Equipment requirements of ISO 17025
Equipment requirements of ISO 17025
Clause 5.5
5.5.1 The laboratory shall be furnished with all items of sampling, measurement and test equipment required for the correct performance of the tests and/or calibrations (including sampling, preparation of test and/or calibration items, processing and analysis of test and/or calibration data). In those cases where the laboratory needs to use equipment outside its permanent control, it shall ensure that the requirements of this International Standard are met.
5.5.2 Equipment and its software used for testing, calibration and sampling shall be capable of achieving the accuracy required and shall comply with specifications relevant to the tests and/or calibrations concerned. Calibration programs shall be established for key quantities or values of the instruments where these properties have a significant effect on the results. Before being placed into service, equipment (including that used for sampling) shall be calibrated or checked to establish that it meets the laboratory’s specification requirements and complies with the relevant standard specifications. It shall be checked and/or calibrated before use (see 5.6).
5.5.3 Equipment shall be operated by authorized personnel. Up-to-date instructions on the use and
maintenance of equipment (including any relevant manuals provided by the manufacturer of the equipment) shall be readily available for use by the appropriate laboratory personnel.
5.5.4 Each item of equipment and its software used for testing and calibration and significant to the result shall, when practicable, be uniquely identified.
5.5.5 Records shall be maintained of each item of equipment and its software significant to the tests and/or calibrations performed. The records shall include at least the following:
a) the identity of the item of equipment and its software;
b) the manufacturer’s name, type identification, and serial number or other unique identification;
c) checks that equipment complies with the specification (see 5.5.2);
d) the current location, where appropriate;
e) the manufacturer’s instructions, if available, or reference to their location;
f) dates, results and copies of reports and certificates of all calibrations, adjustments, acceptance criteria,
and the due date of next calibration;
g) the maintenance plan, where appropriate, and maintenance carried out to date;
h) any damage, malfunction, modification or repair to the equipment.
5.5.6 The laboratory shall have procedures for safe handling, transport, storage, use and planned
maintenance of measuring equipment to ensure proper functioning and in order to prevent contamination or
deterioration.
NOTE Additional procedures may be necessary when measuring equipment is used outside the permanent laboratory for tests, calibrations or sampling.
5.5.7 Equipment that has been subjected to overloading or mishandling, gives suspect results, or has been shown to be defective or outside specified limits, shall be taken out of service. It shall be isolated to prevent its use or clearly labeled or marked as being out of service until it has been repaired and shown by calibration or test to perform correctly. The laboratory shall examine the effect of the defect or departure from specified limits on previous tests and/or calibrations and shall institute the “Control of nonconforming work” procedure (see 4.9).
5.5.8 Whenever practicable, all equipment under the control of the laboratory and requiring calibration shall be labeled, coded or otherwise identified to indicate the status of calibration, including the date when last calibrated and the date or expiration criteria when recalibration is due.
5.5.9 When, for whatever reason, equipment goes outside the direct control of the laboratory, the laboratory shall ensure that the function and calibration status of the equipment are checked and shown to be satisfactory before the equipment is returned to service.
5.5.10 When intermediate checks are needed to maintain confidence in the calibration status of the equipment, these checks shall be carried out according to a defined procedure.
5.5.11 Where calibrations give rise to a set of correction factors, the laboratory shall have procedures to ensure that copies (e.g. in computer software) are correctly updated.
5.5.12 Test and calibration equipment, including both hardware and software, shall be safeguarded from adjustments which would invalidate the test and/or calibration results.
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on Tuesday, November 24th, 2009 at 1:40 pm and is filed under ISO 17025 standard.
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