CQI / IRCA Approved Lead Auditor ISO 13485:2016

This is CQI/IRCA approved course on MDQMS – ISO 13485:2016 Lead Auditor Training (IRCA Course No.2583). This course is in accordance with ISO 19011 and ISO/IEC 17021. The course includes understanding the elements of ISO 13485:2016 Medical Devices - Quality Management System (MDQMS) coupled with a practical approach to plan, effectively conduct and report first party, second party and third party audits of MDQMS which helps organizations to achieve their MDQMS objectives and improve overall MDQMS performance. The course focuses on imparting knowledge and developing skills in conducting audits of MDQMS effectively and independently as a team leader.

• To understand the overview of ISO 13485:2016 – Medical Devices - Quality Management System (MDQMS)
• To enable delegates understand key concepts in Medical Devices - Quality Management System (MDQMS) auditing
• To impart/enhance practical auditing skills to become certificated Lead Auditor
• To enable the delegates to plan, conduct and manage MDQMS audits effectively in accordance with the principles and guidelines of ISO 19011 and ISO/IEC 17021

• To enhance the technical and behavioral competency in conducting effective MDQMS audits as Lead Auditor

  All the delegates / participants are expected to have basic knowledge of the principles and concepts of Medical Devices - Quality Management System
  (MDQMS) including awareness of the need for quality in medical devices, responsibilities, management commitments, terms, definitions and requirements of ISO 13485:2016.

• CQI/IRCA Registration Scheme and benefits of becoming MDQMS Lead Auditor
• Medical Devices - Quality Management System (MDQMS) and its benefits
• Relevant standards, ISO 13485:2016, ISO 19011:2018, ISO/IEC 17021
• The importance of Medical Devices — Quality Management System
• Developing Medical Devices - Quality Management System (MDQMS)
• Introduction to auditing MDQMS
• ISO 13485:2016 auditing techniques
• Managing and leading an ISO 13485:2016 audit team
• Interview techniques
• Recording and reporting nonconformities Audit reporting
• Corrective Action and Audit Close out process
• Continuous Assessment exercises and feedback
• Syndicate and role play exercises and feedback
• Examination as per CQI/IRCA requirements
• Sum-up

• All delegates should have reasonably good understanding on quality management principles, concepts & basic requirements of ISO 9001:2015 and ISO 13485:2016
• It is desired but not essential to have regulatory background of medical devices
• Knowledge of English is essential

Certificate of successful completion shall be issued to all the delegates who attend entire duration of the course & pass the written examination.

5 Days