ISO 17025
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ISO 17025 Laboratory Quality Management
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.
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.
What is Proficiency Testing?
Proficiency testing determines the performance of individual laboratories for specific tests or measurements and is used to monitor laboratories’ continuing performance.
Proficiency testing is also called inter-laboratory comparison. As this term implies, proficiency testing compares the measuring results obtained by different laboratories.
In a proficiency test one or more artifacts are sent around between a number of participating laboratories. Each laboratory measures the artifacts (e.g. a ring gage or a set of gage blocks) according to a given set of instructions and reports its results to the administrator.
The results reported by each laboratory for a measurand are compared to the reference value for that measurand. The reference value can be determined in various ways. The two most common ways are to use a reference laboratory or use the average of the values reported by the participants.
Our Proficiency Testing uses reference laboratories to provide the reference values. The reference laboratories are chosen for each measurand by the technical advisor for the proficiency test in question based on his or her knowledge of the laboratory and the uncertainty the laboratory is able to quote for the measurand.
The reference laboratories are generally accredited laboratories (A2LA or APLAC or NABL) (accredited for the measurand in question), which have been assessed by the technical advisor.
Our Proficiency Testing purchases an accredited test or calibration from the reference laboratory on a commercial basis to establish the reference value for a proficiency test. We are therefore able to select what we consider the most competent laboratory to provide the reference value for each test.
There are different ways to evaluate the results of a proficiency test. For the type of proficiency tests offered by our Proficiency Testing, the result reported by a participating laboratory for a measurand is compared to the reference value by calculating the En-value.
The En-value is calculated as follows:
where:
VLab is the value reported by the participating laboratory
VRef is the reference value
ULab is the uncertainty reported by the participating laboratory
and
URef is the uncertainty of the reference value
The uncertainties shall be expressed using k=2, which corresponds to a 95 % coverage.
The result is considered successful, if the result of the proficiency test is -1 ≤ En ≤ 1. In this case the participating laboratory agrees with the reference value within the stated uncertainty of the two. Based on a number of assumptions, this is expected to be the case at least 95 % of the time.
If a laboratory has any unsuccessful results, i.e En < -1 or En > 1, it is expected that the laboratory investigates the reason for the disagreement and implements corrective action.
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