QUALITY MANUAL (ISO/IEC 17025 : 2008)
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XXX/QM/26
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Test and Calibration methods and method
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5.4.1 General
The laboratory follows appropriate test methods and procedures for
all tests and calibration within its scope. Appropriate procedures are followed
for handling, transport, storage and preparation of test / calibration items
and where applicable estimation of measurement of uncertainty, statistical
analysis of test data.
The laboratory has instructions on the use and operation of all
relevant equipments and has instructions for handling and preparation of test
item. All instructions, standards, manuals and reference data relevant to the
work have been kept up-to-date and are readily available to personnel. In case
of deviation in test method, the laboratory ensures carrying out test /
calibrations after proper selection of methods, their validation and
confirmation from customer.
5.4.2
Selection of methods
The laboratory is selecting the test / calibration method preferably
from national standards. The laboratory may select methods from other national
/ international standards, methods specified by reputed technical organization,
relevant scientific text / journal. The laboratory is using latest valid
edition of standards unless it is not possible or appropriate. When necessary,
the standard is supplemented with additional details to ensure consistent
application.
When the customer does not specify the method of test, the
laboratory is using methods as given in international, national or regional
standards or methods adopted by the laboratory after their validation. The
laboratory informs the customer about the chosen method through test report.
Before selecting a method the laboratory ensures that it can operate the
method. If the standard method changes (alternate method) laboratory is
ensuring that it can operate the method and the results obtained are
statistically compared with those obtained with previous method. The laboratory
is informing the customer if the test / calibration method proposed is not
appropriate. The laboratory keeps the record of raw test data as per Quality
Format
5.4.3
Laboratory developed method
The test methods if required to be developed by the laboratory will
be planned by QAM. The test method is developed and validated by R.O. as per
the planned activity which is approved by TM. Effectiveness of the
communication during the development process is ensured amongst the personnel
involved.
5.4.4
Non-standard methods
QAM decides, depending on necessity, of developing non-standard
methods of tests. This proceeds with an agreement with the customers and in
case no standard test method is available. The test method is validated before
use detailing purpose of test, customer’s requirements, giving all other
details shall be followed.
5.4.5
Validation of method
5.4.5.1 The laboratory has noted that validation is the
confirmation by examination and the provision of objective evidence that the
particular requirements for a specific intended use are fulfilled.
5.4.5.2 The laboratory validates any deviation from
standard methods, a non-standard / laboratory developed method, standard method
used outside their intended scope, and amplifications and modification of
standard method to confirm that the methods are fit for intended use. The
validation shall be extensive as is necessary to meet the needs of given
application or field of application. The laboratory maintains record of the
results obtained. Procedure Quality Process shall be followed with a
statement that the method is fit for intended use.
5.4.5.3 The range, accuracy, of the values obtained
like detection limit, uncertainty of result, repeatability / reproducibility
robustness against external influences as assessed for intended use, shall be
relevant to customers needs.
5.4.6
Uncertainty of measurement
5.4.6.1 The
laboratory performing calibration applies procedure Quality Process for
estimating uncertainty of measurement for calibration.
5.4.6.2
The laboratory performing
testing is applying procedure Quality Process for estimating uncertainty
of measurement. The laboratory is attempting to identify all the components of
uncertainty and making a reasonable estimate and ensuring that reporting of
test results does not give a wrong impression of uncertainty. Reasonable
estimation is based on knowledge of the method and on measurement scope and is
making use of previous experience and validation data.
5.4.6.3
The laboratory is taking into
account all important components of uncertainty in the given situation using
appropriate method of analysis for estimating uncertainty of measurement.
5.4.7.1
The laboratory is checking
calculation and transfer of test and calibration data by next senior person
before reporting.
5.4.7.2
When the laboratory does use
computers or automated equipments for acquisition, processing, recording,
reporting, storage or retrieval of test or calibration data, the laboratory
ensures that a) the software is developed in detail and is validated in the
beginning and b) procedure Quality Process is developed and implemented
for protecting data integrity, confidentiality of data entry, collection, data
storage, data transmission and data processing c) computers and automated
equipment are maintained to ensure proper functioning and are provided with the
environmental and operating conditions necessary to maintain integrity of test
and calibration data.
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