Be VERY careful. One of the most typical and "deadly" mistakes when developing quality systems is to think that quality (and the quality system) lives/exists outside of the organization business processes. That is the surest way to sabotage your quality system maturity journey. Organizations who don't understand that are ALWAYS fighting a corporate dysfunction towards quality excellence. Until people understand that sustainable quality can only exist when it is seamlessly and stealthly embedded in the way business happens, it will be a Sisyphusian uphill battle.Quality System docs sit underneath corporate policy and alongside uncontrolled documents for each department; but if and when work activities hit the QMS scope, work is controlled and directed by the system. Only a very small amount of what we do hits the scope, so the system is nestled amongst much wider / informal systems.
One of the most typical and "deadly" mistakes when developing quality systems is to think that quality (and the quality system) lives/exists outside of the organization business processes. That is the surest way to sabotage your quality system maturity journey. Organizations who don't understand that are ALWAYS fighting a corporate dysfunction towards quality excellence. Until people understand that sustainable quality can only exist when it is seamlessly and stealthly embedded in the way business happens, it will be a Sisyphusian uphill battle.
While I tend to agree with Sidney when it comes to the archaic nature of the pyramid, I still say that if it works, it's OK. We're not in a position to see what you see. I will say, however that with regard to "quality indicators," it's almost always a mistake to believe that if you change the name of a thing, the nature of it will change. They're still instructions.The reason for designing our approach in the way I've described is essentially to make it work and be a meaningful quality management system. We are a huge organisation; making medical devices is a tiny bit of the work that we do, but when we do it, we want to do it to a high standard and provide assurance to our customers that this is the case. We cannot expect or demand that the organisation flexes around our QMS policy and documentation requirements in that regard; it just needs to be concordant with it. Quite frankly, making medical devices does sit outside of many of our other organisational policies and procedures, but where this activity needs to, it will interface with relevant business processes. I understand the sentiment of your point, but National Health Systems are complex beasts. I'm describing a system that sits within and alongside other systems.
The pyramid approach is very archaic.