Ensure your medical laboratories meet international standards for quality and competence with ISO 15189-2012 certification.
Our team of experts will assist you in aligning your laboratory practices with the highest global standards for medical laboratories.
ISO 15189:2012 is an international standard that specifies the requirements for quality and competence in medical laboratories. It provides a framework for laboratories to ensure they produce accurate and reliable medical test results. The standard covers aspects such as personnel qualifications, laboratory equipment, quality control, and management systems. By adhering to ISO 15189:2012, medical laboratories can demonstrate their ability to consistently meet regulatory requirements, improve diagnostic services, and enhance patient safety through high-quality laboratory practices.
We begin by understanding your organization's needs and requirements. This helps us recommend the right certification process for you.
We review your existing processes, policies, and documents to ensure they meet the standards for ISO certification.
We provide guidance and support to implement the necessary changes and improvements to meet the ISO standards.
We perform an internal audit to assess your organization's compliance with the ISO standard and ensure everything is in place.
A third-party certification body conducts the final audit to ensure your organization meets all the requirements for ISO certification.
Once you pass the audit, the certification body issues the ISO certificate, confirming your organization’s compliance with the ISO standards.
Essential documents for ISO Certification
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