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ANSI AAMI ISO 13485 pdf free download

ANSI AAMI ISO 13485 pdf free download.Medical devices — Quality management systems — Requirements for regulatory purposes.
4 Quality management system 4.1 General requirements 4.1.1 The organization shall document a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard and applicable regulatory requirements. The organization shall establish, implement and maintain any requirement, procedure, activity or arrangement required to be documented by this International Standard or applicable regulatory requirements. The organization shall document the role(s) undertaken by the organization under the applicable regulatory requirements. NOTE Roles undertaken by the organization can include manufacturer, authorized representative, importer or distributor. 4.1.2 The organization shall: a) determine the processes needed for the quality management system and the application of these processes throughout the organization taking into account the roles undertaken by the organization; b) apply a risk based approach to the control of the appropriate processes needed for the quality management system; c) determine the sequence and interaction of these processes. 4.1.3 For each quality management system process, the organization shall: a) determine criteria and methods needed to ensure that both the operation and control of these processes are effective; b) ensure the availability of resources and information necessary to support the operation and monitoring of these processes; c) implement actions necessary to achieve planned results and maintain the effectiveness of these processes;d) monitor, measure as appropriate, and analyse these processes; e) establish and maintain records needed to demonstrate conformance to this International Standard and compliance with applicable regulatory requirements (see 4.2.5). 4.1.4 The organization shall manage these quality management system processes in accordance with the requirements of this International Standard and applicable regulatory requirements. Changes to be made to these processes shall be: a) evaluated for their impact on the quality management system; b) evaluated for their impact on the medical devices produced under this quality management system; c) controlled in accordance with the requirements of this International Standard and applicable regulatory requirements. 4.1.5 When the organization chooses to outsource any process that affects product conformity to requirements, it shall monitor and ensure control over such processes. The organization shall retain responsibility of conformity to this International Standard and to customer and applicable regulatory requirements for outsourced processes. The controls shall be proportionate to the risk involved and the ability of the external party to meet the requirements in accordance with 7.4. The controls shall include written quality agreements. 4.1.6 The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application. The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software. Records of such activities shall be maintained (see 4.2.5).The organization shall ensure that changes to documents are reviewed and approved either by the original approving function or another designated function that has access to pertinent background information upon which to base its decisions. The organization shall define the period for which at least one copy of obsolete documents shall be retained. This period shall ensure that documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical device as defined by the organization, but not less than the retention period of any resulting record (see 4.2.5), or as specified by applicable regulatory requirements.ANSI AAMI ISO 13485 pdf download.

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