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.
The ISO 9001 Lead Auditor training enables you to develop the necessary expertise to perform a Quality Management System (QMS) audit by applying widely recognized audit principles, procedures and techniques. About This Course During this training course, you will acquire the knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and the certification process according to ISO/IEC 17021-1. Based on practical exercises, you will be able to master the audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution. After acquiring the necessary expertise to perform this audit, you can sit for the exam and gain "Certified ISO 9001 Lead Auditor' credential. By holding this Certificate,, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices. Learning objectives Understand the operations of a Quality Management System (QMS) based on ISO 9001 Acknowledge the correlation between ISO 9001 and other standards and regulatory frameworks Understand the 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 9001 in the context of a QMS 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 Educational approach This training is based on both theory and best practices used in QMS audits Lecture sessions are illustrated with practical questions and examples Practical exercises include examples and case study discussions Practice tests are similar to the Certification Exam Prerequisites A fundamental understanding of ISO 9001 and comprehensive knowledge of audit principles. What's Included? Refreshments & Lunch (Classroom only) Course Slide Deck Official Study Guides The Exam Who Should Attend? Auditors seeking to perform and lead Quality Management System (QMS) certification audits Managers or consultants seeking to master a Quality Management System audit process Individuals responsible for maintaining conformance with QMS requirements Technical experts seeking to prepare for a Quality Management System audit Expert advisors in Quality Management Accreditation Our Guarantee We are an approved IECB Training Partner. 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 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 and exam retake offered 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. Provided by This course is Accredited by NACS and Administered by theIECB
The “ISO 9001:2015 Lead Auditor” course provides comprehensive training in the ISO 9001:2015 standard and all its requirements from the auditor’s point of view, as well as basic skills necessary to complete an internal audit. It’s a practical-oriented training that should be considered “a must” for every ISO 9001 auditor. This intensive course is specifically designed to train corporate staff to serve as internal ISO 9001 auditors (as required by ISO 9001:2015 ). The interactive training program, complete with quizzes, will provide the necessary technical knowledge and understanding of all ISO 9001:2015 requirements to perform a complete ISO 9001 audit.
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.
ISO 45001 is the first global Occupational Health and Safety Management System standard that replaces OHSAS 18001. The ISO 45001 Lead Auditor training enables you to develop the necessary expertise to perform an Occupational Health and Safety Management System (OH&S MS) audit by applying widely recognized audit principles, procedures and techniques. About This Course During this training course, you 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 be able to master the audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution. After acquiring the necessary expertise to perform this audit, you can sit for the exam and gain the 'IECB Certified ISO 45001 Lead Auditor' credential. By holding an IECB Certificate, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices. Learning objectives Understand the operations of an Occupational Health and Safety Management System (OH&S MS) based on ISO 45001 Acknowledge the correlation between ISO 45001 and other standards and regulatory frameworks Understand the auditor's role in planning, leading and following-up on a management system audit in accordance with ISO 19011 Learn how to interpret the requirements of ISO 45001 in the context of an OH&S MS audit Educational approach This training is based on both theory and best practices used in OH&S MS audits Lecture sessions are illustrated with practical questions and examples Practical exercises include examples and case study discussions Practice tests are similar to the Certification Exam Prerequisites A foundational understanding of ISO 45001 and knowledge of audit principles. What's Included? Refreshments & Lunch* Course Slide Deck Official Study Guides Official Exam Q&A The Exam * Classroom based courses only Who Should Attend? Auditors seeking to perform and lead Occupational Health and Safety Management System (OH&S MS) certification audits Managers or consultants seeking to master an Occupational Health and Safety Management System audit process Individuals responsible for maintaining conformance with OH&S MS requirements Technical experts seeking to prepare for an Occupational Health and Safety Management System audit Expert advisors in Occupational Health and Safety Management Accreditation 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. Provided by This course is Accredited by NACS and Administered by the IECB.
Delivered in either Live Online (4 days) or in our Classroom (5 days), the ISO/IEC 27001 Lead Auditor training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining an Information Security Management System (ISMS) based on ISO 27001. During this training course, you 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. About This Course Based on practical exercises, you will be able to master audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution. After acquiring the necessary expertise to perform this audit, you can sit for the exam and gain the "ISO/IEC 27001 Lead Auditor' credential. By holding this Lead Auditor Certificate, you will demonstrate that you have the capabilities and competencies to` audit organizations based on best practices. The training course is based on both theory and best practices used in ISMS audits Lecture sessions are illustrated with examples based on case studies Practical exercises are based on a case study which includes role playing and discussions Practice tests are similar to the Certification Exam The course is delivered both as a Live Online or Classroom environment, as follows; Day 1: Introduction to Information Security Management Systems (ISMS) and ISO/IEC 27001 Day 2: Audit principles, preparation and launching of an audit Day 3: On-site audit activities Day 4: Closing the audit and Examination Learning Objectives Understand the operations of an Information Security Management System based on ISO/IEC 27001 Acknowledge the correlation between ISO/IEC 27001, ISO/IEC 27002 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/IEC 27001 in the context of an ISMS 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 The exam covers the following competency domains: Domain 1: Fundamental principles and concepts of an Information Security Management System (ISMS) Domain 2: Information Security Management System controls and best practices based on ISO/IEC 27002 Domain 3: Planning an ISMS implementation based on ISO/IEC 27001 Domain 4: Implementing an ISMS based on ISO/IEC 27001 Domain 5: Performance evaluation, monitoring and measurement of an ISMS based on ISO/IEC 27001 Domain 6: Continual improvement of an ISMS based on ISO/IEC 27001 Domain 7: Preparing for an ISMS certification audit Prerequisites A foundational understanding of ISO/IEC 27001 and knowledge of audit principles. What's Included? Refreshments & Lunch (Classroom only) Course Slide Deck Official Study Materials CPD Certificate The Exam Who Should Attend? Auditors seeking to perform and lead Information Security Management System (ISMS) certification audits Managers or consultants seeking to master an Information Security Management System audit process Individuals responsible for maintaining conformance with Information Security Management System requirements Technical experts seeking to prepare for an Information Security Management System audit Expert advisors in Information Security Management Our Guarantee We are an approved IECB Training Partner for all of our courses. 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 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 and exam retake offered Accreditation 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 240 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
