ISO 10013 states that the review and utilization of existing QMS documents and references can significantly shorten the quality management system documentation development time, as well as being an aid in identifying those areas where quality management system inadequacies need to be addressed and corrected. Organizations that are in the process of implementing, or have yet to implement, a quality management system should:

  • identify the processes necessary for the effective implementation of the quality management system,
  • understand the interactions between these processes, and
  • document the processes to the extent necessary to assure their effective operation and control.

It is easy to see the logic behind this suggestion. Those who are new to the ISo 9001 will benefit tremendously from analyzing pre-written QMS documentation. They will be able to see the ISO 9001 requirements in action via the pre-written documents in hand. For example, if you are reading the clause on Quality Policy, it would definitely help to have a sample document in hand in order to understand the requirements of that particular clause better. The same goes for other documentation requirements such as for the quality manual and procedures. For the less-familiar, writing a procedure could be a challenge (maybe because it is a challenge), so wouldn't a pre-written procedure help with the process? This approach is effective and efficient.