WHO Consults on QMS Guideline for Regulators

Regulatory NewsRegulatory News
| 06 March 2019 | By Michael Mezher 

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.
The guideline is part of WHO’s effort to strengthen national regulatory systems around the world as set out in World Health Assembly resolution WHA67.20, which states that “effective regulatory systems are an essential component of health system strengthening and contribute to better public health outcomes.”
WHO also points out that a recent assessment of regulators in 43 low- and middle-income countries found that most of those regulators either had yet to implement a QMS or their QMS needed improvement.
WHO says that regulators should read the guideline in conjunction with ISO 9001:2015; ISO 9000:2015, which provides terms and definitions related to QMS principles; and ISO/TS 9002:2016, which provides general advice on QMS implementation.
The guideline itself takes the 11 clauses (clauses 0-10) from ISO 9001:2015 and adapts them to be more specific to the needs of regulators.
The guideline also includes a step-by-step checklist for implementing a QMS that points to the specific ISO 9001:2015 clause referred to in each step as well as who within the organization should be responsible for overseeing that step.
Lastly the guideline discusses some of the challenges to implementing a QMS that regulators may face, especially when the QMS spans across multiple departments or offices in a decentralized organization and provides recommendations for how to address those challenges.


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