- Posted in Legal, Clinical & Regulatory | October 11, 2011 | Comments (0)
- Tags: regulatory, design, iso, device company, medical device, design control, quality management system, qualification, management system, 13485
- By: BONEZONE
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:
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ISO 9001 – Quality Management |
ISO 14001 – Environmental Management |
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ISO/IEC 20000 – IT Service Management |
ISO/IEC – 27001 – IT Security |
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OHSAS 18001 – Occupational Health & Safety |
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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.
