ISO 15189 – Medical Laboratories

This international standard outlines the requirements for competence and quality for medical laboratories. The ISO 15189 standard is based upon ISO 9001 and ISO/IEC 17025.

Advantages of implementing this standard are:

– Assurance of research results
– Maintains the competency of staff at a high level
– Meets the requirements of (medical) legal legislation and regulatory requirements
– Supports the security of confidentiality of patient data
– Release of adequate test reports

Unlike other standards, accreditation is applied to ISO 15189 and is carried out by the Dutch Bureau of Accreditation (RvA) or relevant national accreditation body in other countries.

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