LAB SYSTEMSINDEX

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Medical laboratories using the standard · International medical-laboratory standard

Medical laboratories — Requirements for quality and competence

ISO 15189 specifies quality and competence requirements for medical laboratories, including governance, resources, pre-examination, examination, post-examination, information, risk, and improvement.

Published international standardVoluntary unless required by accreditation, contract, regulation, or policy

What the authority record establishes

ISO 15189 specifies quality and competence requirements for medical laboratories, including governance, resources, pre-examination, examination, post-examination, information, risk, and improvement.

Voluntary unless required by accreditation, contract, regulation, or policy

The exact official title, issuing body, jurisdiction, version or application record, and linked source define the scope of this page. Readers should not transfer the authority's status to a commercial product or infer transaction-, patient-, system-, site-, or organization-specific applicability from this summary.

Why it matters to this market

Clinical laboratory systems should support patient and specimen identity, orders, methods, results, critical communication, quality, records, and interfaces while clinical competence and diagnostic validity remain outside software alone.

Affected operating stages

  • Request
  • Collection
  • Transport
  • Examination
  • Result Review
  • Reporting
  • Follow-Up
  • Improvement

Capabilities to examine

Request Test-Order And Workload Management

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for request test-order and workload management.

Sample Registration Identity And Lifecycle Management

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for sample registration identity and lifecycle management.

Aliquot Batch Container And Chain-Of-Custody Management

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for aliquot batch container and chain-of-custody management.

Method Test Specification And Acceptance-Limit Management

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for method test specification and acceptance-limit management.

Guided Laboratory Procedure And Worksheet Execution

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for guided laboratory procedure and worksheet execution.

Result Capture Calculation Review And Approval

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for result capture calculation review and approval.

Out-Of-Specification Deviation And Exception Workflow

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for out-of-specification deviation and exception workflow.

Instrument Integration And Bidirectional Worklists

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for instrument integration and bidirectional worklists.

Electronic Signatures Audit Trails And Record History

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for electronic signatures audit trails and record history.

API Integration And Enterprise Interoperability

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for API integration and enterprise interoperability.

Affected buyer audiences

  • medical laboratories
  • laboratory directors
  • quality managers
  • clinical informatics
  • accreditation teams

Implementation questions

  • Which entities, products, populations, transactions, systems, sites, or jurisdictions are actually within scope?
  • What is binding, what is guidance, and what is a technical or consensus standard?
  • Which publication, adoption, effective, application, transition, and enforcement dates differ?
  • Who owns legal, clinical, quality, regulatory, policy, or operational interpretation?
  • How will a source revision affect open work and historical decisions?

Interpretation boundary

A product does not receive ISO 15189 accreditation, and its use does not establish laboratory competence, clinical validity, or correct patient results.