A
product or service should be 'Fit for purpose', conforming to specified
requirements with respect to National standard / International standard /
User's specification. This requires the services of a calibration
laboratory, which should be accredited. 'Accreditation is a process of
formal recognition of technical competence in accordance with the prevailing international standard' by a recognized accreditation institution.
The National Accreditation Board for testing and
calibration Laboratories (NABL) is a full member of Asia
Pacific Laboratory Accreditation Co-operation (APLAC) and International
Laboratory Accreditation Co-operation (ILAC). Because of a comprehensive
requirement of combining inspection and testing in many areas, NABL
provides accreditation for inspection bodies in accordance
with ISO/IEC 17020 International standard, and ISO/IEC 17025:1999.
A Calibration laboratory shall be
accredited according to their 'Best measurement capability'. It means
the least uncertainity of measurement (±) at a confidence probability
level of 95%. The calibration laboratory is not permitted to report a
smaller uncertainity of measurement than the best measurement capability
on its endorsed documents. Obviously, the actual uncertainty of
measurement can never be smaller than the best measurement capability.
The calibration laboratory shall be organized
in such a way as to ensure the integrity and training of its staff
and operations for ensuring unbiased calibration. There should be an
authorized signatory for the calibration certificates/reports issued by
the laboratory. It should have a quality manual, which should be
maintained up-to-date and available for scrutiny, in compliance with
ISO/IEC 17025 and NABL requirements. The quality manual should contain a
quality policy statement, objectives, commitments by the top management,
names, qualifications, experience of persons responsible for the
managerial, scientific/technical activities, measurement capability,
Traceability of calibration of all measuring instruments to standard,
calibration procedures adopted, National/International standards
referred/used.
The laboratories should have authorized
signatories for approving and issuing calibration certificates for each
calibration parameter as mentioned in the scope of accreditation. The
laboratory should have an adequate number of qualified and trained
staff with at least a degree in Physics or Diploma in Engineering. The team should be headed by a P.G. in Physics or Graduate in Mechanical/Instrumentation
Engineering.
The calibration area shall be adequately free from vibrations
generated by air-conditioning plant, vehicular traffic or any other such
sources. Acoustic noise level shall be maintained for proper
performance of calibration. A threshold noise level of 60 dBA is to be
maintained as recommended. Adequate level of illumination has to be
maintained, fluorescent lighting is preferred to avoid localized heating
and temperature drift. The recommended level of illumination is 450-700
lux on the working table with glare index of 19 for the laboratory.
The environmental conditions for the activity
of the laboratory shall be such as not to adversely affect the required
accuracy of measurements. As possible, only the staff engaged in
calibration activity should be permitted entry inside the calibration
area. Laboratory should have equipment of required accuracy in respect
of each parameter covered. Stability of the standards, accuracy of the
values realized through them and repeatability, should be regularly
monitored.
Calibration certificates, performance history sheets, working
standard details should be held safely by the laboratory. Each equipment
should have a record of name, manufacturers name and address, type, range,
identification and serial no., date of procurement and commissioning,
details of calibration, details of maintenance, performance history with
dates. The service manual has to be available at all times.
All the standard equipment of the laboratory
should be calibrated periodically against calibration standards of a
laboratory accreditated by NABL/ equivalent MRA partners having superior
measurement capability or NPL/ other international NMIs. To give
further assurance to the accuracy or uncertainty of measurements, a
laboratory should be required to participate from time to time, in
Proficiency Testing Programmes. There the abnormalities of equipment are
detected in terms of En number, through inter-comparisons and the
appropriate corrective actions should be taken. The standard equipment
shall be replaced/ repaired and re-calibrated with a higher accuracy
standard. Reports on such inter-comparisons should be documented with
reference. This Proficiency Testing practice should be included in the
Quality Manual.