In August of 2018, the International Organization for Standardization (ISO) released the first standard specific to biobanks, ISO 20387. Because medical laboratories and biobanks have many functions in common, there are areas of overlap between this standard and ISO 15189:2022 for medical
ISO 13485 Certification vs ISO 15189 Accreditation for Laboratory Developed Testing (LDTs)
While accreditation and certification are often used interchangeably, they represent distinct concepts. However, both certification and accreditation can apply to the same field and complement each other. Certification and Accreditation: What’s the Difference? ISO defines certification as the
World Accreditation Day 2025: Empowering SMEs
Accreditation is a formal recognition earned by a testing, calibration, or inspection organization that has proven to comply with globally accepted, international standards of quality and competence. Accreditation can sometimes be required by government or industry regulators for certain kinds of
Common NGS Pitfalls of CLIA Certification and ISO Accreditation
A new DNA sequencing technology is transforming the world of genetic testing. This advanced technology is called Next-Generation Sequencing or NGS, and allows scientists, analysts, and geneticists to process millions of fragments of DNA simultaneously, as opposed to one sequence at a time. NGS
Cause Analysis in the Clinical Laboratory
A2LA has been offering accreditation for over forty years. We currently hold Centers for Medicare and Medicaid Services Deemed-Status and are a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement to provide clinical laboratory accreditation to the
Accreditation Case Study: ADL Health
Starting a full-scale clinical testing laboratory amid a global pandemic was a significant undertaking for the team at Advanced Diagnostic Laboratory (ADL) Health; but, despite the challenge, the organization successfully opened its doors in 2020. Headquartered in San Antonio, TX, ADL Health is a
9 Steps to A2LA Accreditation: ISO 15189:2022
If your clinical testing organization is seeking accreditation for the first time, the standards and their requirements can often feel overwhelming. Although the road seems long from the start, A2LA’s friendly customer care representatives, knowledgeable accreditation officers, and expert assessors
Accreditation Case Study: Labcorp’s Center for Esoteric Testing and the Atlantic Division Regional Laboratory
Since its inception in 1995, Labcorp has grown to be one of the largest clinical lab providers in the world. Its flagship location in Burlington, NC is now Labcorp’s Center for Esoteric Testing (CET) and Atlantic Division Regional Laboratory (ADRL). This laboratory serves populations globally for