Sixteen Steps from First Assessment to ISO 9001:2015 Certification
What a national regulatory authority or pharmaceutical manufacturer must put in place, in what order, and how long each implementation stage realistically takes.
We publish a small, selective collection of original articles each year, written by senior consultants drawing directly from our project experience across the UK, Europe, and Africa.
What a national regulatory authority or pharmaceutical manufacturer must put in place, in what order, and how long each implementation stage realistically takes.
Quality management systems rarely stall because of technical gaps. This article sets out the three structural causes and a diagnostic framework for restarting a stalled system.
Why sponsors remain accountable for outsourced clinical supply, and how to move vendor requalification from a calendar formality to a risk-based, performance-informed process.
Where AI can safely take over routine processing in post-approval CMC change management, and where accountable human experts must keep control.
The regulatory agencies involved (NAFDAC, SON, Trademark Registry) and the correct sequence to approach them, from product classification to local representation and trademark filing.
Key indicators of site compliance culture during the opening hours of a facility inspection, and the integrated framework that keeps a site in a daily state of control.
ISO 9001:2026 is an evolution of the 2015 standard. This article sets out what changes, the transition deadlines, and how to use AI safely with human accountability.
Operational methodologies for multi-jurisdictional health system evaluations across English and French regions.
A quality system that supports research may need substantial development before clinical manufacturing or commercial launch. This article explains how to work backwards from the next business milestone, identify the controls and capabilities it requires, and sequence implementation. It also examines where an eQMS supports that work and which decisions need to come first.
When sites manage shared suppliers independently, organisations can duplicate work while missing information that matters elsewhere. This article explains how to establish common supplier oversight while retaining necessary local responsibilities. It also addresses acquired sites that must develop capabilities previously provided by a former parent organisation.
Completing risk assessments does not, by itself, give leadership a reliable view of data-integrity risk or demonstrate that remediation is effective. This article explains how to connect assessments across sites with prioritised actions, accountable ownership and evidence of improvement. It also considers how lessons from existing equipment should inform future purchasing decisions.