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ISO 13485 Lead Auditor - One Page Brochure

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MASTERING THE AUDIT OF A QUALITY MANAGEMENT SYSTEM (QMS) BASED ON ISO 13485, IN COMPLIANCE WITH THE REQUIREMENTS OF ISO 19011 AND ISO 17021

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ISO 13485 Lead Auditor - One Page Brochure

  1. 1. CERTIFIED ISO 13485 LEAD AUDITOR MASTERING THE AUDIT OF A QUALITY MANAGEMENT SYSTEM (QMS) BASED ON ISO 13485, IN COMPLIANCE WITH THE REQUIREMENTS OF ISO 19011 AND ISO 17021 SUMMARY This five-day intensive course enables the participants to develop the necessary expertise to audit a Quality Management System (QMS) based on ISO 13485 and to manage a team of auditors by applying widely recognized audit principles, procedures and techniques. During this training, the participant will acquire the necessary knowledge and skills to proficiently plan and perform internal and external audits in compliance with ISO 19011 and certification audits according to ISO 17021. COURSE AGENDA DAY 1: Introduction to Quality Management System (QMS) concepts as required by ISO 13485 DAY 2: Planning and initiating an ISO 13485 audit DAY 3: Conducting an ISO 13485 audit DAY 4: Conducting an ISO 13485 audit DAY 5: Certification Exam PECB’s 3 Hour Certified ISO 13485 Lead Auditor 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. After successfully completing the exam, participants can apply for the credentials of Certified ISO 13485 Lead Auditor. Those credentials are available for internal and external auditors. For more information, please visit: www.pecb.org GENERAL INFORMATION ▶▶ Certification fees are included in the exam price ▶▶ Participant manual contains more than 450 pages of information and practical examples ▶▶ A participation certificate of 31 CPD (Continuing Professional Development) credits will be issued to the participants PECB Certified ISO 13485 Lead Auditor For additional information, please contact us at info@pecb.org.

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