Quality Policy& Standards
Our unwavering commitment to quality excellence ensures that every product meets the highest international standards, safeguarding health and wellbeing worldwide.
Quality in Numbers
Our commitment to quality is reflected in measurable results and continuous improvement
Our Quality Principles
These fundamental principles guide our approach to quality management and continuous improvement
Customer Focus
We prioritize understanding and meeting customer needs and expectations through continuous engagement and feedback.
Leadership
Our leaders establish unity of purpose and direction, creating an environment where people can engage in achieving quality objectives.
Engagement of People
We empower and engage our people at all levels, recognizing their contribution to the organization's success.
Process Approach
We manage activities and resources as interconnected processes, ensuring consistent and predictable results.
Continuous Improvement
We are committed to continuous improvement in all areas of our operations, driving innovation and excellence.
Evidence-Based Decisions
We make decisions based on the analysis and evaluation of data and information, ensuring objective outcomes.
Our Quality Process
A comprehensive six-step process ensures quality at every stage of production
Design & Development
Rigorous design processes ensuring products meet the highest standards from conception.
Supplier Qualification
Comprehensive evaluation and ongoing monitoring of all suppliers and partners.
Incoming Inspection
Thorough testing and validation of all incoming materials and components.
Production Control
Continuous monitoring and control throughout the manufacturing process.
Final Testing
Comprehensive final testing to ensure products meet all specifications.
Documentation & Traceability
Complete documentation and traceability for all products and processes.
Our Certifications
Internationally recognized certifications that validate our commitment to quality excellence
ISO 9001:2015
Quality Management System
International Organization for Standardization
ISO 13485:2016
Medical Devices Quality Management
International Organization for Standardization
FDA Registration
Food and Drug Administration
U.S. Food and Drug Administration
CE Marking
European Conformity
European Union
Quality Documents
Download our quality management documents and certifications
Quality Manual
PDF • 2.4 MB
Comprehensive quality management system documentation
ISO 9001:2015 Certificate
PDF • 1.8 MB
Official ISO certification document
Quality Policy Statement
PDF • 0.5 MB
Our commitment to quality excellence
Audit Reports
PDF • 3.2 MB
Latest quality audit findings and improvements
Questions About Our Quality Standards?
Our quality team is here to answer any questions about our processes, certifications, or quality assurance measures.