ABSTRACT
Clause 1 of the International Organization for Standardization (ISO) 13485 Standard is used to present the purposes and concepts of the standard and define the scope of application of the standard to quality management system (QMS). The ISO 13485 Standard can also be implemented by suppliers or external parties that provide services, processes, materials, or components for the medical device (MD). The requirements of this Standard apply to the associated services as supplied by the organization and are related to the MD. The ISO 13485:2016 Standard is intended to be a standard for MD manufacturers and other organizations that participate in the life-cycle of the MD that are expected to demonstrate their ability to provide MDs and related services that consistently meet customer requirements. Exclusions are very important because they set the degree of effort and amount of resources that manufacturer will have to invest in implementing and maintaining the QMS.
