ISO 13485 Lead Implementer - Two Page Brochure

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MASTERING THE IMPLEMENTATION AND MANAGEMENT OF A QUALITY MANAGEMENT SYSTEM (QMS) BASED ON ISO 13485

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ISO 13485 Lead Implementer - Two Page Brochure

  1. 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 Management processes based on requirements from of the 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 guidance’s (Medical devices – Quality Management Systems – Guidance on the application of ISO 13485). WHO SHOULD ATTEND? ▶▶ Project managers or consultants wanting to prepare and to support an organization in the implementation of a Quality Management System (QMS) ▶▶ Quality executives ▶▶ SO 13485 auditors who wish to fully understand the Quality Management System implementation process I ▶▶ ndividuals responsible for the quality or conformity in an organization I ▶▶ embers of a quality team M ▶▶ xpert advisors in Quality Management Systems E ▶▶ Regulatory affairs managers ▶▶ Technical experts wanting to prepare for a quality function or for a QMS project management function in the medical device industry COURSE AGENDA DURATION: 5 DAYS DAY 1 Introduction to Quality Management System (QMS) concepts as required by ISO 13485 and initiation of a QMS ▶▶ Introduction to management systems and the process approach ▶▶ Normative frameworks and methodologies related to Quality and Medical Devices ▶▶ Understanding the requirements of ISO 13485 ▶▶ Fundamental principles of Quality and Medical Devices ▶▶ Initiating the QMS implementation DAY 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 ▶▶ Operations management of a QMS DAY 5 DAY 2 Planning the implementation of a QMS based on ISO 13485 ▶▶ Writing a business case and a project plan for the implementation of a QMS ▶▶ efinition of the scope of the QMS D ▶▶ evelopment of a QMS policy D DAY 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 Preparing for an ISO 13485 certification audit Certification Exam ▶▶ PECB’s 3 Hour Certified ISO 13485 Lead Implementer 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. 2. EXAMINATION ▶▶ The “Certified ISO 13485 Lead Implementer” exam fully meets the requirements of the PECB Examination and Certification Program (ECP). The exam covers the following competence domains: »» omain 1: Fundamental principles and concepts of quality and medical devices D »» omain 2: Quality Management System best practice based on ISO 13485 D »» omain 3: Planning a QMS based on ISO 13485 D »» omain 4: Implementing a QMS based on ISO 13485 D »» omain 5: Performance evaluation, monitoring and measurement of a QMS based on ISO 13485 D »» omain 6: Maintaining the effectiveness of a QMS based on ISO 13485 D »» omain 7: Preparing for a QMS certification audit D ▶▶ or more information about the exam, please visit: www.pecb.org F CERTIFICATION ▶▶ After successfully completing the exam, the 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 pass the exam and comply with all the other requirements related to the selected credential: Credential Exam Professional Experience QMSMD Audit Experience QMSMD Project Experience Other Requirements ISO 13485 Provisional Implementer ISO 13485 Lead Implementer Exam None None None Signing the PECB code of ethics ISO 13485 Implementer ISO 13485 Lead Implementer Exam Two years One year of Medical Devices work experience None Project activities totaling 200 hours Signing the PECB code of ethics ISO 13485 Lead Implementer ISO 13485 Lead Implementer Exam Five years Two years of Medical Devices work experience None Project activities totaling 300 hours Signing the PECB code of ethics GENERAL 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 For additional information, please contact us at info@pecb.org www.pecb.org PECB Certified ISO 13485 Lead Implementer

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