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 17021SUMMARY 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. Based on practical exercises, the participant will develop the skills (mastering audit techniques) and competencies (managing audit team and audit program, communicating with customers, conflict resolution, etc.) necessary to efficiently conduct an audit.WHO SHOULD ATTEND? Internal auditors A uditors wanting to perform and lead Quality Management System (QMS) certification audits in the medical device industry P roject managers or consultants wanting to master the Quality Management System audit process I ndividuals responsible for the quality or conformity in an organization Members of a quality team Expert advisors in Quality Management Systems Regulatory affairs managers Technical experts wanting to prepare for a quality audit function in the medical device industryCOURSE AGENDADURATION: 5 DAYSDAY 1 Introduction to Quality Management System (QMS) concepts as required by ISO 13485 Normative frameworks and methodologies related to Quality and Medical Devices Fundamental principles of Quality and Medical Devices ISO 13485 certification process Quality Management System (QMS) Detailed presentation of the clauses of ISO 13485DAY 3 Conducting an ISO 13485 audit Communication during the audit udit procedures: observation, document review, A interview, sampling techniques, technical verification, corroboration and evaluation udit test plans A ormulation of audit findings F Documenting nonconformitiesDAY 5DAY 2 Planning and initiating an ISO 13485 audit F undamental audit concepts and principles A udit the approach based on evidence P reparation of an ISO 13485 certification audit Q MS documentation audit Conducting an opening meetingDAY 4 Concluding and ensuring the follow-up of an ISO 13485 audit Audit documentation uality review Q onducting a closing meeting and conclusion of an C ISO 13485 audit valuation of corrective action plans E SO 13485 surveillance audit I SO 13485 internal audit management program ICertification Exam PECBs 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.www.pecb.org

2. EXAMINATION The Certified ISO 13485 Lead Auditor exam fully meets the requirements of the PECB Examination and Certification Program (ECP). The exam covers the following competence domains: D omain 1: Fundamental principles and concepts of Quality and Medical DevicesD omain 2: Quality Management System (QMS)D omain 3: Fundamental audit concepts and principlesD omain 4: Preparation of an ISO 13485 auditD omain 5: Conducting of an ISO 13485 auditD omain 6: Closing an ISO 13485 auditD omain 7: Managing an ISO 13485 audit program or more information about the exam, please visit: www.pecb.org FCERTIFICATION After successfully completing the exam, the participants can apply for the credentials of Certified ISO 13485 Provisional Auditor, Certified ISO 13485 Auditor or Certified ISO 13485 Lead Auditor, depending on their level of experience. Those credentials are available for internal and external auditors certificate will be issued to participants who successfully pass the exam and comply with all the other A requirements related to the selected credential: CredentialExamProfessional ExperienceQMSMD Audit ExperienceQMSMD Project ExperienceOther RequirementsISO 13485 Provisional AuditorISO 13485 Lead Auditor ExamNoneNoneNoneSigning the PECB code of ethicsISO 13485 AuditorISO 13485 Lead Auditor ExamTwo years One year of Medical Devices work experienceAudit activities totaling 200 hoursNoneSigning the PECB code of ethicsISO 13485 Lead AuditorISO 13485 Lead Auditor ExamFive years Two years of Medical Devices work experienceAudit activities totaling 300 hoursNoneSigning the PECB code of ethicsGENERAL INFORMATION Certification fees are included in the exam price Participant manual contains over 450 pages of information and practical examples A participation certificate of 31 CPD (Continuing Professional Development) credits will be issued to participants In case of failure of the exam, participants are allowed to retake it for free under certain conditionsFor additional information, please contact us at info@pecb.org www.pecb.orgPECBCertified ISO 13485 Lead Auditor