Purchase Orders
All processes, products and services to be provided by suppliers are listed and should be outlined within Purchase Orders. Alpha-Tec Systems reserves the right to specify the following requirements as needed, and request approval prior to shipment, of all products, services and their release, methods, processes, and equipment used in manufacturing or packaging products and its release and shipment to our facility. We also reserve the right to request supplier qualifications, verifications or validations regarding purchased material, and if needed, arrange on-site audits of supplier’s premises. Any requirements not outlined in the Purchase Order are to be considered not applicable. Any failure to meet requirements as outlined will be documented and evaluated, and further action will be taken if necessary. Communicated as per ISO 13485:2016 Sections 7.4.1-7.4.3.