ABSTRACT
The organization is to define, plan, and implement appropriate methods for monitoring and measurement of the realization processes and characteristics of the product. The objective of the methods is to demonstrate the ability of processes to achieve planned results and to verify that product requirements have been met. These activities shall be carried out at applicable stages of the product realization. Handling refers to the short-distance movement of products and process outputs within the work environment. The quality plan shall define the labeling and identification requirements for process results, components, parts, materials, semiproducts, and products throughout the realization processes. The quality plan is an ever-changing document that might be impacted by changes. Risk analysis is performed during the design and development of the product and will lead to design changes—implementing modifications in the medical device to reduce risks to an acceptable level or remove them.
