ISO 13485 and Quality Management for Medical Devices / Internal Auditing
The course consists of two parts: Quality management for Medical Devices and ISO 13485 (2 days) & Internal auditing for medical device companies and ISO 19011 (1 day).
This course is specifically tailored to make the requirements of the ISO 13485 as tangible and concrete as possible, so participants can confidently work in an organisation where ISO 13485 requirements apply. The second, and optional, part of the course will take you through the steps of performing an internal audit based on the principles of ISO 19011.
Outcome and content
The learning goals are:
- To improve the participants ability to understand and work within any area of a quality management system that meets ISO 13485 requirements.
- To increase the ability to interpret if a requirement of the standard has been met or not
- To improve participants abilities to author and implement documented procedures within the organization
As there is no one-size-fits all implementation of a Quality management system, the course focuses on tools and methods to understand the standard and apply the requirements in as efficient way as possible in the organization you work in.
This first part of the course includes the regulatory background for ISO 13485:2016 and is the prerequisite for taking part 2 the internal auditor training.
The learning goal is :
- To provide the participants with the tools and framework to perform internal audit of an ISO 13485 quality management system.
It covers phases and steps, and templates to start from. There are workshops and practical exercises to prepare you for performing internal audits, along with hints and tips on how to prevent the most common mistakes and pitfalls. The skills gains from this course can be used for internal audits as well as supplier audits.
The course comprises lectures, interactive check-points and workshops. The instructors will follow up on learning objectives throughout the course. This means that participants will have to answer questions on the topics covered to ensure that the objectives are met.
The course will be conducted in English.
Who should attend?
Instruction is targeted towards professionals who work with a quality management system in a medical device organization where ISO 13485 requirements apply, and those who typically are engaged in supporting QA related tasks such as CAPA, complaints, risk management, documentation and internal auditing.
There are no pre-requisites for part 1, but it is helpful to have experience from working in a medical device organisation or any other regulated industry with quality management systems.
It is possible to take Part 1 as an independent course.
It is a prerequisite for participating in Part 2 that you have participated in Part 1.
Mie Østergaard Jørgensen, Senior QA/RA Specialist, UNEEG medical A/S
Pia Wissing Jensen, Private Consultant