ISO 17025

Courtesy: ISO 17025

Laboratory activities shall be undertaken impartially and structured and managed so as to
safeguard impartiality.
The laboratory management shall be committed to impartiality.
The laboratory shall be responsible for the impartiality of its laboratory activities and shall not
allow commercial, financial or other pressures to compromise impartiality.
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.
If a risk to impartiality is identified, the laboratory shall be able to demonstrate how it eliminates
or minimizes such risk.
Confidentiality
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.
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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ISO/IEC 17025:2017(E)
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.
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.

Structural requirements
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.
The laboratory shall identify management that has overall responsibility for the laboratory.
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.
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.
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.
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.