Quality & Certifications
Committed to the highest standards of quality, safety, and regulatory compliance in every product we manufacture.
Our Quality Commitment
At IndieCaters, quality is not just a goal—it's a fundamental principle that drives everything we do. Our comprehensive quality management system ensures that every product meets the highest international standards.
We maintain state-of-the-art testing facilities and employ rigorous quality control processes to guarantee the reliability and accuracy of our industrial indicators.
Our Certifications
Internationally recognized certifications that validate our commitment to excellence
ISO 9001:2015
Quality Management System
International standard for quality management systems ensuring consistent quality in products and services.
Key Benefits:
- Enhanced customer satisfaction
- Improved process efficiency
- Better risk management
- Continuous improvement culture
ISO 13485:2016
Medical Device Quality Management
Specialized standard for medical device quality management systems ensuring safety and efficacy.
Key Benefits:
- Medical device compliance
- Regulatory requirement fulfillment
- Enhanced patient safety
- Global market access
FDA 21 CFR Part 820
Quality System Regulation
US FDA regulation for medical device quality systems ensuring safety and effectiveness.
Key Benefits:
- US market compliance
- Regulatory approval pathway
- Quality system requirements
- FDA inspection readiness
CE Marking
European Conformity
European conformity marking indicating compliance with EU health, safety, and environmental standards.
Key Benefits:
- European market access
- EU regulatory compliance
- Product safety assurance
- Free movement within EU
Industry Standards Compliance
Full compliance with international standards and regulations
ISO 11140
Chemical Indicators
International standard for chemical indicators used in sterilization processes.
AAMI ST79
Sterilization Standards
Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.
EN 285
European Sterilization
European standard for steam sterilizers and sterilization processes.
ISO 14971
Risk Management
International standard for risk management of medical devices.
Our Quality Process
A systematic approach to ensuring excellence at every stage
Raw Material Inspection
Rigorous testing of all incoming materials against strict specifications.
- Chemical composition verification
- Physical property testing
- Supplier quality audits
- Certificate of analysis review
In-Process Quality Control
Continuous monitoring and testing during manufacturing processes.
- Real-time process monitoring
- Statistical process control
- Intermediate product testing
- Environmental condition monitoring
Final Product Testing
Comprehensive testing of finished products before release.
- Performance verification
- Stability testing
- Batch release testing
- Documentation review
Quality Assurance Review
Final quality assurance review and release authorization.
- Quality system compliance check
- Regulatory requirement verification
- Customer specification confirmation
- Release authorization
Testing Capabilities
State-of-the-art testing facilities and comprehensive quality assurance
Chemical Testing
- Chemical composition analysis
- Indicator formulation verification
- Reaction kinetics testing
- Stability and shelf-life testing
Physical Testing
- Temperature response testing
- Humidity sensitivity analysis
- Pressure resistance testing
- Dimensional accuracy verification
Performance Testing
- Sterilization cycle validation
- Response time measurement
- Accuracy and precision testing
- Environmental condition testing
Regulatory Testing
- ISO standard compliance testing
- FDA requirement verification
- CE marking validation
- International standard testing
Quality Assurance Guarantee
Our commitment to quality extends beyond manufacturing
Product Warranty
All products come with comprehensive warranty coverage and quality guarantee.
- • 5-year product warranty
- • Performance guarantee
- • Quality replacement policy
- • Technical support included
Documentation
Complete documentation for regulatory compliance and quality traceability.
- • Certificate of analysis
- • Quality test reports
- • Regulatory compliance docs
- • Batch traceability records
Continuous Improvement
Ongoing quality improvement through feedback and process optimization.
- • Customer feedback integration
- • Process optimization
- • Technology upgrades
- • Regular quality audits
Questions About Quality?
Our quality team is here to answer any questions about our certifications, processes, or quality standards.