Our Quality Assurance Mission
We work hand-in-hand with our customers to identify critical characteristics that will help us develop and customize a product plan that meets your needs.
Precision Quality Assurance
We understand the importance of meeting critical dimensional tolerance requirements along with physical and mechanical properties for all clients including healthcare and medical devices. Our creative approach to problem solving allows us to manufacture high quality complex components and assemblies economically. Our quality management system is based off of the principles of ISO- 9001:2015 with a comprehensive plan and system of procedures that guide our daily tasks and quality inspection on every production run. Stelray has a quality inspection program review process that begins with every new project to ensure we understand your product needs from the beginning.
- Self auditing
- Capability studies and gage studies
- Job specific work instructions to ensure consistency
- Team Program Review
Quality Control Inspection
- Fabricated components and assemblies are given to the quality department to ensure dimensional accuracy. Every box of parts is given a stamp of approval prior to shipping.
- The precision instruments utilized by the quality department include:
- Part Specific fixtures
- Gauge pins and Micrometers
- CMM is programmed with parameters for inspection consistency
- ISO 9001:2015 facility
View ISO Certificate
- FDA Registered Manufacturing Facility
- Compliant with 21 CFR 820 and Good Manufacturing Practices
- First Article Inspection(FAI) reports
- Critical Dimension Inspection(IQC points)
- Short Run SPC
- Final inspection report
- Complete Process Validation
- Performance Qualifications(PQ)
- Operational Qualifications(OQ)
- Installation Qualifications(IQ)
- CPK Analysis
Stelray strives to build each product to your exacting specifications. Our Quality Control Engineers and inspectors integrates quality from product design through mold making to production as well as secondary operations such as printing, welding and heat staking. Identifying key quality criteria in each injection molding project is an important element as we examine in great detail before your mold goes into production. Considering material selection, dimensional tolerances, physical and mechanical properties, as well as end user expectations – numerous elements are factored in to achieve manufacturing excellence. Adhering to the principles of Good Manufacturing Practices (GMP), and compliant with 21 CFR 820 allows to further these strict disciplined approaches for the medical industry.
We firmly believe that quality is a measurable and integral component of every product and service we provide. Our commitment to our customer and quality is matched only by our commitment to our own organization.