Your organisation must be able to demonstrate that the overall process (sales right through to delivery to the end user) is under adeqaute control.
There are many very different processes involved, in both the manufacturing and service sectors. Accordingly only the general principles are set out in this Clause of ISO 9000. Each organisation must control the processes involved accordingly.
The process must be carried out in a controlled way, so that plans / procedures / drawings / samples / instructions (as relevant) are to hand, and that all equipment and personnel involved are adequate and that the general conditions are amenable to achieving the plans.
In summary : To ensure that a process is carried out in a controlled manner :
In place of, or in addition to, plans / procedures / instructions, work examples may also be used :
Where it is not possible to prove that a manufacturing process has been sucessfully completed, the standard requires that only suitably trained operators or used. (e.g. in the case of welding work where it is not possible to prove that the weld is adequate, except by destroying the weld, a qualified -"coded" - welder must be used) or else some form of standard operating conditions used, which can be used to provide assurance that if the conditions were correct, the work must be acceptable.
Where such processes or operators are used, adequate records must be maintained to prove that the requirements have been achieved.
