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Home Specialist skills Workplace Essentials ISO 13485 Lead Auditor

ISO 13485 Lead Auditor

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    Learn how to improve the quality of medical devices manufactured by a company
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    Learn how to promote harmonisation of regulatory requirements for manufacturers
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    Learn how to obtain quality objectives from the manufacturer and pass them to the organisation
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    Learn how to engage management actively and undertake management system activities
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    Learn how to provide access and evidence in accordance with regulatory requirements

Overview

Off the shelf (OTS)

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. 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 sit an exam to become certified.

Successful completion of this course requires access an external online assessment. The online assessment platform may not be accessible on Civil Service department IT due to security restrictions. For more information, click here. If you have any questions or believe you may be impacted by these restrictions, please contact support@governmentcampus.co.uk.

Delivery method
Face to face icon

Face to face

Virtual icon

Virtual

Digital icon

Digital

Course duration
Duration icon

35 hours

Competency level
Working icon

Working

Pink building representing strand 4 of the campus map
Delivery method
  • face to face icon

    Face to face

  • Virtual icon

    Virtual

  • Digital icon

    Digital

Course duration
Duration icon

35 hours

Competency level
  • Working icon

    Working