Who should attend this ISO 13485 Internal Auditor Course?
The ISO 13485 Internal Auditor Course is a programme that allows professionals to conduct ISO 13485-based medical device Quality Management System (QMS) Internal Audits. This course can be beneficial for professionals, including:
- Quality Managers
- Engineers
- Technicians
- Regulatory Affairs Professionals
- Manufacturing Managers
- Compliance Officers
- Medical Device Consultants
Prerequisites of the ISO 13485 Internal Auditor Course
There are no formal prerequisites for this ISO 13485 Internal Auditor Course.
ISO 13485 Internal Auditor Course Overview
ISO 13485 defines the requirements for a Quality Management System (QMS) in situations where an organisation must demonstrate its ability to consistently offer medical devices and related services that fulfil customer and applicable regulatory requirements. An ISO 13485 audit helps to identify the present state and health of your QMS and processes. It includes an independent and systematic process audit to determine QMS's conformity or nonconformity.
This training session will provide delegates with auditing techniques for Quality Management Systems following ISO 13485 and ISO 19011. Individuals with excellent auditing skills in medical devices will quickly get higher designations and expand their professional networks. Professionals in roles such as Quality Managers, Regulatory Affairs Specialists, Quality Control Officers, and individuals involved in internal quality audits in the medical device industry should aim to master the ISO 13485 Internal Auditor Training Course.
In this 2-day ISO 13485 Internal Auditor Training course, delegates will gain comprehensive knowledge of Quality Management Systems and how to conduct internal auditing. They will also learn about management's responsibilities for making policy and financial decisions to support QMS, how to plan a medical device, quality process audit, and documentation requirements.
Course Objectives
- To carry out activities in order to achieve audit objectives
- To provide products and services to medical device organisations
- To enhance the organisational ability and meet customer requirements
- To identify the context of a company as well as internal and external issues
- To create a culture of continual improvement and improve decision-making
- To maintain records and implement quality processes within an organisation
After attending this training, delegates can promote awareness of regulations and review the management to identify improvements and regulatory requirements. They will also be able to evaluate the effectiveness of the Quality Management System and document each test during processing.