155 ISO 13485 courses

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

  During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices. After mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and gain the "Certified ISO 13485 Lead Implementer' Certificate. By holding this Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization.  ABOUT THIS COURSE   Learning Objectives * Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks  * Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS * Learn how to interpret the ISO 13485 requirements in the specific context of an organization * Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS * Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices   Course Agenda * Day 1: Introduction to ISO 13485 and initiation of a MDQMS * Day 2: Plan the implementation of a MDQMS * Day 3: Implementation of a MDQMS * Day 4: MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit, and the final exam. ASSESSMENT     Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final 12 question, essay type exam on Day 4 of the course. The overall passing score is 70%, to be achieved within the 150 minute time allowance. Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success. PREREQUISITES   A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles. WHAT'S INCLUDED?   * Certification fees are included on the exam price * Training material containing over 450 pages of information and practical examples will be distributed * An attestation of course completion worth 32 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course. * In case of exam failure, you can retake the exam within 12 months for free WHO SHOULD ATTEND?   * Managers or consultants involved in Medical Devices Quality Management * Expert advisors seeking to master the implementation of a Medical Devices Quality Management System * Individuals responsible for maintaining conformance with MDQMS requirements * MDQMS team members ACCREDITATION PROVIDED BY   This course is Accredited by NACS [http://www.nacs.ee] and Administered by the IECB [https://www.iecb.org]

  During this training course, delegates will acquire the knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and ISO/IEC 17021-1 certification process. Based on practical exercises, you will learn audit techniques and become competent to manage an audit program, audit team, communication with customers, and understand reporting requirements. After acquiring the necessary expertise to perform this audit, you can sit for the exam and gain the "Certified ISO 13485 Lead Auditor' Certificate. By holding this Certificate, delegates can demonstrate that they have the competencies to audit organizations based on best practices. ABOUT THIS COURSE   Learning Outcomes   * Review a Medical Devices Quality Management System based on ISO 13485 * Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks * Understand an auditor's role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011 * Learn how to lead an audit and audit team * Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit * Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011   Course Agenda   * Day 1: Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485 * Day 2: Audit principles, preparation and launching of an audit * Day 3: On-site audit activities  * Day 4: Closing the audit and final exam.   ASSESSMENT     Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final essay style exam, consisting of 12 questions, on Day 4 of the course. The overall passing score is 70%, to be achieved within the 150 minute time allowance. Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success.   PREREQUISITES   An understanding of ISO 13485 requirements and knowledge of audit principles. WHAT'S INCLUDED?   * Certification fees are included on the exam price * Training material containing over 500 pages of information and practical examples will be distributed * An attestation of course completion worth 32 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course. WHO SHOULD ATTEND?   * Auditors seeking to perform Medical Devices Quality Management System (MDQMS) certification audits  * Managers or consultants seeking to understand the Medical Devices Quality Management System audit requirements * Individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements ACCREDITATION PROVIDED BY   This course is Accredited by NACS [http://www.nacs.ee] and Administered by the IECB [https://www.iecb.org]

  ISO 13485 Foundation training enables you to learn the basic elements to implement and manage a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. During this training course, you will be able to understand the different modules of a MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement. After completing this course, you can sit for the exam and gain "Certified ISO 13485 Foundation' Certification. This Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach.  ABOUT THIS COURSE   Learning Objectives * Understand the elements and operations of a Medical Devices Quality Management System (MDQMS) * Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks * Understand the approaches, methods and techniques used for the implementation and  management of a MDQMS   Course Agenda * Day 1: Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485 * Day 2: Medical Devices Quality Management System requirements and Certification Exam     ASSESSMENT     Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final 40 question, multiple choice exam on Day 2 of the course. The overall passing score is 70%, to be achieved within the 60 minute time allowance. Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success.   PREREQUISITES   None WHAT'S INCLUDED?   * Certification fees are included on the exam price * Training material containing over 200 pages of information and practical examples will be distributed * An attestation of course completion worth 14 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course. WHO SHOULD ATTEND?   * Individuals involved in Medical Devices Quality Management * Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS) * Individuals interested to pursue a career in Medical Devices Quality Management ACCREDITATION PROVIDED BY   This course is Accredited by NACS [http://www.nacs.ee] and Administered by the IECB [https://www.iecb.org]

The “ISO 20387 Lead Assessor Course” is a comprehensive program designed to equip individuals with the knowledge and skills needed to assess and evaluate biobanking systems in accordance with ISO 20387:2018. This course focuses on the principles of assessment, audit methodologies, and the specific requirements of ISO 20387. Participants will learn how to lead and conduct assessments of biobanking facilities and organizations to ensure compliance with the standard.

The “ISO 22301:2019 Lead Implementer ” course provides comprehensive training in the ISO 22301:2019 standard and all its requirements from the Implementer ’s point of view, as well as basic skills necessary to execute the requirements. It’s a practical-oriented training that should be considered “a must” for every ISO 22301:2019 Implementer. This intensive course is specifically designed to participants to serve as ISO 22301:2019 Lead Implementers. The interactive training program, complete with quizzes, will provide the necessary technical knowledge and understanding of all ISO 22301:2019 requirements to implement the requirement of the standard.

Become a Certified OHSMS Lead Auditor (IRCA CQI Approved) Welcome to our online event where you can become a expertise to become a certified OHSMS (ISO 45001:2018) Lead Auditor.  Elevate your career with the skills to lead successful quality management system audits. This intensive 5-day course is for serious professionals seeking to: * Plan and lead effective audit teams * Conduct complex supplier and external audits * Deliver accurate, valuable audit reports * Drive continual improvement in organizations Join us for a comprehensive training session that will equip you with the necessary skills to audit quality management systems effectively. Learn from industry experts and gain valuable insights into ISO 9001 standards. Don't miss this opportunity to enhance your auditing capabilities and advance your career in quality management. Register now! Enroll Today and Take Your Career to the Next Level!

The “ISO 17025:2018 Lead Assessor” course provides comprehensive training in Learn how to audit each and every ISO 17025: 2018 and ISO 17011 requirements Learn basic auditing skills; Implement methods to comply with the ISO 17025:2018 requirements. Auditing process and techniques

The “ISO 20000: 2018 Lead Auditor” course provides comprehensive training in the ISO 20000: 2018 standard and all its requirements from the Lead auditor’s point of view, as well as basic skills necessary to Lead audit activities. It’s a practical-oriented training that should be considered “a must” for every ISO 20000: 2018 Lead auditor. The interactive training program, complete with quizzes, will provide the necessary technical knowledge and understanding of all ISO 20000: 2018 requirements to implement the requirement of the standard and complete ISO 20000: 2018 audit . This ISO Lead auditor training should be taken by individual with interest in conducting internal as well as third part audits according ISO 20000: 2018 standards.

The “ISO 27001:2022 Lead Implementer ” course provides comprehensive training in the ISO 27001:2022 standard and all its requirements from the Implementer ’s point of view, as well as basic skills necessary to execute the requirements. It’s a practical-oriented training that should be considered “a must” for every ISO 27001:2022 Implementer. This intensive course is specifically designed to participants to serve as ISO 27001:2022 Lead Implementers.