''7.3.3 Design and development outputs''

The outputs of design and development shall be provided in a form that enables verification against the
design and development input and shall be approved prior to release.

Design and development outputs shall
a) meet the input requirements for design and development,
b) provide appropriate information for purchasing, production and for service provision,
c) contain or reference product acceptance criteria, and
d) specify the characteristics of the product that are essential for its safe and proper use.
Records of the design and development outputs shall be maintained (see 4.2.4).
NOTE Records of design and development outputs can include specifications, manufacturing procedures, engineering drawings, and engineering or research logbooks.
bag
quality_public
created
Fri, 20 Mar 2015 00:41:24 GMT
creator
dirkjan
modified
Fri, 20 Mar 2015 00:41:24 GMT
modifier
dirkjan
tags
ISO13485