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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.
ISO 17025
 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 17025:2005 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.