ISO/IEC 17025 implies that an accredited laboratory specific test(s) meets the requirements. Accreditation is a voluntary agreement between an accreditation entity and a laboratory granted for a specific test or family of tests.

The accreditation bodies need to fulfill and adhere to ISO/IEC 17011. Accreditation protocols such as those that A2LA, L-A-B, NAVLAP... and many others provide confidence to laboratories conducting assays, test, analysis, and metrology... as well for medical and clinical laboratories the standard that applies is ISO 15189, not ISO/IEC 17025.

    Specifically current revision of ISO/IEC 17025 is "General Requirements for the Competency of Test and Calibration Laboratories".

      And ISO 15189 specifies the requirements for medical laboratories - Medical laboratories - particular requirements for quality and competence.

Achieving current ISO 15189 and ISO/IEC 17025 is an accomplishment for laboratories that provide product testing and certification Standardized Practices in Laboratories... and other needs to help in exports. It helps in possibly reducing  inspection, test and analysis, at the point and port of sales / entry.

Accreditation protocols from A2LA, RvA, EMA, AClass, L-A-B and dozens others are some of the many choices for laboratories to seek accreditation .

Laboratory accreditation activities need to be specified and determine in the scope of accreditation. Some of these includes:

  • Biological with specifics of tests and assays... some examples DNA, RNA, Chromosome in blood... isolate DNA, isolate RNA...bacterial culture, genital culture... urine...
  • Metrology - Verification and Calibration of instruments and equipment and need to be specific as the scope and range of metrology,
  • Chemical processes laboratories with particular specifics some examples are...colorimeter, spectrophotometer, enzyme immunoassay (EMIT)...
  • Construction Industry and Materials, destructive and non destructives...
  • Electrical and Electronics... non destructive...
  • Vibration and acoustics,
  • Environmental,
  • Geology, Geophysics - Geotechnical,
  • Inspection Body (for surveillance),
  • Mechanical Testing,
  • Forensics...
  • Non-destructive Testing...
  • Thermal Stress Testing...

The services above are not the only type of laboratory services. Further, accreditation to special laboratories is ongoing and which includes drug testing, pavement-tarmac-asbestos, automotive EMC, specific to environmental lead (Pb), fertilizers, food chemistry, microbiology, characteristics and properties of metals, and as need arise newer scheme will arrive.

 

 

The scope of accreditation states the tests that can conduct including the types and special characteristics... also for the calibrations of devices and equipment.

Accreditation is available to private, independent, in-house and government labs.

Accreditation or Registration?

For ISO/IEC 17025 and ISO 15189 the applicable terms refers to accreditation... under the ISO 9000, ISO 14000... and other management systems the terms to apply is certification | registration. Laboratories are held to higher standards applying the term "accreditation"...

Certification is applicable for management systems like to ISO 9001 to confirm that the quality management system has been verified and validated by a third party certification body.

The main difference between accreditation and certification or registration is the (as the title of ISO/IEC 17025 implies) level of competency in and specificity performing a test or family of tests based ISO/IEC 17025 or ISO 15189 requirements... A2LA is a choice for general testing and metrology, but more specific like medical, foods, radiology - nuclear, and chemical may need the likes of a higly specialized accreditation of others including the GOB.

The level of reliability, confidence, knowledge and reporting uncertainty provided by implementation and maintenance of an effective ISO/IEC 17025 or ISO 15189 management system is significantly higher relating to competence of personnel conducting activities.

For many of our visitors that have inquired on the issue of uncertainty we recommend obtaining a copy of

ISO 5725-1 - Expression of Uncertainty in Measurement.

For ISO 15189 and risk ISO/IEC 14971 as the application of risk within the medical devices sector... an similar others for risks in the biological and chemical fields of testing

Contact us for ISO/IEC 17025 Advanced Audit Team Leader Training, courses that are approved and that a recognized entity carries.

 

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