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Quality First Award Recipient
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We maintain the highest standards and continue to strive
for quality in all aspects of our business.
Specialty Silicone Fabricators, Inc. first registered to ISO 9001: 1994 in December 1996.
In March 2003 KEMA Registered Quality, Inc. audited the company to the ISO 9001:2000 standard.
ISO 9001 Registered
(printer friendly certificate)
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ISO 13485 Registered
(printer friendly certificate)
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SSF is registered with and has been inspected by the Food and Drug Administration and
the State of California Food and Drug Branch. ISP is certified to recognized industry quality system standards
and complies with national and international standards.
- FDA Quality System Regulation (QSR): CFR 21 Part 820: 1996 (Current Good Manufacturing Practices)
- FDA Establishment Registration Number: 2022502
- State of California FDB Device Manufacturing License Number: 44464
- ISO 13485:2003 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
- Japan PAL (Pharmaceutical Affairs Law) MHLW Ministerial Ordinance No. 169: Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-vitro Diagnostic Reagents (Japan regulations by the Ministry of Health Labor and Welfare)
We are the proud recipient of the "Quality First Award" presented by Johnson & Johnson Medical Inc.
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