Iso 13485 2012 pdf
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For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.
#Iso 13485 2012 pdf iso
The following ISO standards are available in read-only text format: ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes ISO 374.
#Iso 13485 2012 pdf for free
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 quality management system. For example, the ISO 13485:2016 standard in PDF format is not available for free download you can access ISO 13485 in read-only (text) format for free or, if needed, purchase the ISO 13485 PDF on the ISO website. 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 system. 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 as applying to medical devices, the requirements apply equally to associated services as supplied by the organization. Zing Multi-Positional Stander ISO 13485:2003 & EN ISO 13485:2012 Product Name: Standards Compliance: Carrot 3000 Positioning Device ECE R44/04 Universal standard Standers Carseats Exercise & Recreational Equipment Alternate Indoor Seating Version: of 4. Requirements of this International Standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Or external parties that provide product, including quality management system-related services to such organizations. This International Standard can also be used by suppliers 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. 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 that consistently meet customer and applicable regulatory requirements.