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Granite is Fully Committed to Quality and Conformance.
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As part of our commitment to safety and durability, Granite products conform to standard UL and CUL safety requirements as requested. Testing is performed to ensure that appropriate products comply with relevant European Union directives and include CE marking, accordingly. Our commitment to quality extends to the development process itself. Granite is fully ISO 9001:2008 and ISO 13485:2003 certified, and is continually improving its development and production processes.
Granite's systems include in part;
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- ISO 9001 certification (North America and China)
- ISO 13485 (North America and China)
- Compliant to FDA 21 CFR Quality System Regulation (QSRs) 21 CFR 820
- Adherence to FDA cGMP
- Compliant to FDA 21 CFR Part 11 Electronic Records and Signatures
- Device History Record maintenance
- Device Master Record retention
- Full ECR/ECN process
- CAR (Corrective / Preventative Action) program
- Continuous improvement programs
- Fully accessible Quality reporting
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As an ISO 9001 facility, Granite has implemented a continuous improvement process. This process affects every aspect of our business, especially production and testing. We also have experience working with our OEM partners within their programs, including six sigma.
The improvement efforts and services have the following additional benefits:
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- Increased efficiencies
- Shorter lead times
- Improved flexibility
- Manufacturability engineering
- Ongoing value engineering and product enhancements
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Granite also utilizes committees for implementation and continued overview. These committees, made up of intra-departmental members, are designed to represent all disciplines and departments and therefore assure management level support for all aspects of the ISO certifications.
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