Description

Internal Auditor Program as per ISO 13485:2016

Master the Audit Process for Medical Device Quality Management Systems

 

In the highly regulated medical device industry, a robust Quality Management System (QMS) is critical for ensuring product safety, efficacy, and compliance. The ISO 13485:2016 standard is the globally recognized benchmark for medical device quality management, covering the entire product lifecycle from design and development to post-market surveillance. This comprehensive internal auditor program is your definitive guide to understanding the standard's requirements and developing the skills to effectively plan, conduct, and report internal audits that drive compliance and continual improvement within your organization. By mastering the principles of ISO 19011 and adopting a risk-based approach, you will gain the confidence to assess your QMS, identify non-conformities, and contribute to the overall effectiveness of your medical device operations.

 

Actionable takeaways for your Job Role

By the end of this course, you will be able to confidently:

  • Interpret the ISO 13485:2016 Standard with a clear, structured understanding of all clauses and their specific application to medical devices.

  • Understand the Relationship between ISO 13485:2016 and ISO 9001:2015, and identify applicable regulatory requirements.

  • Apply ISO 19011 Auditing Principles to plan and prepare for effective, process-based and risk-based internal audits.

  • Conduct Audit Activities including opening meetings, evidence collection, and interviewing to assess QMS conformity.

  • Report Audit Findings accurately, and verify the effectiveness of corrective actions.

  • Apply Knowledge Practically through real-world case studies and interactive workshops that simulate medical device auditing challenges.

 

Quality & Excellence Performance Metrics

Post-training, you will drive these quality parameters to ensure operational excellence in your job-role:

  • Standard Interpretation - Successfully evaluate 100% of applicable ISO 13485 requirements within the assigned audit scope and document compliance status within defined timelines.
  • Audit Planning - Achieve ≥95% completion of assigned internal audits against the approved audit schedule, with audit reports submitted within the defined timeframe.
  • Audit Execution - Document audit evidence and findings for 100% of sampled areas and identify non-conformities requiring corrective action.
  • Non-Conformity Reporting - Ensure 100% of non-conformities are accurately documented with clear reference to the applicable clause(s) and objective evidence.
  • Corrective Action Verification - Verify ≥90% effectiveness of corrective actions, resulting in 0% recurrence of previously identified non-conformities.
  • Regulatory Readiness - Contribute to achieving zero major nonconformities and minimum numbers of minor nonconformities during external assessments in the participant's area of responsibility.
  • Competence & Improvement - Complete competency evaluation of all assigned audit personnel and identify competency gaps with documented recommendations for improvement.

 

Course Curriculum

The course is structured into digestible modules, designed for optimal learning flow :

  • Module 1: Introduction to ISO 13485:2016, Medical Device Regulations, and QMS Fundamentals

  • Module 2: Comprehensive Interpretation of ISO 13485:2016 Clauses and Requirements

  • Module 3: Introduction to Auditing: Definitions, Types of Audits, and Auditor Attributes as per ISO 19011

  • Module 4: Audit Planning & Preparation: Documentation Review, Checklists, and Risk-Based Approach

  • Module 5: Conducting the Audit, Reporting Findings, and Managing Non-conformities

  • Module 6: Corrective Action, Audit Follow-up, and Verification of Effectiveness

  • Module 7: Real-Life Scenarios, Case Studies, and Interactive Q&A Sessions

 

Job Roles That Will Benefit

This course is essential for professionals involved in the implementation, maintenance, and auditing of quality management systems in the medical device industry , including:

  • Quality Assurance and Quality Control Professionals

  • Internal Auditors and Aspiring Lead Auditors

  • Process Owners, Managers, and Management Representatives

  • Regulatory Affairs Personnel and Compliance Officers

  • R&D Personnel and Consultants in the medical device sector

 

Prerequisites

While there are no formal prerequisites for this course, it is highly recommended that participants have a basic understanding of quality management principles, the Plan-Do-Check-Act (PDCA) cycle, and the medical device industry to maximize their learning .

 

Course Features & Included Materials

  • Focused Audit Training: Concentrate on developing practical audit skills and interpreting ISO 13485:2016 requirements.
  • Interactive Sessions: Engage in practical exercises, case studies, and role-play scenarios simulating real audit situations.
  • Expert-Led Sessions: Participate in dedicated Q&A sessions with experienced lead auditors and medical device quality professionals.
  • Knowledge Evaluation: Gauge your understanding with Pre and Post-training Self Evaluation.
  • Verifiable Certificate: Certificate shall be issued as a 'Soft Copy' from our Training Portal. This certificate can be verified anytime from our website https://pathshala.qcin.org/.
  • On successfully passing the examination, the 'Certificate of Successful Completion' will be awarded.
  • Unsuccessful participants will be given the 'Certificate of Attendance'.

 

Enroll Today and Become a Proficient Auditor for Medical Device Quality Systems!

Invest in your skills to ensure regulatory compliance, enhance product quality, and contribute to the safety and effectiveness of medical devices through effective internal auditing.

 

For more information, please contact:

Rohit Varshney at rohit.varshney@qcin.org or call +91 97735 00376