Quality Management System Support
A strong Quality Management System (QMS) is the backbone of any regulated business. At Q6S Solutions, we help Medical Device, Aerospace, and other regulated organisations build and sustain high-performing quality systems.
WHAT WE DO
Our support spans the full lifecycle of quality management, from system design to complaint resolution, ensuring compliance, resilience, and continuous improvement. Whether you're preparing for inspection, managing change, or strengthening your QMS, we provide tailored, hands-on support that delivers measurable impact.
QMS Design & Optimisation
We develop fit-for-purpose QMS frameworks aligned with ISO 9001, AS9100, ISO 13485, FDA QMSR, EU-MDR, and other global standards. Our approach balances regulatory compliance with operational practicality, ensuring your system supports performance, not bureaucracy.
Risk Assessment & Mitigation
We embed risk-based thinking into your processes, helping you proactively identify, evaluate, and control risks. Our strategies support decision-making, reduce uncertainty, and satisfy regulatory expectations.
Change Management & Team Engagement
We guide operational and quality teams through compliant change, ensuring structured planning, clear communication, and stakeholder alignment. Our approach builds ownership, reduces resistance, and embeds lasting improvements.
Compliance Management & Inspection Readiness
We help you demonstrate control, close gaps, and build confidence with regulators. Whether you're preparing for an audit or responding to findings, our support ensures your systems and teams are inspection ready.
Continuous Improvement
We foster a culture of learning and accountability, using Lean, Six Sigma, and data-driven tools to drive sustainable improvements across your operations.
CAPA & Complaints Management
We strengthen your Corrective and Preventive Action processes and complaint handling systems, ensuring issues are resolved at the root and recurrence is prevented. Our approach supports regulatory compliance and customer trust.
Validation Strategy & Approach
We support the planning, execution, and documentation of validation activities, covering equipment, processes, and software. Our strategies align with regulatory expectations and ensure readiness for inspection.
Supplier Quality & Third-Party Management
We help you build robust supplier and third-party quality programs that drive accountability, transparency, and performance. From onboarding and audits to performance reviews and issue resolution, we ensure your partnerships support your quality objectives and regulatory obligations.
OUR APPROACH
We take a hands-on, collaborative approach.
We listen first, diagnose quickly, and act with precision. Every engagement follows a simple, proven process.
01
Discover & Diagnose
Strategic assessment of your systems, risks, and improvement opportunities
02
Design & Align
Co-develop a roadmap that integrates QMS enhancements, risk controls, and change strategies.
03
Engage & Empower
Through coaching, workshops, and mentoring, we build capability and foster ownership across your organisation.
04
Sustain & Strenghten
Provide ongoing support to embed change, track performance, and evolve your quality culture.
YOUR RESULTS
You gain a compliant, efficient, and resilient QMS that adds value to your business.
You’ll see:
Greater confidence before audits & inspections
Fewer compliance gaps & non-conformities
Stronger, clearer operational control
