OUR COMMITMENT TO
Quality is the cornerstone of everything we do. From initial product research through final product delivery — and beyond, thanks to our exceptional post-sale service and support — our business is built on offering customers an unmatched quality experience.
In practice, quality means adhering to the highest industry standards every step of the way. NuSil is ISO 9001 certified, and we use ISO standards throughout our worldwide operations. In addition, our proprietary quality system, NQS™, is certified and compliant with the following standards:
- AS9100 – Quality Management Systems (QMS) Requirements
- 21 CFR Part 210 & 211 cGMP for Finished Pharmaceuticals
- ICH Q7 GMP Guidance for Active Pharmaceutical Ingredients
- IPEC Americas GMP for Pharmaceutical Excipient
Relevant application of the following industry standards is addressed as part of NQS:
- 21 CFR Part 820 QSR for Medical Device
- ISO13485 QMS for Medical Device
- EFFI GMP for Cosmetic Ingredients
To download relevant ISO certificates and other relevant supply chain documents, click below:
TESTING, AUDIT & PERFORMANCE METRICS
Testing is performed on instruments that have been calibrated in conformance with ANSI Z540-1 and ISO 17025, and traceable to National Institute of Standards and Testing (NIST). Product quality is assured by NQS, which begins with an effective design protocol and continues up the supply chain, from vendor qualification through product distribution.
Scheduled reviews of internal audit reports, product performance metrics and customer feedback provide strategic insight into the ongoing effectiveness of NuSil's quality policy and commitment to customer and corporate satisfaction.
ASTM E595 Testing
NuSil Technology has been testing materials to ASTM E595 since 1982, and have continued to expand our commercial testing services. All forms of silicone materials may be tested using this method – including fluids, gels, adhesives, elastomers, and dispersions. Materials nearing the end of their warranty period may be tested to determine stability for extension of shelf life.
NuSil’s testing laboratories are staffed with trained chemists and material inspection specialists with extensive experience in all areas of Quality Assurance. Testing is performed on instrumentation calibrated to NIST traceable standards and, as an ISO 9001 certified company, NQSTM maintains scheduled auditing and calibration of all test equipment.
NuSil will prepare a certified report of test results within ten (10) business days of sample receipt. Large custom orders or special sample preparation requirements may require additional time. Quantified test results will be presented for your records. All test results and customer affiliations are treated as confidential.
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