Iso 13485 design control
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#ISO 13485 DESIGN CONTROL ISO#
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. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. 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. The updated ISO 13485:2016 replaces all previous versions in March 2019.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. It underpins the manufacturers’ duty of ensuring devices consistently meet customer and applicable regulatory requirements. ISO 13485 applies to both manufacturers of medical devices and organisations that support medical device manufacturers.
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The revised standard includes the need for a risk-based approach to the QMS, an enhanced focus on regulatory requirements and the responsibilities of top management, increased controls over suppliers and outsourced activities, and an emphasis on risk management throughout the product lifecycle. ISO 13485:2016 introduces a host of subtle, yet detailed, changes requiring more thorough documentation on the work environment, risk management, design control and regulatory requirements. ISO 13485:2012 maintains its status as the harmonised standard and the presumption of conformity until the end of the transition period. The international quality management system (QMS) standard for medical devices, ISO 13485:2016 (Medical Devices – Quality management systems – Requirements for regulatory purposes) was published 1 March 2016, with the International Accreditation Forum (IAF) allowing certified organisations three years to transition from previous versions. LRQA supports clients in their efforts to meet the stringent requirements of ISO 13485, fine-tuning product development lifecycles to ensure a timely market launch. In the highly-regulated world of medical device manufacturing, organisations have a duty to show that every device meets both customer expectations and applicable regulations.