Research SOP: Quality Manual: Section 5.6

Policy

The PTL laboratory has a calibration plan to calibrate and/or verify its equipment.

Measurement made by the equipment is traceable to National standards through an unbroken chain of NABL Accredited Laboratory

5.6 Measurement traceability

5.6.1 General

All equipment used for testing, including equipment for subsidiary measurements (e.g. for environmental conditions) having a significant effect on the accuracy or validity of the result of the test are calibrated before being put into service The laboratory has established

a program for the calibration of its equipment.

Such a program include a system for selecting, using, calibrating, checking, controlling and maintaining measurement standards, reference materials used as measurement standards, and measuring and test equipment used to perform.

5.6.2 Specific requirements

5.6.2.1 Calibration

The PTL Laboratory is a testing laboratory and hence this clause is not applicable to us.

5.6.2.2 Testing

5.6.2.2.1 All equipments having significant effect on the test results are calibrated at NABL accredited laboratories or NPL and thereby providing traceability to national standards and hence to SI units.

When the situation arises that associated contribution from the calibration contributes little to the total uncertainty of the test result and calibration is not needed, the laboratory ensures that the equipment used can provide the uncertainty of measurement needed.

5.6.2.2.2 Where traceability to SI units is not possible, traceability of measurements is ensured through the use of certified reference materials from competent suppliers, agreed methods and/or consensus standards which are clearly described and by participation in inter laboratory comparisons where possible.

5.6.3 Reference standards and reference materials

5.6.3.1 Reference standards

The PTL Laboratory has a program and procedure (PTL/QSP/17) for the calibration of its reference standards, by a calibration body that is traceability to SI units. Such reference standards are used for calibration only and calibrated before and after any adjustment

5.6.3.2 Reference materials

PTL ensures that all the reference materials used in the laboratory have traceability to SI units or they are certified reference materials. Internal /working reference standards are checked to the extent practicable and feasible.

Reference materials are identified through a list and traceability is maintained.

5.6.3.3 Intermediate checks

Intermediate checks are being carried out to maintain confidence in the calibration status.

A documented procedure (PTL/QSP/17) and program has been prepared to carry out intermediate checks.

5.6.3.4 Transport and storage

The laboratory has procedure (PTL/QSP/17) for safe handling, transport, storage and use of reference standards and reference materials in order to prevent contamination or deterioration and in order to protect their integrity.

Precautions are taken at all stages to protect materials, samples from damage during handling.

Records

A list of equipment has peen prepared to show the calibration status

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