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BSI Enhances its Medical Device Training Curriculum with RABQSA

The ISO 13485:2003 TPECS Curriculum

BSI’s ISO 13485:2003 Requirements competency-based 2-day course teaches a general understanding of the concepts of the standards and how their requirements impact the day-to-day operations of organizations. An experienced instructor explains the clauses of the standards in detail, and includes auditing their requirements. Students learn by participating in group exercises and in-depth discussions.

ISO 13485 Internal Auditor module requires one day and includes:

  • Principles and techniques for auditing a management system
  • Application of audit sampling
  • Instruction on sufficient note-taking
  • Definition of audit follow-up, etc.

ISO 13485 Lead Auditor module requires one day and includes:

  • The process of assigning objectives, scope and criteria to an audit
  • Importance of keeping to a timetable
  • How to conduct opening and closing meetings
  • Issue resolution
  • Audit report distribution, etc.

BSI’s ISO 13485:2003 TPECS is a key addition to an already expansive Medical Device Training Catalog including CE Marking, Design Controls, Implementation, and Specialized Regulatory courses. With more than 70% of the top 100 Medical Device companies choosing BSI as an expert training provider, BSI continues to strive to improve their course offering to meet the changing demands of markets.


BSI is a partner to industry and government with a focus to support their business objectives through the transfer of knowledge of best practices, assurance services to identify and measure performance indicators, training services to aid the building of organizational competency and enable continuous improvement, and the tools to monitor, enhance and report on compliance against the customer's management system objectives. The world's first National Standards Body, BSI draws upon over 100 years of experience to partner with organizations in 147 countries from its 50 offices. For additional information, please visit


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