ISO13485:2016
ISO13485 standard
Medical equipment – quality management system
Requirements for regulatory purposes
This standard is available for free and is read-only, and this version is not editable.
Summary
The ISO13485 standard specifies the requirements for a quality management system in which an organization must demonstrate its ability to provide medical devices and related services that consistently comply with customer regulatory requirements and applicable regulations.
ISO13485:2016 can also be used by suppliers or external parties providing products.
The requirements of ISO13485:2016 are applicable to organizations regardless of their size and regardless of their type except where expressly stated. Wherever requirements are specified for medical devices, the requirements apply equally to related services provided by the organization.
If applicable regulatory requirements allow design and development controls to be removed, this permission can be used as justification for removing them from the quality management system.
If any of the requirements in clauses 6, 7 or 8 of ISO13485:2016 are not applicable due to the activities performed by the organization or the nature of the medical device to which the quality management system is applied, the organization need not implement these items. It is a requirement in the quality management system. For any condition determined not to be applicable, the organization shall record the justification described in 4.2.2.
General information
Condition : published
Date of Release : March 2014
Edit version: 03
number of pages : 51
Technical Committee : ISO/TC 210 Quality management and related general aspects for medical devices
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