customer communication .15
7.3 Design and development .15
7.3.1 Design and development planning .15
7.3.1.1 Design and development planning — Supplemental .15
7.3.1.2 Design documentation — Supplemental .15
7.3.2 Design and development inputs .16
7.3.2.1 Design and development inputs — Supplemental .16
7.3.3 Design and development outputs.16
7.3.3.1 Design and development outputs – Supplemental.16
7.3.4 Design and development review.17
7.3.4.1 Design and development review — Supplemental.17
7.3.5 Design and development verification.17
7.3.6 Design and development validation .18
7.3.7 Control of design and development changes.18
7.3.7.1 Control of design and development changes — Supplemental.18
7.4 Purchasing .18
7.4.1 Purchasing process .18
7.4.1.1 Purchasing process — Supplemental .19
7.4.1.2 Criteria for supplier selection, evaluation, and re-evaluation — Supplemental.19
7.4.1.3 Supplier-provided processes that require validation — Supplemental .19
7.4.2 Purchasing information .19
7.4.2.1 Purchasing information — Supplemental .19
7.4.3 Verification of purchased product .20
7.4.3.1 Verification of purchased product — Supplemental .20
7.5 Production and service provision.20
7.5.1 Control of production and service provision.20
7.5.1.1 Control of production and service provision — Supplemental.20
7.5.1.2 Process controls — Supplemental.20
7.5.2 Validation of processes for production and service provision .21
7.5.2.1 Validation of processes for production and service provision — Supplemental .21
7.5.3 Identification and traceability.21
7.5.3.1 Identification and traceability — Supplemental.21
7.5.3.2 Identification and traceability maintenance and replacement — Supplemental .22
7.5.3.3 Product status — Supplemental.22
7.5.4 Customer property.22
7.5.4.1 Customer property — Supplemental.22
7.5.5 Preservation of product .22
7.5.5.1 Preservation of product — Supplemental .22
7.5.5.2 Periodic assessment of stock — Supplemental .22
7.6 Control of monitoring and measuring equipment.23
7.6.1 Control of monitoring and measuring equipment — Supplemental .23
7.6.2 Environmental conditions — Supplemental .24
8 Measurement, analysis and improvement .24
8.1 General.24
8.2 Monitoring and measurement .25
8.2.1 Customer satisfaction .25
8.2.2 Internal audit .25
8.2.2.1 Internal audit — Supplemental .25
8.2.2.2 Response times — Supplemental .26
iv © ISO 2010 – All rights reserved

ISO/TS 29001:2010(E)
8.2.3 Monitoring and measurement of processes.26
8.2.4 Monitoring and measurement of product .26
8.2.4.1 Monitoring and measurement of product — Supplemental .26
8.2.4.2 Acceptance inspection — Supplemental .26
8.3 Control of nonconforming product .27
8.3.1 Release or acceptance of nonconforming product — Supplemental.27
8.3.2 Field nonconformity analysis — Supplemental .27
8.3.3 Customer notification — Supplemental .28
8.4 Analysis of data .28
8.4.1 Analysis of data — Supplemental.28
8.5 Improvement .28
8.5.1 Continual improvement .28
8.5.2 Corrective action .29
8.5.2.1 Corrective action — Supplemental .29
8.5.2.2 Response times — Supplemental .29
8.5.3 Preventive action.29
8.5.3.1 Preventive action — Supplemental.29
Bibliography.30

ISO/TS 29001:2010(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
In other circumstances, particularly when there is an urgent market requirement for such documents, a
technical committee may decide to publish other types of document:
⎯ an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in
an ISO working group and is accepted for publication if it is approved by more than 50 % of the members
of the parent committee casting a vote;
⎯ an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical
committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting
a vote.
An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a
further three years, revised to become an International Standard, or withdrawn.
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.
ISO/TS 29001 was prepared by Technical Committee ISO/TC 67, Materials, equipment and offshore
structures for petroleum, petrochemical and natural gas industries.
This third edition cancels and replaces the second edition (ISO/TS 29001:2007), of which it constitutes a
minor revision.
In this third edition of ISO/TS 29001, the boxed text has been revised in order to ensure that it constitutes the
text of ISO 9001:2008 unaltered and in its entirety. No changes other than editorial have been made outside
the boxed text.
The fourth edition of ISO 9001 (ISO 9001:2008) cancelled and replaced the third edition (ISO 9001:2000),
which was amended to clarify points in the text and to enhance compatibility with ISO 14001:2004.
Since the third edition, the title of ISO 9001 has been revised such that it no longer includes the term “Quality
Assurance”. This reflects the fact that the quality management system requirements specified in ISO 9001
now also aim to enhance customer satisfaction, in addition to the quality assurance of a product.

