Further changes to ISO 13485 are intended to further reduce supplier risk and improve quality. Purchasing information has been reformulated and specified in the standard to ensure that purchase requirements are met, including specifications, product acceptance, supplier qualifications and quality system requirements. Like the FDA Quality System (QSR) Regulation, a written agreement must be reached to indicate that changes to the purchased product must be notified prior to the implementation of the amendments. ISO has strengthened the text relating to the verification of purchased products to ensure that it is appropriate on the basis of the supplier`s assessment and is proportionate to the risks associated with the part purchased. Communication with your suppliers is the key. Your suppliers near and far need to know that the changes they make have an impact on the products you make. Written agreements help communicate between your organizations. Conversely, a delivery contract explains how the supplier promises to provide all goods or services reported over a period of time and at what cost. It also includes the buyer`s obligations as to when and how the goods are purchased. The delivery agreement helps to facilitate the management of companies working together, eliminates ambiguities and establishes the framework for ordering and delivering goods and services.
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. I recommend that a supplier quality contract be put in place at the beginning of the development process. Maintaining quality in your supply chain at the beginning of the game certainly can`t hurt. If you start educating your suppliers and working productively with them at this point, avoid surprises later in the development cycle – if it may be too late to change a key component or supplier. This is a mandatory agreement that must be signed with all suppliers providing critical components of a service. Z.B.
raw material, sterilization, packaging. Choosing the appropriate QMS for ISO 13485:2016 Compliance In addition to the five key elements mentioned, there are some key elements that should also be addressed in the agreement. In addition to defining the content of a vendor agreement and reviewing concrete examples, this presentation helps you decide how best to implement these agreements in your business. Supplier control has always been a requirement of the FDA and ISO 13485, but the current expectation is that you effectively document this control as part of your vendor management program, and the SAQ agreements can be an easy way to demonstrate this control to major or critical suppliers. 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. Quality agreement is an essential part of the supplier management system and ensuring that these products are taken into account will provide a solid basis for the quality of incoming products. John Wooden, legendary basketball coach and leader, asked, “If you don`t have time to do it right, when do you have time to do it?” Life sciences organizations have to do it right the first time, which means that our suppliers have to do it right the first time.