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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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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Overview
The ISO 13485 standard governs quality management for medical devices and related services.
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This 3-day course enables participants to develop the necessary expertise to support an organization in designing, documenting, implementing, and maintaining an effective Quality Management System (QMS) for medical devices based on the requirements of ISO 13485 Management System Standard (MSS).
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Who Should Attend
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Those involved in QMS design, documentation, implementation, operation, and maintenance of an ISO 13485-based QMS
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QMS auditors, who wish to fully understand the QMS implementation process within the context of medical devices industry and associated regulations
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Senior managers involved in, and/ or affected by, the outcome of QMS audits in medical devices
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Expert advisors in Quality Management Systems
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Technical experts wanting to prepare for a quality function or for a QMS project management function
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Those considering QMS certification to the ISO 13485 standard and may, or may not, have already implemented an ISO 9001 compliant QMS.
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Management representatives
- Implementation team members
ISO 13485
Lead Implementer
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.
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Onsite training
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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
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Learning Objectives
On completion of this course, delegates will be able to:
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Understand the implementation of a QMS, in accordance with the requirements of ISO 13485
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Understand the concepts, principles, methods and techniques required for effective QMS management in medical devices
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Identify the risks and opportunities associated with an organization adopting the standard
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Understand the relationship between the components of a QMS and compliance with the requirements of different stakeholders, including customers, suppliers, and regulators
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Support an organization in implementing, managing and maintaining a QMS as specified in ISO 13485
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Manage a team implementing an ISO 13485-compliant QMS
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Advise the senior management of an organization on best practices in managing product or service quality related to medical devices
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Analyse data and information and make the right decisions within the context of the standard.
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Prepare an organization for an ISO 9001 certification audit.
Course Agenda and Content
Introduction to the course
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Course objectives and structure
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Management Systems (MS) and Management System Standards (MSS)
ISO 13485:2016
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What is ISO 13485:2016?
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Importance of ISO 13485 for an organisation
ISO 13485 vs. ISO 9001
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Terminology
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Scope
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Focus
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Continual improvement
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Similarities between the two QMS standards
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Differences between the standards
ISO 13485:2016 Requirements - Overview
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General requirements
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Documentation requirements
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Management responsibility
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Resources
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Product realisation
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Infrastructure
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Risk management
Development of an ISO 13485-compliant QMS
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Project management approach and stages
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Gap analysis of existing management system elements (current state) against the requirements of the standard
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Leadership and approval of the QMS project
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Project initiation for QMS development and implementation
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QMS scope
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QMS documentation structure
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Mandatory documents of an ISO 13485-compliant QMS
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Definition of the document management process
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Quality management policies
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Risk assessment
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Planning of product and service provision
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Definition of the QMS organizational structure
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PDCA cycle and QMS requirements mapping
QMS Implementation
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Operations Management
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Training and awareness planning
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Communications planning
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Product and service requirements, design, and purchasing process
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Product and service realization and control.
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QMS Measurement, and Continuous Improvement
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Monitoring, measurement, analysis and evaluation of the QMS effectiveness
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Internal audit
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Management review
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Treatment of issues and non-conformities
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Continual improvement
Auditing
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Types of audit: 1st 2nd and 3rd party audits
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Internal auditing skills
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Internal audit objectives
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Planning, preparation, and management of audits
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Reporting audit results
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Internal audit and the PDCA cycle
ISO 13485 Certification Audit
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Prerequisites
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The role of the certification body/ Registrar
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Certification cycle (from initial certification to re-certification)
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Stage 1 audit
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Stage 2 audit
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Certification and registration
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Certification Exam.
Prerequisites
Proficiency in the English language, willingness to learn, and open mind to new ways of
working.
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Completion of the ISO 13485 Foundation training 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 Foundation exam
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Practice test (mock exam) similar to the certification exam.
Certification Exam
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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 in Quality Management
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ISO 13485 requirements for QMS
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Planning, developing, and implementing a QMS
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Monitoring, measuring, and evaluating QMS performance
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Continual improvement of QMS
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Preparing for the certification audit.
Certification
The ISO 13485 Lead Implementer 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 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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