Medical guidelines, prescribing how to diagnose a disease and how to treat this can be very helpful. On the other side, if a physician is obliged to follow this to the letter, it can be a burden, limiting common sense.
The same holds for ISO15189, partly helpful for improving the quality of their output and partly a burden forcing clinical laboratories into a lot of work.
What is your opinion on the balance between benefit and burden?
ISO norms are good if you are on a competitive market. It defines a basic level that everybody has to attain. Nobody gets a competitive advantage because the burden is the same for everybody. Other benefits depend on the specific implementation.
I believe that, in any fields and/or disciplines every activities shall be done following specific accepted criteria otherwise quality service or results may no longer expect. ISO provides different guidance for different areas in away that by implementing these requirements organizations should increase their quality and acquired many customers, they easily promote or purchase their products and services because peoples need quality and safe services. When we take ISO 15189:2012 which is specifically used by medical laboratories in developing quality management system and evaluating their own competency. It is obvious that implementing these minimum requirements is very challenging and difficult especially for developing countries, requires additional resources including lab personnel but it is a must to follow and adhered to it in order to provide reliable lab services. Every lab professional would also understand it as per their regular tasks.
General these guides and norms have burdens but the benefits are very very great and totally incomparable its burdens.
Surely, it is better to pursue excellence rather than accept adequate but what evidence is there that excellence actually makes things better for our patients? That said, I want to work in an excellent lab not merely an adequate one. I want to have confidence in the results I issue. I do get intrigued at the variation in what UKAS assessors accept, though. Perhaps the model is still finding it's shape?
The guidelines which have been framed for ISO in medical/ medical laboratories are based on practically tested as per QMS requirements. The benefits are amazing. It will keep you to connect with the customer all the time and more over competitive too. Now if you talk about burden, then I would say 'Yes' if you are in beginning phase of it's implementation. You might be facing some hurdles which you think that is not necessary. But it's other way around. Have patience, if you follow, it will certainly bring many benefits that you have not thought of. That's why this is ISO..Thank you..
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