Course Title

1. Introduction to ISO 13485 and Medical Device Quality Management

• Defining medical device quality management and its regulatory significance

• Overview of the ISO 13485 standard structure and its relationship to ISO 9001

• The role of the lead auditor within certification and regulatory processes

• Overview of medical device quality failures and their consequences including (product recalls and patient safety incidents)

2. ISO 13485 Requirements — Quality Management System

• 2.1 Documentation and RecordsQuality manual, procedures, and record control requirements
  Document control and retention requirements specific to medical devices
  

• 2.2 Management ResponsibilityManagement commitment and quality policy requirements
  Management review process requirements
  

3. ISO 13485 Requirements — Resource Management

• Human resource competency and training requirements

• Infrastructure requirements including (work environment and contamination control)

• Personnel hygiene and health requirements specific to device manufacturing

4. ISO 13485 Requirements — Product Realization

• 4.1 Planning and Design ControlsProduct realization planning requirements
  Design and development control requirements including (design inputs, outputs, and verification/validation)
  

• 4.2 Purchasing and ProductionPurchasing control and supplier evaluation requirements
  Production and service provision control requirements including (process validation)
  

5. ISO 13485 Requirements — Risk Management and Traceability

• Applying risk management principles throughout the product lifecycle including (ISO 14971 references)

• Device traceability and identification requirements

• Unique device identification (UDI) awareness

• Sterile product and packaging control requirements

6. ISO 13485 Requirements — Measurement, Analysis, and Improvement

• Monitoring and measurement requirements including (customer feedback and complaint handling)

• Internal audit requirements specific to medical device QMS

• Nonconforming product control requirements

• Corrective and preventive action (CAPA) requirements

7. Regulatory Context for Medical Device Auditing

• Overview of 21 CFR Part 820: Quality System Regulation and its relationship to ISO 13485

• Overview of EU Medical Device Regulation (MDR) requirements and audit implications

• Understanding regulatory audit types including (notified body audits and regulatory inspections)

• Distinguishing certification audits from regulatory inspections

8. Audit Program Planning and Management

• Establishing an audit program including (objectives, scope, and resource allocation)

• Lead auditor competence and qualification requirements

• Determining audit frequency based on risk and product criticality

• Coordinating audit logistics including (scheduling and multi-site considerations)

9. Preparing for the Audit

• Defining audit scope and criteria for a specific ISO 13485 audit

• Reviewing documentation including (quality manual, previous audit reports, and regulatory correspondence)

• Developing audit checklists aligned to product risk classification

• Preparing an audit plan and briefing the audit team

10. Audit Techniques and Evidence Gathering

• 10.1 Gathering Objective EvidenceInterviewing techniques specific to design, production, and quality personnel
  Observation techniques including (verifying practice against validated procedures)
  

• 10.2 Document and Record ReviewReviewing design history files, device master records, and batch records
  Sampling methodology for evidence collection in regulated environments
  

11. Auditing Design and Development Controls

• Auditing design input and output documentation

• Auditing design verification and validation records

• Auditing design change control processes

• Common design control non-conformances including (inadequate traceability and incomplete validation)

12. Auditing Production and Post-Market Processes

• Auditing process validation and production control records

• Auditing complaint handling and post-market surveillance processes

• Auditing corrective and preventive action (CAPA) effectiveness

• Common production-related non-conformances including (inadequate process control and unresolved complaints)

13. Leading the Audit Team

• Assigning audit team roles and responsibilities

• Managing audit team coordination during multi-day audits

• Resolving disagreements or inconsistencies among audit team findings

• Mentoring and developing team member auditors

14. Audit Reporting and Certification Decision Support

• Structuring the audit report for certification body requirements

• Classifying findings including (minor non-conformance, major non-conformance, and observation)

• Conducting the closing meeting and presenting findings to organizational leadership

• Supporting the certification decision-making process

15. Follow-Up, Surveillance, and Continual Improvement

• Verifying corrective action effectiveness following a non-conformance

• Planning surveillance audit cycles

• Reporting audit program trends to certification body management

• Applying lessons learned to improve future audit planning

16. Group Discussion and Case Studies

• Case studies on ISO 13485 audit findings including (design control gaps, CAPA ineffectiveness, and regulatory inspection outcomes) and lessons learned

• Group discussion on common lead auditor challenges including (technical complexity, regulatory ambiguity, and auditee resistance)

• Sharing regional best practices including (medical device sector growth and regulatory alignment across Middle East markets)

• Discussion on the lead auditor's role in supporting patient safety through rigorous, objective auditing