Universal Punch Corporation
An ISO 9001:2015 registered company by DQS Inc., Universal Punch Corp. has been a world-class manufacturer of the highest quality header tooling, medical instruments, and special gaging for over 50 years. We strive to continually create new products and to always be attentive to the needs of our customers. As part of our continuing commitment to provide precision and excellence in all of our products, we have expanded into a state of the art 65,000sq.ft. manufacturing facility. Our spacious plant is equipped with increased machining capacity, expanded heat-treating facilities, calibration and inspection laboratories and clean room. Our laboratory ensures that all products sold conform to specifications for ANSI or ISO standards. All measuring equipment and gaging masters are directly traceable to N.I.S.T. All certification processes and procedures conform to ISO/IEC Guide 17025.
Universal Punch Corp. is known for maximum quality and dependability. We offer the largest worldwide stocking and distribution of 6-Lobe (TX), 6-Lobe Extra (TXP), Cruciform, Phillips, PZ-Drive, Stardrive, 12point, Square, Hexagon, Enhanced Hexalobular and special products through our international suppliers. Our in-house vacuum heat-treating facility provides the control necessary to make tools with the highest structural integrity, as well as tools that will withstand the severest heading application. In addition, complete inventories of standard tooling are available for immediate delivery in a variety of materials, finishes, and coatings. Our capabilities allow us to produce custom punches and exotic gaging. Modern CNC Form Grinding, CNC Turning, production CNC milling, wire EDM, conventional EDM, custom press-type work, allow us to perform for you with speed, reliability, and precision.
Internal ISO Quality Systems
Our quality system has established lines of management control with defined levels of responsibility to assure the effectiveness of our policy. We employ the best talent, machinery, and inspection equipment for our manufacturing lines. This builds and coordinates a high quality atmosphere to ensure customer satisfaction. Together as a "TEAM", Universal's management team and employees are strongly committed to delivering only the best quality product, "ON TIME and "EVERY TIME".
Certified to ISO9001: 2015 For the scope of Machining and Packaging of Medical Components and Instruments.
Compliant to ISO13485:2016 For the scope of Machining and Packaging of Medical Components and Instruments.
Registered FDA to part 21 CFR 820.30 Design Control Guidance For Medical Device Manufacturers.
Compliant to: ISO Guide 17025:2017 General requirements for the competence of testing and calibration laboratories.
ISO9001:2005 - Standards for Quality Management Systems
DQS Inc. complete verification programs covered under ISO 9001:2015 establishes and maintains quality assurance guidelines of recognized standards, such as ISO 9000 of the International Organization for Standardization. DQS Inc. is the leading ISO 9000 registrar headquartered in the United States and conducts quality assessments of manufacturers' facilities to help them meet these requirements. Covered under their assessments are safety, performance, quality assurance, unannounced factory follow-up inspection.
Compliant ISO13485:2016 Design and Manufacture of Medical Devices
Universal Punch Corp. is compliant to medical products manufactured to specifications for safe intended use every time. With every product submission, the regulatory bodies require proof that your product has been manufactured under a certified quality management system. Our internal, customer and registrar quality system audits ensure compliance with standards.
FDA Registered Contract Manufacturer for Medical Devices
Universal Punch Corp. has been dedicated to delivering the highest quality tools, gages and surgical instruments to our customers in the medical device sector for more than 25 years. Our robust FDA registered quality system has allowed us to build long lasting relationships with global industry leaders within the medical device field such as Stryker, Smith & Nephew, Biomet, Johnson & Johnson DePuy, Medtronic, Globus and Zimmer. A partnership with Universal provides the product development and quality system resources you need to complement and expand your internal capabilities.
Laboratories are responsible for establishing metrological traceability in accordance with this document. Calibration results from laboratories conforming to this document provide metrological © ISO/IEC 2017 - All rights reserved 25 ISO/IEC 17025:2017(E) traceability. Certified values of certified reference materials from reference material producers conforming to ISO 17034 provide metrological traceability. There are various ways to demonstrate conformity with this document: third party recognition (such as an accreditation body), external assessment by customers or self-assessment. Internationally accepted paths include, but are not limited to, the following. http://www.snti.ru/cd/ISOIEC17025-2017.pdf
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UNIVERSAL PUNCH CORP.
4001 W. Macarthur Blvd. • Santa Ana, CA 92704 USA
phone 714-556-4488 fax 714-556-6314 email@example.com