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ISO 13485 Implementation 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
2 students enquired about this course

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Overview

ISO 13485 Implementation Course Overview

This ISO course has been designed to provide participants with the knowledge to effectively implement a quality management system in line with the requirements of ISO 13485. Training will also indicate how to develop quality policies, the core characteristics of risk assessments, the significance of legislation, and how to create an efficacious management review process. By attending this ISO course, trainees will gain the capability to follow their Quality Management System and subsequently enhance business performance. Furthermore, with the knowledge gained from this two-day training course, delegates will be able to find ways to increase efficiency and cost savings through quality management, monitor supply chains in order to achieve continuous improvement, and meet customer and regulatory requirements.

Description

ISO 13485 Implementation Course Outline

The following subjects will be taught during the ISO 13485 course:

  • Describe the fundamentals of quality management systems
  • Explain the purpose, structure, and requirements of ISO 13485
  • Apply a process of implementing a quality management system that meets the requirements of ISO 13485

Who is this course for?

Anybody who would like to learn how to lead the implementation of an ISO 13485 compliant medical device quality management system.

Requirements

Prerequisites

  • No prerequisites are required for this course, however, a basic knowledge of medical devices, ISO 9001, or ISO 13485 would be beneficial.

Who should attend this ISO 13485 Training Course?

  • Anyone involved in defining, planning, or implementing an ISO 13485 based Quality Management System
  • Management representatives
  • Implementation team members

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.

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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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