This Supplier Quality Assurance (QS) seminar will provide you with the information you need to establish supplier quality agreements (saQ agreements) with your major suppliers. This also involves understanding which suppliers should have these agreements to meet the expectations of FDA body auditors and ISO 13485 Notified. Ms. Lane`s Training experience spans more than 25 years of training in all areas of ISO 13485 and FDA cGMP in the companies in which she has worked, as well as for the BIOMEDICAl asQ division and ASQ sections. She has taught medical quality and regulatory courses at Northeastern University, Boston, MA. Ms. Lane is active in her local chapter of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), the Society of Women Engineers and the IEEE. Betty holds an engineering degree from the Rensselaer Polytechnic Institute and an MBA from Northeastern University. Supplier management and ISO 13485:2016 procurement processes have numerous updates all aimed at reducing risk: supplier, product and patient. ISO 13485 has been expanded to define licensing, monitoring and re-evaluation requirements for suppliers and supplier files. As more and more companies relocate their operations, the focus is much more on managing supplier quality. The lack of supplier deliveries or the supply of products that do not meet the required specifications is not only costly, but also dangerous for patients, as they jeopardize the availability of life-saving products in the supply chain. 7:04 a.m.
In addition to the corrective measures mentioned above, Exact may at any time test a supplier or be disqualified for reasons such as: the issuance of corrective measures, poor audit and/or quality performance and the supplier`s lack of response. Detailed supplier quality agreements with major suppliers, whether self-sustaining or part of a larger supplier contract, are becoming increasingly important as more and more medical technology companies seek to expand their outsourcing. Both European notified organizations under ISO 13485 and the FDA require companies to enter into detailed agreements with their major suppliers. The GHTF supplier`s guide document is now an expectation of the FDA and most ISO 13485 auditors. These auditors must verify that you have objective evidence for the control or suppliers of products and services. Supplier-QS agreements can be an important part of the evidence of this control. 5.03 Training. The supplier must provide adequate training to ensure that staff are competent and qualified to produce quality products. The supplier verifies and documents the skills and skills required to manufacture, inspect, handle and supply products to Exactch. The supplier must provide appropriate training to ensure that staff comply with applicable procedures and instructions. The provider maintains staff data sets on training.
In addition to the five key elements mentioned, there are a few key elements that should also be addressed in the agreement. This presentation will help you understand what the current guides that you include in the supplier agreements offer. Quality assurance (QS) contracts are generally more flexible than standard supplier agreements and can therefore be more detailed and simpler to modify than standard supplier contracts, which often require legal and management authorization. SAQ agreements with your suppliers can be the easiest way to assure your business and external auditors that you have sufficient control over your key critical suppliers. The SAQ agreements indicate who is responsible for what between you and your supplier.