Clinical

ISO 15189 is an internationally-recognized standard, with over 40 ILAC-recognized accreditation bodies offering ISO 15189 accreditation programs. In some countries it is the standard by which laboratories are reimbursed. Although ISO 15189 is not mandatory in the U.S., an increasing number of clinical labs have recognized the benefit of being accredited by an internationally-recognized accreditation body (such as INTERAS) along with their CLIA accreditation.

Similar to how you expect your customers to select a laboratory based upon their qualifications and credentials, so should you when choosing an ISO 15189 accreditor. Anyone can self-declare competence in offering ISO 15189 accreditations, but you need to ask yourself: “What are their credentials and who has accredited them?” When it comes to INTERAS, the answer is easy. INTERAS’s over 45 years of experience in accrediting specifically to ISO standards and our signatory status within the ILAC MRA for the accreditation of clinical laboratories to ISO 15189 speak for themselves. Our technical expertise is second-to-none as is our experience with management systems and ISO standards. We not only accredit laboratories to these standards, but we are expert enough in their development and implementation to train others in how to utilize them to better their laboratory’s performance.

ISO 9001 is a registration of a quality management system and serves as the basis for many of the other ISO standards because of its intentional generalness.

INTERAS assigns assessors with the education and expertise to complement a laboratory’s desired Scope of Accreditation. All of our clinical assessors have extensive experience in assessing CLIA laboratories and have been found to meet INTERAS’s stringent requirements for being contracted members of our assessor corps. A lead assessor is assigned as are additional assessors depending on the extensiveness of the laboratory’s desired Scope of Accreditation. The time spent on-site by our assessors is not only commensurate with the desired Scope and but also takes into account the time necessary for a thorough review of the laboratory’s management system. All of our assessors, while undeniably technical experts, also undergo extensive training on the assessment of all QMS elements. INTERAS approaches this training as an ongoing investment to ensure the high caliber of our assessor corps. All assessors are observed and evaluated performing actual assessments and this evaluation process occurs at regular intervals throughout the term of their contract with INTERAS, ensuring a continual level of consistency and expertise.

Absolutely. A peer evaluation team is selected to cover all areas for which an accreditor is seeking recognition under the ILAC MRA. Therefore, each team selected to evaluate INTERAS includes at least one member with internationally-recognized expertise in the clinical field. This individual then systematically examines all aspects of the INTERAS clinical laboratory accreditation program, including observation of one or more actual INTERAS on-site assessments of a clinical laboratory to ISO 15189.

For more information about ILAC, peer evaluation, and INTERAS’s formal recognitions, see the “About INTERAS” category of the FAQ.

Assessor teams are selected based upon a laboratory’s desired Scope of Accreditation.