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  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

  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

  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.

This module aims to develop knowledge and practical skills in Import/Export Customs Diagnostic enabling the learner to create a procedural manual to complete international trade operations.

This programme will guide your team of up to 12 people toward delegating more effectively. The 3 part series of digital self-paced and instructor-led content explores how you can utilise practical frameworks to elevate productivity and performance. By identifying the styles of delegation that are commonly used, you will create an optimal strategy for successful delegation. During the facilitated live session there will be the opportunity to share best practice and discuss planned application to your role.

Duration 3 Days 18 CPD hours This course is intended for This course is intended for beginner to intermediate business and requirements analysts who are looking to improve their elicitation and requirements writing and documentation skills. This course is also a great fit for technical writers, product and software testers, project managers, product owners who work closely with business analysts or who perform some for of business analysis themselves. Overview Understand the role of the business analyst and core competencies for performing successfully Discuss the criticality of business analysis and requirements for successful project outcomes Understand the main professional associations and standards supporting business analysts in the industry Discuss the common problems with requirements and explore approaches to address these issues Obtain a clear understanding of the various requirements types and the significance for eliciting each type Demonstrate your ability to identify stakeholders Explore various methods for understanding and analyzing stakeholders Discuss and apply good planning practices to requirements elicitation efforts Obtain knowledge and understanding of over 15 current and commonly applied elicitation techniques Understand how to progress from elicitation to analysis to documentation Write well-formed and validated requirements Gain understanding of the best practices for writing quality requirements Learn the technical writing techniques that apply directly to writing requirements documents Discuss writing pitfalls, risks that impact requirements, and how to address them Learn best practices for communicating and collaborating with stakeholders, sharing the results of elicitation and the resulting documentation Learn approaches for validating requirements Understand the difference between validating requirements and validating the solution With elicitation serving as a major component of the requirements process, it is imperative that business analysts maintain high competency levels in elicitation practices and technique use to help organizations overcome the requirements related challenges faced on projects. Regardless whether you are a practitioner just starting off your career in business analysis or whether you have been performing the role for some years, this course will provide insight into the latest thoughts on elicitation and writing effective requirements and present a number of current techniques that are being applied on projects across industries today. Review of Foundational Concepts Definition of a business analysis Definition of business analyst BA role vs. PM role Business analysis competencies Benefits of business analysis Purpose for having a BA standard IIBA?s BABOK© Guide and PMI?s Practice Guide in Business Analysis Business analysis core concepts Discussion: Project challenges Understanding Requirements Common problems with requirements Understand the problem first Define the business need Situation statements and moving to requirements Understanding requirement types Business requirements Stakeholder/User Requirements Solution Requirements Functional Requirements Non-Functional Requirements Assumptions and Constraints Discussions: Requirement problems, business needs, and identifying non-functional requirements Discovering Stakeholders Definition of a stakeholder Stakeholder types Identifying stakeholders Performing stakeholder analysis Stakeholders and requirements Tips for identifying stakeholders Grouping stakeholders Creating a RACI model Tips for analyzing stakeholders Documenting results of stakeholder analysis Workshop: Discovering stakeholders Preparing for Requirements Elicitation Planning for elicitation Benefits of elicitation planning What do you plan? The elicitation plan Setting objectives for elicitation Determining the scope for elicitation Establishing pre-work Determining the outputs for the session The iterative nature of elicitation Elicitation roles Elicitation planning techniques Discussions: Who to involve in elicitation, planning impacts, and unplanned elicitation Workshop: Planning for elicitation Conduct Requirements Elicitation Elicitation skillset Types of elicitation techniques Using active listening in elicitation Techniques for performing elicitation Benchmarking/Market Analysis Brainstorming Business Rules Analysis Collaborative Games Concept Modeling Data Mining Data Modeling Document Analysis Focus Groups Interface Analysis Interviews Observation Process Modeling Prototyping Survey or Questionnaire Workshops Write Effective Requirements Elicitation and Analysis Requirements related issues Implications of bad requirements Elicitation and documentation Writing skillset Documenting requirements Modeling requirements Defining the project life cycle Impact of project life cycle on documentation Requirements specifications Characteristics of good requirements Guidelines for writing textual requirements Structuring a requirement Writing pitfalls Traceability Requirements attributes Risks associated to requirements Discussions: Project Life Cycle and Correcting Poorly Written Requirements Workshops: Documenting Requirements and Identify Characteristics of Good Requirements Confirm and Communicate Elicitation Requirements Business analysis communication Requirements communication Communication skills The 7 Cs Timing of communication Planning communication Importance of Collaboration Planning collaboration Documenting communication/collaboration needs Confirming elicitation results Verify requirements Characteristics of good requirements (revisited) Requirements checklist Requirements validation Signing off on requirements Discussions: Responsibility for Communication, Eliciting Communication Needs, Validation Signoff Workshops: Communicating Requirements and Obtaining Signoff Evaluate the Solution Business analyst role in solution evaluation Why solutions under perform What we are looking for in solution evaluation When does solution evaluation occur Performing solution evaluation Planning solution evaluation Metrics that might exist Evaluating long term performance Qualitative vs. quantitative measures Tools & techniques used in solution evaluation Comparing expected to actuals When solution evaluation discovers a variance Tools/techniques for analyzing variances Proposing a recommendation Communicating results of solution evaluation Discussion: Addressing Variance Wrap up and Next Steps Useful books and links on writing effective requirements BABOK© Guide Business Analysis for Practitioners: A Practice Guide Additional course details: Nexus Humans BA04 - Eliciting and Writing Effective Requirements training program is a workshop that presents an invigorating mix of sessions, lessons, and masterclasses meticulously crafted to propel your learning expedition forward. This immersive bootcamp-style experience boasts interactive lectures, hands-on labs, and collaborative hackathons, all strategically designed to fortify fundamental concepts. Guided by seasoned coaches, each session offers priceless insights and practical skills crucial for honing your expertise. Whether you're stepping into the realm of professional skills or a seasoned professional, this comprehensive course ensures you're equipped with the knowledge and prowess necessary for success. While we feel this is the best course for the BA04 - Eliciting and Writing Effective Requirements course and one of our Top 10 we encourage you to read the course outline to make sure it is the right content for you. Additionally, private sessions, closed classes or dedicated events are available both live online and at our training centres in Dublin and London, as well as at your offices anywhere in the UK, Ireland or across EMEA.

