What does ISO 15189 cover?
ISO 15189 addresses quality and competence in medical laboratories. It concerns the reliability of the full examination pathway, including activities before and after analysis. Accreditation recognizes competence within a defined scope; it is different from general management-system certification.
Who it is for
Medical laboratories assessing the quality and competence of examination services.
Key areas to understand
Start with these areas. Identify which requirements apply to your activities and who is responsible for them.
- 1Control specimen identification and handling.
- 2Demonstrate staff competence and examination performance.
- 3Manage reporting, quality control and risks to laboratory service quality.
Evidence to prepare
This list is a starting point. Check the standard for all required documents. For each item, record who is responsible, the activity or site it relates to, and a recent example showing how it works.
- Examination scope and method records
- Staff authorization and competence evidence
- Equipment and quality-control records
- Specimen acceptance and rejection records
- Report amendments and investigation records
Keep records that explain what was checked, which requirement was used and who checked it. Include any action taken when a requirement was not met. Link each record to the work it supports.
An internal audit example
Suggested checks from 4Auditee
Use an appropriately de-identified case to trace a sample from receipt to report authorization. Check how identification, suitability, quality-control results and staff authorization were established. If a report was amended, follow the communication and correction trail.
Choose a sample that suits your activities and risks. If you find a gap, record the requirement, the evidence and what was missing. Check more examples if the first results suggest a wider problem.
A common problem to check
A quality manual does not demonstrate competence for every examination. Match evidence to the laboratory’s actual accreditation scope.
Prepare for assessment
The assessment type for this guide is laboratory accreditation. Confirm the requirements, what will be assessed and how the assessment will work with the responsible body or customer. These steps help you prepare. You must also follow the scheme’s official rules.
- Define what is covered. List the products, services, activities and sites. Record the standard edition, additional scheme rules and customer requirements.
- Find what is missing. Compare the requirements with current work. Prioritise gaps by risk. Assign someone responsible and a completion date.
- Keep records of everyday work. Check a sample of actual records and speak with the people involved. Make sure they understand their responsibilities.
- Check the results. Complete internal reviews and audits. Check that corrective actions worked before closing problems.
From one site to many
Make it easy to find who is responsible at each site. Keep company policies separate from records of local work. Link each site’s records to its activities, risks and requirements so you can spot gaps at individual sites.
Sites that share a management system do not automatically qualify for one certificate or assessment. Confirm which sites can be included and how they will be checked with the assessment body.
About this guide and its sources
4Auditee wrote this guide using the public source below. The evidence list, audit example and preparation steps are our suggestions. Read the official standard and scheme rules for the full requirements. This guide does not include the standard’s full text or provide certification.
BSI: ISO 15189 reference information