For laboratories related with explaining technical
competency underpinned by sound quality system elements, ISO/IEC 17025:2017 is
the more appropriate standard. Even so,
if the laboratory is providing a more holistic, quality management realization
that explains customer focus and continual improvement, it may determine to
also sustain a certified ISO 9001 management system.
ISO/IEC 17025:2017 specifies the general requirements for
the competence, impartiality and consistent operation of laboratories.
ISO/IEC 17025:2017 is applicable to all organizations
performing laboratory activities, regardless of the number of personnel.
Laboratory customers, regulatory authorities, organizations
and schemes using peer-assessment, accreditation bodies, and others use ISO/IEC
17025:2017 in confirming or recognizing the competence of laboratories.
ISO/IEC 17025 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.
ISO/IEC 17025 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, such as sampling and the
design/development of new methods, the requirements of those clauses do not apply.
ISO/IEC 17025 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.
ISO/IEC 17025:2017, General requirements for the competence
of testing and calibration laboratories, is the international reference for
laboratories carrying out calibration and testing activities around the world.
Producing valid results that are widely trusted is at the
heart of laboratory activities. ISO/IEC 17025:2017 allows laboratories to
implement a sound quality system and demonstrate that they are technically
competent and able to produce valid and reliable results.
ISO/IEC 17025 also helps facilitate cooperation between
laboratories and other bodies by generating wider acceptance of results between
countries. Test reports and certificates can be accepted from one country to
another without the need for further testing, which, in turn, improves
international trade.
In order to reflect the latest changes in market conditions and technology, the new edition of the standard encompasses the activities and new ways of working of laboratories today. It covers technical changes, vocabulary and developments in IT techniques and takes into consideration the latest version of ISO 9001 on quality management.
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