The experience required to design and implement a quality management system is not the same as that required to oversee or manage a quality management system. When an organization decides that they need some type of ISO certification or accreditation, they often begin by delegating the implementation of the system to their Quality Manager. After all, with “Quality” in the title of the manager’s position and the management system, what could possibly go wrong?
So, this is what (fairly consistently) goes wrong...
Mr. (Ms.) Quality Manager has probably never designed and implemented a quality management system, so he (she) starts with a Google search or by reaching out to a previous employer or good buddy who works for an organization who has the ISO certification his organization is seeking. Armed with a downloaded or “benchmarked” copy of another company’s documentation, the Quality Manager begins the drudgery of replacing the logos and company name throughout a manual, policies, procedures, and work instructions.
Thus, the organization that has not designed its own quality management system is now in the process of implementing another organization’s processes and procedures. This “square peg in a round hole” method often requires great force and can damage inter-company communications and culture. After a few months of work (possibly during a pre-assessment audit or, worse yet, during the initial audit), the organization learns that their activities (processes) do not follow their documentation system (and, yes, they are supposed to).
This “false start” is more common that many would like to admit. I equate it to this: You may be a very good driver. [The phenomenon of Illusory Superiority shows that the vast majority of drivers consider themselves better than average.] But you may actually be a very good driver (in fact, not just in your opinion). You've received training, passed exams, been permitted, then licensed. Maybe you have continued your education by taking defensive driving classes. Maybe you have decades of experience and measure your success in tens of thousands of safe miles. And your experience may be very diverse (off-road, city, interstate, regions or countries far from home).
Now suppose you were asked to design and build an automobile. After all, you are a very good driver. Perhaps you now recognize that your training and experience are not ideal for this particular task; they are “task-adjacent."
Organizations can prevent false starts by reaching out for assistance as soon as the decision is made to pursue certification. Bringing in a consultant with experience and expertise in the design and implementation of quality management systems at the very beginning of the implementation minimizes the amount of time that the consultant will be needed. A good, experienced consultant will minimize the need for rework, help the client avoid common design flaws, and make sure the quality management system is integrated into the organization's core business.