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Accreditation Support

Assistance to help your laboratory achieve quality standards

Clinicians often look for a medical testing laboratory that is accredited. Accreditation helps increase clinicians’ confidence in the technical competence of your laboratory, assuring them that the test, calibration and measurement data you supply are accurate and reliable. From your laboratory’s perspective, accreditation compliance helps to increase the value your facility can bring to organizations, clinicians and patients.
 

We are committed to helping you meet the requirements established by leading organizations, such as:
 


 


 

ISO 15189, An Emerging Global Standard for Laboratory Quality

Developed by the International Organization for Standardization (ISO), ISO 15189 specifies requirements for quality and competence among medical laboratories. This standard involves the management of resources that are used to support the core processes of any medical laboratory. It also specifies the requirements for quality and competence, including a defined quality system.

CLIA, CAP, and API are some of the leading accreditation programs for US laboratories

Since 1988, the Clinical Laboratory Improvement Amendments (CLIA) have helped to ensure the quality of results produced by medical testing laboratories. The Laboratory Accreditation Program from the College of American Pathologists (CAP) provides scientifically rigorous standards across the spectrum of laboratory test disciplines. American Proficiency Institute (API) is one of the largest proficiency testing providers in the world serving over 18,000 clinical laboratories.


Accreditation involves a range of quality metrics, including:

  • Calibration
  • Test method verification
  • Test requests
  • Pesonnel
  • Procedures
  • Proficiency testing
  • Quality control and quality assessment
  • Record and specimen retention
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Support for Your Laboratory’s Quality-Improvement Efforts

To help your laboratory meet these requirements, we have assembled a number of resources and easy-to-use documentation and offer a range of technical and regulatory support:

Product Performance and Evaluation

  • Directions for Use (DFU)
  • Safety data sheets (SDS)
  • Reagent stability testing
  • Certificates of Analysis (CoA)

     

Supplier Selection and Evaluation

  • Quality standards
  • Support with supplier assessment and performance evaluations
  • Certified service and support resources
  • Mutually beneficial supplier relationships
  • Training courses to certify users