QUALITY + COMPLIANCE
Acero Precision, an ISO 9001 + ISO 13485 certified organization, is committed to providing our customers with the highest level of quality and compliance during the manufacturing process. These aspects are critical in maintaining the high expectations and performance of these crucial products. Our team provides extensive care every step of the way to guarantee requirements, specifications, and compliance is met when producing products for our customers.
Acero Precision actively maintains validations for all new equipment and processes prior to implementation:
CNC’s, Blasting Units, CMM’s, and Vision Systems
Coating, Anodization, Welding, EDM, Gun drilling, Centerless Grinding
Cleaning and Passivation processes utilizing a Validated DIRO Water System
Proprietary software used for shop floor SPC, Data collection and retention inspection plans and training
Acero Precision has a robust QMS that provides us with real-time data on job quality and Internal Gage Calibration/Maintenance.
Our QMS also provides our customers with Certificates of Conformance Outside process certifications, Rohs and Reach Compliance, material certification, and comprehensive and multistage contract review process.
Acero Precision possess comprehensive First article and in-process inspection procedures and provide lot traceable inspection data with all shipments.
As leaders in the medical device manufacturing industry, regulatory compliance and certifications are top priority.
Acero Precision maintains
As a leading OEM (Original Equipment Manufacturer), Acero Precision is also compliant with FDA registrations and actively holds both ISO 13485:2016 and ISO 9001: 2015 certificates. With these ISO certifications, paired with the ANVISA GMP Certification, Acero continues to demonstrate and strengthen its commitment to providing safe and effective medical devices and components in the market.