CDG Training Private Limited

Lead Auditor: ISO 13485:2016 Medical devices - Quality management systems
This training is designed to give you the relevant skills and knowledge to carry out audits of quality management systems (QMS) for medical devices.
The principles of ISO 13485 set out an explicit management system so that you can audit, examine and continually improve systems for a QMS.
CDG Training’s ISO 22301:2019 Lead Auditor or Business Continuity Management Certification exhibits proven knowledge about the key concepts of business continuity, understand the benefits of a business continuity management system and become familiar with the requirements of ISO 22301. Continuity management is all about the reaction to a natural disaster or cyber attack. It begins with the policies and procedures developed, tested, and used when an incident occurs. The policy defines the program's scope, key parties, and management structure. It needs to describe the necessity of the business continuity criticality of governance in this phase. Business continuity management provides you with knowledge of the roots of the creation and modification of a business continuity plan checklist and the identification of the team responsible for implementation. In a nutshell, Business Continuity Management Certification explains the business needs, revenue-generating components of the company, external-facing aspects, or some other subset of the total organization.
On training completion, you will:
• Understand the requirements of ISO 13485:2016, and the quality system requirements of the Medical Device Regulation
• Understand the role of internal audit in the maintenance and improvement of management systems
• Possess in-depth knowledge of the ISO 13485:2016 audit and certification process
• Have the skills and knowledge needed to plan and conduct third party audits against the requirements of the ISO 13485:2016 and report the compliance of the management systems against the standard requirements so that any corrective action can be undertaken
Please note: Participants should have some prior knowledge of ISO 13485:2016 before attending this training.