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  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

  This training course aims to equip you with in-depth knowledge on ISO 9001 requirements, as well as the best practices and approaches used for the implementation and subsequent maintenance of a QMS. By attending this training course, you can help organizations utilize a structured and evidence-based approach for managing the quality of their products and services. Apart from this, you will also learn about the importance of customer focus and benefits of setting the foundations of an organizational culture which enables and supports quality. The training course is followed by a certification exam. If you pass, you can gain the "Certified ISO 9001 Lead Implementer' credential. This certificate validates your competence to implement a QMS based on the requirements of ISO 9001. About This Course   Learning objectives   By the end of this training course, the participant will be able to: Explain the fundamental concepts and principles of a quality management system (QMS) based on ISO 9001 Interpret the requirements of ISO 9001 for a QMS from the perspective of an implementer Initiate and plan the implementation of a QMS based on ISO 9001, by utilizing best practice Support an organization in operating, maintaining, and continually improving a QMS based on ISO 9001 Prepare an organization to undergo a third-party certification audit   Educational approach   This training course is learner-centred and contains: Theories, approaches, and best practices used in management system implementation, operation, maintenance, and continual improvement Theoretical basis supported by practical examples, throughout the four days of the training course Interaction between the trainers and participants by means of questions and discussions Essay-type homework exercises at the end of each day Quizzes with stand-alone items (after each section) and scenario-based quizzes (at the end of each day), intended to prepare the participants for the certification exam Accreditation   Assessment   The exam covers the following competency domains: Domain 1: Fundamental principles and concepts of a quality management system Domain 2: Initiation of a QMS implementation Domain 3: Planning of a QMS implementation based on ISO 9001 Domain 4: Implementation of a QMS based on ISO 9001 Domain 5: Monitoring and measurement of a QMS based on ISO 9001 Domain 6: Continual improvement of a QMS based on ISO 9001 Domain 7: Preparation for a QMS certification audit   The exam itself is a 12 question, essay type format, to be completed within a 150 minute window. The exam pass mark is 70%. Exam results are provided within 24 hours. Our Guarantee   We are an official IECB Training Provider If you fail an exam, you can try again for free If you feel you need additional training, you can train for free too Prerequisites   The main requirements for participating in this training course are a basic knowledge of ISO management system standards, overall knowledge of ISO 9001, and the MS implementation principles. An understanding of ISO's quality management principles may also facilitate the learning process. What's Included?   Official Study Guides 4 day's Instructor led training Exam fees Who Should Attend?   The ISO 9001 Lead Implementer training course is intended for: Personnel responsible for maintaining and improving the quality of the products and services of the organization Personnel responsible for meeting customer requirements Consultants, advisors, professionals wishing to obtain in-depth knowledge of ISO 9001 requirements for a QMS Professionals wishing to acquaint themselves with best practice methodology for implementing a QMS Individuals responsible for maintaining the conformity of QMS to ISO 9001 requirements Members of QMS implementation and operation teams Individuals aspiring to pursue a career in quality management Provided by   This course is Accredited by NACSand Administered by the IECB.

Most of our students come to us specifically to improve their speaking and listening skills and we help them to do this by using the Callan Method (see below for further details). BSGS is an accredited Callan Method school. We provide experienced and friendly teachers. Moreover, our prices are very competitive!

Most of our students come to us specifically to improve their speaking and listening skills and we help them to do this by using the Callan Method (see below for further details). BSGS is an accredited Callan Method school. We provide experienced and friendly teachers. Moreover, our prices are very competitive!

Understand the principles of the “Visual Factory”, basic “Visual Management Systems” and how to apply it to your working environment This workshop introduces the tools and practices of Visual Management as one of the basic components of a Lean Management System. It shows how it can be used effectively to support standardization and problem solving across all functions, allowing the detection of product and process abnormalities in your value stream in real time. It also serves as a communication tool by visually defining for people what "good" is, what the "standard" is, and whether it is being maintained. It allows a proactive approach to data gathering, leading to rapid data analysis, and aids decision making that results in corrective actions being taken in a cost effective way. To achieve this, the workshop looks at how to identify critical product and process information, how to record and display it, who needs to see it, and how does it lead to action that resolves a problem or a non-conformance when it occurs. The workshop also details the principles used in designing and implementation a "Visual Management System" in order to migrate your organization from one of gathering and analysing data, and reacting to abnormalities, to one of seeing waste, managing exceptions, and improving processes in real time.

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This 3-day FAA Level 3 Award course offers a variety of first aid situations and teaches how to respond to an emergency. It gives delegates the confidence to deal with any of these situations safely and efficiently.