How many controls does ISO 15189:2022 have?

ISO 15189:2022 contains 64 controls organized across 5 domains.

Where does ISO 15189:2022 apply?

ISO 15189:2022 is applicable in International (ISO). Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.

What frameworks does ISO 15189:2022 map to?

ISO 15189:2022 has control-to-control mappings with 243 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.

How do I get started with ISO 15189:2022 compliance?

Start by understanding the framework's key controls and domains. Our compliance platform provides AI-powered gap analysis and mapping tools to help you assess your current posture and build a remediation plan.

ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 (4th edition) specifies requirements for quality and competence in medical (clinical) laboratories. It covers examination processes (pre-examination, examination, post-examination), quality management systems, and resource requirements specific to medical laboratories.

Domains

Clause 8: Management System Requirements

Clause 7: Process Requirements

Clause 6: Resource Requirements

Clause 5: Structural and Governance Requirements

Clause 4: General Requirements

Frequently Asked Questions

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