vi © ISO 2010 – All rights reserved

ISO/TS 29001:2010(E)
Introduction
0.1 General
ISO 9001:2008, Quality management systems — Requirements
Introduction
0.1 General
The adoption of a quality management system should be a strategic decision of an organization. The
design and implementation of an organization's quality management system is influenced by
a) its organizational environment, changes in that environment, and the risks associated with that
environment,
b) its varying needs,
c) its particular objectives,
d) the products it provides,
e) the processes it employs,
f) its size and organizational structure.
It is not the intent of this International Standard to imply uniformity in the structure of quality management
systems or uniformity of documentation.
The quality management system requirements specified in this International Standard are complementary
to requirements for products. Information marked “NOTE“ is for guidance in understanding or clarifying the
associated requirement.
This International Standard can be used by internal and external parties, including certification bodies, to
assess the organization's ability to meet customer, statutory and regulatory requirements applicable to the
product and the organization's own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration
during the development of this International Standard.

NOTE This Technical Specification does not address competitive or commercial matters such as price, warranties,
guarantees or clauses intended to sustain commercial objectives.
ISO/TS 29001:2010(E)
0.2 Process approach
ISO 9001:2008, Quality management systems — Requirements
0.2 Process approach
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.
For an organization to function effectively, it has to determine and manage numerous linked activities. An
activity or set of activities using resources, and managed in order to enable the transformation of inputs into
outputs, can be considered as a process. Often the output from one process directly forms the input to the
next.
The application of a system of processes within an organization, together with the identification and
interactions of these processes, and their management to produce the desired outcome, can be referred to
as the “process approach”.
An advantage of the process approach is the ongoing control that it provides over the linkage between the
individual processes within the system of processes, as well as over their combination and interaction.
When used within a quality management system, such an approach emphasizes the importance of
a) understanding and meeting requirements,
b) the need to consider processes in terms of added value,
c) obtaining results of process performance and effectiveness, and
d) continual improvement of processes based on objective measurement.
The model of a process-based quality management system shown in Figure 1 illustrates the process
linkages presented in Clauses 4 to 8. This illustration shows that customers play a significant role in
defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information
relating to customer perception as to whether the organization has met the customer requirements. The
model shown in Figure 1 covers all the requirements of this International Standard, but does not show
processes at a detailed level.
NOTE In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes.
PDCA can be briefly described as follows.
Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements
and the organization's policies.
Do: implement the processes.
Check: monitor and measure processes and product against policies, objectives and requirements for the product and
report the results.
Act: take actions to continually improve process performance.

viii © ISO 2010 – All rights reserved

ISO/TS 29001:2010(E)
Figure 1 — Model of process-based quality management system

0.3 Relationship with ISO 9004
ISO 9001:2008, Quality management systems — Requirements
0.3 Relationship with ISO 9004
ISO 9001 and ISO 9004 are quality management system standards which have been designed to
complement each other, but can also be used independently.
ISO 9001 specifies requirements for a quality management system that can be used for internal application
by organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the
quality management system in meeting customer requirements.
At the time of publication of this International Standard, ISO 9004 is under revision. The revised edition of
ISO 9004 will provide guidance to management for achieving sustained success for any organization in a
complex, demanding, and ever changing, environment. ISO 9004 provides a wider focus on quality
management than ISO 9001; it addresses the needs and expectations of all interested parties and their
satisfaction, by the systematic and continual improvement of the organization's performance. However, it is
not intended for certification, regulatory or contractual use.

NOTE ISO 9004:2009 has now been published, and has cancelled and replaced ISO 9004:2000.
ISO/TS 29001:2010(E)
0.4 Compatibility with other management systems
ISO 9001:2008, Quality management systems — Requirements
0.4 Compatibility with other management systems
During the development of this International Standard, due consideration was given to the provisions of
ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community.
Annex A shows the correspondence between ISO 9001:2008 and ISO 14001:2004.
This International Standard does not include requirements specific to other management systems, such as
those particular to environmental management, occupational health and safety management, financial
management or risk management. However, this International Standard enables an organization to align or
integrate its own quality management system with related management system requirements. It is possible
for an organization to adapt its existing management system(s) in order to establish a quality management
system that complies with the requirements of this International Standard.

NOTE For this Technical Specification, Annex A, as described above, is not provided and is not considered part of
this Technical Specification. If the comparison of ISO 9001:2008 and ISO 14001:2004 is required, the reader is
encouraged to review Annex A of the referenced ISO 9001:2008 document.

