IVD and Laboratories
ISO 15189: Quality and Competence of Medical Laboratories
ISO 15189 specifies requirements for quality and competence in medical laboratories, and accreditation bodies use it to accredit clinical laboratories. It isn't a device manufacturing standard, but it shapes what IVD makers' laboratory customers need from them, and it applies directly to device firms that run their own medical laboratories.
At a Glance
- Standard
- ISO 15189
- Subject
- Quality and Competence of Medical Laboratories
- Group
- IVD and Laboratories
- Industries
- 1 industry guides reference it
A plain-language summary of scope, not the standard itself. Buy the current edition from the publisher and check which edition your auditor or market expects.
What It Covers
The standard covers impartiality and confidentiality, personnel competence, facilities and environmental conditions, equipment and calibration, reagents and consumables, and the full examination process. That runs from pre-examination (requests, patient preparation, specimen collection and transport), through examination (method verification or validation, measurement uncertainty, quality control and external quality assessment), to post-examination (reporting, release of results and specimen retention). It also includes management system and risk management requirements focused on patient care.
For IVD makers, the customer view matters most. An accredited laboratory has to verify a manufacturer's method before putting it into use, so it relies on the performance claims, quality control recommendations, lot information and change notifications the manufacturer provides. Vague instructions or unannounced reagent changes create problems for the lab, and laboratory complaints are often the first sign of a performance problem.
Some device firms operate laboratories themselves, for clinical studies, as reference labs or as services alongside their products. Those laboratories may pursue ISO 15189 accreditation in their own right. In the US, clinical laboratory testing is regulated under CLIA, and ISO 15189 accreditation is voluntary.
Who It Applies To
- Clinical and medical laboratories seeking or maintaining accreditation
- IVD manufacturers whose customers are accredited laboratories
- Device and diagnostics firms that run their own medical laboratories
- Sites testing specimens for IVD clinical performance studies
What Auditors Check
Method Verification and Validation
Records showing each examination method was verified or validated before use, against the manufacturer's claims where applicable.
Personnel Competence
Training, competence assessment and authorization records for each examination a person performs.
Quality Control and EQA
Internal quality control data, rules and responses, plus external quality assessment or proficiency testing results and follow-up.
Measurement Uncertainty
Estimated measurement uncertainty for quantitative examinations and how it's reviewed.
Equipment and Reagent Control
Calibration and maintenance of equipment, and acceptance testing of new reagent lots before use.
Nonconforming Work and Complaints
Records of nonconforming examinations, corrective actions and complaint handling.
Related Services
Internal Audit Program
A risk-based internal audit program, run by your team or our advisors, with reports written for FDA to read.
Supplier Audits and Supplier Controls
Risk-based supplier selection, quality agreements, monitoring and supplier audits that hold up under QMSR.
BIMO (Clinical) Inspection Readiness
Readiness for FDA bioresearch monitoring inspections of device clinical studies: sponsors, CROs and sites.
Ongoing Advisory and Continuous Readiness
Periodic re-assessments, a live action plan and yearly mock inspections that keep readiness from decaying.
Industry Guides That Reference ISO 15189
Questions
Does an IVD manufacturer need ISO 15189?
Not for manufacturing. IVD makers build their QMS on ISO 13485. ISO 15189 matters if you operate a medical laboratory, and it matters indirectly because your accredited laboratory customers depend on your documentation to meet their own verification and quality control obligations.
How is ISO 15189 different from ISO/IEC 17025?
Both cover laboratory competence. ISO 15189 is written specifically for medical laboratories and includes the pre- and post-examination steps that involve patients and clinicians. ISO/IEC 17025 is the general standard for testing and calibration laboratories of any kind.
Is ISO 15189 accreditation required in the US?
No. Clinical laboratory testing in the US is regulated under CLIA, and ISO 15189 accreditation is voluntary. Laboratories may pursue it for international work, customer expectations or a stronger quality framework.
What do accredited laboratories need from an IVD supplier?
Clear performance claims and limitations, quality control guidance, lot-specific information and advance notice of changes that could affect results. Labs use this to verify methods and investigate unexpected results, so gaps tend to show up as complaints or customer audit findings.
ISO 15189
Check Your Quality System Against ISO 15189
An AI-assisted first pass maps your existing documents against the requirements in scope, and an advisor reviews every result. Please don't send confidential documents yet: secure upload is set up after onboarding.
