ISO 15189 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 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
- 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:
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Laboratories are required to be assessed ever year to ensure they are meeting the requirements of ISO 15189 and PJLA policies/criteria. Click Here to download locate PJLA’s medical program documents.
Apply for ISO 15189 Accreditation
ISO 15189 Accreditation may be applied for online through our easy application form.
To receive additional information about our accreditation programs, please contact our office at
1-877-369-5227 or (248) 519-2603 or email us at [email protected].