Medical Devices Quality Management System – Foundation Certification

This foundation level certification validates foundational to advanced competence in Medical Devices Quality Management System. Professionals certified at this level demonstrate comprehensive understanding and practical application of Medical Devices Quality Management System requirements and principles within their organizations.

This certification scheme validates foundational knowledge and understanding of ISO 13485:2016 MDQMS requirements, management principles, and the structure of a Medical Devices Quality Management System. This is a knowledge-based certification that establishes baseline understanding.

Who Is This For?

Purpose & Objectives

This certification program is designed to validate your competence and knowledge of Medical Devices Quality Management System requirements. Upon completion, you will be able to:

• ✓Understand and apply Medical Devices Quality Management System principles within your organization
• ✓Explain the key clauses and requirements of ISO 13485:2016
• ✓Describe the Plan-Do-Check-Act (PDCA) cycle as applied to medical devices quality management system
• ✓Identify the roles and responsibilities within a MDQMS
• ✓Support organizational compliance with ISO 13485:2016 requirements

Eligibility Requirements

Competency Framework

Candidates for the Foundation certification in Medical Devices Quality Management System must demonstrate competence in:

• ▶Knowledge of ISO 13485:2016 standard structure and requirements
• ▶Understanding of MDQMS terminology and key concepts
• ▶Awareness of the PDCA cycle applied to MDQMS
• ▶Understanding of management system principles
• ▶Knowledge of documentation and record-keeping requirements

Assessment & Examination

• ✓Multiple-choice examination format
• ✓Minimum passing score: 70%
• ✓Online proctored examination available
• ✓Results provided within 48 hours

Certificate Validity & CPD

• ✓Certificate validity period: 3 years from date of issue
• ✓Continuing Professional Development (CPD) required for renewal
• ✓Minimum 15 CPD hours per year in relevant domain
• ✓Recertification examination or portfolio assessment at renewal
• ✓Digital certificate and verification via QA Assessor registry

Code of Conduct

All certified professionals must adhere to the QA Assessor Code of Conduct:

• ▶Acting with integrity, objectivity, and professional competence
• ▶Maintaining confidentiality of all information obtained during professional activities
• ▶Reporting any conflicts of interest or ethical concerns
• ▶Committing to continuous professional development
• ▶Upholding the reputation of the certification and the profession