International – WHO Consults on QMS Guideline for Regulators

The World Health Organization (WHO) in January released for consultation a draft of its upcoming guideline on implementing quality management systems (QMS) for national regulatory authorities (NRAs).

Specifically, the 96-page draft guideline is meant to fill the gaps for NRAs looking to implement a QMS based on the International Organization for Standardization’s (ISO) 9001:2015 Quality Management Systems – Requirements standard, as other existing QMS guidelines do not specifically focus on how regulators can implement a QMS.

“The expectation is that this will increase the reproducibility of the quality and consistency of outputs (products and services), customer focus and stakeholder satisfaction,” WHO writes, noting that the guideline can be applied across “all regulatory functions, including registration and marketing authorization, vigilance, market surveillance and control, licensing establishments, regulatory inspections, laboratory access and testing, clinical trials oversight and lot release.”

The consultation is set to run for three months from 15 March to 15 June 2019, with the goal of having a final guideline released by the end of the year…