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Home Specialist skills Workplace Essentials ISO 13485 Lead Implementer

ISO 13485 Lead Implementer

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    Be able to evaluate the expectations and requirements of the customers
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    Be able to promote harmonisation of regulatory requirements for manufacturers
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    Be able to enhance the credibility and image of a company to represent compliance
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    Be able to engage management actively and undertake management system activities
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    Be able to design and development consultancy for a respiratory inhaler manufacturer

Overview

Off the shelf (OTS)

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.

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

21 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

21 hours

Competency level
  • Working icon

    Working