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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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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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
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ISO 9001: Quality Management Systems - Requirements
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Overview
The 5-day Lead Auditor training course aims to provide participants with the knowledge, and develop the skills and expertise necessary to:
-
Audit a Quality Management System (QMS) based on ISO 9001:2015
-
Ensure that the organization is competent in maintaining and continually improving its QMS
-
Perform third party audits by applying widely recognized audit principles, procedures and techniques
-
Proficiently plan and perform internal and external audits in compliance with ISO 19011 and the certification process according to ISO 17021.
-
Manage audit teams and audit programmes, communicate with customers, resolve conflicts, etc.
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Learning Objectives
On completion of this course you will have:
Learned the following:
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QMS purpose and the ISO 9000 principles of quality management
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Essential definitions to help you interpret the ISO 9001 requirements and audit
meeting same
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Role and responsibilities of an auditor and lead auditor
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Learned how to:
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Analyse ISO 9001 clauses and suggest examples of objective evidence that would show conformance with these requirements
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Plan and conduct an interview with top management
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Evaluate an organisation’s quality policy and objectives
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Prepare an on-site audit plan that establishes effective audit trails across processes and between members of an audit team
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Audit processes for conformance and effectiveness, including any specific quality objectives
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Prepare thoroughly for an audit and produce process-based checklists
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Gather objective evidence through observation, interviewing and reviewing documentation
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Evaluate objective evidence and correctly identify conformance and non-conformance with requirements
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Report findings accurately against requirements of ISO 9001, write and grade non-conformity reports and evaluate proposals for corrective action
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Relate your audit findings to the policy and objectives of the organisation and present your overall evaluation to top management
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Course Agenda and Content
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Day 1: Introduction to Quality Management and ISO 9001
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Course objectives and structure
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The standard and regulatory framework
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Fundamental principles of quality management
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Quality Management System (QMS)
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Certification process
Day 2: Audit Principles, Preparation and Conducting an Audit
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Fundamental audit concepts and principles
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Audit approach, based on evidence and risk
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Initiating the audit
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Stage 1 audit
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Preparing the stage 2 (on-site) audit
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Stage 2 audit - Part 1
Day 3: On-site audit activities
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Stage 2 audit - Part 2
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Communication during the audit
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Audit procedures
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Creating audit test plans
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Drafting audit findings and non-conformity reports (NCR)
Day 4: Closing the audit
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Audit documentation and quality review
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Closing the audit
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Evaluating action plans by the auditor
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Beyond the initial audit
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Managing an internal audit programme
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Competence and evaluation of auditors
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Closing the training
Day 5: Certification Exam
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Prerequisites
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ISO 9001 Foundation Certification or basic knowledge of ISO 9001 is recommended
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 certification exam
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Practice test (mock exam) similar to the certification exam.
Examination and Certification
Examination
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Duration 90 min
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Format closed book, 60 multiple-choice questions
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Pass mark 70% (42 correct answers)
Competence Domains Being Tested
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Fundamental principles and concepts of quality management
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Quality Management Systems (QMS)
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Fundamental principles and concepts of auditing
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Preparation for an QMS certification audit
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Conducting a QMS certification audit
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Closing a QMS certification audit
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Managing an ISO 9001-based QMS audit programme
Certification
The ISO 9001 Lead Auditor certificate will be issued to delegates passing the exam.
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For general course information please click on the link here.
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N.B. Please read our Terms & Conditions (T&Cs) and ask for clarifications, if any, before booking your training event.
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Book now to reserve an on-site or online instructor-led training event of your choice for your company's delegates.
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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.
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For queries, including non-obligation quotes, please contact us.
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ISO 9001
Lead Auditor
Course details
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5 days (09.00 - 17.00 GMT)
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Online, instructor-led, via zoom.us, or onsite, in classroom
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£1190 + VAT per delegate
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Deadline for payment/ registration: 2 calendar days before course start
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Included: 5 days online instructor-led training, delegate workbook, online exam, and certificate.
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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