Organization requirements of ISO 17025
Organization requirements of ISO 17025
Clause 4.1
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);
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.
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