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For ‘in-house’ departments, quality manuals which document
operating policies and procedures need to be verified. These
will cover not only existing activities such as purchasing, repair
and pre-planned maintenance but also other activities such as
document control, corrective action and quality records.
If ‘in-house’ maintenance is chosen, enough time and money
must be allocated for training of technicians to a level
equivalent to that of the supplier so that they are able to provide
a high-quality, safe service. Regular on-going training provided
by the supplier should be the norm.
10.5 Spares
Suppliers have a responsibility to provide spares for seven years
after delivery of the last example of a particular model.
The responsibility for obsolete devices more than seven years
old is that of the Trust, and the need for insurance should be
assessed and acted upon.
10.6 Modifications
If a modification is undertaken on a CE marked device, other
than by the manufacturer, then responsibility for the safety and
liability for the modification changes to the organisation that
has completed the modification. One particular example is if a
device labelled as single-use is reprocessed for further use.
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