The FDA in 21 CFR 820.50 requires companies to control all their suppliers, including suppliers of materials, services, consultants and contractors, if they can have an impact on product quality or quality system. In accordance with clause 7.4.1 of ISO 13485, device manufacturers must have a procedure that contains the following requirements: Conversely, a delivery contract indicates how the supplier promises to provide all declared products or services 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. A standard operating procedure should be put in place to indicate the types of creditors and services for which a quality agreement is required. At a minimum, an agreement must be reached at any time when an OCM is used, as well as with all suppliers of critical materials. They are recommended for suppliers of large quantities of raw materials or components. The ICH`s industry guide Q10 Pharmaceutical Quality System recommends that the owner, as a member of a pharmaceutical-grade system, ultimately be responsible for ensuring that “processes are in place to ensure control of outsourced activities and the quality of materials purchased.” He says these processes involve risk quality management and critical activities such as: 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. Betty Lane has more than 20 years of experience in quality assurance and medical device regulation.
It has implemented or updated quality systems for many small and medium-sized medical device and diagnostic companies. Their work allows companies to manage their operations in accordance with FDA and ISO 13485 requirements, allowing the sale of their products worldwide. Its background in the development of the digital system has enabled it to facilitate design controls and software validation when it has become FDA and industry requirements. The agreement must indicate which controlled and documented changes can be made by the contractor only with notification to the owner and those that must be discussed, verified and approved by the owner before they can be implemented. Supplier Quality Assurance Agreements (QS) can play a crucial role in helping companies show regulators not only that they control their suppliers properly, but also that they are informed and know what their suppliers are doing. Manufacturers of all types of medical devices are responsible for the product they manufacture and sell. However, more and more companies are relocating some or all of their production or other activities. Regulators and certification bodies are therefore interested in companies that sell the product in order to have sufficient knowledge and control of their suppliers to ensure that the products are safe and meet the requirements imposed on them. This article explains why supplier agreements are desirable and sometimes even necessary, which suppliers should have agreements on supplier quality and what should be included in these agreements.