Our Quality commitment
Rolenn Manufacturing’s Quality Team has extensive experience with the demanding requirements for the Aerospace and Medical Device industries and uses a range of methods and tools to support elements of the Quality System such as Process Development, Product Realization, Risk Management and mitigation strategies.
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Rolenn Manufacturing has established, documented, and implemented a quality management system which is continuously reviewed and evaluated for effectiveness in accordance with ISO 9001, ISO 13485, FDA QSR 21 CFR part 820.
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cGMP and QSR compliant globally
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ISO 9001 certification
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ISO 13485 certification
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ISO Class 7 & 8 Cleanrooms
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Climate-controlled inspection laboratory
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Test method development, first article inspections, Gauge R&R
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Process Validations (IQ, OQ, PQ)
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Electronic Record Keeping
Testing
Polymer Testing
We perform post-production testing following the
ASTM D2240 standards.
This test method covers twelve types of rubber hardness measurement devices known as durometers: Types A, B, C, D,DO, E, M, O, OO, OOO, OOO-S, and R.
Qualifications
We want to give you the peace of mind of being delivered with fully operational products.
We have a high degree of assurance in our manufacturing process and with our experience we are able to provide qualifications for a new product line very shortly.
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Certified Clean Rooms
Class 7 and 8 Clean Rooms
When contamination is a risk, our clean rooms can fulfill your needs for safe molded products