162 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 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 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.

The “ISO 27001: 2013 Lead Auditor” course provides comprehensive training in the ISO 27001: 2013 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 27001: 2013 Lead auditor.

  During this training course, you will be able to understand the different modules of ISMS, including ISMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement.   About This Course After attending this course, delegates will; Understand the basic concepts of Information Security Management Acknowledge the correlation between ISO/IEC 27001 and other standards and regulatory frameworks Understand the process approaches used to effectively manage Information Security 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 150 minute time allowance. Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success.   Our Guarantee   We are an Accredited Training Provider of IECB. You can learn wherever and whenever you want with our robust classroom and interactive online training courses. Our courses are taught by qualified practitioners with a minimum of 25 years commercial experience. We strive to give our delegates the hands-on experience. Our courses are all-inclusive with no hidden extras.  The one-off cost covers the training, all course materials, and exam voucher. Our aim: To achieve a 100% first time pass rate on all our instructor-led courses. Our Promise: Pass first time or 'train' again for FREE. *FREE training offered for retakes - come back within a year and only pay for the exam. Accreditation Prerequisites   Basic knowledge on Information Security Management is preferred. What's Included?   Delegates will be provided with; Course Slide deck Participant Guide Exam fees Who Should Attend?   Individuals interested in Information Security Management process approaches Individuals seeking to gain knowledge about the main principles and concepts of Information Security Management Individuals interested to pursue a career in Information Security Management Provided by   This course is Accredited by NACS and Administered by theIECB

  ISO 45001 is the first global Occupational Health and Safety Management System standard that replaces OHSAS 18001. The ISO 45001 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining an Occupational Health and Safety Management System (OH&S MS) based on ISO 45001. About This Course   During this training course, you will also gain a thorough understanding of the best practices of an OH&S MS and be able to apply them to continually improve the organization's OH&S performance and ensure the well-being of employees by providing a safe and healthy workplace.   After mastering all the necessary concepts of Occupational Health and Safety Management Systems, you can sit for the exam and gain the "Certified ISO 45001 Lead Implementer' credential. By holding this Certificate, you will be able to demonstrate that you have the practical skills and professional knowledge to implement ISO 45001 in an organization.   Learning objectives   Acknowledge the correlation between ISO 45001 and other standards and regulatory frameworks Master the concepts, approaches, methods and techniques used for the implementation and effective management of an OH&S management system Learn how to interpret the ISO 45001 requirements in the specific context of an organization Learn how to support an organization to effectively plan, implement, manage, monitor and maintain an OH&S management system Acquire the expertise to advise an organization in implementing OH&S management system best practices   Educational approach   This training is based on both theory and best practices used in the implementation of an OH&S MS Lecture sessions are illustrated with questions and examples that help translate theory into practice Practical exercises include examples and discussions Practice tests are similar to the Certification Exam Prerequisites   A foundational understanding of ISO 45001 and knowledge of implementation principles. Who Should Attend?   Managers or consultants involved and concerned with Occupational Health and Safety Management Expert advisors seeking to master the implementation of an Occupational Health and Safety Management System Individuals responsible for maintaining conformance with OH&S MS requirements OH&S MS team members What's Included?   Refreshments & Lunch * Course Slide Deck Official Study Guides Official Exam Q&A The Exam   * Classroom courses only   Accreditation Assessment   Course delegates will sit a combination of in-course quizzes and exercises, as well as a final 12 question, essay type exam on Day 4 of the course. Overall pass mark is 70%, to be completed within the 150 minute time window. Provided by   This course is Accredited by NACS and Administered by the IECB.