For the Standardization of Measures Performed with IVDs,
The need of being accredited laboratory
1Semra
Koyunoğlu,
Semra.koyunoglu@titck.gov.tr
2Osman
Arıkan Nacar,
3İsmet
Köksal,
4Saim
Kerman
Turkish Medicine and Medical Devices Agency
Republic of Turkey Ministry of Healty, Ankara, TURKEY
Introduction
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Results & Discussion
For the standardization of measurements performed with IVDs, the tests and medical laboratories
should be accredited. Laboratory accreditation enables authorized laboratories to be recognized
officially; thus it offers a suitable instrument for reliable test, measurement and calibration.
Successful performance in a proficiency test can provide individual staff and their direct managers with additional confidence. Other management, including those without relevant technical
Accreditation is an efficient marketing instrument for test, calibration and measurement activities and
expertise, can also be re-assured by their laboratory’s staff successful performance, often in areas of critical significance to their organization’s activities and responsibilities.
independently verified laboratories have the characteristics of a transit document for contractors.
External users of laboratory services, including their clients and the parties affected by the outcomes of testing, can also be given added confidence when made aware that a laboratory is
Laboratory accreditation is reverenced at national and international dimension as an indicator of
willing to have its testing or measurement performance regularly evaluated through proficiency testing.
technical reliability.
It enables to have a common attitude for determining countries’ laboratory
proficiency. Furthermore, it promotes laboratories to accept internationally-recognized test and
measurement practices.
International agreements are taken as an international recognition forms by accredited laboratories.
When sufficient test material is available to more than one operator within a participating laboratory, the laboratory has the added benefit of being able to compare the results of its operators
This recognition reduces or removes the need for product and material re-testing or reduces the
on test materials which are also being tested or measured by other external laboratories. This can assist the laboratory to not only compare the performance of its own operators, but might
expenses of exporters.
also provide some inputs to the laboratory’s estimates of its measurement uncertainty for the relevant tests. This might also allow the laboratory to evaluate the between-operator repeatability
Laboratory accreditation is useful for providing compliance with standards and determining whether a
achieved by the laboratory compared to published data for the test methods concerned.
correct performance is displayed or not.
In addition to commercial test and calibration services, manufacturing organisations may use
laboratory accreditations for building their own in-house laboratories correctly.
In some proficiency testing programs, where there is sufficient, stable material provided to participants, the un-used material could be useful for internal quality control monitoring of testing as
a form of reference material. Where appropriate, the reference values assigned to the material might be considered useful as internal reference values for quality control of testing, operator
training.
Depending on the design of the proficiency test, some programs will be useful in determining the precision or comparative accuracy of the methods used in the program. Often, such
information is not published or otherwise generally available.
Finally, the successful performance of a laboratory in a proficiency test may provide regulators and accreditation bodies with confidence in the laboratories whose data they endorse or
otherwise recognize. The clear benefit for the laboratories is the continuation of their standing as competent organizations. However, the internal benefits to laboratories, their staff and
management should be of most value if they view proficiency testing as a vital tool for ongoing maintenance of confidence and improvement, irrespective of whether or not the laboratory
needs to participate for accreditation purposes.
Material & Method
Conclusion
Laboratory accreditation is a means of determining the technical competence of laboratories to perform specific types of testing, measurement and calibration. It also provides formal
European and International Standards
recognition to competent laboratories, thus providing a ready means for customers to identify and select reliable testing, measurement and calibration services able to meet their needs.
Laboratory accreditation benefits laboratories by allowing them to determine whether they are performing their work correctly and to appropriate standards, and provides them with a
ISO/IEC 17011:2004:
benchmark for maintaining that competence.
Conformity assessment – General requirements for accreditation bodies accrediting
Accreditation is an effective marketing tool for testing, calibration and measurement organisations, and a passport to submit tenders to contractors that require independently verified
conformity assessment bodies
laboratories. Laboratory accreditation is highly regarded both nationally and internationally as a reliable indicator of technical competence.
Laboratory accreditation uses criteria and procedures specifically developed to determine technical competence, thus assuring customers that the test, calibration or measurement data
ISO/IEC 17025:2005:
supplied by the laboratory or inspection service are accurate and reliable.
General requirements for the competence of testing and calibration laboratories
Finally, through a system of international agreements accredited laboratories receive a form of international recognition, which allows their data to be more readily accepted on overseas
ISO 15189:2007** (ISO 15189:2012):
Medical Laboratories - Particular requirements for quality and competence
markets. This recognition helps to reduce costs for manufacturers and exporters that have their products or materials tested in accredited laboratories, by reducing or eliminating the need for
retesting in another country.
Many countries around the world have one or more organisations responsible for the accreditation of their nation’s laboratories. Most of these accreditation bodies have now adopted ISO/IEC
ISO/IEC 17020:1998** (ISO/IEC 17020:2012):
17025 as the basis for accrediting their country’s testing and calibration laboratories, or ISO 15189 for medical laboratories. This has helped countries employ a uniform approach to
General criteria for the operation of various types of bodies performing inspection
determining laboratory competence. It has also encouraged laboratories to adopt internationally accepted testing and measurement practices, where possible. This uniform approach allows
countries to establish agreements among themselves, based on mutual evaluation and acceptance of each other’s laboratory accreditation systems. This effectively reduces costs for both the
ISO/IEC Guide 65:1996 / EN 45011:1998** (ISO/IEC 17065:2012):
manufacturer and the importers, as it reduces or eliminates the need for products to be retested in another country.
General requirements for bodies operating product certification systems
ISO 14065:2007:
Greenhouse gases -- Requirements for greenhouse gas validation and verification bodies
for use in accreditation or other forms of recognition
ISO/IEC 17024:2003** (ISO/IEC 17024:2012):
General requirements for bodies operating certification of persons
Laboratories can have either all or part of their testing and calibration activities accredited. The accreditation process involves a thorough evaluation of all the elements of a laboratory that
ISO/IEC 17043:2010:
Conformity Assessment - General requirements for proficiency testing
ISO/IEC 17021:2006** (ISO/IEC 17021:2011):
Conformity assessment - Requirements for bodies providing audit and certification of
contribute to the production of accurate and reliable test data. The evaluation process can take one to several days, and involves the use of specialist technical assessors who evaluate the
specific types of testing or measurement being performed. The assessment criteria are based on the international standards ISO/IEC 17025 or ISO 15189, which are used for evaluating
laboratories throughout the world. Laboratory accreditation bodies use this standard specifically to assess factors relevant to a laboratory’s ability to produce precise, accurate test and
calibration data, including the:
• Technical competency of staff
management systems
• Validity and appropriateness of test methods
ISO Guide 34:2009:
• Traceability of measurements and calibrations to national standards
General requirements for competence of reference material producers
• Suitability, calibration and maintenance of test equipment
• Testing environment
ISO 15195: 2003 (In conjunction with ISO/IEC 17025:2005):
• Sampling, handling and transportation of test items
Laboratory medicine - Requirements for reference measurement laboratories
• Quality assurance of test and calibration data
At the end of the assessment a detailed report on the evaluation is presented to the laboratory, highlighting any areas that require attention and corrective action prior to the laboratory being
recommended for accreditation. Once accredited, the laboratory is re-evaluated periodically to ensure its continued compliance with requirements, and to check that its standard of operation
is being maintained. The laboratory may also be required to participate in relevant proficiency testing programs between reassessments, as a further demonstration of technical competence.
References
1. Website: https://www.ilac.org
2. Website: http://www.ukas.com
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3. Website: http://www.cofrac.fr
4. Website: https://www.zlg.de