Supplier Quality Assurance Agreements for FDA and ISO 13485 Compliance
November 15, 2012 - Palo Alto CA US
This webinar will provide you the information you need to create supplier quality agreements (QA Agreements) with key suppliers and to understand which of your suppliers should have these agreements to meet expectations of the FDA and ISO 13485 Notified Body auditors. Why Should You Attend: This presentation will provide an understanding of what the current guidance documents suggest you include in supplier agreements. 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 your suppliers can be the easiest way to assure both your company and auditors that you have sufficient control of your key and critical suppliers. 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.