ISO 13485 Auditor/Lead Auditor Training Course

Enhance your Auditing Capabilities.

Enhance your auditing capabilities and gain confidence in effectively auditing a QMS using recognized best practices.
Our training program aligns with ISO 13485:2016 and ISO 19011, the "Guidelines for auditing management systems," ensure you comprehend the fundamental principles and practices of successful QMS audits.

Through a step-by-step approach, you'll be expertly guided through the entire audit process, from initiation to follow-up, over a span of 4 days.

After the course, you are confident in leading successful ISO 13485 audits, ensuring compliance, driving quality improvements, and enhancing organisational performance in the medical device industry.

This program equips you with the knowledge and skills necessary to lead and execute a successful management systems audit. You'll learn to articulate the purpose of an ISO 13485:2016 QMS audit, fulfilling requirements for third-party certification. Moreover, you'll acquire the proficiency to initiate, plan, conduct, report, and follow up on a QMS audit, establishing conformity and elevating organizational performance.

Our training focuses on audit principles derived from the globally recognized standard, ISO 19011:2011. Specifically tailored for Medical Device organisations, it emphasizes the areas to be audited and the methods to verify compliance within the medical device industry.

Regardless of whether you are auditing an internal quality system against medical device regulations, ISO 13485, or assessing suppliers and contract manufacturers, this training equips you with the necessary tools and expertise.

The course language is English.

At the course you will meet:
Naram El-Shamary, Managing Partner, ImproveMatic – Quality by Simplicity

Course facts
4 days
Price this year
26.200 DKK excl. VAT
Sign up here
30. apr.
3. maj

Your advantages when choosing this course

Your benefits

• You will be able to plan, perform, report and follow-up on internal and external audits
• You will be able to select and apply the suited methods and tools for the specific audit
• You will gain a deeper understanding of the link between the regulation and the quality management system from an auditing perspective.

Your company's benefits

• Enhanced Audit Capability: Employees can effectively conduct audit according to 13485:2016 and ISO19011
• Compliance & Quality Assurance: Trained auditors ensure adherence to relevant standards, regulations, and best practices
• Cost Savings: Effective audits can identify inefficiencies, process gaps, and potential cost-saving opportunities within the organization.

Target group

The course is ideal for:
• Professionals transitioning to audit roles
• Professionals conducting internal and external audits
• Professionals seeking documented competency as auditors
• Management Representatives.

Course agenda

This course will be conducted over 4 days including accomondation

• Audits – Purpose & objectives
• Understanding ISO13485 & ISO19011 and their significance in the medical device industry
• Overview of the audit process and resources
• Roles and responsibilities
• Effective communication & cultural considerations
• Audit principles, methods and techniques: Best practice of effective auditing
• Effective auditing
• Handling challenging situations
• Documentation of audit findings
• Classification of audit findings
• Reporting and documenting audits results
• Audit closure and follow-up

The course consists of informative lectures and interactive sessions, allowing participants to engage with the content and collaborate with fellow learners. This interactive approach will enhance understanding and enable participants to apply their knowledge directly.

The course is based on the speakers' own practical and real-life cases from the Medical Device industry.

Sign up here
30. apr.
3. maj