These quality system requirements came into force on January 1, 2003. There are no regulatory quality system requirements for Class I medical devices.

Management systems (03.100.70) General (11.040. The Medical Devices Regulations require class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO 13485:2003.

It is the responsibility of the organization to ensure that claims of conformity to this International Standard reflect any exclusion of design and development controls. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. ISO 13485:2016 Standard 7.5.1 Control of production and service provision Itay Abuhav 0 The organization is required to perform the realization of the product and the provision of the service under controlled conditions. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.The processes required by this International Standard that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings. This International Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.Requirements of this International Standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated.

Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

En iso 13485 2016