0.5 Goal of this Technical Specification
The goal of this Technical Specification is the development of a quality management system that provides for
continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply
chain and from service providers.
This Technical Specification, coupled with applicable customer-specific requirements, defines the fundamental
quality management system requirements for those subscribing to this Technical Specification.
This Technical Specification is intended to avoid multiple certification audits and provide a common approach
to a quality management system for the petroleum, petrochemical and natural gas industries.

x © ISO 2010 – All rights reserved

TECHNICAL SPECIFICATION ISO/TS 29001:2010(E)

Petroleum, petrochemical and natural gas industries — Sector-
specific quality management systems — Requirements for
product and service supply organizations
1 Scope
1.1 General
ISO 9001:2008, Quality management systems — Requirements
1 Scope
1.1 General
This International Standard specifies requirements for a quality management system where an organization
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable
statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including
processes for continual improvement of the system and the assurance of conformity to customer and
applicable statutory and regulatory requirements.
NOTE 1 In this International Standard, the term “product” applies only to
a) product intended for, or required by, a customer,
b) any intended output resulting from the product realization process.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.

1.1.1 Field of Application — Supplemental
This Technical Specification defines the quality management system for product and service supply
organizations for the petroleum, petrochemical and natural gas industries.
Boxed text is original ISO 9001:2008 text unaltered and in its entirety. The petroleum, petrochemical, and
natural gas industry sector-specific supplemental requirements are outside the boxes.
ISO/TS 29001:2010(E)
1.2 Application
ISO 9001:2008, Quality management systems — Requirements
1.2 Application
All requirements of this International Standard are generic and are intended to be applicable to all
organizations, regardless of type, size and product provided.
Where any requirement(s) of this International Standard cannot be applied due to the nature of an
organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless
these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the
organization's ability, or responsibility, to provide product that meets customer and applicable statutory and
regulatory requirements.
1.2.1 Application — Supplemental
Where exclusions are made, claims of conformity to this Technical Specification are not acceptable unless
these exclusions are limited to requirements within the subclauses listed below in this subclause, and such
exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and
applicable regulatory requirements:
⎯ 7.3 Design and development;
⎯ 7.5.1 Control of production and service provision;
⎯ 7.5.2 Validation of processes for production and service provision;
⎯ 7.5.4 Customer property.
2 Normative references
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 9000:2005, Quality management systems — Fundamentals and vocabulary

3 Terms and definitions
ISO 9001:2008, Quality management systems — Requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 apply.
Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean
“service”.
2 © ISO 2010 – All rights reserved

ISO/TS 29001:2010(E)
3.1 Terms and definitions for the petroleum, petrochemical and natural gas industries
For the purposes of this document, the terms and definitions given in ISO 9000:2005 and the following apply.
3.1.1
acceptance criteria
specified limits of acceptability applied to process or product characteristics
3.1.2
acceptance inspection
demonstration through monitoring or measurement that the product complies with specified requirements
3.1.3
calibration
comparison and adjustment to a standard of known accuracy
3.1.4
control feature
organization's documented method for performing an activity under controlled conditions to achieve conformity
to specified requirements
3.1.5
delivery
point in time and physical location at which the agreed transfer of ownership takes place
3.1.6
design acceptance criteria
defined limits placed on characteristics of materials, products, or services established by the organization,
customer, and/or applicable specifications to achieve conformity to the product design
3.1.7
design validation
process of proving a design by testing to demonstrate conformity of the product to design requirements
3.1.8
design verification
process of examining the result of a given design or development activity to determine conformity with
specified requirements
3.1.9
field nonconformity
product nonconformity that is detected after delivery or use has started
3.1.10
manufacturing acceptance criteria
defined limits placed on characteristics of materials, products, and services established by the organization to
achieve conformity to the manufacturing or service requirements
3.1.11
tender
offer made by an organization in response to an invitation to provide a product
ISO/TS 29001:2010(E)
4 Quality management system
4.1 General requirements
ISO 9001:2008, Quality management systems — Requirements
4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system and
continually improve its effectiveness in accordance with the requirements of this International Standard.
The organization shall
a) determine the processes needed for the quality management system and their application throughout
the organization (see 1.2),
b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both the operation and control of these
processes are effective,
d) ensure the availability of resources and information necessary to support the operation and monitoring
of these processes,
e) monitor, measure where applicable and analyze these processes, and
f) implement actions necessary to achieve planned results and continual improvement of these
processes.
These processes shall be managed by the organization in accordance with the requirements of this
International Standard.
Where an organization chooses to outsource any process that affects product conformity to requirements,
the organization shall ensure control over such processes. The type and extent of control to be applied to
these outsourced processes shall be defined within the quality management system.
NOTE 1 Processes needed for the quality management system referred to above include processes for
management activities, provision of resources, product realization, measurement, analysis and improvement.
NOTE 2 An “outsourced process” is a process that the organization needs for its quality management system and
which the organization chooses to have performed by an external party.
NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of
conformity to all customer, statutory and
...