Knowledge and competences on accreditation and certification standards and on conformity assessment process involving several schemes (products, persons, management systems, inspections, testing – medical – calibration laboratories, CE marking). Medical devices directives/regulation expert (ISO 13485).
Skills: Design and implementation of management system for certification and accreditation purposes. Developing Management systems documents editing (management manuals, operating procedures, working instructions, records, flow-charts and diagrams). Risk evaluation/assessment definition and reporting.
Role on Linkedin: owner of the ISO 15189 Medical Laboratories Accreditation group : https...