Dear Henry,
A SOP for changing SOP's is coming but not with us yet. It is called a
document control procedure and part of the Quality Management system as
described in the ISO 9000 family of Quality Management standards (latest one
is ISO 9002 as I recall). Clinical laboratories and associated
accreditation systems are likely to be moving towards the standard ISO 15182
"Quality management in the clinical laboratory" which refers to ISO 9002 for
the quality management aspects. That includes CPA; draft new standards are
being released at present for consultation which will bring CPA's standards
in line with the relevant ISO standards. It is intended that these will be
brought into effect in April 2002. But you will be OK as far as this is
concerned in your forthcoming inspection.
David
%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
|