ISO 17025 Quality Manual contains or refers to the related procedures, including technical procedures. It is the structure of the documentation to outline in the management system.
The laboratory shall have instructions on the use and operation of all relevant equipment, and on the handling and preparation of items for testing and/or calibration, or both, where the absence of such instructions could communicate the results of tests and/or calibrations. All instructions, standards, manuals and reference data relevant to the work of the laboratory shall be kept up to date and shall be made readily available to personnel. Deviation from test and calibration methods shall occur only if the deviation has been documented, technically justified, authorized, and accepted by the customer.
Laboratory management system policy with regard to quality, including a quality policy statement, shall be defined in the ISO 17025 Manual. The general objectives and be evaluated during management review. The quality policy statement is issued under the authority of top management. It shall include at least the following:
- The commitment of management laboratory to good professional practice and to the quality of testing and calibration in servicing its customers;
- explanation of the quality of the services provided by the laboratory of the Board;
- The purpose of the system for management in relation to the quality;
- A requirement that all involved in the testing and calibration activities within the laboratory staff familiarize themselves with the documentation concerning the quality and the implementation of policies and procedures in their work; and
- The commitment of the laboratory management to meet this international standard and continuously improve the effectiveness of the management.
A common problem seen with labs preparing for their first ISO/IEC 17025 accreditation process is that they also focused on the accreditation itself rather than on the internal practices that the accreditation is based on become. This can lead to the formation of a quality that is much better than it seems self-practice – but each ISO 17025 accreditation auditor goes to the differences marks quickly. Thus, the best way to approach creating quality manual is an opportunity to review and improve its internal processes. Expect, as everyone through sketching, drafting and promoting finalizing the manual, they should expose weaknesses in their current quality assurance procedures and the need for measures to address them. In this way, quality manual is much more than an item on a checklist – it is a leading force for improvement within the right organization, which is exactly what it is intended.
