Seriously, not much surprising here. What this guide definitely does is place early research in the framework of Q10 and point out that there is one quality system to rule them all and that level of rigor is based on risk.
The guidances that health authorities adopt for themselves can tell us much about what they think is important. WHO recently revised the Guidance on QMS for National Inspectorates to align with international standards and the latest quality management system (QMS) principles and to expand the document’s scope. This guidance is pretty much saying “Get with the times.”
Nothing here is that unfamiliar to folks who are familiar with IS 9001 or most other standards. There are sections on management, management system planning, resources, personnel, infrastructure and documentation. There is a section on a section on operational planning and performance evaluation. WHO states inspections, should be planned in advance and risk management principles should be established for prioritizing inspection.
The document is in it’s comment period through September.