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Internal Audits for Auditors Training Course in the Medical Device Industry According to ISO 13485

Face to face Training2 daysIntermediateVirtual Classroom

Ensure Compliance and Safety with ISO 13485 Internal Auditor Training Course

According to ISO 13485:2016, internal audits are mandatory for manufacturers of medical devices. Our Internal Audits for Auditors in the Medical Device Industry According to ISO 13485 training course covers everything you need to know about these audits, focusing on the specifics of ISO 13485:2016. You’ll learn how to plan, prepare, conduct and evaluate internal audits according to ISO 19011:2018 through practical examples from the medical device industry. You'll gain confidence in handling different audit situations and learn about the unique aspects of auditing in this sector. Additionally, you'll understand the requirements for a comprehensive management system across your organisation.

The course covers legal and normative frameworks (ISO 13485:2016, EU regulations), conducting audits as per ISO 19011:2018, the importance and types of internal audits, requirements and planning for internal auditors, practical preparation and execution of audits, key areas and questions for audits, documentation and follow-up on audit results, tracking and defining corrective actions, and workshops with case studies and role plays. You can find more agenda info below.

This 2-day course is ideal for medical device manufacturers and operators, managers and specialists aiming to become auditors, internal auditors seeking to expand their knowledge, senior quality management staff, quality management representatives, product and project managers, and employees in quality and regulatory affairs.


Why take this course?

  • Ensure safety: Ensure product safety of your medical devices via thorough internal audits.
  • Boost your expertise: Learn to conduct mandatory audits successfully and enhance process improvement through effective audits.
  • Gain certification: Receive a globally recognised TÜV SÜD certificate upon completion.

Benefit from small class sizes, direct interaction with our leading experts, and receive a globally recognised TÜV SÜD certificate upon completion. Equip yourself with the skills and knowledge to perform effective internal audits and ensure the highest standards of quality and safety in your medical devices. Book your place today to improve your auditing capabilities.

Course Testimonial

"The training was quite in line as we wanted to be. Many important topics were covered as per audience preferences."

  • 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].

Net Price (excl. VAT)
from£ 1,350.00

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Book training course Internal Audits for Auditors Training Course in the Medical Device Industry According to ISO 13485
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From 29/07/24
Virtual Classroom
£ 1,350.00 add. VAT

Course No.
1868

Duration
2 days

Show Agenda

Location
Virtual Classroom

Price

Net Price
£ 1,350.00
plus VAT:
£ 270.00

Total Price (inc. VAT)
£ 1,620.00

Course No.
1870

Duration
2 days

Show Agenda

Location
Virtual Classroom

Price

Net Price
£ 1,350.00
plus VAT:
£ 270.00

Total Price (inc. VAT)
£ 1,620.00