ISO 15189 specifies requirements for quality and competence in medical laboratories. It covers the examination process from pre-examination through examination to post-examination and reporting, addressing both the management system and the technical requirements specific to laboratory medicine.
What ISO 15189 delivers for your organisation.
The core requirements your organisation will need to meet.
Management system, impartiality and confidentiality of patient data
Competence, training and authorisation of laboratory personnel
Pre-examination processes including collection, handling and transport
Examination processes, method validation and quality control
Post-examination: result review, reporting and turnaround
Risk management and quality assurance of examination results
Our structured approach from initial assessment through to completion.
We assess the laboratory against ISO 15189 across the full examination pathway.
We develop the quality manual, standard operating procedures and validation records.
We implement quality control practice, train staff, and conduct internal audit and management review.
We prepare the laboratory for the accreditation body's assessment, including witnessed examinations.
Our expertise spans across diverse sectors, delivering tailored certification solutions.
Common questions answered by our consultants.
Others we support in Laboratory & Testing.
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