Medical Devices Quality Management System – Internal Auditor Certification

This internal auditor 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 competence to plan, conduct, report, and follow up ISO 13485:2016 MDQMS internal audits in accordance with ISO 19011:2018, including identifying nonconformities and generating formal audit reports.

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:

• ✓Plan and conduct internal audits per ISO 19011:2018
• ✓Identify nonconformities and opportunities for improvement
• ✓Generate structured audit reports with evidence-based findings
• ✓Evaluate the effectiveness of MDQMS controls and processes
• ✓Follow up on corrective actions and verify their effectiveness

Eligibility Requirements

Competency Framework

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

• ▶Audit planning and preparation per ISO 19011:2018
• ▶Audit evidence gathering and evaluation techniques
• ▶Nonconformity identification and classification
• ▶Audit reporting and documentation
• ▶Corrective action follow-up and verification

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