Weiss-Aug Successfully Passes ISO 13485 Audit
During the week of August 10th 2010, Weiss-Aug completed an intense 5 day audit to obtain ISO 13485 certification. Weiss-Aug currently provides custom insert/injection/reel-to-reel/over-molding, precision metal stamping and custom assembly to various major medical device OEM's. This effort is part on an ongoing dedication to providing customized support to its medical customers.
The scope of ISO 13485 certification encompasses the following:
- Scope of Certification: Contract Manufacturer of Metal Stampings, Plastic Injection Moldings, Insert Moldings, and Assemblies
- Formal Validation Procedures & Protocols Implemented
- Compliance with 21 CFR Part 820 (Quality System Regulations)
- Certificate Available October 2010
Throughout the audit, the auditor was very impressed by the advanced systems Weiss-Aug has in place. It was mentioned many first time audits result in re audits and failure because companies are new to these types of systems and have immature systems in place. Weiss-Aug has had ISO/TS 16949 certification, which is a very difficult automotive certification, which helped in preparation for ISO 13485. Weiss-Aug is committed to continuous improvement, and is dedicated to providing the best support to its medical customers.
