Service Products - Requirements (10775 results)

  • Servicex
  • Requirementsx
ISO 13485 2003 Medical Devices

ISO 13485 2003 Medical Devices

ISO 13485:2003 - Medical devices -- Quality management systems -- Requirements for regulatory purposes 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 requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization. If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality ISO-13485:2003 basically consists of: 1) certain ISO-9001 requirements and 2) newly defined requirements catering specifically to the medical device industry As such, ISO-13485 differs from ISO-9001 in certain ways, modifying or even excluding some of the latter's requirements. For instance, the ISO-13485 excludes the ISO-9001's requirements related to continual improvement because most medical device regulations require organizations ISO-9001 customer satisfaction requirements were also excluded because some of the committee members who worked on ISO-13485 found them to be too subjective...

Copyright © 2000 - 2017 IndiaBizClub. All rights reserved