This course provides participants with a comprehensive understanding of ISO 13485:2016, the globally recognized Quality Management System (QMS) standard for medical devices. It equips internal auditors with the knowledge and skills required to evaluate conformity, assess process effectiveness, and ensure regulatory alignment. Through a combination of conceptual learning, terminology clarification, requirement interpretation, and hands‑on audit practice, participants learn how to plan, conduct, document, and report internal audits in accordance with ISO 19011. The course also introduces Exemplar Global expectations, auditor qualifications, and the professional responsibilities required to perform effective internal audits.
- Understand the purpose, structure, and requirements of ISO 13485:2016.
- Apply key terminology, definitions, and QMS concepts.
- Analyze and interpret the requirements of the standard.
- Plan, conduct, and document internal audits using ISO 19011 guidelines.
- Identify audit findings, nonconformities, and opportunities for improvement.
- Understand auditor roles, responsibilities, and qualification expectations.
- Use audit checklists and documentation effectively.
Day 1 – Foundations & Standard Requirements
Module 1: Course Introduction & QMS Background
- Course overview and expectations
- Background, history, and rationale of quality management
- Importance of QMS in medical device industry
- Regulatory context and risk‑based thinking
- Introduction to ISO 13485 structure
Module 2: Terminology, Definitions & Documentation
- Key ISO 13485:2016 terminology
- Definitions used in medical device QMS
- Introduction to documents and resources
- Documentation hierarchy and control
- Understanding mandatory documented information
Day 2 – Requirements Analysis & Audit Fundamentals
Module 3: Analysis of ISO 13485:2016 Requirements
- Clause‑by‑clause interpretation
- Process approach and PDCA
- Risk management integration
- Operational and support process requirements
- Performance evaluation and improvement
Module 4: Audits & Audit Findings
- Types of audits and audit principles
- Audit findings: conformity, nonconformity, OFIs
- Evidence gathering and sampling
- Exemplar Global & ANAB overview
- Auditor qualifications and competency expectations
Day 3 – Audit Practice, Roles & Reporting
Module 5: Auditor Roles, Responsibilities & Tools
- Roles and responsibilities during audits
- Professional behavior and ethics
- The audit checklist: purpose and structure
- Documentation in the management system
- Preparing audit plans and schedules
Module 6: Planning & Conducting Audits (Workshop)
- Planning and conducting audits step‑by‑step
- Interviewing techniques and observation skills
- Recording findings and preparing reports
- Conducting opening and closing meetings
- Practical audit simulation and feedback
- Internal auditors and audit program coordinators.
- Quality Assurance managers and specialists.
- ISO 13485 implementation teams.
- Regulatory and compliance professionals.
- Medical device manufacturing personnel involved in QMS oversight.
- Anyone seeking competency in ISO 13485 internal auditing.