Duration 3 Days 18 CPD hours This course is intended for The primary audience for this course are Application Consultants, Business Analysts, Business Process Owners/Team Leads/Power Users, Solution Architects, and System Architects. Overview Describe the SAP BusinessObjects Business Intelligence tools.Learn about the use cases and get an overview of basic functions of the most important BusinessObjects reporting tools. In this course, students describe the SAP BusinessObjects Business Intelligence tools and learn about the use cases by getting an overview of basic functions of the most important BusinessObjects reporting tools. Overview of SAP BusinessObjects Business Intelligence (BI) 4.1 Describing SAP Analytics Solutions Identifying the Components of SAP BusinessObjects 4.1 Semantic Layer in SAP BusinessObjects BI 4.1 Describing Semantic Layer Technology Creating a Universe in the Information Design Tool SAP Crystal Reports Creating a Report in SAP Crystal Reports for Enterprise Creating a Report in SAP Crystal Reports 2013 Differentiating SAP Crystal Reports 2013 and SAP Crystal Reports for Enterprise SAP BusinessObjects Web Intelligence Creating Web Intelligence Documents in SAP BusinessObjects Web Intelligence SAP BusinessObjects Analysis, Edition for Microsoft Office Creating a Workbook in SAP BusinessObjects Analysis, Edition for Microsoft Office SAP BusinessObjects Analysis, Edition for OLAP Creating a Workspace with SAP BusinessObjects Analysis, Edition for OLAP SAP BusinessObjects Design Studio 1.2 Creating an Analytical Application in SAP BusinessObjects Design Studio 1.2 SAP BusinessObjects Dashboards Creating a Dashboard with SAP BusinessObjects Dashboards SAP BusinessObjects Explorer Creating an SAP BusinessObjects Explorer Information Space SAP Lumira and SAP Predictive Analysis Visualizing Data in SAP Lumira Forecasting in SAP Predictive Analysis Additional course details: Nexus Humans SAPBI Introduction to SAP BusinessObjects BI Solutions training program is a workshop that presents an invigorating mix of sessions, lessons, and masterclasses meticulously crafted to propel your learning expedition forward. This immersive bootcamp-style experience boasts interactive lectures, hands-on labs, and collaborative hackathons, all strategically designed to fortify fundamental concepts. Guided by seasoned coaches, each session offers priceless insights and practical skills crucial for honing your expertise. Whether you're stepping into the realm of professional skills or a seasoned professional, this comprehensive course ensures you're equipped with the knowledge and prowess necessary for success. While we feel this is the best course for the SAPBI Introduction to SAP BusinessObjects BI Solutions course and one of our Top 10 we encourage you to read the course outline to make sure it is the right content for you. Additionally, private sessions, closed classes or dedicated events are available both live online and at our training centres in Dublin and London, as well as at your offices anywhere in the UK, Ireland or across EMEA.

