Bos General Quality Agreement For Suppliers
This presentation gives you an overview of what the current guidance documents in supplier agreements offer. Quality assurance agreements (QAAs) are generally more flexible than standard supplier agreements and can therefore be more detailed and easier to amend than standard supply contracts, which often require legal authorization and management approval. QS agreements with your suppliers can be the easiest way to assure both your company and your external auditors that you have sufficient control over your key critical suppliers. The SAQ`s agreements contain details on who is responsible for what between you and your supplier. However, since such agreements are detailed and supplier-specific, they should only be used for suppliers for whom they provide added value. Their work allows companies to manage their operations in accordance with FDA and ISO 13485 requirements and manage quality system requirements at other locations such as Europe and Canada. Its background in the digital system allows it to facilitate compliance with design controls and software validations. His areas of expertise include training, auditing, supplier management, document and records management, design controls and software validation. Detailed QA agreements with major suppliers, whether stand-alone or part of a broader supplier agreement, are becoming increasingly important as more and more medical technology companies want to increase their outsourcing. Both the European notified bodies iso 13485 and the FDA require companies to enter into detailed agreements with their main suppliers. The ghtF supplier guide is now an expectation of both the FDA and most ISO 13485 auditors.
These auditors must verify that you have objective evidence of control or suppliers of products and services. Supplier-SAQ agreements can be an important part of the proof of this control. In addition to defining the content of a supplier agreement and reviewing concrete examples, this presentation helps you decide how best to implement these agreements in your company.