Management system of ISO 17025
Management system of ISO 17025
Clause 4.2
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, programs, 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;
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.
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on Tuesday, November 24th, 2009 at 12:32 pm and is filed under ISO 17025 standard.
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