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Quality

Quality of the organisation, staff, and assays performed is embedded in our Quality Management System (QMS), which is based on the ISO 9001:2015 standards and the OECD Guidelines of Good Clinical Laboratory Practice (GxP) and supervised by the Quality System Manager (QSM).

OBJECTIVES
  • Ensure a constant quality of biomarker analysis and reporting

  • Define a QA audit program and facilitate audits accordingly

  • Perform internal and external audits

  • Ensure that all all procedures are laid down in SOPs and reviewed by QSM

  • ​Facilitate study-related GLP or GCLP audits during all critical study phases

ISO 15189

Coagulation Profile B.V. teamed up with Quadra Consultancy to start with implementation of ISO 15 189. After an initial GAP analysis, the documentation for the quality management system will be adapted and a handbook has been drafted.   ​

Internal audits are planned for August 2024

ISO 9001

We have been independently assessed by BSI against internationally recognised standards showing our commitment to quality and assurance. ​

ISO 9001:2015 Quality Management System certified by BSI
FS731406

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