standard for measuring water

Reference number
ISO/IEC 17025:2005(E)
© ISO 2005
INTERNATIONAL
STANDARD
ISO/IEC
17025
Second edition
2005-05-15
General requirements for the competence
of testing and calibration laboratories
Exigences générales concernant la compétence des laboratoires
d'étalonnages et d'essais
ISO/IEC 17025:2005(E)
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ISO/IEC 17025:2005(E)
© ISO 2005 — All rights reserved iii
Contents Page
Foreword............................................................................................................................................................ v
Introduction ...................................................................................................................................................... vi
1 Scope..................................................................................................................................................... 1
2 Normative references ........................................................................................................................... 2
3 Terms and definitions.......................................................................................................................... 2
4 Management requirements .................................................................................................................. 2
4.1 Organization ......................................................................................................................................... 2
4.2 Management system............................................................................................................................ 3
4.3 Document control ................................................................................................................................ 4
4.3.1 General .................................................................................................................................................. 4
4.3.2 Document approval and issue............................................................................................................. 4
4.3.3 Document changes.............................................................................................................................. 5
4.4 Review of requests, tenders and contracts ....................................................................................... 5
4.5 Subcontracting of tests and calibrations ........................................................................................... 6
4.6 Purchasing services and supplies ...................................................................................................... 6
4.7 Service to the customer ....................................................................................................................... 6
4.8 Complaints............................................................................................................................................ 7
4.9 Control of nonconforming testing and/or calibration work.............................................................. 7
4.10 Improvement......................................................................................................................................... 7
4.11 Corrective action.................................................................................................................................. 8
4.11.1 General .................................................................................................................................................. 8
4.11.2 Cause analysis ..................................................................................................................................... 8
4.11.3 Selection and implementation of corrective actions......................................................................... 8
4.11.4 Monitoring of corrective actions ......................................................................................................... 8
4.11.5 Additional audits .................................................................................................................................. 8
4.12 Preventive action ................................................................................................................................. 8
4.13 Control of records................................................................................................................................ 9
4.13.1 General .................................................................................................................................................. 9
4.13.2 Technical records ................................................................................................................................ 9
4.14 Internal audits....................................................................................................................................... 9
4.15 Management reviews......................................................................................................................... 10
5 Technical requirements..................................................................................................................... 10
5.1 General ................................................................................................................................................ 10
5.2 Personnel............................................................................................................................................ 11
5.3 Accommodation and environmental conditions ............................................................................. 12
5.4 Test and calibration methods and method validation..................................................................... 12
5.4.1 General ................................................................................................................................................ 12
5.4.2 Selection of methods......................................................................................................................... 13
5.4.3 Laboratory-developed methods ........................................................................................................ 13
5.4.4 Non-standard methods....................................................................................................................... 13
5.4.5 Validation of methods........................................................................................................................ 14
5.4.6 Estimation of uncertainty of measurement...................................................................................... 14
5.4.7 Control of data.................................................................................................................................... 15
5.5 Equipment........................................................................................................................................... 15
5.6 Measurement traceability................................................................................................................... 17
5.6.1 General ................................................................................................................................................ 17
5.6.2 Specific requirements........................................................................................................................ 17
5.6.3 Reference standards and reference materials................................................................................. 18
5.7 Sampling............................................................................................................................................. 19
ISO/IEC 17025:2005(E)
iv © ISO 2005 — All rights reserved
5.8 Handling of test and calibration items ..............................................................................................19
5.9 Assuring the quality of test and calibration results ........................................................................20
5.10 Reporting the results ..........................................................................................................................20
5.10.1 General ................................................................................................................................................20
5.10.2 Test reports and calibration certificates...........................................................................................20
5.10.3 Test reports.........................................................................................................................................21
5.10.4 Calibration certificates.......................................................................................................................22
5.10.5 Opinions and interpretations .............................................................................................................22
5.10.6 Testing and calibration results obtained from subcontractors......................................................23
5.10.7 Electronic transmission of results ....................................................................................................23
5.10.8 Format of reports and certificates .....................................................................................................23
5.10.9 Amendments to test reports and calibration certificates ...............................................................23
Annex A (informative) Nominal cross-references to ISO 9001:2000 ...........................................................24
Annex B (informative) Guidelines for establishing applications for specific fields ..................................26
Bibliography.....................................................................................................................................................27
ISO/IEC 17025:2005(E)
© ISO 2005 — All rights reserved v
Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that are members of
ISO or IEC participate in the development of International Standards through technical committees
established by the respective organization to deal with particular fields of technical activity. ISO and IEC
technical committees collaborate in fields of mutual interest. Other international organizations, governmental
and non-governmental, in liaison with ISO and IEC, also take part in the work. In the field of conformity
assessment, the ISO Committee on conformity assessment (CASCO) is responsible for the development of
International Standards and Guides.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
Draft International Standards are circulated to the national bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the national bodies casting a vote.
