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
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
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