ISO/IEC 17025 implies that a laboratory confirming to the requirements of this standard its results sustain based on the scope of accreditation that carries.

Accreditation bodies need to fulfill and adhere to ISO/IEC 17011. Accreditation protocols such as those that A2LA, L-A-B, NAVLAP, RvA and the GOB Accreditation Platform carries provides 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.

    ISO/IEC 17025:2005, General Requirements for the Competency of Test and Calibration Laboratories.

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

Achieving ISO 15189 and ISO/IEC 17025:2005 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 the GOB Accreditation and Recognition Platform are some of the many choices for laboratories.

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 the calibrations for which the laboratory is under accreditation.

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, such as ISO 9001, confirming that the management system has been verified and validated by a third party registration body or a subsidiary of the latter, at times namely a registrar. The main difference between accreditation and certification | as registration is the (as the title of ISO/IEC 17025 implies) level of competency in and specificity performing within the ISO/IEC 17025 or ISO 15189 requirements... A2LA is an excellent choice for general testing and metrology, but more specific like medical, foods, radiology and nuclear may need the likes on accreditation platform such as the GOB.

The level of reliability, confidence and knowing 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 getting

ISO 5725-1 - Expression of Uncertainty in Measurement.

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

For ISO/IEC 17025 Advanced Audit Team Leader Training, seek a course that is approved and that a recognized entity carries.

 

Laboratory Services... ISO 17025 (& A2LA)Home Portal...