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/IEC 17025 was prepared by the ISO Committee on conformity assessment (CASCO).
It was circulated for voting to the national bodies of both ISO and IEC, and was approved by both
organizations.
This second edition cancels and replaces the first edition (ISO/IEC 17025:1999), which has been technically
revised.
ISO/IEC 17025:2005(E)
vi © ISO 2005 — All rights reserved
Introduction
The first edition (1999) of this International Standard was produced as the result of extensive experience in
the implementation of ISO/IEC Guide 25 and EN 45001, both of which it replaced. It contained all of the
requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they
operate a management system, are technically competent, and are able to generate technically valid results.
The first edition referred to ISO 9001:1994 and ISO 9002:1994. These standards have been superseded by
ISO 9001:2000, which made an alignment of ISO/IEC 17025 necessary. In this second edition, clauses have
been amended or added only when considered necessary in the light of ISO 9001:2000.
Accreditation bodies that recognize the competence of testing and calibration laboratories should use this
International Standard as the basis for their accreditation. Clause 4 specifies the requirements for sound
management. Clause 5 specifies the requirements for technical competence for the type of tests and/or
calibrations the laboratory undertakes.
Growth in the use of management systems generally has increased the need to ensure that laboratories which
form part of larger organizations or offer other services can operate to a quality management system that is
seen as compliant with ISO 9001 as well as with this International Standard. Care has been taken, therefore,
to incorporate all those requirements of ISO 9001 that are relevant to the scope of testing and calibration
services that are covered by the laboratory's management system.
Testing and calibration laboratories that comply with this International Standard will therefore also operate in
accordance with ISO 9001.
Conformity of the quality management system within which the laboratory operates to the requirements of
ISO 9001 does not of itself demonstrate the competence of the laboratory to produce technically valid data
and results. Nor does demonstrated conformity to this International Standard imply conformity of the quality
management system within which the laboratory operates to all the requirements of ISO 9001.
The acceptance of testing and calibration results between countries should be facilitated if laboratories comply
with this International Standard and if they obtain accreditation from bodies which have entered into mutual
recognition agreements with equivalent bodies in other countries using this International Standard.
The use of this International Standard will facilitate cooperation between laboratories and other bodies, and
assist in the exchange of information and experience, and in the harmonization of standards and procedures.
INTERNATIONAL STANDARD ISO/IEC 17025:2005(E)
© ISO 2005 — All rights reserved 1
General requirements for the competence of testing and
calibration laboratories
1 Scope
1.1 This International Standard specifies the general requirements for the competence to carry out tests
and/or calibrations, including sampling. It covers testing and calibration performed using standard methods,
non-standard methods, and laboratory-developed methods.
1.2 This International Standard is applicable to all organizations performing tests and/or calibrations. These
include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or
calibration forms part of inspection and product certification.
This International Standard is applicable to all laboratories regardless of the number of personnel or the extent
of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the
activities covered by this International Standard, such as sampling and the design/development of new
methods, the requirements of those clauses do not apply.
1.3 The notes given provide clarification of the text, examples and guidance. They do not contain
requirements and do not form an integral part of this International Standard.
1.4 This International Standard is for use by laboratories in developing their management system for quality,
administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies
may also use it in confirming or recognizing the competence of laboratories. This International Standard is not
intended to be used as the basis for certification of laboratories.
NOTE 1 The term 'management system' in this International Standard means the quality, administrative and technical
systems that govern the operations of a laboratory.
NOTE 2 Certification of a management system is sometimes also called registration.
1.5 Compliance with regulatory and safety requirements on the operation of laboratories is not covered by
this International Standard.
1.6 If testing and calibration laboratories comply with the requirements of this International Standard, they
will operate a quality management system for their testing and calibration activities that also meets the
principles of ISO 9001. Annex A provides nominal cross-references between this International Standard and
ISO 9001. This International Standard covers technical competence requirements that are not covered by
ISO 9001.
