Abstract
M.B.A.
Laboratories have historically been required to demonstrate competence to
test or calibrate against a scope of accreditation that details specific tests
and/or measurements in order to ensure equivalence of technical output.
The international standardisation community appears to believe that greater
focus on quality system elements will contribute to increased confidence in
the work performed by organisations that implement them. Unfortunately, a
valid system only guarantees consistent output. The potential danger of
laboratory tests that are consistent but wrong is too great to be ignored.
These fundamentally conflicting philosophies of competence versus
compliance are now being combined into one document, the recent revision of
ISOIIEC Guide 25 into the ISOIIEC FDIS 17025 General requirements for the
competence of testing and calibration laboratories.
In preparing for the change to the new standard, smaller laboratories are
faced with a potential disproportionate increase in documentation
requirements even though their demonstrated competence is already
accepted internationally.
The primary aim of this research is to determine if there are differences
between implementation of the revised standard in a smaller laboratory to that
of the larger laboratory that should be considered in order to ensure that the
smaller facility is not subject to a potential technical barrier to trade.
As part of the research, a questionnaire was created and distributed to test
assumptions about the current knowledge of quality requirements within
laboratories, the value obtained to date with implementing such systems and
the ability of the laboratory staff to cope with more in-depth or any additional
quality criteria that might be introduced...