What is the right kind of vehicle?
It's a silly question because we all know that the answer depends on one's particular needs, values and budget. Depending on these and other factors, you might choose a sports car, a panel van, a scooter, a bicycle, a sedan, an airplane, a pickup truck, etc. To me, it's clear that there is no one best type of vehicle for all occasions (though I know a couple Prius owners who might disagree).
My mantra as a consultant over the years has been that are many ways to be in compliance with regulations. There isn't a single way to design documentation or procedures. There are established ways for doing things but each company needs to evaluate what the best way is for the to reach regulatory goals. This can be challenging, however, because many of us learned our craft at a large company that insisted on doing things a particular way. Once removed from the company, these "best ways" are not necessarily as valuable as they used to be, but we stick with them because they're what we know best.
Let's try and put this into an example. In the US, we drive our cars on the right side of the road and in the UK they drive on the left. Neither approach is inherently better, but there is tremendous value in picking a standard and sticking to it. At the corporate level, there can be a lot of value to choose some local standards and sticking with them. But only a great fool would travel from one country to the other and insist on driving on the side they're accustomed to. What is correct and valuable behavior in one situation is not necessarily so in another.
The requirements regulators impose on IVD companies are, in many ways, like rules of the road. There are many rules related to safe conduct that range from the general (such as speed limits) to the exactingly specific (such as axel widths) but you won't see many rules limiting where one may drive, how a route must be chosen or what kind of car can be used. Automotive regulations seem pretty impressive and yet we can look around to see the wide range of different vehicles that all conform to the definition of "road worthy".
I drive an Infiniti. I find the mix of some luxury features with a clean, basic design to the right level of comfort for me. But I remember the days of driving my 10-year-old Camry that had 200,000 miles on it. I’m a little more comfortable in my car now and have additional buffer if things go wrong (i.e., air bags) and I might even go more places now that I don’t worry about the car breaking down. But my old Camry got me lots of cool places for not much money. That Camry was the right car for me when I bought it, just as my Infiniti is the right car for me now.
Picking the right kind of quality system isn't much different from picking the right car. Your budget constraints may take precedence over your comfort and convenience. You may need to emphasize the mitigation of specific risks. You may be looking to emphasize the more intangible qualities of elegance or robustness. There are many different ways to get where you're going and each solution has its own tradeoffs and options.
Most small companies will need to start out with a basic, no-frills model... the Kia of quality systems, if you will. The system will need to be functional and complete but it won’t need the same features that may be necessary for a larger organization. The risks faced by a single product company simply aren’t the same as the risks for a large, multi-national company --- and the systems that are put in place need to reflect that difference.
What has become clear to me over the years that the greatest risks tend to lie at the extremes. A system that is overly simple may not protect the company adequately during difficult moments, just as the cheapest smallest car may not do well in a traffic accident. By the same token, there is also risk in driving around the largest, most unwieldy system. Trying to remain in compliance with an overly complex system may provide you with some kinds of safety, but may do so at the expense of others. A heavy SUV might done fine in a collision, but you could be more likely to flip it on a curvy road.
These are general observations. What matters is that you pause to consider what kind of system your company needs, not simply default into the kind of system your quality person used at their last job. Quality systems work best and deliver the greatest value when they are tailored for your company's specific needs.