Certified for Quality and Compliance

Swiss Machine Products is both ISO 9001 & ISO 13485 Medical Device certified. We are committed to maintaining the highest levels of quality and consistency across every stage of production. Our certifications demonstrate our dedication to process control, traceability, and compliance with global manufacturing standards. These achievements reflect our long-standing commitment to precision, customer satisfaction, and continuous improvement.
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ISO 9001: Quality Management System

Our ISO 9001 certification confirms that Swiss Machine Products follows a structured quality management system designed to ensure consistent results, efficient operations, and continual improvement. Every part we manufacture is backed by documented processes, employee accountability, and rigorous inspection procedures.
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Process control and continuous improvement
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Traceability and documentation of all operations
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Consistent production of conforming parts
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Customer feedback and performance monitoring
AMTIVO ISO 9001:2015 Certified Quality Management logo with ANAB Accredited Management Systems Certification Body logo.
Certificate of Registration granted to Swiss Machine Products, Inc. for ISO 9001:2015 certification for providers of precision machined parts, signed by CEO Mike Tims.

ISO 13485: Medical Device Manufacturing

ISO 13485 certification verifies that our quality system meets the strict requirements for medical device manufacturing. This standard ensures that all processes, from design review to final inspection, meet regulatory and customer-specific needs for safety, traceability, and product integrity.
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Compliance with medical device manufacturing regulations
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Full traceability and controlled documentation
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Risk management and validation of processes
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Focus on product safety and performance consistency
AMTIVO logo with text ISO 13485:2016 Certified Medical Devices Quality Management
ISO 13485:2016 certificate for Swiss Machine Products, Inc. for providers of precision machined parts, issued by American Systems Registrar, LLC, valid from August 4, 2024 to August 3, 2027.
Gloved hand measuring metal part thickness with digital caliper displaying 5.298 mm.

Commitment to Quality

Beyond certification, Swiss Machine Products continually invests in advanced metrology systems, employee training, and process optimization. These efforts ensure that we not only meet certification standards but also exceed customer expectations in accuracy, delivery, and reliability.
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