ISO 13485:2016规定了质量管理体系的要求，其中组织需要证明其提供医疗器械和相关服务的能力，以始终满足客户和适用的监管要求。此类组织可以参与生命周期的一个或多个阶段，包括医疗器械的设计和开发、生产、储存和分销、安装或维修，以及相关活动的设计和开发或提供（例如技术支持）。ISO 13485:2016也可用于向此类组织提供产品（包括质量管理体系相关服务）的供应商或外部方。 ISO 13485:2016的要求适用于任何规模和类型的组织，除非明确规定。 如果规定要求适用于医疗设备，则要求同样适用于组织提供的相关服务。 ISO 13485:2016要求的适用于组织但非由组织执行的过程是组织的责任，并通过监控、维护和控制这些过程纳入组织的质量管理体系。 如果适用的监管要求允许排除设计和开发控制，这可以作为将其排除在质量管理体系之外的理由。这些监管要求可以提供质量管理体系中需要解决的替代方法。组织有责任确保符合ISO 13485的声明: 2016年反映了对设计和开发控制的任何排除。 如果ISO 13485:2016第6、7或8条中的任何要求因组织开展的活动或质量管理体系适用的医疗器械的性质而不适用，则组织无需将此类要求纳入其质量管理体系。对于任何被确定为不适用的条款，组织应按照4.2.2所述记录理由。

ISO 13485:2016 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. 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. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. 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 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.

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. These regulatory requirements can provide alternative approaches that are to be addressed in the 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.

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. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.