Who should attend this ISO 13485 Lead Auditor Course?
The ISO 13485 Lead Auditor Course provides the knowledge and skills required to conduct audits of medical device Quality Management Systems against the requirements of ISO 13485. This course can be beneficial for professionals, including:
- Lead Auditors
- Quality Control Managers
- Regulatory Affairs Managers
- Compliance Officers
- Manufacturing Managers
- Quality Assurance Professionals
- Internal Auditors
Prerequisites of the ISO 13485 Lead Auditor Course
There are no formal prerequisites for this ISO 13485 Lead Auditor Course. However, some knowledge of quality management systems, auditing techniques, and regulatory requirements, along with practical experience in medical device manufacturing, would greatly benefit the delegates.
ISO 13485 Lead Auditor Training Course Overview
ISO 13485 sets the standards for a Quality Management System (QMS) in scenarios where organisations need to consistently demonstrate their ability to provide medical devices and related services that meet customer and regulatory requirements. This training equips learners with the skills required for implementing a quality management system for medical devices and conducting audits to ensure organisational performance.
Acquiring knowledge from this training benefits organisations by streamlining processes and reducing operational challenges. Individuals pursuing this training can enhance their expertise and capabilities, opening new career opportunities and potential income growth. Professionals in roles that are responsible for quality management systems, should aspire to master ISO 13485 Lead Auditor training.
The Knowledge Academy's 5-day ISO 13485 Lead Auditor Training Course offers a comprehensive understanding of quality management and the art of auditing systems. Delegates will delve into the implementation phases of ISO frameworks and gain expertise in gap analysis to support various clauses. They will also explore risk management, learning how to map identified risks and monitor continuous improvement.
Course Objectives:
- To improve the quality of medical devices manufactured by a company
- To promote harmonisation of regulatory requirements for manufacturers
- To provide access and evidence in accordance with regulatory requirements
- To engage management actively and undertake management system activities
- To protect the confidentiality of all documents and information obtained in the audit
- To obtain quality objectives from the manufacturer and pass them to the organisation
After completing this training, delegates will be able to implement this ISO standard by specifying company requirements and the scope of medical devices. They will also be able to take on responsibilities associated with auditing authority for the management and performance of all audit activities.