ISO 13485 is that the internationally recognized standard for quality management systems within the medical device industry. It specifies requirements for a top quality management system where an organisation must demonstrate its ability to supply medical devices, which related services consistently meet customer requirements and applicable regulatory requirements. it’s designed and intended to be used by organisations for the planning and development, production, installation, servicing and sales of medical devices. Like other ISO management system standards, certification to ISO 13485 isn’t a requirement of the quality, and organizations can reap many benefits from implementing the quality without undergoing the certification process. However, third-party certification can demonstrate to regulators that you simply have met the wants of the quality.
ISO 13485:2012 specifies requirements for a top quality management system where a corporation must demonstrate its ability to supply medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations are often 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 style and development or provision of associated activities. ISO 13485:2012 also can be employed by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of ISO 13485:2012 are applicable to organizations no matter their size and no matter their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the wants apply equally to associated services as supplied by the organization. The processes required by ISO 13485:2012 that are applicable to the organization, but aren’t performed by the organization, are the responsibility of the organization and are accounted for within 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 will be used as a justification for his or her exclusion from the standard management system. These regulatory requirements can provide alternative approaches that are to be addressed within the quality management system. it’s the responsibility of the organization to make sure that claims of conformity to ISO 13485:2012 reflect any exclusion of design and development controls.
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