If there's two facts about the quality of an analytical laboratory that you'll never read in a Quality Manual, it's the following:
(1) Quality is primarily a function of the calibre of the people you employ, their skills and their levels of dedication.
(2) If you devise job definitions which make people's work excessively routine and repetitive, if there is insufficient opportunity to learn new skills, or to exercise discretionary judgement, and if you generally require your employees to follow the steps of a process which is prescribed for them, then those employees will lack pride in their work, will have low levels of dedication, and, unless you rigorously enforce performance metrics and have the power to sack underperforming employees, the work of those employees will generally be of a low quality.
Despite the evidential truth of these statements, the corporate management of an analytical laboratory will eagerly buy into the notion that quality is a function of management systems and processes. Such a notion not only appeals to the self-aggrandising instincts of the management, it also absolves them of responsibility for the thing they really hate doing: namely, thinking critically and imaginatively about the job definitions and career development of their own employees.
To be clear, good management processes and systems are still a necessary condition for quality. High calibre employees working within a bureaucratic, inefficient management system, will find their efforts stymied on a regular basis. The point, however, is that quality systems are not alone sufficient to ensure analytical quality.
Many managers of analytical laboratories are smart enough to realise this. They know that systems and processes won't solve the underlying problem of poor calibre staff, wafer-thin levels of talent, and levels of dedication which can only be measured with a micrometer. They despair, however, of solving this fundamental problem, and decide instead that their only goal should be to cover themselves. And in this context, the perfect way of covering your managerial backside is to introduce quality systems and processes revolving around documentation, audits and accreditation.
After doing all this, the analytical laboratory will still be as piss-poor as it was to begin with, perhaps even more so, but this is of no concern to the corporate manager, who will happily move onto his or her next role, proudly claiming to have transformed the quality of the laboratory. And they'll have the accreditation certificates to prove it.