Overview
The 5-day Lead Auditor training course aims to provide participants with the knowledge, and develop the skills and expertise necessary to:
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Audit a Quality Management System (QMS) based on ISO 9001:2015
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Ensure that the organization is competent in maintaining and continually improving its QMS
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Perform third party audits by applying widely recognized audit principles, procedures and techniques
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Proficiently plan and perform internal and external audits in compliance with ISO 19011 and the certification process according to ISO 17021.
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Manage audit teams and audit programmes, communicate with customers, resolve conflicts, etc.
Based on practical exercises, the participants will master the audit tools and techniques.

ISO 13485: 2016
Lead Auditor


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Empower Your Team with Industry-Leading Training Programs
Tailored corporate training for leadership, technical skills and professional development
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We serve corporate clients investing in peoples' knowledge, skills, and competencies, to improve business performance, enhance process, product and service quality, and achieve sustained growth and profitability.
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We understand the meaning of the business terms "Voice of the Customer" and what constitutes "value" from the customer's point of view.
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We also understand the difference between "value" and "waste" from the business and individual learner point of view.
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We care about the people, the knowledge enhancement of which is entrusted to us by their organisation or themselves.
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We focus on learning (not just on training, and issuing certificates) and providing post-training advice and support through workshops and consulting services.
Stratos Lazaridis
CEO The Marvel Academy
Corporate Training Solutions
Mob: +44 (0)749 114 7156
Contents
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Introduction
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Overview
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Who should attend
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Learning objectives
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Course agenda and content
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Prerequisites
- Training approach
- Examination
- Competence domains being tested
- Certification
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General course information
ISO 18404 Six Sigma & Lean Implementation - Lean Practitioner
Introduction
Lean Thinking is a term used to describe the process of making business decisions in a Lean way. It is regarded as the foundation of any Lean practice, such as: Lean manufacturing, Lean Services, Lean IT, Transactional Lean, Lean Healthcare, Lean Accounting, Lean Start-up, etc.
Lean Thinking is:
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Business improvement methodology aiming to provide a new way of thinking about how to organize human activities to deliver more benefits to society and value to individuals while identifying and eliminating waste.
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A term that was coined by James P. Womack and Daniel T. Jones to capture the essence of their in-depth study of Toyota's Production System (TPS).
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A way of thinking about an activity and seeing the waste inadvertently generated by the way the process is organized.
The aim of Lean Thinking is to create a Lean Enterprise, i.e. an organisation that:
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Grows in a sustainable way by linking and satisfying the four interrelated "voices", i.e. VOC, VOE, VOP, and VOB associated with needs and requirements of the following:
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Business customers (Voice of the Customer) - product or service quality, cost (price), and delivery (QCD)
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Employees (Voice of the Employee) - salary, benefits, professional development, and career progression opportunities
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Business processes (Voice of the Process) - performance of core, management, and supporting business processes
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Business (Voice of the Business)- sustainable and profitable business growth, sales, revenues, compliance, etc.
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Aims to deliver defect-free and fairly priced products or services profitably
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Strives to identify and eliminate "waste" (muda) from its processes, products or services, without sacrificing quality, while minimizing unnecessary overheads to the business and costs related to customers, suppliers and the environment.
Overview
This 3-day interactive and highly practical course will provide first-hand experience of the approaches and tools of Lean that are used to affect continual improvement which is:
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Strategic business goal for most organizations
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Requirement in standards such as ISO 9001, ISO 13053, and ISO 18404.
Lean methods provide a simple and effective approach to identifying and removing waste in processes, thereby improving the following:
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Process execution speed (Lead Time),and flow of materials, information, and value
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Efficiency and effectiveness of day-to-day operational activities.
Who should attend
This course is designed for:
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Lean and Six Sigma Practitioners who wants to apply effective and structured Lean continual improvement techniques and methodologies to help their organization make step change improvements in quality and efficiency
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Those individuals who aspire to become certified to the ISO 18404 standard by meeting the relevant requirements of the standard
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Senior Managers and Quality Management Professionals in organisations aspiring to be certified to the ISO 18404 standard.
Learning objectives
On completion of the course delegates will be able to:
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Describe the Lean principles, tools and techniques of continual improvement
