Policy
The PTL is using equipment and reference materials for complying with the required specifications and is capable of achieving the desired accuracy.
5.5 Equipment
5.5.1 The PTL laboratory is furnished with all items of sample preparation, measurement, and test equipment required for the correct performance of the tests (including, preparation of test items, processing, and analysis of test data). It is always ensured that the requirements of this International Standard are met.
5.5.2 Equipment and its software used for testing are capable of achieving the accuracy required and comply with specifications relevant to the tests concerned.
The equipment available is as per AOAC/BIS standards and their performance is examined before being placed in service. So as to meet the requirements of standard specifications & intended capability of the laboratory. All new equipment/reference standards are put in use after calibration by a NABL-approved laboratory only.
5.5.4 Each item of equipment and its software used for testing and significant to the result is, when practicable, be uniquely identified.
5.5.5 Records of PTL Laboratory are maintained of each item of equipment and its software significant to the tests and/or calibrations performed. The records 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
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 the 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 PTL laboratory has procedures (PTL/QSP/16) for safe handling, transport storage, use, and planned maintenance of measuring equipment to ensure proper functioning and in order to prevent contamination or deterioration.
No measuring equipment is being used for testing outside of the laboratory.
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, is taken out of service. It is isolated to prevent its use or clearly labeled or marked as being out of service until it has been repaired and shown by test to perform correctly. The laboratory examines the effect of the defect or departure from specified limits on previous tests and institutes the `Control of nonconforming work" procedure (PTL/QSP/06).
5.5.8 Whenever practicable, all equipment under the control of the laboratory and requiring calibration are 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 ensures 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 are carried out according to defined procedures (PTL/QSP/16).
5.5.11 Where calibrations give rise to a set of correction factors, the laboratory have procedures (PTL/QSP/16) to ensure that copies (e.g. in computer software) are correctly updated.
5.5.12 Test equipment, including both hardware and software, are safeguarded from adjustments, which would invalidate the test results.
END OF THE DOCUMENT
3. PTL /QSP/03 Procedure for Purchasing, Services, and Supplies
4. PTL /QSP/04 Procedure for Service to the Customer
5. PTL /QSP/05 Procedure for Customer Complaints
6. PTL QSP/06 Procedure for Control of Non-Conforming Testing.
7. PTL /QSP/07 Procedure for Improvement
8. PTL /QSP/08 Procedure for Corrective Action
9. PTL /QSP/09 Procedure for Preventive Action
10. PTL /QSP/10 Procedure for Control of Records
11. PTL /QSP/11 Procedure for Internal Audit
12. PTL /QSP/12 Procedure for Management Review
13. PTL /QSP/13 Procedure for Training
14. PTL /QSP/14 Procedure for Housekeeping
15. PTL /QSP/15 Procedure for Estimation of Uncertainty of measurement
16. PTL /QSP/16 Procedure for Equipment
17. PTL /QSP/17 Procedure for Measurement Traceability and Calibration
18. PTL /QSP/18 Procedure for Sampling
19. PTL /QSP/19 Procedure for Handling of Test and Calibration Items
20. PTL /QSP/20 Procedure for Assuring the Quality of Test
21. PTL /QSP/21 Procedure for Reporting of Results
22. PTL/QSP/22 Procedure for use of NABL Symbol
Note: Replace DTL with PTL for Drug Testing Laboratory.
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