Internal Audits for Auditors Training Course in the Medical Device Industry According to ISO 13485
According to ISO 13485:2016, internal audits are mandatory for manufacturers of medical devices. During this training course 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.
- Manufacturer and operator 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
- Senior staff from quality management
- Quality management representative
- Product manager, project manager, employee quality affairs and regulatory affairs
- You will learn to successfully carry out the mandatory audits in the medical device industry.
- As an internal auditor for medical devices, you contribute to process improvement through effective audits.
- You can guarantee the required product safety of your medical devices through internal audits.
- You will get to know communication techniques for successful audits.
- Legal and normative framework (ISO 13485:2016 Specifics of standards regarding audit requirements, EU regulations)
- Audit performed in accordance with ISO 19011:2018
- Importance of internal audits
- Requirements for internal auditors
- Overview of different audit types
- Frequency of internal audits
- Planning of audits
- Prepare audits in a practical way
- Which areas are audited?
- Audit questions
- Audit process
- Audit documentation
- Audit execution (incl. introductory and final discussion)
- Communication within the audit team and audited parties
- Follow-up and evaluation of audit results
- Define and track corrective actions
- Extensive workshop with practical case studies and role plays
- Course delivered by one of TÜV SÜD's leading industry experts
- Small class sizes enhance trainer-delegate relationship
- Receive globally recognised TÜV SÜD certificate upon completion
TÜV SÜD additionally offers the opportunity to deliver this training as a dedicated in-house course, delivered solely to your organisation to meet your needs and requirements. To receive a quote and find out more information, please contact us at [email protected].