top of page
Back to Home page
Contents
  • Overview
  • Who should attend
  • Learning objectives
  • Course agenda and content
  • Prerequisites
  • Training approach
  • Examination
  • Competence domains being tested
  • Certification
  • General course information
​
​

Overview

 

The 5-day Lead Auditor training course aims to provide participants with the knowledge, and skills necessary to:

  • Audit a Quality Management System (QMS) based on the requirements of ISO 13485:2016 and ISO 19011

  • Ensure that the organization is competent in maintaining and continually improving its QMS for medical devices

  • Perform second and 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.

Based on practical exercises participants will master the management systems' auditing tools and techniques.

 

  • ​Who Should Attend

  • ​

  • Those who require an in-depth understanding of the range of auditing techniques and protocols associated with the Lead Auditor role.

  • Quality practitioners, particularly those with a responsibility to design, implement and manage an audit programme for internal audits, supplier audits and other external audits from customers and/or certification bodies.

  • Those auditing Quality Management Systems against the ISO 13485 requirements

  • Internal quality auditors who are looking to enhance their quality auditing knowledge and skills

  • Senior managers involved in, and/ or affected by, the outcome of QMS audits.

ISO 13485 QMS for medical devices Lead Auditor training
ISO 13485
Lead Auditor
  Training Course details
​
  • 5 days (09.00 - 17.00 GMT)
  • Online instructor-led via zoom.us
  • £1190 + VAT per delegate
  • Deadline for payment/ registration: 2 calendar days before course start
  • Included: 5 days online instructor-led training, delegate workbook, online exam, and certificate.
​
Onsite training
​
  Please refer to our Terms & Conditions:

  • Trainer's expenses for onsite training, paid by the client

  • Fixed onsite training expenses policy

​

Learning Objectives

 

On completion of this course you will have:

 

Learned the following:

  • QMS purpose and the ISO 9000 principles of quality management

  • Essential definitions to help you interpret the ISO 13485 requirements and auditing to comply with same

  • Role and responsibilities of a Lead Auditor

 

Learned how to:

  • Interpret ISO 13481 clauses and suggest examples of objective evidence that would show conformance with its requirements

  • Plan and conduct an interview with top management of the organisation adopting the standard

  • Evaluate the organisation’s quality policy and objectives

  • Prepare an on-site audit plan that establishes effective audit trails across processes and between members of an audit team

  • Audit processes for conformance and effectiveness, including any specific quality objectives

  • Prepare for an audit and produce process-based checklists

  • Gather objective evidence through observation, interviews and documentation review

  • Evaluate objective evidence and identify non-conformance with the requirements of the standard

  • Report findings accurately, write and grade non-conformity reports and evaluate proposals for corrective action

  • Relate audit findings to the policy and objectives of the organisation

  • Present the audit findings to top management

 

Acquired the expertise necessary to:

  • Perform internal QMS audits, based on ISO 13485, by following the ISO 19011 guidelines

  • Perform third-party QMS certification audits, based on ISO 13485, by following the guidelines of ISO 19011 and the specifications of ISO 17021

  • Manage a team of auditors.

 

Understood the following:

  • Operation, maintenance, and continual improvement of an ISO 9001-compliant QMS

  • Relationship between a QMS and satisfying the requirements of various stakeholders associated with it.

 

Improved your skills and ability in the following areas:

  • Analysis of data and information associated with the internal and external environment of an organization

  • Effective audit-related decision-making in the context of a QMS.

 

Course Agenda and Content

​

Day 1: Introduction to Quality Management and ISO 13485

​

  • Course objectives and structure

  • The standard and regulatory framework

  • Fundamental principles of quality management

  • Quality Management System (QMS)

  • Certification process

 

Day 2: Audit Principles, Preparation and Conducting an Audit

​

  • Fundamental audit concepts and principles

  • Audit approach, based on evidence and risk

  • Initiating the audit

  • Stage 1 (documentation) audit

  • Preparing the stage 2 (on-site) audit

  • Stage 2 audit - Part 1

 

Day 3: On-site audit activities

​

  • Stage 2 audit - Part 2

  • Communication during the audit

  • Audit procedures

  • Creating audit test plans

  • Drafting audit findings and non-conformity reports (NCR)

 

Day 4: Closing the audit

​

  • Audit documentation and quality review

  • Closing the audit

  • Evaluating action plans by the auditor

  • Beyond the initial audit

  • Managing an internal audit programme

  • Competence and evaluation of auditors

 

Day 5: Certification Exam

 

Prerequisites

​

The following are general prerequisites for attending our training courses:

  • Proficiency in the English language

  • Consideration for other course participants

  • Willingness to actively participate during the training sessions, and an open mind to learn new

      ways of working.

 

ISO 13485 Foundation Certification or basic knowledge of ISO 9001 is recommended

 

Training Approach

 

The course covers both theory and practice:

  • Slide-based training sessions, illustrated with examples

  • Business cases

  • Preparation for the certification exam

  • Practice test (mock exam) similar to the certification exam.

 

Examination and Certification

 

​Examination

 

  • Duration       90 min.

  • Format         closed book

  • Questions    60 multiple-choice questions

  • Pass mark   70% (42 correct answers)

 

Competence Domains Being Tested

 

  • Fundamental principles and concepts of quality management in medical devices

  • Quality Management Systems (QMS)

  • Fundamental principles and concepts of auditing per ISO 19011

  • Preparation for an QMS certification audit

  • Conducting a QMS certification audit

  • Closing a QMS certification audit

  • Managing an ISO 13485-based QMS audit programme.

 

Certification

 

The ISO 13485 Lead Auditor certificate will be issued to delegates passing the exam.

 

General Course Information

​

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:

  • List of training courses please click here.

  • Consulting services please click here

  • Workshops please click here.

​

For queries, including non-obligation quotes, please contact us.

​

​

ISO 13485 QMS for medical devices Lead Auditor classroom training
Training course certificate
Lead Auditor training
bottom of page