> It can be done by enforcing that the company must establish and document the processes to ensure quality
You have no ideea.
It's sooo extremely easy to fake everything! I'm working with ISO15189 right now. I could just fill paperwork saying I did things that I didn't really do. Nobody could tell the difference. Sometimes there's an audit. It's announced months in advance and they only just look at the paperwork. I'm the only one here that knows the analysers have trace logs and how do get/print them. Some of those logs are just CSV text files. I could fake those too.
According to ISO, the company should do an audit every year. Last one was 3 years ago, but I'm certain that someone wrote down every year that they did it.
You have no ideea.
It's sooo extremely easy to fake everything! I'm working with ISO15189 right now. I could just fill paperwork saying I did things that I didn't really do. Nobody could tell the difference. Sometimes there's an audit. It's announced months in advance and they only just look at the paperwork. I'm the only one here that knows the analysers have trace logs and how do get/print them. Some of those logs are just CSV text files. I could fake those too.
According to ISO, the company should do an audit every year. Last one was 3 years ago, but I'm certain that someone wrote down every year that they did it.