ISO 13485:2016 Medical Devices Quality Management System personnel certification scheme with five progressive levels (Foundation to Lead Auditor). Self-declared alignment with ISO/IEC 17024:2012. Not accredited by a National Accreditation Body.
QA Assessor offers a structured personal certification pathway for professionals seeking to demonstrate competence in medical devices quality management system. Our certification programmes are designed in self-declared alignment with ISO/IEC 17024:2012 and cover five progressive levels, from foundational knowledge through to lead auditor capability.
Each certification level validates specific competencies relevant to medical devices quality management system, enabling professionals to advance their careers and contribute effectively to their organisations’ management systems.
Choose the certification level that matches your experience and career goals
Validates foundational knowledge and understanding of standard requirements, management principles, and system structure.
Validates awareness-level competence including the ability to support management system activities under supervision.
Validates competence to design, implement, operate, and continually improve a conformant management system.
Validates competence to plan, conduct, report, and follow up internal audits in accordance with ISO 19011:2018.
Validates advanced competence to lead audit teams and manage audit programmes per ISO 19011:2018.
Demonstrate verified competence in medical devices quality management system to employers and clients
ISO/IEC 17024:2012 self-declared alignment – not accredited by a National Accreditation Body
Progressive levels from foundation to lead auditor
Continuous learning through CPD requirements and recertification
Environmental Management System
Food Safety Management System
Business Continuity Management System
Information Security Management System
Anti-Bribery Management System
AI Management System
Occupational Health & Safety Management System
Energy Management System
Quality Management System
Start your journey to becoming a certified medical devices quality management system professional today
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