ISO 15189:2012

An international standard for assuring accuracy and good practices in a medical laboratory.

ISO 15189:2012 is an international standard designed for the accreditation of medical laboratories. This standard includes an assessment of the laboratories quality management system and technical practices. It aligns with good medical laboratory practices such as the importance of: appropriate technical qualifications, ethical practices, safe environmental conditions, rigorous traceable reporting requirements, the use of validated methods, sample storage, retention and disposal requirements and traceable equipment and reference standards.

ISO 15189:2012 can be utilized by regulators or by end users as it gives them confidence laboratories are competent to perform medical tests/examination results, have staff committed to the quality of their lab, that their service has up to date technologies and its procedures and techniques reflect current best practice.

Why Become Accredited to ISO 15189:2012

  • Increase your ability to produce reliable results within client timeframes
  • Reduce Potential Costs and Risks
  • Promote your laboratory has appropriate procedures for ethics, confidentiality and the safety of the patient
  • Promote Compliance to International Standards

PJLA offers accreditation in various fields such as:

  • Serology
  • Syphilis Serology
  • Unexpected antibody detection
  • Chemistry (Routine)
  • General Immunology
  • Compatibility testing
  • Hematology
  • Microbiology
  • Unexpected antibody identification
  • Immuno-hematology
  • Endocrinology
  • Cytology
  • Pathology
  • Toxicology
  • Histopathology
  • Radio-bioassay
  • ABO grouping and Rh typing
  • Oral Pathology
  • Histocompatibility
  • Urinalysis
  • Parasitology
  • Clinical Cytogenetics
  • Mycology
  • Mycobacteriology
  • Bacteriology

Laboratories are required to be assessed ever year to ensure they are meeting the requirements of ISO 15189:2012 and PJLA policies/criteria. Click Here to download locate PJLA’s medical program documents.

Apply for ISO 15189:2012 Accreditation

ISO 15189:2012 Accreditation may be applied for online through our easy application form. To receive additional information about our accreditation programs, please contact our office at 1-877-369-LABS (5227)(248) 519-2603 or email us at

Apply for Accreditation with PJLA