What does all this mean for life sciences organizations? This means that quality management systems must involve suppliers and subcontractors by informing them of product specifications and requirements and ensuring that they cooperate and communicate all relevant changes. This means that the quality management system must be fully integrated into properly structured data to ensure that all vendor activities, detailed material control results, supplier non-compliance, supplier corrective actions and audit results are continuously considered in the vendor`s monitoring and reassessment process. This is the key to achieving preventative and prescient signals that will drastically improve the quality and fulfillment of customer expectations in your business. 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. It is recommended that the quality agreement be separated from the supply agreement and other commercial or commercial agreements, so that it is independent of the pricing, payment terms, volume of work and other elements of these documents and can therefore be modified or separated independently from each other. The appropriate QMS choice for ISO 13485:2016 Compliance 1. Goal and scope 2. Conditions, including validity and termination dates 3. Dispute resolution provisions 4. Owner`s responsibilities in relation to contractual facility – this should be detailed enough to cover all the responsibilities defined in ISO 13485.
5. Managing Changes and Reviews Detailed supplier-QS agreements with major suppliers, whether self-sustaining or part of a broader supplier agreement, 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.