Laboratory accreditation

Accreditation means “Formal Recognition” by a National or International Body that a testing or calibration laboratory is competent to carry out specific tests or calibrations. In other words, it is the recognition of the lab’s competence and capability by a national or international body.

ISO/IEC 17025: 2017 – GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES

An accredited laboratory ensures two key criteria in testing or calibration. These are accuracy or validity of result and tractability of result to SI unit. During accreditation assessment process, these key technical aspects are verified by the technical assessor (who is a field expert) for each test or calibration of the laboratory scope. ISO/IEC 17025 standard provides criteria for assessment for this purpose. Finally laboratory gets accreditation certificate along with scope from the accreditation agency who is ILAC MRA. Periodic reassessment is needed to renew the validity of accreditation.

In many non-accredited laboratory the above two criteria is not fulfilled due to certain lapses in the laboratory quality management system. Some of the major lapses are:

  • Equipment are not calibrated from the ISO/IEC 17025 accredited agency.
  • Necessary Certified Reference Materials covering the full range of testing is not available.
  • Adequate quality control check (such as PT and ILC) is not done in planned and systematic manner to ensure validity of result.
  • Competency of technical personnel is not monitored by objective manner (such as replicate testing, testing of CRM etc.)
  • Uncertainty of measurement result is not estimated.
  • Many of the test methods are non-standard methods (such as ISO, IS, ASTM, JIS etc.) and those methods are not technically validated.

ISO/IEC 17025 accreditation gives international recognition of test and calibration laboratory and ensures reliability of laboratory results to the clients and end user.

Other accreditation’s in the laboratory field are:

ISO/IEC 17043: 2010 – Conformity assessment — General requirements for proficiency testing.

ISO 17034: 2016 – General requirements for the competence of reference material producers.

ISO 15189: 2012 – Medical laboratories — Requirements for quality and competence.

ISO/IEC 17020: 2012 – Conformity assessment — Requirements for the operation of various types of bodies performing inspection.