Quality Management Standard for Medical Devices
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 organizationThe 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
استاندارد مدیریت کیفیت درتجهیزات پزشکی 13485 ISO
استاندارد ISO134853 تخصصی برای تجهیزات پزشکی می باشد برای اببات انطباق با الزامات اتحادیه اروپا , می توان سیستم مدیریت کیفیت بر استاندارد ISO13485راپیاده سازی نمود و گواهینامه آن را دریافت کرد. در این استاندارد توجه ویژه به اصول GMPو GHPدارد وانجام ریسک آنالیز ، شناسائی مشکالت احتمالی و برنامه جهت جلوگیری از آن و توجه به نگهداری و تعمیرات و خدمات تجهیزات پزشکی انجام می شود در این استاندارد نظارت دقیق و مستند سازی امور و الزامات ویژه برای تجهیزات پرخطر و قابل کاشت فعال و... اشاره نموداست.
استاندارد ایزوهای مرتبط:
صدور و اخذ گواهی استاندارد مدیریت کیفیت درتجهیزات پزشکی 13485 ISO توسط گروه ایزوکاران در کوتاهترین زمان و بهترین خدمات
جهت پاسخگویی سریع به سوالات شما درباره 13485 ISO به آدرس تلگرامی isokaran@ مراجعه نمایید.
