105 Newton House, Birchwood Park, Warrington, WA3 6FW
01925 377150

ISO 13485 Foundation Course

This one day ISO 13485 foundation course will give you a detailed understanding of the 2016 version of ISO 13485, the quality management system used for the medical device industries.

In-House Only

To book this course please call us on

01925 377150

COURSE OVERVIEW

This one day ISO 13485 foundation course will give you a detailed understanding of the 2016 version of ISO 13485, the quality management system used for the medical device industries.  The course will give you an understanding of why ISO 13485 is used and how it links to other quality management systems.  The course is aimed at any person that plays a role in maintaining a company’s medical device quality management system and is an ideal starting point in the career of any prospective quality manager working within this industry.

This one day course has been designed to provide an insight into the use of ISO 13485:2016 as the basis for a quality management system implemented by medical device manufacturers.  Time will be spent during the course exploring the requirements of ISO 13485:2016 and how the standard interacts with ISO 9001:2015.

COURSE CONTENT

The ISO 13485 foundation course consists of a mixture of presentations and group exercises.  Upon completion of the course you can expect to have gained a detailed understanding of the following areas:

  • The history of ISO 13485 and medical device management systems
  • The processes & procedures that may be required to meet the standard’s requirements.
  • How the assessment process works
  • The different clauses and requirements in ISO 13485:2016
  • How ISO 13485 relates to ISO 9001

WHO SHOULD ATTEND?

The ISO 13485 foundation course is aimed at any person that plays a role in maintaining a company’s medical device quality management system.  It is also an ideal starting point in the career of any prospective quality manager within this industry as well as other members of senior management or the auditing team.

USEFUL INFORMATION

Course Duration

1 Day

Start and Finish Times

09:00 – 17:00

What's Included?

Comprehensive delegate folder and certificates. Public courses include lunch and refreshments throughout the day.

COURSE OUTCOME

By the end of this ISO 13485 foundation course, delegates will be able to:

  • Understand the basic requirements of ISO 13485 and how they apply to processes within your organisation.
  • Start the process of implementing a QMS designed specifically for an organisation within the medical device industry.
  • Understand the benefits of adopting ISO 13485 within your organisation

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