Duration 2 Days 12 CPD hours This course is intended for Executives, Project Managers, Business Analysts, Business and IT stakeholders working with analysts, Quality and process engineers, technicians, corrective action coordinators or managers; supervisors, team leaders, and process operators; anyone who wants to improve their ability to solve recurring problems. Overview At the completion of this course, you should be able to: Identify the different types of tools and techniques available Apply change management successfully Review what to look for when applying business case thinking to Root Cause Analysis Develop a process to systematically approach problems Business success is dependent on effective resolution of the problems that present themselves every day. Often the same or similar problems continue causing repeated losses in time or money and your staff become experts at fixing rather than preventing the problems. Learn to find and fix root causes and develop corrective actions that will effectively eliminate or control these problems. Section 1: RCA Foundation Concepts and Objectives Section Learning Objectives Discuss Definitions ? IT Perspective Discuss What is a problem and why do they exist? What is Root Cause? RCA Benefits and Approaches Event and Casual Analysis Event and Causal Analysis: Exercise 1c Worksheet RCA Tools for each approach Section Summary and Conclusions Section 2: Enhance use of RCA tools Why use a Particular Method Tool: Change Analysis Change Analysis Examples Tool: How to Resolve Conflict Tool: 5 Why?s Example Learning Management Problem Tool: Cause and Effect Tool: Fault Tree Analysis Why do we use Fault Tree Analysis? How does it work? Fault Tree Diagram Symbols Example #1 of FTA: Car Hits Object Tool: Failure Modes and Effects Analysis (FMEA) Example: Failure Modes and Effects Analysis Tool: Design / Application Review Section 3: Problem Resolution and Prevention Section Objectives The Secret of Solving Problems: -A Note about Statistical Control -A Note about Fire Fighting Technique: Business Process Mapping Example: IGOE Technique: Lean Six Sigma and DMAIC Lean Six Sigma Benefits Importance of Understanding the Business Process The Business Process Mandate Technique: Process Modeling Graphical Notation Standard (BPMN): -What is Business Process Modeling Notation (BPMN)? -Benefits of BPMN -Basic Components of BPMN Technique: Business Process Maturity Model Five Levels of Maturity Section 4: Capability Improvement for RCA Steps in Disciplined Problem Solving RCA as a RCA Process Key RCA Role Considerations Sustainable RCA Improvement Organizational Units Process Area Goals, Practices Specific and General Practices Specific Practice Examples Software Maturity Survey SWOT Analysis Worksheet Recognize the importance of the Change Management component in your RCA implementation Using the ADKAR Model to Communicate Change Review ADKAR© Model ? -Awareness of the need for change -Desire to participate and support the change -Knowledge on how to change -Ability to implement required skills and behaviors -Reinforcement to sustain the change The ADKAR Model: Reinforcement Section 5: Course Summary and Conclusions Plan the Proposal and Business Case Example: 1 Page Business Case Resource Guide Questions