Quality
ISO 9001:2015 AND
ISO 13485 :2016 Certified
Twin City EDM & Manufacturing has a long history of high-quality manufacturing. We hold ISO 9001:2015 certification, along with ISO 13485:2016, which ensures process consistency, customer satisfaction, and medical-traceable performance in every project.
Our commitment to this certification reflects our dedication to continuous improvement, measurable quality, and long-term client partnerships.
What Being ISO 9001:2015 / ISO 13485:2016 Certified Means for You
ISO 9001:2015 is a comprehensive standard developed by the International Organization for Standardization (ISO). It outlines requirements for a quality management system (QMS) that consistently delivers products and services that meet both customer and regulatory requirements.
For our customers, this means:
- Clear documentation and accountability at every stage of the process.
- Reliable part performance and delivery timelines.
- Strong change control and corrective action systems.
- Commitment to continual improvement.
- Regular third-party audits and internal reviews.
Quality Process
Twin City EDM’s ISO 9001:2015 and ISO 13485:2016 certified quality process begins before a single chip is cut. We work with you from day one to make sure projects meet your specifications, tolerances, and inspection criteria. Our quality assurance program integrates seamlessly with production workflows to reduce risk, accelerate delivery, and protect part integrity, delivering outcomes that exceed expectations.
Our team builds custom quality control plans for each project, including:
- First article inspection (FAI)
- PPAP (Production Part Approval Process) documentation
- Complete material and process traceability
- Compliance with customer-specific drawing and material callouts
- Process audits and continuous improvement tracking
Because we serve highly regulated industries, our internal processes prevent nonconformance and flag potential risks before they become problems. Every operator, engineer, and inspector plays a role in maintaining the level of quality our clients expect.
Additional Certifications and Compliance Standards
- ISO 13485:2016 Compliant – We maintain traceability, risk management, and cleanliness standards required for medical device manufacturing. Our experience includes implants, surgical tools, and diagnostic assemblies.
- MIL-SPEC and ITAR Compliance – We meet strict defense sector regulations for identification, marking, and manufacturing controls, including proper handling of controlled materials and documentation.
- ASTM 485 – Ensures we meet metallurgical and material standards for critical components, especially in aerospace and structural applications.
- MIL-W-13855, MIL-L-45208A, and MIL-Q-9858A – These defense-focused quality control frameworks cover inspection methods, process control, and reliability requirements. We integrate these into our workflows when applicable, especially for military and aerospace programs.
We also provide PPAP documentation and quality assurance plans upon request. Ask us for more details or certification documentation.
FDA Registered
Twin City is proud to be an FDA-registered manufacturer, reflecting our commitment to meeting the regulatory requirements that apply to the products and markets we serve. Our registration supports our focus on consistent manufacturing practices, quality control, and reliable documentation throughout our operations.
We understand that customers in regulated industries need confidence in the companies they choose to manufacture their products. That’s why we maintain processes designed to support quality, consistency, and traceability from production through delivery.
Our FDA registration is one part of Twin City’s broader commitment to dependable manufacturing and serving customers with the standards and accountability their applications require.
Work With an ISO 9001:2015 / ISO 13485:2016
Certified Partner Who Understands Quality
Twin City EDM understands your reputation is on the line, and we deliver consistent
quality through advanced inspection, certified systems, and a team that understands what’s at stake.
Whether your project is headed to an operating room or a battlefield, we’ll make sure it’s built to spec, every time.
Contact us to review our certifications or request a quality plan for your next program.