NOTE 1 It might be necessary to explain or interpret certain requirements in this International Standard to ensure that
the requirements are applied in a consistent manner. Guidance for establishing applications for specific fields, especially
for accreditation bodies (see ISO/IEC 17011) is given in Annex B.
NOTE 2 If a laboratory wishes accreditation for part or all of its testing and calibration activities, it should select an
accreditation body that operates in accordance with ISO/IEC 17011.
ISO/IEC 17025:2005(E)
2 © ISO 2005 — All rights reserved
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/IEC 17000, Conformity assessment — Vocabulary and general principles
VIM, International vocabulary of basic and general terms in metrology, issued by BIPM, IEC, IFCC, ISO,
IUPAC, IUPAP and OIML
NOTE Further related standards, guides, etc. on subjects included in this International Standard are given in the
Bibliography.
3 Terms and definitions
For the purposes of this document, the relevant terms and definitions given in ISO/IEC 17000 and VIM apply.
NOTE General definitions related to quality are given in ISO 9000, whereas ISO/IEC 17000 gives definitions
specifically related to certification and laboratory accreditation. Where different definitions are given in ISO 9000, the
definitions in ISO/IEC 17000 and VIM are preferred.
4 Management requirements
4.1 Organization
4.1.1 The laboratory or the organization of which it is part shall be an entity that can be held legally
responsible.
4.1.2 It is the responsibility of the laboratory to carry out its testing and calibration activities in such a way as
to meet the requirements of this International Standard and to satisfy the needs of the customer, the
regulatory authorities or organizations providing recognition.
4.1.3 The management system shall cover work carried out in the laboratory’s permanent facilities, at sites
away from its permanent facilities, or in associated temporary or mobile facilities.
4.1.4 If the laboratory is part of an organization performing activities other than testing and/or calibration,
the responsibilities of key personnel in the organization that have an involvement or influence on the testing
and/or calibration activities of the laboratory shall be defined in order to identify potential conflicts of interest.
NOTE 1 Where a laboratory is part of a larger organization, the organizational arrangements should be such that
departments having conflicting interests, such as production, commercial marketing or financing do not adversely
influence the laboratory's compliance with the requirements of this International Standard.
NOTE 2 If the laboratory wishes to be recognized as a third-party laboratory, it should be able to demonstrate that it is
impartial and that it and its personnel are free from any undue commercial, financial and other pressures which might
influence their technical judgement. The third-party testing or calibration laboratory should not engage in any activities that
may endanger the trust in its independence of judgement and integrity in relation to its testing or calibration activities.
4.1.5 The laboratory shall
a) have managerial and technical personnel who, irrespective of other responsibilities, have the authority
and resources needed to carry out their duties, including the implementation, maintenance and
improvement of the management system, and to identify the occurrence of departures from the
management system or from the procedures for performing tests and/or calibrations, and to initiate
actions to prevent or minimize such departures (see also 5.2);
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© ISO 2005 — All rights reserved 3
b) have arrangements to ensure that its management and personnel are free from any undue internal and
external commercial, financial and other pressures and influences that may adversely affect the quality of
their work;
c) have policies and procedures to ensure the protection of its customers' confidential information and
proprietary rights, including procedures for protecting the electronic storage and transmission of results;
d) have policies and procedures to avoid involvement in any activities that would diminish confidence in its
competence, impartiality, judgement or operational integrity;
e) define the organization and management structure of the laboratory, its place in any parent organization,
and the relationships between quality management, technical operations and support services;
f) specify the responsibility, authority and interrelationships of all personnel who manage, perform or verify
work affecting the quality of the tests and/or calibrations;
g) provide adequate supervision of testing and calibration staff, including trainees, by persons familiar with
methods and procedures, purpose of each test and/or calibration, and with the assessment of the test or
calibration results;
h) have technical management which has overall responsibility for the technical operations and the provision
of the resources needed to ensure the required quality of laboratory operations;
i) appoint a member of staff as quality manager (however named) who, irrespective of other duties and
responsibilities, shall have defined responsibility and authority for ensuring that the management system
related to quality is implemented and followed at all times; the quality manager shall have direct access to
the highest level of management at which decisions are made on laboratory policy or resources;
j) appoint deputies for key managerial personnel (see Note);
k) ensure that its personnel are aware of the relevance and importance of their activities and how they
contribute to the achievement of the objectives of the management system.
NOTE Individuals may have more than one function and it may be impractical to appoint deputies for every function.
