Quality Assurance
Ensuring precision, compliance, and reliability across every stage of development
In sectors where performance and safety are non-negotiable – such as defence, space, and medical – quality assurance must be seamlessly integrated into every phase of our offer. Plextek’s challenge is to maintain agility and innovation while upholding rigorous standards that meet both regulatory and client expectations.
With over 35 years of experience delivering complex engineering solutions across highly regulated sectors, Plextek has embedded quality at the heart of its innovation process. Our heritage is built on a rigorous approach to quality assurance that ensures every product and system we develop meets the highest standards of reliability, safety, and compliance.
By combining technical excellence with a proactive quality culture, Plextek consistently delivers outcomes that exceed expectations – whether it’s ensuring regulatory compliance for medical devices or maintaining mission-critical performance in defence systems.
Why Quality Assurance matters
In high-stakes sectors like defence, space and medical, the cost of failure is too great to leave quality to chance. At Plextek, Quality Assurance is not a checkpoint, it’s a continuous, integrated discipline that underpins every stage of our engineering and product development lifecycle. It ensures that innovation is delivered with precision, compliance, and confidence.
Our approach
Our approach combines deep expertise in rigorous standards such as ISO 9001, AS9100, and ISO 13485 with agile, data-driven methodologies that fit to the complexity of each project. We embed quality from concept through to production, using requirement definition and quality planning, real-time risk management, design control and review, advanced verification techniques, supplier quality assurance, production quality controls and continuous improvement to ensure every component and system performs as intended.
Measurable benefits
This proactive, systems-level approach delivers measurable benefits: reduced rework and waste, faster time to market, and enhanced customer trust. It also unlocks innovation potential, by creating a stable, compliant foundation that allows our engineers to push boundaries without compromising on reliability or safety.
Real-world challenges
Our clients face a common challenge: how to innovate rapidly while maintaining the highest standards of quality, safety, and compliance. Whether it’s developing life-critical medical devices or mission-ready defence systems, the margin for error is zero, and the pressure to deliver is immense.
At Plextek, we’ve helped organisations overcome these challenges by embedding robust Quality Assurance practices into every stage of the product lifecycle. For example, in the medical sector, we’ve supported clients in achieving ISO 13485 compliance for complex diagnostic devices, ensuring regulatory approval and patient safety. In defence, our rigorous testing and verification processes have enabled the deployment of high-reliability systems in harsh operational environments.
Our Quality Management System, certified to ISO 9001:2015 and ISO 13485:2016, ensures traceability, risk mitigation, and continuous improvement across all projects. This approach not only reduces rework and accelerates time to market but also builds long-term trust with our clients.
- Integrated Quality Management Systems (QMS)
Our ISO 9001:2015 and ISO 13485:2016 certified QMS ensures traceability, compliance, and continuous improvement across all projects. This system enables real-time monitoring, structured documentation, and seamless audit readiness.
- Design Verification & Validation (V&V)
We apply rigorous V&V processes throughout the development lifecycle, using simulation, prototyping, and formal testing to ensure that every design meets its intended function and regulatory requirements.
- Risk-Based Quality Planning
Leveraging tools like FMEA and fault tree analysis, we proactively identify and mitigate risks early in the design process reducing costly rework and enhancing product reliability.
- Supplier Quality Assurance
Our robust supplier evaluation and monitoring framework ensures that all components and services meet stringent quality standards, supporting consistent performance and compliance throughout the supply chain.
- Regulatory Compliance Expertise
We support clients in navigating complex regulatory landscapes, including CE marking, FDA submissions, and defence standards ensuring products are compliant from concept to commercialisation.
- Continuous Improvement & Root Cause Analysis
Using Lean, Six Sigma, and 8D methodologies, we drive continuous improvement initiatives that enhance efficiency, reduce nonconformities, and foster a culture of quality across teams.
What sets Plextek Apart in Quality Assurance
At Plextek, quality is not just a function, it’s a philosophy embedded in every layer of our engineering process. What sets us apart is our ability to combine deep domain expertise, certified quality systems, and cutting-edge innovation to deliver solutions that are not only compliant but also transformative.
Our unique position stems from decades of experience in regulated sectors such as defence, space, medical, and communications, where we’ve consistently delivered high-reliability systems underpinned by rigorous quality assurance. We’re not just implementers – we’re active contributors to industry standards and research, ensuring our clients benefit from the latest thinking in quality engineering and compliance.
“Quality is the foundation of trust in every solution we deliver. At Plextek, our commitment to rigorous quality assurance enables us to innovate with confidence - knowing that every product meets the highest standards of performance, safety, and compliance.”
Dennis Hayes
QHSE Manager
Talk to Our Experts
Ready to elevate your quality standards?
At Plextek, we don’t just deliver products, we engineer end-to-end solutions with quality built in from concept to deployment. Whether you’re navigating complex regulations or seeking to enhance reliability and performance, our team is here to help you explore possibilities and get started with confidence.
