Guardian Assessment Private Limited having its registered office in Mumbai at Lokhandwala Location in Andheri West has been the first choice for participants aspiring for ISO 13485 lead auditor certifications course. Guardian offers world-class and cost-effective training facility on safety and health management which includes audit planning and techniques, thorough analysis of international standards and practices on risk assessment, documentation features and other standard information needed to perform auditing.
The aim of this course is to provide delegates with the knowledge and skills required to perform first, second and third-party audits of medical devices quality management systems against ISO 13485:2016, in accordance with ISO 19011 and ISO/IEC 17021, as applicable. In detail, the training course will provide technical knowledge and practical skills to become a competent Lead Auditor.
Our Medical Devices Quality Management Systems Auditor/Lead Auditor Training Course teaches the fundamental auditing principles and practices, in conformance with national and international accepted norms and regulations relating to MD-QMS requirements.
By attending this course, participants will also gain the necessary auditing skills through activity-based learning, and practical auditing experience with coaching, group workshops and open forum discussions. Experienced trainers will guide participants through the entire audit process; from initiation to conducting audit follow-up.
Successful completion of this training course, by passing the relevant examination and skills assessment, will demonstrate knowledge and basic skills to undertake and lead a management systems audit.
To provide participants with the knowledge and skills required performing audits against the requirement of the medical devices quality management and this includes requirements of the ISO 13485. Participants gaining the criteria shall be awarded with Lead Auditor Training Certificate (Successfully completed) and if a participant does not meet the requirements, he/she shall be awarded with the attendance certificate of the Lead Auditor Training Course of ISO 13485.
Explain the purpose of a medical devices quality management system, of medical devices quality management system standards, of management system audit, of third-party certification, and the business benefits of improved performance of the occupational medical devices quality management system.
Explain the role of an auditor to plan, conduct, report and follow up an medical devices quality management system audit in accordance with ISO 13485, as appropriate.
Plan, conduct, report and follow-up an audit of an occupational medical devices quality management system to establish conformity (or otherwise) with ISO 13485, as appropriate.
This course will help you:
If you wish to attend the training Please write a mail to guardianassessment@gmail.com and we shall be happy to help you.
Contact Details:
Guardian Assessment Pvt. ltd
812, B Wing, Samarth Aishwarya, Lokhandwala Rd, Highland Park, Andheri West, Mumbai, Maharashtra 400053 (India)
Mobile NO. : +919930007532
Office No: 02266955527/ 02266955528
Mail: guardianassessment@gmail.com
Website: http://www.guardiancertification.com