BSI Enhances its Medical Device Training Curriculum with RABQSA

RABQSA International (RABQSA) and BSI Group America have co-developed an innovative Medical Devices training curriculum, created for individuals wishing either to become trained to audit to the Medical Devices Standard (ISO 13485) or simply to understand the requirements of a medical devices quality management system.

This new curriculum, Training Provider and Examiner Certification Scheme (TPECS), is a modular, RABQSA competency-based training certification designed to reflect innovative learning and audit practices, industry expectations and demonstrate that individuals achieve the level of knowledge and skill competency required for RABQSA personnel certification. The curriculum is intended to enable organizations and individuals to easily prepare and demonstrate their ability to produce medical devices and related services, while consistently meeting customer and regulatory requirements. Allowing for flexibility in course duration, the TPECS course structure includes a collaborative training experience and the reduction in training days from five to four days with online testing available. BSI’s format for each includes three courses: Requirements, Internal Auditor and Lead Auditor. These classes are held in multiple U.S. and Canadian locations.

Further, BSI offers the option to take in-class exams and re-take competency exams online via their recently launched Learning Management System, including a user-friendly interface, streamlined grading and electronic certificate delivery.

BSI introduces the ISO 13485 training offering to an existing robust suite of TPECS training courses including:

 

ISO 9001 – Quality Management

ISO 14001 – Environmental Management

ISO/IEC 20000 – IT Service Management

ISO/IEC – 27001 – IT Security

OHSAS 18001 – Occupational Health & Safety

 

BSI’s robust offerings in the TPECS format ensure that individuals can easily expand their qualifications to meet the growing needs of their organization. This feature is the cornerstone of the TPECS format supporting the expansion of an Internal or Lead Auditor certification to any of the areas listed by merely attending the 2 day Requirements portion of the relevant subject area.


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 www.bsiamerica.com/tpecs.