This one day interactive session provides clear concepts, terminology and fundamentals to effectively implement the standard. Cost effective implementation techniques and process approach in conducting audits for bottom-line results, are emphasized.

Content Overview :

  • Intent Comprehension of the Standard
  • Terms, Definitions and Concepts
  • Format of new 13485:2003 Standard
  • Direct comparison of ISO 9001:2008 to ISO 13485:2003
  • Major changes from previous revision, differences, and relationships.
  • Understand Linkages between 13485 and GMPs
  • Process Approach and System Approach concepts
  • Process Approach methods in Internal Auditing
  • Understand the Role of Management during Implementation
  • Powerful Implementation Techniques to minimize implementation difficulties

Who Should Attend :

All Employees involved in developing, implementing and maintaining a Quality Management System including:

  • ISO Management Representative
  • Business Managers
  • Supervisors and Staff
  • Auditors of Medical Device

Student Material :

  • ISO 13485 and Related Standard
  • Student Workbook

Fees and General :

  • Fee: US $695
  • One Day of instruction and discussion

If you like, we can provide more information, please call us at (770)518-9967, e-mail us at info@enhancequality.com or use the feedback form.
If you would like to request a proposal for our services, please submit a Proposal Request

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