The Templated Quality System: Mistakes Made
Time and time again I walk into an organization to audit their quality management system and I find that the overall processes and controls are well understood and executed, but the documentation just doesn’t match actual practices. Templates are great tools to help an organization meet the documentation requirements of ISO 9001, AS9100, or any standard. The problem is, most companies buy the templates and insert the name but never modify the templates to their particular processes. The results from such miss use of this tool are non-conformances found during a surveillance or registration audit.
Templates can help save time and help an organization cover all of the requirements of the standard, but they can hurt and organization if they are not used properly. Plan your processes and understand the standard that you have chosen to become certified to. Knowing what is required and what is not can help you to modify the templates to reflect your organizations actual practices. Most non-conformances, about 90% to be exact, are written against what the organization has required of itself or documentation that does not match the processes, not the standard. So if you are thinking of buying a template system, know what you are getting into and spend the time to modify them to match your processes.
It is either the documentation does not reflect the process or it is so detailed no one reads it. A problem with templated documentation is it requires customization, a task very few people relish doing so it falls by the side until the first external audit.