Quality built into every piece, from prototype to production run
With Autocam Medical, you’ll never need to “inspect in” quality. We offer customers a company-wide, world-class Quality Management System (QMS), which is based on lean manufacturing principles. In every one of our four state-of-the-art facilities, we strive for process standardization, zero customer disturbances and waste reduction.
Our QMS encompasses three inter-connected areas:
1. Quality Control (QC), which involves planned inspections during and after production to ensure that parts are manufactured according to customer specifications.
2. Quality Assurance (QA), which is a process-driven approach that ensures that our entire system can meet customer requirements at the highest standard. QA involves internal and third-party audits, including those required for ISO certification.
3. Quality Improvement (QI), which is a continuous, company-wide effort that involves many strategies for improving quality and efficiency.
Quality Control (QC) Instruments
Autocam Medical measures quality with precise instruments, including Zeiss CMMs, OGP SmartScopes and feature-specific gauges. Click here to learn more about our precision measurement, analysis and inspection instruments.
Quality Improvement (QI) Strategies
Corrective and Preventive Action (CAPA)
Engineering Change Review (ECR)
Process Verification and Validation (IQ, OQ, PQ)
Operation Control Plans (OCP)/Statistical Sampling
Gage Control and Gage R&R
Statistical Process Control (SPC)
Area Improvement Teams
Process Failure Mode and Effects Analysis (PFMEA)
Geometric Dimensioning and Tolerancing (GD&T)
Error-proofing (Active and Passive)
Design of Experiment (DOE)
Total Preventive Maintenance (TPM)
Production Part Approval Process (PAPP/First Article Inspection)
Process Capability Studies (CP, CPK, PP, PPK)
Third-party Material Testing and Validation
Certificates of Registration
All Autocam Medical locations are ISO 13485:2008, ISO 9001:2003 certified and FDA registered. Click here to view or download copies of our registered certificates.