18 Educators providing 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 and Administered by the IECB

  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 and Administered by the IECB

  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 and Administered by the IECB

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.

The “ISO 14298:2021 Lead Implementer Course” is designed to provide participants with the knowledge and skills necessary to lead the implementation of a Security Printing Management System based on ISO 14298:2021. This comprehensive course covers the key principles, requirements, and best practices for establishing and maintaining an effective security printing management system. Participants will learn how to develop, implement, and manage processes that comply with the ISO 14298 standard.

The “ISO 42001:2023 Lead Auditor Course” integrates the principles of ISO 42001:2023, the International Standard for Artificial Intelligence Management, with the methodologies outlined in ISO 19011:2018, the Guidelines for Auditing Management Systems. The course equips participants with the skills and knowledge required to lead Artificial Intelligence audits effectively, ensuring compliance with ISO 42001:2023, and applies the principles of ISO 17011:2017 for conformity assessment bodies.

The NCSP® ISO 27001 Specialist accredited (APMG International), certified (NCSC/GCHQ-UK), and recognized (DHS-CISA-USA) certification course teaches Digital Business, Operational Stakeholders, Auditors, and Risk Practitioners a Fast-Track approach to adopting and adapting the ISO 27001 controls in the context of a NIST Cybersecurity Framework program.This course looks at the impact of adapting a principled approach to an enterprise risk management framework to better support cybersecurity decisions within the context of the selected informative reference. It guides participants on the best approach to adapt, implement, and operate (AIO) a comprehensive cybersecurity program that integrates into existing organizational capabilities and incorporates the selected Informative Reference. NCSP® ISO 27001 Specialist introduces the integration of typical enterprise capabilities with cybersecurity from the perspective of the selected cybersecurity informative reference. The overall approach places these activities into systems thinking context by introducing the Service Value Management System composed of three aspects, governance, assurance, and the Z-X Model. With this in place, the course presents the approach to adapt, implement, operate, and improve the organizational cybersecurity posture that builds on the application of the FastTrack™ presented in the NCSP Practitioner. The NIST Cybersecurity Professional (NCSP®) program is the industry's first accredited certification training program that teaches organizations how to build a Digital Value Management Overlay System capable of leveraging the NIST Cybersecurity Framework to deliver the secure, digital business outcomes expected by executives, government regulators, and legal advisors.

  In this training course, you will be acquainted with the various aspects of a QMS based on ISO 9001, such as the role of top management, risks and opportunities, quality policy, processes that shape product and service provision activities, requirements for performance evaluation, and the importance of continual improvement. After completing this course, you can sit for the exam and gain the "Certified ISO 9001 Foundation" credential. In holding this credential, you demonstrate that you have a general knowledge of ISO 9001 requirements for a QMS and enables you to be part of QMS implementation projects. About This Course   Learning objectives   Upon successful completion of this training course, the participants will be able to: Describe the quality management concepts, principles, and definitions Explain the main ISO 9001 requirements for a quality management system Identify potential actions and approaches that organizations can use to achieve conformity to ISO 9001   Educational approach   The training course is participant centered and contains: Lecture sessions are illustrated with graphics, examples, and discussions  Interactions between participants by means of questions and suggestions Quizzes with similar structure to the exam Accreditation Prerequisites   There are no prerequisites to participate in this training course.   What's Included?   Certificate and examination fees are included in the price of the training course. Over 200 pages of instructional materials containing explanations, guidance, and practical examples. An attestation of course completion worth 14 CPD (Continuing Professional Development) credits will be issued. In case of exam failure, you can retake the exam within 12 months for free. Who Should Attend?   The ISO 9001 Foundations training course is intended for: Managers and consultants seeking knowledge about the basic concepts of quality management Professionals wishing to get acquainted with ISO 9001 requirements for a QMS Personnel responsible for maintaining and improving the quality of products and services of their organization Individuals wishing to pursue a career in quality management Assessment     Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final 40 question, multiple choice type 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.   Provided by   This course is Accredited by NACS and Administered by the IECB

  In this training course, you will learn about the various aspects of a CMS, including the compliance policy, compliance culture, compliance risk assessment, operational controls, performance measurements, leadership and commitment, internal audit, management review, and continual improvement. After completing the training course, you can sit for the exam. If you successfully pass the exam, you can gain the 'Certified ISO 37301 Foundation' credential. By gaining this Credential, you can demonstrate that you have the necessary professional capabilities to be part of an ISO 37301 CMS implementation project About This Course   By participating in this training course, you will: Understand the basic compliance management concepts, definitions, and approaches Get acquainted with the ISO 37301 requirements for a compliance management system Develop a general understanding of how an organization can meet the requirements of ISO 37301   Course Agenda   Day 1: Introduction to compliance concepts, CMS, and clauses 4-6 of ISO 37301 Day 2: Clauses 7-10 of ISO 37301 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 type 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.   What's Included?   Certification fees are included in the exam price. Training material containing over 200 pages of information and practical examples will be given to each participant. An attestation of course completion worth 14 CPD (Continuing Professional Development) credits will be issued to participants who have attended the training course. In case participant(s) fail to pass the exam, they can retake the exam once for free within 12 months of the initial exam date. Prerequisites   There are no prerequisites to participate in this training course. Accreditation Provided by   This course is Accredited by NACS and Administered by the IECB.