Iso 13485 standard pdf iso#
If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 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. 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. The processes required by ISO 13485:2016 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. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization. The numbering of the QM-Elements of DIN EN ISO 13485:2016 is used for the chapters. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. The following references are used to address the requirements of the standards: 13485:2016 Requirement of the EN ISO 13485:2016 + AC:2016 MDD/MPG: Questions related to the requirements of the MDD 93/42/EEC (MPG, Germany, resp.).
ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. 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. ISO 1345:2016 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.