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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.
MAXIMEDGE is one of the top leading ISO training and Certification providers in Nigeria. Our ISO 13485:2016lead auditors training in Nigeria is top notch,We provide the best ISO training, audit and Consultancy service in Lagos, Port Harcourt, Abuja, Kano, Ibadan, Benin City, Bayelsa, Warri, Nigeria and other major cities with the service of implementation, training, auditing, and registration. We provide different ISO Standards like ISO 27001, ISO 9001, ISO 14001, ISO 13485, ISO 22000, ISO 17025, ISO 45001, and many others ISO 9001 compliance can be achieved by any organization in Nigeria.
This course meets the training requirements for individual auditor certification.
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:
Explain the purpose of an Medical Device Quality Management Systems, its standards, management system audits, third-party certification, and the business benefits of better Medical Device Quality Management Systems performance.
The training encourages active participation and will help participants advance their skills. The actual application of assessment information and skills is prioritized. Delegates can apply their skills and knowledge to all phases of the evaluation process by using realistic case studies. This course was created with input and feedback from numerous trainers, clients, and training consultants from around the world.
Learn to identify the principles of a Quality Management System according to ISO 9001:2015.
This MAXIMEDGE training course is ideal to a wide range of professionals but will greatly benefit:
5 Days Course, typically starts at 9:30 A.M. and ends by 6:30 P.M (IST). Available batch will be confirmed after registerations. 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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