Blueprint Genetics: ISO 15189 – Quality Management System for clinical research laboratory
Blueprint Genetics is Finnish laboratory that develops and conducts diagnostic genetic tests for professional use. Blueprint Genetics’ customers are hospitals and clinical research centers in Europe and Northern America.
Team Kasve acted as an outsourced quality manager for Blueprint Genetics and was responsible for building up quality management system to match ISO 15189, QMS for medical laboratories, and US CLIA, Clinical Laboratory Improvement Amendments, requirements. Team Kasve was also responsible for internal audits and training of personnel as well as acted as quality manager in accreditation audits conducted by FINAS and CLIA. Team Kasve built quality management system received appraisals from both authorities for functionality and coverage.
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Credibility for a Start-up with a QMS Certificate
Kasve supported Buddy Healthcare in building up the EN ISO 13485 compliant Quality Management System and developed company's internal auditing further.
Etsimo: ISO 13485:2016 Quality Management System
Team Kasve built up together with Etsimo key personnel an ISO 13485:2016 QMS that, for example, enhances the company’s R&D activities, risk management and training of personnel.
Cerenion: ISO 13485:2016 Quality Management System
Kasve helped to build up ISO 13485:2016 QMS that, for example, enhances company’s R&D activities, risk management and training of personnel. Kasve also participated into software development documentation.