ISO 13485 Lead Auditor ISO 13485 Lead Auditor Training Course The ISO 13485 Lead Auditor training equips you with essential skills to conduct audits of a Medical Devices Quality Management System (MDQMS) following recognized audit standards and practices. Why Attend? This training provides in-depth knowledge to plan and execute internal and external audits in compliance with ISO 19011 and ISO/IEC 17021-1. Through practical exercises, you’ll gain expertise in audit planning, conducting audit activities, managing an audit team, engaging in customer communications, and resolving conflicts effectively. By the end of the course, you’ll be prepared to sit for the certification exam and apply for a “PECB Certified ISO 13485 Lead Auditor” credential, demonstrating your competency in auditing MDQMS in alignment with industry best practices. Who Should Attend? Learning Objectives Educational Approach Prerequisites Participants should have a basic understanding of ISO 13485 and knowledge of audit principles. Course Agenda Examination The “PECB Certified ISO 13485 Lead Auditor” exam complies with the PECB Examination and Certification Program, covering: For exam formats, available languages, and other details, contact us . Certification Requirements Credential Exam Professional Experience MS Audit Experience Additional Requirements PECB Certified ISO 13485 Provisional Auditor Lead Auditor Exam None None Sign the PECB Code of Ethics PECB Certified ISO 13485 Auditor Lead Auditor Exam 2 years (1 in MDQMS) 200 hours Sign the PECB Code of Ethics PECB Certified ISO 13485 Lead Auditor Lead Auditor Exam 5 years (2 in MDQMS) 300 hours Sign the PECB Code of Ethics PECB Certified ISO 13485 Senior Lead Auditor Lead Auditor Exam 10 years (7 in MDQMS) 1,000 hours Sign the PECB Code of Ethics PECB Master Credential holders must complete four additional Foundation exams. contact us Certification Validity Requirements Audit activities should align with best practices, encompassing: General Information For more information, contact us .
ISO 13485 Lead Implementer Why should you attend? The ISO 13485 Lead Implementer training equips you with the essential skills to support an organization in establishing, implementing, managing, and maintaining a Medical Devices Quality Management System (MDQMS) based on the ISO 13485 standard. This course provides a comprehensive understanding of best practices for Medical Devices Quality Management, enabling you to enhance an organization’s performance by consistently delivering safe and high-quality medical devices. After mastering the core concepts of Medical Devices Quality Management Systems, you’ll be prepared to take the certification exam and earn the “PECB Certified ISO 13485 Lead Implementer” credential. With this certification, you’ll demonstrate your ability to implement ISO 13485 in an organization, showcasing your practical knowledge and professional capabilities in medical device quality management. Who should attend? Learning objectives Educational approach Prerequisites Course Agenda Examination The “PECB Certified ISO 13485 Lead Implementer” exam aligns with the PECB Examination and Certification Programme. It assesses skills across seven competency domains: For detailed information on exam formats, available languages, and additional specifics, please contact us . Certification Requirements To qualify for PECB Implementer Certifications, candidates must meet the following criteria: Credential Exam Professional Experience MDQMS Project Experience Other Requirements PECB Certified ISO 13485 Provisional Implementer Pass the PECB ISO 13485 Lead Implementer Exam or equivalent None None Sign the PECB Code of Ethics PECB Certified ISO 13485 Implementer Pass the PECB ISO 13485 Lead Implementer Exam or equivalent 2 years (1 year in Medical Devices Quality Management) 200 hours Sign the PECB Code of Ethics PECB Certified ISO 13485 Lead Implementer Pass the PECB ISO 13485Lead Implementer Exam or equivalent 5 years (2 years in Medical Devices Quality Management) 300 hours Sign the PECB Code of Ethics PECB Certified ISO 13485 Senior Lead Implementer Pass the PECB ISO 13485Lead Implementer Exam or equivalent 10 years (7 years in Medical Devices Quality Management) 1,000 hours Sign the PECB Code of Ethics Note: Individuals with both Lead Implementer and Lead Auditor credentials are eligible for the PECB Master Credential if they complete four additional Foundation Exams relevant to this scheme. For more details, contact us Implementation Activities To be valid, the implementation activities should include: General Information Achieving the ISO13485 Lead Implementer certification proves your expertise in implementing and managing an effective MDQMS, positioning you to improve medical device quality and safety.
Why should you attend? The ISO 13485 Foundation training provides an introduction to implementing and managing a Medical Devices Quality Management System (MDQMS) based on the ISO 13485 standard. During this course, you’ll gain a foundational understanding of MDQMS principles, including policy development, procedural guidelines, performance measurement, management commitment, internal auditing, management reviews, and continuous improvement. Upon completing this course, you can take the certification exam to become a “PECB Certificate Holder in ISO 13485 Foundation.” This credential demonstrates your grasp of the essential methodologies, requirements, framework, and approach for managing medical device quality effectively. Who should attend? Learning objectives Educational approach Prerequisites Course Agenda Examination The ISO 13485 Foundation Exam meets the standards of the PECB Examination and Certification Programme. It covers two key domains: For details on exam format, language options, and other specifics, please contact us . Certification Requirements To attain the ISO 13485 Foundation certification, candidates must fulfill the following criteria: Designation Exam Professional Experience MDQMS Audit/Assessment Experience MDQMS Project Experience Other Requirements PECB Certificate Holder in ISO 13485 Foundation Pass the PECB ISO 13485 Foundation Exam None None None Signing the PECB Code of Ethics Additional Information This certification confirms your knowledge of MDQMS essentials and enables you to support the delivery of safe, high-quality medical devices.
