Overview - An intense learning programme called the Lead Auditor Course for Medical Device Quality Management System (MD-QMS) CQI I IRCA is created to give participants the information and abilities they need to carry out successful audits of medical device businesses.
An introduction to the ISO 13485:2016 standard, which specifies the standards for a quality management system specifically for medical devices, is given at the beginning of the course. The main clauses of the standard will become clearer to the participants, and they will learn how to integrate them into their organization's QMS.
Risk management, an essential part of the QMS in the medical device business, is covered in the course. Participants will gain knowledge of how to recognise, examine, and assess hazards related to medical devices, especially those related to patient safety and potential reputational damage.
Another important component of the training is the design of quality management systems. Participants will get knowledge on how to create an efficient QMS that complies with ISO 13485:2016. To assure standard compliance and enhance the efficacy and efficiency of the QMS, this includes developing processes, policies, and work instructions.
A crucial requirement of the ISO 13485:2016 standard is internal audits. Internal audits of the QMS will be planned, prepared for, and carried out by the participants. 
They will also learn how to summarize audit findings, offer recommendations for improvement, and report on audit outcomes.
The course also covers supplier management, which is essential for making sure that the supply chain for medical devices is dependable and that the supplied goods and services adhere to the necessary standards. Participants will obtain knowledge on how to evaluate suppliers' performance in light of the needs of the organization.

Objective -

• Provide an understanding of the principles and requirements of ISO 13485:2016 and related regulatory requirements for medical devices.
• Develop practical auditing skills that can be applied in various auditing situations.
• Enable participants to plan, conduct, report, and follow up on an audit of a medical device QMS against ISO 13485:2016 requirements.
• Enhance participants' ability to analyze and evaluate medical device QMS documentation and audit evidence.
• Develop participants' skills in communicating effectively with auditees and stakeholders during the audit process.
• Prepare participants for the CQI I IRCA Lead Auditor certification exam.

                                                                                          
How would taking this course benefit my Career?

Are you looking for a comprehensive course on Medical Device Quality Management Systems? Look no further! Our ISO 13485:2016 MD-QMS CQI | IRCA Lead Auditor Training provides a wide range of benefits to help you understand and implement this important system. Here are some key benefits of our course:

• Get up to date with the latest medical device quality management systems and regulations
• Learn how to develop, implement, and maintain an ISO 13485:2016 compliant quality management system
• Understand the requirements of the ISO 13485:2016 standard and how to audit it effectively
• Acquire the necessary skills to become an CQI | IRCA Lead Auditor in Medical Device Quality Management Systems
• Get access to valuable resources, such as case studies, templates, sample documents, and more.

                                                                                                                    
 

FAQs:

Course content of ISO 13485 Lead Auditor Training:

• A set of ISO 13485 standards
• Auditing criteria for the ISO 13485:2016 Standard, including the PDCA Cycle
• Examining the documentation of medical device quality management systems
• Checking compliance with ISO 19011 standards
• Audit Planning: Audit Plan Checklists, Non-Conformance Reports Auditing Roles and Responsibilities of the Auditor
• Exercises, case studies, and follow-up verification are all included in the audit reporting process.
• Registration as an auditor, accreditation, and certification

Course Duration:

40 Hours + 2 Hrs 15 mins Examination (Non English speaking Learner)

Course Duration & Structure:

5 Days Course, typically starts at 9:30 A.M. and ends by 6:30 P.M (IST). Presentations, Examples, Exercises requiring group work, Brainstorming, Readings, and Sharing of Practical Experiences are all included in the course. A 45-minute lunch break each day.

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