4611017-EN
Internal audits for auditors in the medical device industry according to ISO 13485
Instructor-led Training2 Days
ENBeginnerPräsenztraining
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 standard parameters (ISO 13485:2016, characteristics of the standards concerning audit requirements, EU regulations)
- Conducting audits as per ISO 19011:2018
- Significance of internal audits
- Requirements of the internal auditors
- Overview of the various audit types
- Frequency of internal audits
- Planning audits
- Preparing audits in a practice-oriented manner
- Which areas will be audited?
- Audit questions
- Audit process
- Audit documentation
- Performing the audit (incl. initial and wrap-up meeting)
- Communication in the audit team and audited parties
- Follow-up and evaluation of audit results
- Corrective action determination and tracking
- Case studies and, if applicable, role playing
- You will learn to successfully carry out the mandatory audits in the medical device industry.
- As an internal auditor for medical devices, you make a contribution 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.
- 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
Basic knowledge of ISO 13485
- The seminar deals with internationally valid standards and is also suitable for implementation abroad.
- This seminar is part of the modular training for the I. and II. Party Process Auditor Medical Devices.
Dieses Onlinetraining wird von der TÜV SÜD Akademie GmbHin Deutschland durchgeführt. Bei diesem Onlinetraining gelten daher die AllgemeinenGeschäftsbedingungen und Prüfungsordnungen sowie Datenschutzinformationen der TÜV SÜD Akademie GmbH. Bei Rückfragen stehenwir Ihnen gerne zur Verfügung.
This training is being operated by TÜV SÜD Akademie GmbHin Germany. The GeneralTerms and Conditions as well as the PrivacyNotice of TÜV SÜD Akademie GmbH apply. Incase of any questions, do not hesitate to contact us.