QMS creation & implementation
A complete, proportionate management system designed around the organisation, its products, processes, markets and regulatory responsibilities.
Quality management systems
From first procedure to successful certification.
Practical support to create, implement, certify and maintain quality management systems aligned with ISO 13485, ISO 9001 and other standards relevant to your organisation.
A QMS built around the business.
RHQC can develop a complete system from the ground up, strengthen an existing framework or lead a focused certification-readiness programme.
The objective is not documentation for its own sake. Every process is designed to be usable, proportionate and capable of demonstrating effective control during day-to-day operation and external assessment.
ISO 13485
Specialist support to establish, implement and maintain a medical-device QMS and prepare for initial certification, surveillance and recertification audits.
ISO 9001 & wider standards
Quality-system support for ISO 9001 and other applicable frameworks, including integration with existing medical-device or product-compliance arrangements.
Certification planning
Gap assessment, implementation roadmap, certification-body readiness, evidence preparation and practical support throughout the certification process.
Procedures & quality documentation
Quality manuals, policies, procedures, forms, process maps and records that are controlled, usable and aligned with the way the organisation actually operates.
Management responsibility
Quality objectives, management review, responsibilities, competence, training, resource planning and management-representative support.
Operational quality processes
Document and record control, design controls, supplier management, traceability, complaints, CAPA, change control, validation and post-market processes.
Ongoing QMS maintenance
Flexible retained support to keep the system current, manage change, monitor performance, prepare for audits and strengthen continual effectiveness.
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