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#ISO 13485 LATEST VERSION 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. Following the last revision, this third edition of March 1, 2016, incorporates 12 years of technological progress and global regulatory changes. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system.
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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. Following consultation with interested parties in November 2018, a decision has now been made by the relevant Technical. Even before that transition period had ended moves were being made to revise the standard. 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. The last ISO 13485 revision was published in 2016 and the transition period for migration to this version ended in March 2019. The latest revision of ISO 13485 was conducted with the participation of the FDA. All ISO standards are reviewed every 5 years to establish if a revision is needed in order to keep it relevant for the most current marketplace. It was published in two versions: ISO 13485 for manufacturers (original. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization. ISO 13485: 2016 is the most recent version of ISO 13485, the preceding version being ISO 13485: 2003. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated.
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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.