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"Our PEOPLE make a difference in the quality
of your product."
ISP Quality Policy: "Commitment and Conformance"
Innovative Surgical Products, Inc. is dedicated to a manufacturing philosophy
based on a total, collective commitment to quality at every level.
We believe that "QUALITY" is not only a measurable result of conformance, but also an attitude that is developed and applied at all levels through pride of workmanship, recognition of performance, and a positive and healthy work environment.
ISP's commitment to a total quality program is the primary vehicle in our efforts to attain our goal of zero defects and our basic objectives of total product conformance and complete customer satisfaction.
ISP 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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