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Quality Manual Michael Koch Quality Manual – Why? ISO/IEC 17025 states the necessity for an accredited laboratory to have a quality system with certain requirements as well as procedures to keep documents under control The quality manual is the keystone of the documentation of a quality system. Quality Manual Contents Document Control Quality Manual – ContentsISO/IEC 17025 – 4.2.1 The laboratory shall establish, implement and maintain a quality 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. Quality Manual – Contents ISO/IEC 17025 – 4.2.2 The laboratory’s quality system policies and objectives shall be defined in a quality manual (however named). The overall objectives shall be documented in quality policy statement. The quality policy statement shall be issued under the authority of the chief executive. Quality Manual – Contents ISO/IEC 17025 – 4.2.2 (followed) It shall include at least the following: the laboratory management’s commitment to good professional practice and to the quality of its testing and calibration in servicing its clients; the management’s statement of the laboratory‘s standard of service; the objectives of the quality system; Quality Manual – Contents ISO/IEC 17025 – 4.2.2 (followed) 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 the laboratory management’s commitment to compliance with this International Standard. Quality Manual – Contents ISO/IEC 17025 – 4.2.3 The quality manual shall include or make reference to the supporting procedures including tech