J
Hi,
I have a background in the medical device industry, but currently work at an IT department at a major (>15.000 employees) hospital. In regards to having a quality system the organization is very inmature and there are only a few systems that are run with some of the most basic ITIL processes (Incident, Problem, Change). In order to get a better control over the IT environment I have suggested to my superiors that we should look at the IEC 80001-1.
I beleive the standards looks fine in theory, but I would like to hear some real life experiences. If anyone has implemented (started to implement) the standard, I would be very happy to hear your thoughts and experiences.
I have a background in the medical device industry, but currently work at an IT department at a major (>15.000 employees) hospital. In regards to having a quality system the organization is very inmature and there are only a few systems that are run with some of the most basic ITIL processes (Incident, Problem, Change). In order to get a better control over the IT environment I have suggested to my superiors that we should look at the IEC 80001-1.
I beleive the standards looks fine in theory, but I would like to hear some real life experiences. If anyone has implemented (started to implement) the standard, I would be very happy to hear your thoughts and experiences.