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ISO 13485:2016 Medical Device Quality Management Systems Lead Auditor Training Course

Virtual delivery, IRCA Accredited

SGS Academy

Summary

Price
£4,140 inc VAT
Study method
Online + live classes
Duration
5 days · Full-time
Qualification
No formal qualification
Additional info
  • Exam(s) / assessment(s) is included in price
  • Tutor is available to students
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Overview


The aim of this course is to provide students with the knowledge and skills required to perform first, second (including supplier) and third party audits of quality management systems against ISO 13485:2016, in accordance with ISO 19011.

Resources

  • ISO 13485 Medical Devices Quality Management Systems Lead Auditor -

Description

Upon completion of this course, learners will be able to:

  • Explain the purpose of a medical device quality management system (MD QMS), interaction with appropriate medical device regulatory authority requirements, quality management systems standard, third-party certification, and the business benefits of the quality management system;
  • Explain the role and responsibilities of an auditor to plan, conduct, report and follow-up a quality management system in accordance with ISO 19011 (and ISO 17021 where appropriate);
  • Plan, conduct, report and follow-up an audit of a medical device quality management system to establish conformity (or otherwise) with ISO 13485 and applicable medical device regulatory requirement documents in accordance with ISO 19011, ISO/IEC 17021.

Learners will need to demonstrate acceptable performance in these areas to complete the course successfully.

Who is this course for?

This course is designed for learners who have prior knowledge of medical device quality management principles, concepts, the requirements of ISO 13485 plus requirements of regulatory authorities.

This course is not designed as a foundation or introductory course.

Requirements

ISO 13485

  • Knowledge of the requirements of ISO 13485, which may be gained by completing a CQI and IRCA Certified MD QMS ISO 13485:2016 Foundation (FD 132) course or equivalent.

Medical Device management System Audit

  • The Plan, Do, Check, Act (PDCA) cycle.
  • The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.
  • Commonly used quality management terms and definitions within ISO 13485 and ISO 9000.
  • The process approach used in MD QMS.
  • A working knowledge of risk management principles related to the design of a medical device, for example ISO 14971

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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