Equipment (QM 27)

QUALITY MANUAL (ISO/IEC 17025 : 2008)

Document ID	:	XXX/QM/27
Title	:	Equipment
Issue No.	:		Issue Date                     :
Revision No.	:		Revision Date                :
Reference ISO Clause	:		Page                               :

5.5.1       The laboratory is furnished with all items of measurement and test equipments necessary for correct performance of test and calibration. The laboratory does not use any equipment, outside its control.

5.5.2       The equipments used for testing and calibration are ensured to be capable of achieving the accuracy required and is complying with specification relevant to tests and calibration. Calibration programme for calibration of testing and calibration equipment are in place and equipments are calibrated before being put into service to establish that these meet the laboratory’s specification requirements and comply with the relevant standard specification. Some equipment are checked / calibrated before use, and some are checked / calibrated periodically.

5.5.3       The equipments are operated only by the authorized personnel. The laboratory has ensured availability of work instruction sop for use and maintenance of test equipment including manufacturer’s manual which are readily available to authorized personnel.

5.5.4       The laboratory identifies all equipments with manufacturer’s name, type, serial number and a unique identification number.

5.5.5       Records are maintained of each item of equipment significant to tests performed. The record contains the following details is being kept as per Quality Format, equipment (Log Book).

·    The identity of the equipment;

·    The manufacturer’s name, type of identification, serial number or other identification;

·    Checks that equipment complies with specification;

·    The current location, where appropriate;

·    The manufacturer’s instruction;

·    Dates, results and certificate of calibration, adjustments, acceptance criteria, due date of calibration;

·    Maintenance plan, Quality Format and maintenance done;

·    Any damage, malfunction, modification or repair.

5.5.6       The laboratory has implemented procedure Quality Procedure for safe handling, transport, storage, use and planned maintenance of measuring equipment for proper functioning and to avoid contamination.

5.5.7       When equipment has been subjected to overloading or mishandling, giving suspect result or has been shown to be defective or giving results outside specified limits, the equipment shall be isolated with a label “OUT OF ORDER” until it is repaired and calibrated. The laboratory shall examine the nature of defect and institute procedure for non-confirming work as per Quality Procedure.

5.5.8       All equipments used for testing / measurement, requiring calibration, are labeled with date of calibration and when next due, after calibration, is carried out.

5.5.9       The laboratory ensures that the function and calibration status of equipments are checked to show satisfactory performance before pressing it into service on the event of their going out of control of laboratory.

5.5.10    Laboratory carries out intermediate checks to maintain confidence in calibration status of equipment and follows procedure Quality Procedure.

5.5.11    The laboratory shall follow the procedure Quality Procedure to apply corrections when calibration of equipment gives rise to a set of correction factors.

5.5.12    Test and calibration equipment including hardware and software, after calibration, is safeguard from adjustment to avoid invalidation of test / calibration result as per procedure Quality Procedure.