Documented Information for QMS
We’re creating our documentation hierarchy as part of implementing a QMS based on ISO 9001 and were thinking of creating for each of our core business processes for delivery of services a short (1-2 page) high-level overview document in addition to our Quality Manual, SOPs, work instructions and templates. These documents will identify the inputs (lists of requirements, documentation, other resources, clients needs & expectations), activities, process workflow diagram, supporting processes and outputs (records, data/metrics) associated with the specific process (i.e., much like turtle diagrams). We are interested to hear thoughts from other organizations on the below questions, if your organization happens to also make use of separate process overview documents:
  • Do your process overview documents include different content than that mentioned above?
  • Are your process overview documents managed as controlled documents and, if so, where do they fit within your organization’s controlled documentation hierarchy?
  • Do you duplicate information in these documents that can be found elsewhere in SOPs or other documents (e.g., required roles to carry out the process, list of clients & their needs/expectations, key performance indicators/metrics, etc) or, do you instead make reference/link to other documents where the information is located?
  • If the activities within the process are carried out by multiple organizational areas (Divisions, Units, Centres, etc), then how have you assigned responsibility to maintain these documents? (e.g., centralize the maintenance to a Quality Management Division, or assign to someone in one of the multiple organizational areas).
​​​​​​​Thank you