Iso 13485 latest version
Risk-based approach for the control of all necessary processes for the.
#Iso 13485 latest version iso
ISO 13485 outlines a comprehensive quality management system for the design and manufacture of medical devices. The main changes to the current version are: Adaptation to statutory requirements. In the 2003 version, risk management played a much smaller role, focusing mainly on product design. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2. The new version of ISO 13485, published first in 1996 and revised in 2003, was officially released March 1. If any requirement in Clauses 6, 7 or 8 of this International Standard 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 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 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 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. Wherever requirements are specified asĪpplying to medical devices, the requirements apply equally to associated services as supplied by the organization. Requirements of this International Standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated.
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This International Standard 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 13485 latest version software
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 thatĬonsistently meet customer and applicable regulatory requirements. Industry requirements are on the increase as regulatory bodies, standards organizations, and patients expect ever more safety and effectiveness. In the latest version of ISO 13485, the standard has more explicit requirements for software validation.