When you want Cpk and Quality data, Pacific Plastics & Engineering is able to provide you with immediate, accurate and up-to-date information about your medical device, bio-tech product, or assemblies. We stringently manage each client's project with a dedicated project manager to ensure a quality customer service experience.
Our Quality Assurance System promises we deliver defect-free products on time and in a reliable manner. The QA system is what has led us to winning awards and how we've continued our twenty years of success. Our QA system offers:
- Quality Management Systems that are ISO 13485:2003 registered
- ISO 9001:2000 registered in our domestic and international locations
- Guidance through phased clinical trials and IQ/OQ - PQ/PPQ qualifications
- CMM and Micro-Vu system QA measurement capabilities
PPE is registered by Lloyd's Register Quality Assurance (LRQA) to the ISO 9001:2000 Standard for Quality, in addition to the ISO 13485:2003 Medical Device Standard. We are audited twice per year to maintain these standards, and can support your documentation for these standards:
- DOE (Design of Experiments)
- Cpk (Process Capability)
- First Articles
- PPAP Capabilities (OUT)
- SPC (Statistical Process Control)
When you need testing and studies done for your medical device, PPE is ready to conduct fully capable, quantitative studies on your behalf.
