''7.5.1.1 General requirements''

The organization shall plan and carry out production and service provision under controlled conditions.

Controlled conditions shall include, as applicable
a) the availability of information that describes the characteristics of the product,
b) the availability of documented procedures, documented requirements, work instructions, and reference materials and reference measurement procedures as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring devices,
e) the implementation of monitoring and measurement,
f) the implementation of release, delivery and post-delivery activities, and
g) the implementation of defined operations for labelling and packaging.

The organization shall establish and maintain a record (see 4.2.4) for each batch of medical devices that provides traceability to the extent specified in 7.5.3 and identifies the amount manufactured and amount approved for distribution. The batch record shall be verified and approved.

NOTE A batch can be a single medical device
bag
quality_public
created
Fri, 20 Mar 2015 01:12:57 GMT
creator
dirkjan
modified
Fri, 17 Apr 2015 08:33:00 GMT
modifier
dirkjan
tags
ISO13485