According to ISO 13485:2016, internal audits are mandatory for manufacturers of medical devices. During the seminar you will learn about the specifics of ISO 13485:2016 regarding the audit requirements. You will learn how to plan, prepare, conduct and evaluate internal audits according to ISO 19011:2018. By means of practical examples from the medical device industry you will gain confidence in the execution of audits and will be able to react to different audit situations. You will learn about the special features of audits in the medical device industry and the requirements for a management system in the entire organization.
- Legal and normative framework (ISO 13485:2016 Special requirements of the standards regarding audit requirements, MDD 93/42/EEC and 2007/47/EC, EU Regulation (2017/745 - MDR), MDSAP)
- Audit performance according to ISO 19011:2018
- Importance of internal audits
- Requirements for internal auditors
- Overview of the different audit types
- Frequency of internal audits
- Create audit checklists
- Audit planning
- Preparation of audits
- Which areas are audited?
- Audit issues
- Audit procedure
- Audit documentation
- Audit performance (incl. introductory and final discussion)
- Follow-up and evaluation of audit results
- Determination and follow-up of corrective actions
- Practical case studies and role plays if necessary
Who should attend
- Manufacturers and operators of medical devices
- Managers and specialists from the medical device industry who want to work as auditors
- Internal auditors who want to expand their knowledge
- Leading employees from the quality management
- Quality Management Representative
- Product manager, project manager, staff member for quality affairs and regulatory affairs
Basic knowledge of ISO 13485
certificate of attendance TÜV SÜD Akademie
The seminar deals with internationally valid standards and is also suitable for implementation abroad.
Fachdozenten der TÜV SÜD Akademie
- You will learn to carry out successfully the internal audits in the medical device industry.