ISO/IEC 17025:2017(E)
Note 3 to entry: The specified requirements may be, for example, that a manufacturer's specifications are met.
Note 4 to entry: Verification in legal metrology, as defined in VIML, and in conformity assessment in general,
pertains to the examination and marking and/or issuing of a verification certificate for a measuring system.
Note 5 to entry: Verification should not be confused with calibration. Not every verification is a validation (3.9).
Note 6 to entry: In chemistry, verification of the identity of the entity involved, or of activity, requires a description
of the structure or properties of that entity or activity.
[SOURCE: ISO/IEC Guide 99:2007, 2.44]
3.9
validation
verification (3.8), where the specified requirements are adequate for an intended use
EXAMPLE A measurement procedure, ordinarily used for the measurement of mass concentration of
nitrogen in water, may be validated also for measurement of mass concentration of nitrogen in human serum.
[SOURCE: ISO/IEC Guide 99:2007, 2.45]
4 General requirements
4.1 Impartiality
4.1.1 Laboratory activities shall be undertaken impartially and structured and managed so as to
safeguard impartiality.
4.1.2 The laboratory management shall be committed to impartiality.
4.1.3 The laboratory shall be responsible for the impartiality of its laboratory activities and shall not
allow commercial, financial or other pressures to compromise impartiality.
4.1.4 The laboratory shall identify risks to its impartiality on an on-going basis. This shall include those
risks that arise from its activities, or from its relationships, or from the relationships of its personnel.
However, such relationships do not necessarily present a laboratory with a risk to impartiality.
NOTE A relationship that threatens the impartiality of the laboratory can be based on ownership,
governance, management, personnel, shared resources, finances, contracts, marketing (including branding), and
payment of a sales commission or other inducement for the referral of new customers, etc.
4.1.5 If a risk to impartiality is identified, the laboratory shall be able to demonstrate how it eliminates
or minimizes such risk.
4.2 Confidentiality
4.2.1 The laboratory shall be responsible, through legally enforceable commitments, for the
management of all information obtained or created during the performance of laboratory activities.
The laboratory shall inform the customer in advance, of the information it intends to place in the public
domain. Except for information that the customer makes publicly available, or when agreed between the
laboratory and the customer (e.g. for the purpose of responding to complaints), all other information is
considered proprietary information and shall be regarded as confidential.
4.2.2 When the laboratory is required by law or authorized by contractual arrangements to release
confidential information, the customer or individual concerned shall, unless prohibited by law, be
notified of the information provided.
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4.2.3 Information about the customer obtained from sources other than the customer (e.g. complainant,
regulators) shall be confidential between the customer and the laboratory. The provider (source) of this
information shall be confidential to the laboratory and shall not be shared with the customer, unless
agreed by the source.
4.2.4 Personnel, including any committee members, contractors, personnel of external bodies, or
individuals acting on the laboratory's behalf, shall keep confidential all information obtained or created
during the performance of laboratory activities, except as required by law.
5 Structural requirements
5.1 The laboratory shall be a legal entity, or a defined part of a legal entity, that is legally responsible
for its laboratory activities.
NOTE For the purposes of this document, a governmental laboratory is deemed to be a legal entity on the
basis of its governmental status.
5.2 The laboratory shall identify management that has overall responsibility for the laboratory.
5.3 The laboratory shall define and document the range of laboratory activities for which it conforms
with this document. The laboratory shall only claim conformity with this document for this range of
laboratory activities, which excludes externally provided laboratory activities on an ongoing basis.
5.4 Laboratory activities shall be carried out in such a way as to meet the requirements of this
document, the laboratory’s customers, regulatory authorities and organizations providing recognition.
This shall include laboratory activities performed in all its permanent facilities, at sites away from its
permanent facilities, in associated temporary or mobile facilities or at a customer's facility.
5.5 The laboratory shall:
a) define the organization and management structure of the laboratory, its place in any parent
organization, and the relationships between management, technical operations and support
services;
b) specify the responsibility, authority and interrelationship of all personnel who manage, perform or
verify work affecting the results of laboratory activities;
c) document its procedures to the extent necessary to ensure the consistent application of its
laboratory activities and the validity of the results.
