ISO 15189 Certification Consulting Company | Quality Catalyst

ISO 15189 Certification

ISO 15189:2012 is a medical laboratory regulation standard. Its standards aid laboratories in the development of quality management systems as well as the assessment of their own competence. Regulators, accrediting organizations, and consumers utilize the standard to validate or acknowledge a lab’s competency.

Document control, internal audits, occurrence management, and risk management are all common components of the standard. ISO 15189 compliance raises the total quality of a laboratory’s services and products, which has a direct impact on the quality of health care.

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  • The benefits of implementing ISO 15189 Certification include:

    1. Risk reduction
    2. Cost-saving
    3. Globally recognized
    4. Improves access to information
    5. Manages competency
    6. Demonstrates compliance
    7. Modernization of practices
    8. Continual improvement of medical lab procedures


A highly skilled professional with extensive knowledge in ISO, SOC, CMMI, and PCI DSS standards. With a deep understanding of these frameworks, can provide valuable expertise to organizations seeking to implement and comply with these industry-leading standards. Whether it's ensuring adherence to ISO management system standards, conducting SOC assessments, guiding CMMI process improvement initiatives, or achieving PCI DSS compliance, reliable support and guidance throughout the journey is ensured.