Internal audit on Medical Device QMS - ISO 13485:2016
- Offered byUDEMY
Internal audit on Medical Device QMS - ISO 13485:2016 at UDEMY Overview
Duration | 2 hours |
Total fee | ₹449 |
Mode of learning | Online |
Credential | Certificate |
Internal audit on Medical Device QMS - ISO 13485:2016 at UDEMY Highlights
- Earn a certificate of completion from Udemy
- Learn from 1 downloadable resources
- Get full lifetime access of the course material
- Comes with 30 days money back guarantee
Internal audit on Medical Device QMS - ISO 13485:2016 at UDEMY Course details
- For Medical device companies looking to set up their QMS and get ISO 13485:2016 certified
- For Professionals tasked with overseeing a management system meeting ISO 13485 standards
- For Professionals tasked with overseeing an internal audit based on ISO 13485 requirements
- For Quality managers
- For Risk managers
- For Medical device practitioners interested in the ISO 13485 framework
- For Anyone who wishes to be able to properly conduct a mock audit independently
- Conducting an entire internal audit based on ISO 13485:2016 requirements
- General concepts and principles of auditing
- Establishing and preparing for the audit
- Performing the audit (How to conduct a mock audit based on compiled checklist?)
- Reporting the audit results
- Post-audit activities and CAPA planning
- Internal audit on Medical Device QMS - ISO 13485:2016 is another course created by Stendard Academy to help you gain the skills, and learn how to be an internal auditor for the ISO 13485:2016 standard
- In the course, we will cover the general principles of auditing, and walk through all the clauses in this standard, to provide a holistic picture of how audits are and can be performed
- This will be done as part of a comprehensive mock audit, performed according to an audit checklist we crafted to thoroughly assess each line in the standard
Internal audit on Medical Device QMS - ISO 13485:2016 at UDEMY Curriculum
General concepts and principles of auditing
Introduction to the general auditor course
Understanding Terminology
How to be a good auditor?
Establishing and preparing for the audit
Introduction to managing the audit
Establishing and preparing for the audit
Performing the audit (How to conduct a mock audit based on compiled checklist)
Performing the audit
Case Study: How to record a non-conformance?
How to conduct a mock audit based on compiled checklist (Clause 1 to 4)?
How to conduct a mock audit based on compiled checklist (Clause 5 to 6)?
How to conduct a mock audit based on compiled checklist (Clause 7)?
How to conduct a mock audit based on compiled checklist (Clause 8)?
Reporting the audit results
Reporting the audit results
Post-audit activities and CAPA planning
Following up on post-audit activities
Case study to determine Correction, Corrective Action and Preventive Action
Acceptance of corrective and preventive action
Conclusion
Bonus Lecture
Internal audit on Medical Device QMS - ISO 13485:2016 at UDEMY Entry Requirements
- Prerequisite: Familiarising with compiled audit checklist
- Not mentioned
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