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Select and apply the correct tools and techniques within the operating business environment to:
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Eliminate or minimise non-value adding process tasks and activities type I and type II waste)
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Reduce the end-to-end process Lead Time
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Contribute to value creation, in the form of products or services, and delivery to business customers
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Use the principles of total productive maintenance (TPM), and other Lean tools and techniques such as the Lean Triad (5S, Poka Yoke, and SMED) to reduce machine and system downtime and enhance process performance
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Demonstrate to the organization that Lean tools and techniques can be applied to improve employee engagement and productivity and continual process and business improvement
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Use Lean measures and metrics, such as Lead Time, Cycle Time, Unit Time, Takt Time, OEE (Overall Equipment Effectiveness), TEPP (Total Effective Equipment Performance) to quantify process performance improvements
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Use the Kaizen approach to implement "quick wins", using Lean tools and techniques
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Relate effective Lean continual improvement activities to the management of organizational quality and efficiency.
Course Agenda and Content
Day 1
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Introductions and course administration
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Learning objectives
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Course structure - Overview
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Lean basics: philosophy (Lean Thinking), principles, and Lean Temple
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Overview of Lean tools and techniques
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Customers, value and waste
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3 Ms of Lean (muda, mura, and muri)
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8 forms of Lean waste (muda)/ NVA)
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SIPOC diagram, process and value stream mapping and analysis
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Lean metrics and measures
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Production levelling/ smoothing (heijunka)
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Process levelling techniques
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Process design basics
Day 2
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Push vs. pull systems, Kanban
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Error/ mistake-proofing to enhance product and service quality
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Visual management system
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Process control plans
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Total Productive Maintenance (TPM)
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5S for workplace organization
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Single Minute Exchange of Dies (SMED)
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Lean Enterprise
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Daily Kaizen
Day 3
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Day In the Life Of (DILO) analysis
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Business problem-solving frameworks
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Formal Kaizen events vs, Kaizen Blitz
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Lean management
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Lean teams
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PDCA for continual improvement
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Lean start-up
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Enterprise 4.0
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Services 4.0
Prerequisites
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Proficiency in the English language, willingness to learn, and open mind to new ways of working.
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Understanding the basics of Six Sigma, Lean, and Lean Six Sigma at (minimum) Yellow belt level is recommended
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Any knowledge related to the ISO 13053 standard (Parts 1 and 2) will be highly beneficial.
Training Approach
The course covers both theory and practice:
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Slide-based training sessions, illustrated with examples
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Business cases
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Preparation for the Lean Practitioner exam
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Practice test (mock exam) similar to the certification exam.
Examination
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Duration 90 min.
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Format Closed book
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Questions 60 multiple-choice questions
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Pass mark 70% (min. 42 correct answers)
Certification
The ISO 18404 Lean Practitioner certificate will be issued to delegates passing the exam.
For general course information please click on the link here.
N.B. Please read our Terms & Conditions (T&Cs) and ask for clarifications, if any, before booking your training event.
Book now to reserve an on-site or online instructor-led training event of your choice.
For more details about our:
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List of training courses please click here.
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Consulting services please click here
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Workshops please click here.
For queries, including non-obligation quotes, please contact us.

Training Course details
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3 days (09.00 - 17.00 GMT)
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Online instructor-led via zoom.us
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£690 + VAT per delegate
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Deadline for payment/ registration: 2 calendar days before course start
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Included: 3 days online instructor-led training, delegate workbook, online exam, and certificate.
Onsite training
Please refer to our Terms & Conditions:
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Trainer's expenses for onsite training, paid by the client
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Fixed onsite training expenses policy