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Corporate Training for Teams

ISO 13485:2016 Internal Audit (Medical Devices)

Spade Learning Academy, Online (+1 locations)
Length
2 days
Next course start
Please enquire for course dates (+2 start dates)
Course delivery
In Company, Virtual Classroom
Length
2 days
Next course start
Please enquire for course dates (+2 start dates)
Course delivery
In Company, Virtual Classroom

Course description

The ISO 13485 Internal Audit Two-Day Course equips participants with the knowledge and skills necessary to conduct effective internal audits of quality management systems (QMS) in accordance with ISO 13485:2016. This course focuses on developing competence in audit planning, conducting audits, reporting findings, and implementing corrective actions within medical device manufacturing environments. Participants will gain practical insights and hands-on experience through interactive exercises and case studies.

Benefits:

  • Enhance auditing skills and knowledge specific to ISO 13485:2016 requirements.
  • Prepare for and contribute to successful ISO 13485 certification audits within your organization.
  • Improve QMS effectiveness and compliance through structured audit practices.
  • Network with peers and industry experts to exchange insights and best practices in QMS auditing.

Upcoming start dates

Choose between 2 start dates

Please enquire for course dates

  • In Company
  • United Kingdom
  • English

Please enquire for course dates

  • Virtual Classroom
  • Online
  • English

Suitability - Who should attend?

Who Should Attend:

  • Quality managers, internal auditors, and lead auditors responsible for auditing QMS within medical device manufacturing organizations.
  • Professionals involved in implementing, maintaining, or seeking certification to ISO 13485:2016.
  • Consultants and advisors supporting medical device companies in QMS implementation and compliance.

Outcome / Qualification etc.

Course Objectives:

  • Understand the principles and requirements of ISO 13485:2016 and their application in QMS audits.
  • Learn the role and responsibilities of an internal auditor in conducting audits within the medical device industry.
  • Gain proficiency in audit planning, preparation, and execution based on ISO 19011 guidelines.
  • Develop skills in assessing conformity and effectiveness of QMS processes against ISO 13485 requirements.
  • Learn techniques for documenting audit findings, preparing audit reports, and communicating results.
  • Understand the importance of corrective actions and follow-up activities to maintain QMS compliance.

Certification:

Participants will receive a certificate of completion upon fulfilling the course requirements, demonstrating their competence in conducting internal audits based on ISO 13485:2016 principles.

Training Course Content

Day 1:

  • Introduction to ISO 13485: Overview of the standard, key requirements, and audit principles.
  • Role and responsibilities of an internal auditor: Competence requirements and ethical considerations.
  • Audit planning and preparation: Setting audit objectives, scope, and criteria.
  • Conducting audit activities: Techniques for gathering evidence and conducting interviews.
  • Documenting audit findings: Writing non-conformities, observations, and audit reports.

Day 2:

  • Reporting audit results: Communicating findings to stakeholders and management.
  • Corrective actions and follow-up: Implementing corrective actions, verifying effectiveness, and closing out findings.
  • Case studies and practical exercises: Applying audit principles and techniques in simulated scenarios.
  • Q&A session and review: Addressing participant queries, reinforcing key concepts, and preparing for audits.
  • Certification criteria and assessment: Evaluating participant understanding through knowledge checks and case study reviews.

Course delivery details

Course Format:

  • Duration: Two days (16 hours)
  • Delivery: Instructor-led training, available in both in-person and virtual formats.
  • Interactive Learning: Practical workshops, simulations, and group discussions to enhance learning.
  • Comprehensive Materials: Participants will receive course handouts, audit templates, and a certificate of completion.

Expenses

Class Size and price: Up to 15 delegates £3,450.00

Spade Learning Academy
71-75 Shelton St, Covent Garden
WC2H 9JQ London

Spade Learning Academy

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