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.

 

What You Will Learn

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

  • 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 internal audits.

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

  • Report Audit Findings accurately, document non-conformities, and verify the effectiveness of corrective actions.

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

 

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: Audit Principles and Planning as per ISO 19011

  • Module 4: Conducting the Audit, Reporting Findings, and Managing Non-conformities

  • Module 5: Real-Life Scenarios, Case Studies, and Interactive Q&A Sessions

 

Who Is This Course For?

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

  • Consultants and Assessors in the medical device sector

 

Prerequisites

While there are no formal prerequisites, it is highly recommended that participants have a basic understanding of quality management principles and the medical device industry to maximize their learning.

 

Course Features & Included Materials

  • Interactive Learning: Engage in hands-on exercises and scenario-based workshops to reinforce auditing skills.
  • Expert-Led Sessions: Participate in dedicated Q&A sessions with experienced medical device auditors.
  • Comprehensive Learning Materials: Digital Learning Materials and a copy of ISO 13485:2016 (For Training Purposes only).
  • Knowledge Evaluation: Gauge your understanding with Pre and Post-training assessments.
  • 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/, by entering its unique ID number or scanning the QR Code.
  • 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.