Medical Devices Quality Management System – Lead Auditor Certification

This lead 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 defines the requirements for the ISO 13485:2016 MDQMS Lead Auditor certification, established by QA Assessor as a Personnel Certification Body operating in accordance with ISO/IEC 17024:2012. The scheme is designed to validate the competence of professionals in relation to ISO 13485:2016 — Medical devices — Quality management systems — Requirements for regulatory purposes.

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:

• ✓Lead audit teams and manage audit programmes
• ✓Conduct first, second, and third-party audits against ISO 13485:2016
• ✓Manage client relationships and audit team dynamics
• ✓Evaluate complex management system environments
• ✓Produce formal audit reports suitable for certification purposes

Eligibility Requirements

Competency Framework

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

• ▶Audit programme management and strategic planning
• ▶Lead auditor responsibilities and team leadership
• ▶Complex audit planning for multi-site operations
• ▶Audit reporting for certification and regulatory purposes
• ▶Client relationship management and professional ethics

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