ISO 13485:2016 Workshop

Overview

May, 2019

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 ISO 13485:2016

On March 1st, 2016, the approved version of ISO 13485:2016 was published.
The publication date was the start of a three year transition period. Introduced by
the International Organization for Standardization in July 2003, ISO 13485 is
recognized throughout the world as a quality management system standard
designed specifically for medical device manufacturers.

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 What is ISO 13485:2016

- ISO 13485:2016 is an internationally recognized quality standard which states the

requirements of the Quality Management System (QMS) for the design and
manufacture of Medical Devices throughout the world. Certification to ISO 13485
requires its quality system to pass a third party Medical Device Single Audit Program,
or “MDSAP” audit.
- The ISO 13485 standard is an effective solution to meet the comprehensive
requirements for a QMS. Adopting ISO 13485 provides a practical foundation for
manufacturers to address the Medical Device Directives, regulations, and
responsibilities as well as demonstrating a commitment to the safety and quality of
medical devices.
- A survey of ISO 13485 certification at the end of 2015 shows that despite the global
recession, the number of companies that have implemented an ISO 13485 Quality
Management System still shows a general positive trend worldwide.

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 Who should
register
Organizations that design and assemble medical devices
Medical component manufacturers
Companies who manufacture private label medical devices and hope to
eventually place them in the EU market
Manufacturers that want to prepare for future IVD regulatory obligations
to enter the EU
Companies who store and/or distribute medical products
Companies who install and/or service medical devices
Companies that design, develop, or provision associated services and
technical support

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 What you will
learn

1. Why certification to ISO 13485 is essential to your business

2. Important Aspects of the Standard
3. Relationship of ISO 13485:2016 to other national standards
4. Relationship of ISO 13485:2016 to ISO 9001:2015
5. Minimum requirements of ISO 13485:2016 & MDSAP
5. Advantages of Registration to ISO 13485:2016
6. Initiating the steps of an ISO 13485:2015 implementation
project and the detailed steps to registration

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