Quality Manual vs. Quality Management System (QMS)

Quality Manual vs. Quality Management System

What is the difference between a Quality Manual and a Quality Management System (QMS)?

A quality manual is just a document, while a quality management system is a network of processes. Your quality manual is supposed to document your system; it is not supposed to be your system. Your manual is not your system—they are two different things. Your quality manual is all about paperwork, while your quality management system (QMS) is a web of real processes. A quality management system is a set of interrelated or interacting elements that organizations use to direct and control how quality policies are implemented and quality objectives are achieved.

A process-based QMS uses a process approach to manage and control how its quality policy is implemented and quality objectives are achieved. A process-based QMS is a network of many interrelated and interconnected processes (elements).

Each process uses resources to transform inputs into outputs. Since the output of one process becomes the input of another process, processes interact and are interrelated by means of such input-output relationships. These process interactions create a single process-based QMS.

Obviously, a quality system is not a manual, nor is it a computer program. This is an important point. It is important because many consultants sell quality manuals and computer programs that claim to provide an instant solution: usually, all you have to do is edit the manual or install the computer program and, bingo, you have got a complete QMS. This is false and misleading. A manual is just a document and a computer program is just an information system; it is not a real QMS that exists in the real world. Your quality management system does not sit on your shelf, nor does it live inside your computer.

All of this needs to be clarified because some people think that once they have written their quality manual or purchased a computer program to manage ISO documents, they are finished. This is because they believe that their quality manual or their computer program is their quality management system. As we have seen, this is wrong.

Of course, there is nothing wrong with writing a quality manual or using computers to help you manage or document your quality management system. Just do not confuse a paper system with a real system.

ISO wants you to establish a quality management system that complies with the ISO 9001:2008 standard and to document that system using a quality manual. That is your basic mission.

The Quality Documentation Triangle Structure

The structure of QMS documentation is typically represented as a hierarchy or triangle, consisting of the following levels:

1. Policies: Define the direction and commitments of the organization.
2. Procedures: Detail the methods and processes used to implement policies.
3. Work Instructions: Provide step-by-step directions for specific tasks.
4. Records: Provide objective evidence of activities performed and results achieved.