''4.2.4 Control of records''

Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain [[legible|Legible]], readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.

The organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than two years from the date of product release by the organization or as specified by relevant regulatory requirements.
bag
quality_public
created
Thu, 19 Mar 2015 20:21:10 GMT
creator
dirkjan
modified
Fri, 20 Mar 2015 11:06:00 GMT
modifier
dirkjan
tags
ISO13485