Quality Management System

• Implementation and/or maintenance of a QMS meeting the requirements of EN ISO 13485:2016, ISO 9001:2015, 21 CFR Part 820 or MDSAP.
• Validation covering devices and equipment.
• Complaints and Recalls.
• Support during QMS regulatory authority audits from preparation to execution to audit response.
• Supplier audits.
• Internal audits.
• Mock inspections.
• Remediation programs.
• Root Cause Analysis and CAPA.

CHIARA is a member of British In Vitro Diagnostic Association