ISO 15189 Accreditation: The International Standard for Medical Laboratories

ISO 15189 is the international standard that specifies requirements for quality and competence in medical laboratories. Published by the International Organization for Standardization (ISO) and most recently revised in 2022, it is recognized by accreditation bodies in over 100 countries as the definitive benchmark for laboratory quality management.

Who Needs ISO 15189?

ISO 15189 is relevant to any medical laboratory that:

• Operates outside the United States and wants internationally recognized accreditation
• Exports test results to multiple countries and needs a single recognized standard
• Seeks to demonstrate quality to international hospital networks, insurance companies, or regulatory bodies
• Is located in a country where ISO 15189 accreditation is required by law or regulation
Countries where ISO 15189 is the primary laboratory accreditation standard:
• European Union (all 27 member states)
• United Kingdom (UKAS accreditation)
• United Arab Emirates (DCAS/EIAC accreditation)
• Saudi Arabia (SAAC accreditation)
• Canada (CALA accreditation)
• Australia (NATA accreditation)
• South Africa (SANAS accreditation)
• India (NABL accreditation)
• Brazil (CGCRE accreditation)

ISO 15189:2022 — What Changed in the Latest Revision

The 2022 revision of ISO 15189 introduced significant updates compared to the 2012 version:

New Requirements in ISO 15189:2022

• Risk-based thinking — laboratories must formally assess and manage risks across all pre-analytical, analytical, and post-analytical phases
• Impartiality — new requirements to identify and manage threats to impartiality
• Competence of personnel — expanded requirements for competency assessment, including remote and contracted staff
• External providers — stronger requirements for evaluating and monitoring reference laboratories and suppliers
• Point-of-care testing — explicit requirements for POCT programs, including operator training and connectivity
• Digital health — new guidance on laboratory information systems, data integrity, and cybersecurity

Key Differences from ISO 15189:2012

The 2022 revision aligns more closely with ISO 9001:2015 and ISO/IEC 17025:2017, making it easier for multi-site organizations to integrate their quality management systems. The structure follows the Annex SL high-level framework used by all modern ISO management system standards.

ISO 15189 vs. CAP Accreditation

Both ISO 15189 and CAP accreditation are peer-reviewed, on-site inspection programs with rigorous quality requirements. The key differences:

Aspect	ISO 15189	CAP
Geographic scope	International (100+ countries)	Primarily USA, with international presence
Accreditation body	National accreditation bodies (UKAS, EIAC, NATA, etc.)	College of American Pathologists
CLIA deemed status	No	Yes (in USA)
Inspection frequency	Every 2–4 years (varies by country)	Every 2 years
Checklist format	Principle-based requirements	Prescriptive checklist items
Cost	Varies by country and accreditation body	~$3,000–$15,000 per inspection cycle

The ISO 15189 Accreditation Process

Step 1: Gap Assessment

Before applying for accreditation, conduct a thorough gap assessment against the ISO 15189:2022 standard. Identify which requirements are already met, which are partially met, and which are not yet addressed.

Step 2: Quality Management System Implementation

Develop and implement a quality management system (QMS) that addresses all ISO 15189 requirements. This includes:

• Quality manual
• Document control system
• Risk register
• Competency assessment program
• Internal audit program
• Management review process

Step 3: Application to Accreditation Body

Apply to the national accreditation body in your country. In the UAE, this is EIAC (Emirates International Accreditation Centre). In Saudi Arabia, it is SAAC (Saudi Accreditation Center). In the UK, it is UKAS.

Step 4: Document Review

The accreditation body reviews your quality management documentation before scheduling an on-site assessment.

Step 5: On-Site Assessment

Trained assessors visit your laboratory to verify that your QMS is implemented effectively. They review records, interview staff, and observe laboratory processes.

Step 6: Accreditation Decision

If the assessment is successful, accreditation is granted for a defined period (typically 2–4 years). Surveillance assessments are conducted annually or biennially.

How LabComply Supports ISO 15189 Compliance

LabComply's ISO 15189 module maps every requirement of the 2022 standard to specific laboratory activities:

• Clause 5 (Structural requirements) — organizational chart, scope of activities, impartiality declaration
• Clause 6 (Resource requirements) — personnel competency, equipment calibration, reference material management
• Clause 7 (Process requirements) — pre-analytical, analytical, and post-analytical process controls
• Clause 8 (Management system requirements) — document control, internal audit, management review, CAPA

The platform generates a real-time ISO 15189 compliance score and produces an accreditation readiness report you can share with your assessor.

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LabComply serves laboratories in the United States, Canada, the UAE, Saudi Arabia, the United Kingdom, and across the European Union. Our platform is built to support every major accreditation standard — CAP, CLIA, COLA, ISO 15189, TJC, and DNV.