ISO 13485 Training
On-site 2-day training course
Benefits of ISO 13485 QMS
Standard content
Implementation strategies
ISO 13485 Implementation
resources |
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ISO
13485:2003 On-Site Training Course
 Who
Should Attend
This two-day training course is for Quality Engineers, Quality Managers,
Documentation Management, Regulatory Affairs, and any other medical
device manufacturing personnel involved in the maintenance of QMS for
the ISO 13485:2003 standard.
Learning Objectives
Completing the course gives you an understanding and knowledge
of:
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Format of the ISO 13485:2003 standard
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Relationship with ISO 9001:2000 and
medical device regulations such as FDA 21 CFR 820, MMD
93/42/EEC and Canadian Medical Device Regulations
-
Contents of elements and specific
requirements for medical device manufacturers
-
Approaches to developing documentation
for the processes specific to ISO 13485:2003 standard
ISO Training Course Description
The training focuses on practical aspects of
development and implementation of an effective ISO 13485:2003
QMS. It includes extensive group assignments with emphasis on
development of efficient processes to support the requirements of the standard.
For the course curriculum - click here
ISO training course materials include
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A
copy of the presentation (produced by the client)
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Numerous templates of procedures required by ISO 13485:2003
standard
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Three publications by the instructor related to quality
management system for ISO 13485:2003 standard
For
Instructor Qualifications Click Here
Order your ISO
13485:2003 Training today and
Call us to
schedule your training.
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