Quality
CERTIFIED BY THE HIGHEST INDUSTRY STANDARDS
We are committed to meeting the precise product development and manufacturing requirements of the world’s leading medical device, life science, commercial, and electronics technologies.
Quality assurance is integral to every client program and is involved from design to delivery of final product.
We are committed to creating precision parts with:
- Zero tolerance for error
- Traceability and consistent manufacture to precise customer specifications
- A complete understanding of and adherence to the FDA’s rigorous quality requirements
- The people, processes, facilities, and equipment to do the job right
MOS standard quality systems ensure that that components and devices meet appropriate codes. In addition, we can duplicate customer testing protocols in our facility as requested.
Dedicated to Quality
MOS employs process validation, as required by the FDA which identifies variables that could impact the manufacturing process. This ensures both compliance to regulatory requirement and consistently high-quality parts and assemblies.
Additional standard quality processes include:
- Prospective Validation: Changes made to a component or process are validated prior to delivery of the affected part or assembly.
- Design of Experiments (DOE) identifies possible causes of performance variations, which reduces or eliminates variations by controlling process parameters.
- Ultrasonic washing: Clean room molds and tooling are disassembled, ultrasonically washed, and reassembled between each production run.
As your plastics solution company, our job is to evaluate and question the traditional ways of doing things – from design, tooling, molding & materials to process and packaging, in order to consistently deliver quality products to every customer, no matter how unique their requirements.
KS Maintains all Certifications Required for Manufacturing Medical Devices Through our MOS Plastics Division.
- ISO13485 and ISO9001 Certified to ensure strict procedural and documentation compliance with your industry regulations
- Certified by State of California Department of Health to manufacture medical devices
- Class 7 (Class 10K) controlled and audited cleanrooms to ensure cleanliness of molded parts
- In-house Visual and Probe CMM equipment to perform detailed part inspections and First Article Reporting
- Perform Part validation inclusive of IQ, OQ, & PQ
Exceeding the Most Rigorous Standards. Yours.
In addition to our standa rd quality processes, most of our customers have their own quality guidelines and test protocols. From impact tests, to leak tests, to Statistical Process Control (SPC), we specialize in duplicating your quality processes and tests in our facility.