Control of Contamination
[ISO 13485 Cl 6.4.2]
Control of Contamination
ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) specifically for the medical device industry. The purchasing process, as outlined in ISO 13485, is a critical aspect of ensuring that medical devices are safe and meet regulatory requirements. Here’s an explanation of the purchasing process as per ISO 13485 Cl 7.4
Overall, the purchasing process in ISO 13485 is aimed at ensuring that medical devices are manufactured from raw materials, packing materials, consumables, accessories, and components sourced from approved suppliers and meet in-house specifications, including quality, safety, and regulatory compliance. A scheduled internal audit two times a year is essential to assure effective implementation throughout