ISO 13485 Foundation - One Page Brochure

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FAMILIARIZE YOURSELF WITH THE BEST PRACTICES FOR IMPLEMENTING AND MANAGING A QUALITY MANAGEMENT SYSTEM (QMS) BASED ON ISO 13485

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ISO 13485 Foundation - One Page Brochure

  1. 1. CERTIFIED ISO 13485 FOUNDATION FAMILIARIZE YOURSELF WITH THE BEST PRACTICES FOR IMPLEMENTING AND MANAGING A QUALITY MANAGEMENT SYSTEM (QMS) BASED ON ISO 13485 SUMMARY This course enables the participants to learn about the best practices for implementing and managing a Quality Management System (QMS) as specified in ISO 13485, as well as ISO 14969 (Medical devices – Quality Management Systems – Guidance on the application of ISO 13485). The participant will learn the different components of a QMS manual, required procedures, records, measuring performance, management’s commitment, internal audit, management review and maintaining effectiveness. COURSE AGENDA DAY 1: Introduction to Quality Management System (QMS) concepts as required by ISO 13485 DAY 2: Implementing requirements from ISO 13485 and Certification Exam PECB’s 1 Hour Certified ISO 13485 Foundation exam is available in different languages. The candidates who do not pass the exam will be able to retake it for free within 12 months from the initial exam date. A certificate of Certified ISO 13485 Foundation will be issued to participants who successfully pass the ISO 13485 Foundation Exam: ▶▶ No experience requirements ▶▶ No certification fee ▶▶ No annual maintenance fee ▶▶ Certified for life For more information, please visit: www.pecb.org GENERAL INFORMATION ▶▶ Participant manual contains more than 200 pages of information and practical examples ▶▶ A participation certificate of 14 CPD (Continuing Professional Development) will be issued to the participants PECB ISO 13485 Foundation For additional information, please contact us at info@pecb.org.

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