Quality Management

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Quality ISO Management Systems

ISO 13485 Training

On-site 2-day training course
Benefits of ISO 13485 QMS
Standard content
Implementation strategies
ISO 13485 Implementation
resources
iso 13485:2003 training, iso 13485 quality manual, iso 13485 consulting

 

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:

  • Format of the ISO 13485:2003 standard

  • 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

  • A copy of the presentation (produced by the client)

  • Numerous templates of procedures required by ISO 13485:2003 standard

  • 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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