''7.5.1.2.1 Cleanliness of product and contamination control''

The organization shall establish documented requirements for cleanliness of product if
a) product is cleaned by the organization prior to sterilization and/or its use, or
b) product is supplied non-sterile to be subjected to a cleaning process prior to sterilization and/or its use, or
c) product is supplied to be used non-sterile and its cleanliness is of significance in use, or
d) process agents are to be removed from product during manufacture.

If product is cleaned in accordance with a) or b) above, the requirements contained in 6.4 a) and 6.4 b) do not
apply prior to the cleaning process.

''7.5.1.2.2 Installation activities''
If appropriate, the organization shall establish documented requirements which contain acceptance criteria for installing and verifying the installation of the medical device.

If the agreed customer requirements allow installation to be performed other than by the organization or its authorized agent, the organization shall provide documented requirements for installation and verification.

Records of installation and verification performed by the organization or its authorized agent shall be maintained (see 4.2.4).

''7.5.1.2.3 Servicing activities''
If servicing is a specified requirement, the organization shall establish documented procedures, work instructions and reference materials and reference measurement procedures, as necessary, for performing servicing activities and verifying that they meet the specified requirements.

Records of servicing activities carried out by the organization shall be maintained (see 4.2.4).
NOTE Servicing can include, for example, repair and maintenance.
bag
quality_public
created
Thu, 16 Apr 2015 14:57:03 GMT
creator
dirkjan
modified
Thu, 16 Apr 2015 15:15:01 GMT
modifier
dirkjan
tags
ISO38485