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 14001 Lead Auditor training enables you to develop the necessary expertise to perform an Environmental Management System (EMS) audit by applying widely recognized audit principles, procedures and techniques. About This Course During this training course, you 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 be able to master audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution. After acquiring the necessary expertise to perform this audit, you can sit for the exam and gain "Certified ISO 14001 Lead Auditor' Certificate. By holding this Certificate, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices. Learning objectives Understand the operations of an Environmental Management System (EMS) based on ISO 14001 Acknowledge the correlation between ISO 14001, ISO 14040 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 14001 in the context of an EMS 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 Educational approach This training is based on both theory and best practices used in EMS audits Lecture sessions are illustrated with examples based on case studies Practical exercises are based on a case study which includes role playing and discussions Practice tests are similar to the Certification Exam Prerequisites A fundamental understanding of ISO 14001 and comprehensive knowledge of audit principles. Who Should Attend? Auditors seeking to perform and lead Environmental Management System (EMS) certification audits Managers or consultants seeking to master an Environmental Management System audit process Individuals responsible for maintaining conformance with EMS requirements Technical experts seeking to prepare for an Environmental Management System audit Expert advisors in Environmental Management What's Included? Refreshments & Lunch (Classroom courses only) Course Slide Deck Official Study Guides CPD Certificate The Exam Accreditation 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. Provided by This course is Accredited by NACS and Administered by the IECB
ISO 22301 Lead Auditor training enables you to develop the necessary expertise to perform a Business Continuity Management System (BCMS) audit by applying widely recognized audit principles, procedures and techniques. About This Course During this training course, you 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 be able to master audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution. After attending this 4 day course, candidates can sit for the exam with the aim of gaining the "ISO22301 Lead Auditor' credential. You will then be in a position to demonstrate that you have the capabilities and competencies to audit organizations based on best practices. Learning objectives Understand the operations of a Business Continuity Management System based on ISO 22301 Acknowledge the correlation between ISO 22301 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 22301 in the context of a BCMS 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 Educational approach This training is based on both theory and best practices used in BCMS audits Lecture sessions are illustrated with examples based on case studies Practical exercises are based on a case study which includes role playing and discussions Practice tests are similar to the Certification Exam Prerequisites A foundational understanding of ISO 22301 and knowledge of audit principles. What's Included? Refreshments & Lunch (Classroom courses only) Course Slide Deck Official Study Materials CPD Certificate The Exam fees Who Should Attend? Auditors seeking to perform and lead Business Continuity Management System (BCMS) certification audits Managers or consultants seeking to master a Business Continuity Management System audit process Individuals responsible for maintaining conformance with Business Continuity Management System requirements Technical experts seeking to prepare for a Business Continuity Management System audit Expert advisors in Business Continuity Management Our Guarantee We are an approved IECB Training Partner. 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 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. Assessment The exam is a 12 question essay type exam completed in the afternoon of Day 4. The pass mark for the exam is 70%. Exam results are provided within 24 hours. Provided by This course is Accredited by NACSand administered by the IECB. Accreditation
Delivered in either our Live Online format (4 days) or in our Classroom (5 days), the ISO 37001 Lead Auditor training course enables you to develop the necessary expertise to perform an Anti-bribery Management System (ABMS) audit by applying widely recognized audit principles, procedures and techniques. About This Course During this training course, you 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 be able to master the audit techniques and become competent to manage an audit program and audit team. After acquiring the necessary expertise to perform this audit, you can sit for the exam and gain the "Certified ISO 37001 Lead Auditor' credential. By holding this Certificate, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices. Learning objectives Understand the operation of an Anti-bribery Management System based on ISO 37001 and its principal processes Understand the correlation between ISO 37001 and other standards and regulatory frameworks Understand the auditor's role in planning, leading and following-up on a management system audit in accordance with ISO 19011 Interpret the requirements of ISO 37001 in the context of an ABMS audit Strengthen the personal skills necessary for an auditor to act with due professional care during an audit Educational approach Lecture sessions are illustrated with practical questions and examples Practical exercises include examples and discussions Practice tests are similar to the certification exam Prerequisites A foundational understanding of ISO 37001 and knowledge of audit principles. What's Included? Refreshments & Lunch (Classroom only) Course Slide Deck Official Study Guides CPD Certificate The Exam Who Should Attend? Auditors seeking to perform and lead Anti-bribery Management System (ABMS) certification audits Managers or consultants seeking to master an Anti-bribery Management System audit process Individuals responsible for maintaining conformance with ISO 37001 requirements Technical experts seeking to prepare for an Anti-bribery Management System audit Expert advisors in Anti-bribery Management Accreditation Assessment The exam is delivered in a 12 question essay format, to be completed within 150 minutes and gaining a 70% pass mark. Exam results are provided within 24 hours. Provided by This course is Accredited by NACS and Administered by the IECB.