4.1.6 Top management shall ensure that appropriate communication processes are established within the
laboratory and that communication takes place regarding the effectiveness of the management system.
4.2 Management system
4.2.1 The laboratory shall establish, implement and maintain a management system appropriate to the
scope of its activities. The laboratory shall document its policies, systems, programmes, procedures and
instructions to the extent necessary to assure the quality of the test and/or calibration results. The system’s
documentation shall be communicated to, understood by, available to, and implemented by the appropriate
personnel.
4.2.2 The laboratory's management system policies related to quality, including a quality policy statement,
shall be defined in a quality manual (however named). The overall objectives shall be established, and shall
be reviewed during management review. The quality policy statement shall be issued under the authority of
top management. It shall include at least the following:
a) the laboratory management's commitment to good professional practice and to the quality of its testing
and calibration in servicing its customers;
b) the management’s statement of the laboratory's standard of service;
c) the purpose of the management system related to quality;
ISO/IEC 17025:2005(E)
4 © ISO 2005 — All rights reserved
d) a requirement that all personnel concerned with testing and calibration activities within the laboratory
familiarize themselves with the quality documentation and implement the policies and procedures in their
work; and
e) the laboratory management's commitment to comply with this International Standard and to continually
improve the effectiveness of the management system.
NOTE The quality policy statement should be concise and may include the requirement that tests and/or calibrations
shall always be carried out in accordance with stated methods and customers' requirements. When the test and/or
calibration laboratory is part of a larger organization, some quality policy elements may be in other documents.
4.2.3 Top management shall provide evidence of commitment to the development and implementation of
the management system and to continually improving its effectiveness.
4.2.4 Top management shall communicate to the organization the importance of meeting customer
requirements as well as statutory and regulatory requirements.
4.2.5 The quality manual shall include or make reference to the supporting procedures including technical
procedures. It shall outline the structure of the documentation used in the management system.
4.2.6 The roles and responsibilities of technical management and the quality manager, including their
responsibility for ensuring compliance with this International Standard, shall be defined in the quality manual.
4.2.7 Top management shall ensure that the integrity of the management system is maintained when
changes to the management system are planned and implemented.
4.3 Document control
4.3.1 General
The laboratory shall establish and maintain procedures to control all documents that form part of its
management system (internally generated or from external sources), such as regulations, standards, other
normative documents, test and/or calibration methods, as well as drawings, software, specifications,
instructions and manuals.
NOTE 1 In this context “document” could be policy statements, procedures, specifications, calibration tables, charts,
text books, posters, notices, memoranda, software, drawings, plans, etc. These may be on various media, whether hard
copy or electronic, and they may be digital, analog, photographic or written.
NOTE 2 The control of data related to testing and calibration is covered in 5.4.7. The control of records is covered in
4.13.
4.3.2 Document approval and issue
4.3.2.1 All documents issued to personnel in the laboratory as part of the management system shall be
reviewed and approved for use by authorized personnel prior to issue. A master list or an equivalent
document control procedure identifying the current revision status and distribution of documents in the
management system shall be established and shall be readily available to preclude the use of invalid and/or
obsolete documents.
4.3.2.2 The procedure(s) adopted shall ensure that:
a) authorized editions of appropriate documents are available at all locations where operations essential to
the effective functioning of the laboratory are performed;
b) documents are periodically reviewed and, where necessary, revised to ensure continuing suitability and
compliance with applicable requirements;
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© ISO 2005 — All rights reserved 5
c) invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured
against unintended use;
d) obsolete documents retained for either legal or knowledge preservation purposes are suitably marked.
4.3.2.3 Management system documents generated by the laboratory shall be uniquely identified. Such
identification shall include the date of issue and/or revision identification, page numbering, the total number of
pages or a mark to signify the end of the document, and the issuing authority(ies).
4.3.3 Document changes
4.3.3.1 Changes to documents shall be reviewed and approved by the same function that performed the
original review unless specifically designated otherwise. The designated personnel shall have access to
pertinent background information upon which to base their review and approval.
4.3.3.2 Where practicable, the altered or new text shall be identified in the document or the appropriate
attachments.
4.3.3.3 If the laboratory's document control system allows for the amendment of documents by hand
pending the re-issue of the documents, the procedures and authorities for such amendments shall be defined.
Amendments shall be clearly marked, initialled and dated. A revised document shall be formally re-issued as
soon as practicable.
4.3.3.4 Procedures shall be established to describe how changes in do

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