1. CERTIFIED ISO 13485 LEAD IMPLEMENTER MASTERING THE IMPLEMENTATION AND MANAGEMENT OF A QUALITY MANAGEMENT SYSTEM (QMS) BASED ON ISO 13485 SUMMARY This five-day intensive course enables the participants to develop the necessary expertise to support an organization in implementing and managing a Quality Management System (QMS) based on ISO 13485. Participants will also gain a thorough understanding of best practices used to implement quality processes based on requirements from ISO 13485. This training is consistent with the project management practices established in ISO 10006 (Quality Management Systems Guidelines for Quality Management in Projects). This training is fully compatible with ISO 14969 guidances (Medical devices Quality Management Systems Guidance on the application of ISO 13485).COURSE AGENDADURATION: 5 DAYSDAY 1 Introduction to Quality Management System (QMS) concepts as required by ISO 13485 and initiation of a QMS ntroduction to management systems and the process I approach ormative frameworks and methodologies related to N Quality and Medical Devices nderstanding the requirements of ISO 13485 U undamental principles of Quality and Medical Devices F nitiating the QMS implementation IDAY 3 Implementing a QMS based on ISO 13485 mplementation of a document management I framework esign of controls and writing of procedures D evelopment of a training and awareness program D and communicating about the quality roduct realization processes P perations management of a QMS ODAY 5DAY 2 Planning the implementation of a QMS based on ISO 13485 riting a business case and a project plan for the W implementation of a QMS efinition of the scope of the QMS D evelopment of a QMS policy DDAY 4 Controlling, monitoring and measuring a QMS and the certification audit of a QMS in accordance with ISO 13485 C ontrolling and monitoring a QMS I SO 13485 internal audit M anagement review of a QMS I mplementation of an improvement program P reparing for an ISO 13485 certification auditCertification Exam www.pecb.org

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WHO SHOULD ATTEND? roject managers or consultants wanting to prepare and to support an organization in the implementation of a P Quality Management System (QMS) uality executives Q SO 13485 auditors who wish to fully understand the Quality Management System implementation process I ersons responsible for the quality or conformity in an organization P embers of a quality team M xpert advisors in Quality Management Systems E egulatory affairs managers R echnical experts wanting to prepare for a quality function or for a QMS project management function in the T medical device industryLEARNING OBJECTIVES o understand the implementation of a Quality Management System in accordance with ISO 13485 T o gain a comprehensive understanding of the concepts, approaches, standards, methods and techniques T required for the effective management of a Quality Management System o understand the relationship between the components of a Quality Management System and the compliance T with customer and regulatory requirements o acquire necessary expertise to support an organization in implementing, managing and maintaining a QMS as T specified in ISO 13485 o acquire necessary expertise to manage a team implementing an ISO 13485 T o develop knowledge and skills required to advise organization on best practices in the management of quality T o improve the capacity for analysis and decision making in the context of quality management T o prepare an organization for an ISO 13485 audit TPECBwww.pecb.orgCertified ISO 13485 Lead Implementer 3. EXAMINATION he Certified ISO 13485 Lead Implementer exam fully meets the requirements of the PECB Examination and T Certification Program (ECP). The exam covers the following competence domains: DOMAIN 1: FUNDAMENTAL PRINCIPLES AND CONCEPTS IN MEDICAL DEVICES QUALITY MANAGEMENT1Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can understand, interpret and illustrate the main Medical Devices Quality Management concepts related to a Medical Devices Quality Management System (MDQMS) DOMAIN 2: MEDICAL DEVICES QUALITY MANAGEMENT BEST PRACTICES BASED ON ISO 134852Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can understand, interpret and provide guidance on how to implement and manage Medical Devices Quality Management requirements based on best practices of ISO 134853DOMAIN 3: PLANNING A MDQMS BASED ON ISO 134854DOMAIN 4: IMPLEMENTING A MDQMS BASED ON ISO 13485567Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can plan the implementation of a MDQMS in preparation for an ISO 13485 certificationMain Objective: To ensure that the ISO 13485 Lead Implementer candidate can implement the processes of a MDQMS required for an ISO 13485 certification DOMAIN 5: PERFORMANCE EVALUATION, MONITORING AND MEASUREMENT OF A MDQMS BASED ON ISO 13485 Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can evaluate, monitor and measure the performance of a MDQMS in the context of an ISO 13485 certification DOMAIN 6: CONTINUAL IMPROVEMENT OF A MDQMS BASED ON ISO 13485 Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can provide guidance on the continual improvement of a MDQMS in the context of ISO 13485 DOMAIN 7: PREPARATION FOR A MDQMS CERTIFICATION AUDIT Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can prepare and assist an organization for the certification of a MDQMS against the ISO 13485 standard The Certified ISO 13485 Lead Implementer exam is available in different languages, including English, French, Spanish and Portuguese Duration: 3 hours For more information about the exam, please visit: www.pecb.orgwww.pecb.org 4. CERTIFICATION After successfully completing the exam, participants can apply for the credentials of Certified ISO 13485 Provisional Implementer, Certified ISO 13485 Implementer or Certified ISO 13485 Lead Implementer, depending on their level of experience A certificate will be issued to participants who successfully passed the exam and comply with all the other requirements related to the selected credential: CredentialExamProfessional ExperienceQMSMD Audit ExperienceQMSMD Project ExperienceOther RequirementsISO 13485 Provisional ImplementerISO 13485 Lead Implementer ExamNoneNoneNoneSigning the PECB code of ethicsISO 13485 ImplementerISO 13485 Lead Implementer ExamTwo years One year of Medical Devices Management work experienceNoneProject activities totaling 200 hoursSigning the PECB code of ethicsISO 13485 Lead ImplementerISO 13485 Lead Implementer ExamFive years Two years of Medical Devices Management work experienceNoneProject activities totaling 300 hoursSigning the PECB code of ethicsGENERAL INFORMATION C ertification fees are included in the exam price P articipant 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.orgwww.pecb.orgPECBCertified ISO 13485 Lead Implementer