Supplier Quality Agreements – required by ISO 13485:2016 for suppliers of all Outsourced Processes – Webinar –

The “Supplier
Quality Agreements – required by ISO 13485:2016 for suppliers of all
Outsourced Processes” webinar has been added to’s

In this webinar you will learn how to create detailed quality agreements
(QA Agreements) for key suppliers, particularly those for outsourced
processes, and to understand which of your suppliers should have these
agreements to meet the expectations of the FDA and ISO 13485:2016 and
MDSAP. The agreements discussed will meet the expectations of the GHTF
and NBOG supplier guidance documents which are now an expectation of
both the FDA and most ISO 13485 auditors. These supplier QA agreements
can be an important part of demonstrating that you have control of your
key suppliers.

Why Should You Attend:

This presentation will provide an understanding of what the current
guidance documents suggest you include in supplier agreements for
several types of key suppliers. Quality Assurance (QA) agreements are
usually more flexible than standard supplier agreements and can
therefore be more detailed and easier to modify than standard supplier
contracts which often require legal, as well as management approval. QA
agreements with you suppliers can be the easiest way to assure both your
company and auditors that you have sufficient control of your key and
critical suppliers and those who supply outsourced processes. QA
agreements give details of who is responsible for what between you and
your supplier. Yet, because these agreements are detailed and specific
to a particular supplier, they should only be used for those suppliers
where they provide value. Even if your key suppliers are only from
different branches of your own company, a supplier QA agreement can be
an important tool to show the FDA and ISO 13485 Notified Body auditors
that you have the required control of these suppliers.

For more information about this webinar visit

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