Control of documents in a hospital (2001,Oct,1w)
First I heard that staffs of Hospital A revised its manual referring to another hospital's medical errors. It was a preventive action for HospitalA. After a month or so, by chance, I asked some of nurses of the hospital about the revised manual but they answered they did not know the manual.
The staffs said they surely distributed the manual to each nurse station. I searched the manual at a station and finally found it at the corner of the bookshelf. The head nurse of the station received the manual but forgot to inform it to nurses and train them.
From the standpoint of control of documents in 4.2.3 clause of a) to gj of ISO9001: 2000, you may find some nonconformities as follows. Of course, the hospital has no registration of ISO9001: 2000.
The manual has or is;
a) No approval
b) No review by the staffs and the head nurse
c) No identification of the revision
d) Not available at the points of nurses' use
Last month, a Japanese business magazine reported that about ten hospitals in Japan have now ISO9000 certification. Very few!
If Hospital A had a system of control of documents according to ISO9001, the confusion mentioned above might be avoided if it uses the system effectively.