| Description: |
This course will learn you the basics of planning, preparing, executing and reporting of internal audits to cover the ISO 13485 requirements.
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| Objectives: |
At the end pf the course you are able to perform internal audits on an ISO 13485 quality management system to verify if it is effectively implemented and maintained.
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| Who should attend: |
The course is intended for employees which who are going to perform internal audits.
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| Subjects: |
Subjects that are discussed during the course, are.:
- keys to improvement
- structure of the ISO13485 standard
- position of ISO 13485 in the medical device industry
- audit preperation
- objective evidence
- audit report writing
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Duration:
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1 day
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Location:
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Apeldoorn area, The Netherlands |
| Number of attendees: |
minimum 6 and maximum 12 |