ISO 13485 : 2003 Medical Devices
Internal Auditor Training Course
Our innovative techniques boost confidence to conduct effective audits
A training course suitable for those wishing to conduct internal audits to ISO 13485. This 2-day ISO 13485 Internal Auditor training course enables delegates to interpret the requirements of the ISO 13485 medical devices standard from an auditing perspective, conduct effective audits and produce audit findings.
Delegates completing the Batalas ISO 13485 internal auditing training course will be able to audit their quality management system for conformity to ISO 13485, the effectiveness of their business processes, and to identify opportunities for improvement. Improving QMS performance and continual improvement are key elements of this internal auditing training course.
The format of the ISO 13485 internal auditing training course is highly interactive, with tutor-led sessions interspersed with individual and group exercises. An case study is used to practice auditing skills.
Course Content
- Medical devices, quality and auditing terminology
- Structure & intent of the medical devices standard ISO 13485 :2003
- Types of audit
- Internal audit objectives
- Internal audit scope and criteria
- The audit process
- Roles and responsibilities of the internal auditor
- Auditing skills
- Planning, preparation and management of audits
- Checklist development
- Conducting process audits
- Reporting audit findings
- Verifying corrective action
- Interviewing skills
In-company training courses
This course is only available as an in-company event. ISO 13485 medical devices training courses can be tailored to your own requirements. Our training advisors can provide more details on the options available to your organisation.
More information
Associated courses
The following training courses are closely associated with this ISO 13485 internal auditor training course.
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