5.6 The laboratory shall have personnel who, irrespective of other responsibilities, have the authority
and resources needed to carry out their duties, including:
a) implementation, maintenance and improvement of the management system;
b) identification of deviations from the management system or from the procedures for performing
laboratory activities;
c) initiation of actions to prevent or minimize such deviations;
d) reporting to laboratory management on the performance of the management system and any need
for improvement;
e) ensuring the effectiveness of laboratory activities.
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5.7 Laboratory management shall ensure that:
a) communication takes place regarding the effectiveness of the management system and the
importance of meeting customers' and other requirements;
b) the integrity of the management system is maintained when changes to the management system
are planned and implemented.
6 Resource requirements
6.1 General
The laboratory shall have available the personnel, facilities, equipment, systems and support services
necessary to manage and perform its laboratory activities.
6.2 Personnel
6.2.1 All personnel of the laboratory, either internal or external, that could influence the
laboratory activities shall act impartially, be competent and work in accordance with the laboratory's
management system.
6.2.2 The laboratory shall document the competence requirements for each function influencing the
results of laboratory activities, including requirements for education, qualification, training, technical
knowledge, skills and experience.
6.2.3 The laboratory shall ensure that the personnel have the competence to perform laboratory
activities for which they are responsible and to evaluate the significance of deviations.
6.2.4 The management of the laboratory shall communicate to personnel their duties, responsibilities
and authorities.
6.2.5 The laboratory shall have procedure(s) and retain records for:
a) determining the competence requirements;
b) selection of personnel;
c) training of personnel;
d) supervision of personnel;
e) authorization of personnel;
f) monitoring competence of personnel.
6.2.6 The laboratory shall authorize personnel to perform specific laboratory activities, including but
not limited to, the following:
a) development, modification, verification and validation of methods;
b) analysis of results, including statements of conformity or opinions and interpretations;
c) report, review and authorization of results.
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6.3 Facilities and environmental conditions
6.3.1 The facilities and environmental conditions shall be suitable for the laboratory activities and
shall not adversely affect the validity of results.
NOTE Influences that can adversely affect the validity of results can include, but are not limited to, microbial
contamination, dust, electromagnetic disturbances, radiation, humidity, electrical supply, temperature, sound
and vibration.
6.3.2 The requirements for facilities and environmental conditions necessary for the performance of
the laboratory activities shall be documented.
6.3.3 The laboratory shall monitor, control and record environmental conditions in accordance with
relevant specifications, methods or procedures or where they influence the validity of the results.
6.3.4 Measures to control facilities shall be implemented, monitored and periodically reviewed and
shall include, but not be limited to:
a) access to and use of areas affecting laboratory activities;
b) prevention of contamination, interference or adverse influences on laboratory activities;
c) effective separation between areas with incompatible laboratory activities.
6.3.5 When the laboratory performs laboratory activities at sites or facilities outside its permanent
control, it shall ensure that the requirements related to facilities and environmental conditions of this
document are met.
6.4 Equipment
6.4.1 The laboratory shall have access to equipment (including, but not limited to, measuring
instruments, software, measurement standards, reference materials, reference data, reagents,
consumables or auxiliary apparatus) that is required for the correct performance of laboratory activities
and that can influence the results.
NOTE 1 A multitude of names exist for reference materials and certified reference materials, including reference
standards, calibration standards, standard reference materials and quality control materials. ISO 17034 contains
additional information on reference material producers (RMPs). RMPs that meet the requirements of ISO 17034
are considered to be competent. Reference materials from RMPs meeting the requirements of ISO 17034 are
provided with a product information sheet/certificate that specifies, amongst other characteristics, homogeneity
and stability for specified properties and, for certified reference materials, specified properties with certified
values, their associated measurement uncertainty and metrological traceability.
NOTE 2 ISO Guide 33 provides guidance on the selection and use of reference materials. ISO Guide 80 provides
guidance to produce in-house quality control materials.
6.4.2 When the laboratory uses equipment outside its permanent control, it shall ensure that the
requirements for equipment of this document are met.
6.4.3 The laboratory shall have a procedure for handling, transport, storage, use and planned
maintenance of equipment in order to ensure proper functioning and to prevent contamination or
deterioration.
6.4.4 The laboratory shall verify that equipment conforms to specified requirements before being
placed or returned into service.
