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ISO 13485 Lead Auditor Training

Online Course

Training Deals

Summary

Price
£499 inc VAT
Finance options

Online

E-Commerce

PO Booking

Telephone
Study method
Online
Duration
Self-paced
Qualification
No formal qualification
Additional info
  • Tutor is available to students
45 students enquired about this course

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Overview

ISO 13485 Lead Auditor Course Overview

This highly interactive course enables individuals to plan, lead, and report audits within their own organisation, with their suppliers and with third-party organisations. This course will benefit our delegates by ensuring that they are able to conduct effective audits in any auditing situation. This will be achieved through the attainment of the relevant skills in planning, coordinating, reporting, and reviewing with regards to QMS auditing. By putting these skills into practice, certified individuals can improve overall organisational performance. Our expert instructors will provide informative and engaging sessions and will include a hands-on run through of the complete auditing process, including managing an audit programme and reporting the results. It is essential that our candidates understand the role of an ISO 13485 Lead Auditor, and can explain their role in terms of the entire auditing process outlined in this course. At the end of the course, delegates will be required to take an exam in order to become certified.

Description

ISO 13485 Lead Auditor Course Outline

The following subjects will be taught during this course

  • Introduction
  • Key Terms and Definitions
  • The Relationship Between ISO 13485 and ISO 9001
  • Team Leader Skills
  • ISO 13485 Quality Management System Clause 1 and 2
  • ISO 13485 Quality Management System Clause 3 and 4
  • Structure and Intent of the Medical Devices Standard ISO 13485:2012
  • Medical Devices, Quality, and Auditing Terminology
  • Processes, Procedures, and Records
  • Checklist Development
  • Types of Audit and Objectives
  • Internal Audit – Roles and Responsibilities
  • Lead Auditor Responsibilities
  • The Audit Process
  • The Closing Meeting
  • Auditing Skills, Scope, and Criteria
  • Reporting Audit Findings
  • Planning, Preparation, and Management of Audits
  • Interviewing Skills
  • Improvement
  • Corrective Action and Verifying
  • Preventative Action

Who is this course for?

Anybody who would like to learn how to lead an ISO 13485 audit.

Requirements

Who Should Attend this ISO 13485 Training Course?

This course has been recommended for professionals who are involved in implementing and/or auditing quality management systems for medical devices, or those leading a supplier quality assurance programme.

Prerequisites

An understanding of quality management concepts and principles would be valuable to delegates.

Questions and answers

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Legal information

This course is advertised on Reed.co.uk by the Course Provider, whose terms and conditions apply. Purchases are made directly from the Course Provider, and as such, content and materials are supplied by the Course Provider directly. Reed is acting as agent and not reseller in relation to this course. Reed's only responsibility is to facilitate your payment for the course. It is your responsibility to review and agree to the Course Provider's terms and conditions and satisfy yourself as to the suitability of the course you intend to purchase. Reed will not have any responsibility for the content of the course and/or associated materials.

FAQs

Study method describes the format in which the course will be delivered. At Reed Courses, courses are delivered in a number of ways, including online courses, where the course content can be accessed online remotely, and classroom courses, where courses are delivered in person at a classroom venue.

CPD stands for Continuing Professional Development. If you work in certain professions or for certain companies, your employer may require you to complete a number of CPD hours or points, per year. You can find a range of CPD courses on Reed Courses, many of which can be completed online.

A regulated qualification is delivered by a learning institution which is regulated by a government body. In England, the government body which regulates courses is Ofqual. Ofqual regulated qualifications sit on the Regulated Qualifications Framework (RQF), which can help students understand how different qualifications in different fields compare to each other. The framework also helps students to understand what qualifications they need to progress towards a higher learning goal, such as a university degree or equivalent higher education award.

An endorsed course is a skills based course which has been checked over and approved by an independent awarding body. Endorsed courses are not regulated so do not result in a qualification - however, the student can usually purchase a certificate showing the awarding body's logo if they wish. Certain awarding bodies - such as Quality Licence Scheme and TQUK - have developed endorsement schemes as a way to help students select the best skills based courses for them.
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