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Yogesh Pawar
CTO
TechnoSysCon
Shree Nathji Heights,
Plot No.- 72,
Behind Chikhli Telephone Exchange,
C.D.C. Purnanagar, Chinchwad, Pune. PIN - 411019
Telefax - +91 20 2749 0009,
Mobile - 09423005866
info@technosyscon.com,
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ISO/IEC 17025:2005 Consultants In Pune India
ISO/IEC 17025:2005
- General Requirements for the Competence of Testing
and Calibration Laboratories.
The standard, first
published in 1999, has been acknowledged as the
international benchmark for approving the competence
of the testing and calibration laboratories that
play a vital role in trade, in product development
and manufacturing, and in protection of the consumer.
The new standard does not suggest changes to the
technical requirements. The modifications relate
mainly to the management requirements in order
to harmonize with the quality management standard
ISO 9001:2000. Accreditation bodies will allow
laboratories up to two years to implement the
new standard.
ISO/IEC 17025:2005 specifies the general requirements
for the competence to carry out tests and/or calibrations,
including sampling. It covers testing and calibration
performed using standard methods, non-standard
methods, and laboratory-developed methods.
It is applicable to all organizations performing
tests and/or calibrations. These include, for
example, first-, second- and third-party laboratories,
and laboratories where testing and/or calibration
forms part of inspection and product certification.
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ISO/IEC 17025:2005 is applicable to all laboratories
regardless of the number of personnel or the extent
of the scope of testing and/or calibration activities.
When a laboratory does not undertake one or more
of the activities covered by ISO/IEC 17025:2005,
such as sampling and the design/development of
new methods, the requirements of those clauses
do not apply.
ISO/IEC 17025:2005 is for use by laboratories
in developing their management system for quality,
administrative and technical operations. Laboratory
customers, regulatory authorities and accreditation
bodies may also use it in confirming or recognizing
the competence of laboratories. ISO/IEC 17025:2005
is not intended to be used as the basis for certification
of laboratories.
Compliance with regulatory and safety requirements
on the operation of laboratories is not covered
by ISO/IEC 17025:2005.
ISO/IEC 17025:2005 has been revised to align the
ISO 17025:1999 version with ISO 9001:2000. Thus,
ISO harmonized lab system accreditation by recognizing
the ISO 9001:2000 standard as the basis for sound
management of lab systems. This is now found in
Clause 4 of ISO/IEC 17025. The technical part,
in Clause 5 contains all of the requirements that
testing and calibration labs have to meet if the
wish to demonstrate that they operate a management
system, are technically competent and are able
to generate technically valid results
ISO/IEC 17025:1999 replaced ISO/IEC Guide 25:1990
& EN 45001:1989 as the contemporary standard
to be adhered to by all testing & calibration
laboratories. It integrated the requirements of
ISO 9001 & 9002(1994) & embodied the extensive
experience gained over a time span of 10 years
of lab systems implementation.
ISO/IEC 17025 promotes cooperation between laboratories
and other bodies to assist in the exchange of
information & experience and the harmonization
of standards & procedural goals. As a rule,
within an organization any technology should be
subjected to calibration & testing and measured
by a sampling scheme that results in data collection
and analysis. It is then possible to gauge the
effect on the activities or goods produced and
plan appropriately for improvement. Essentially,
this is the goal of all standards introduced in
the business environment.
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