there’s Cavist Quality.
Quality Assurance and Controls
Cavist is unwavering in its commitment to quality assurance. With over 25 years of experience, we have meticulously crafted a comprehensive set of processes to uphold the highest manufacturing standards for every custom project. Our stringent quality control measures applied before, during, and after production, exemplify our commitment to delivering a service that not only meets, but exceeds customer requirements and expectations.
Quality Processes
Processes
Our commitment to meeting requirements, satisfying customers, and improving the QMS, its processes and resulting products is reflected in the following quality policy:
- Supplying products and services that meet customer specifications, including requirements for quality.
- Working with our customers to meet their evolving expectations. We will remain their vendor of choice by continually improving our business practices, manufacturing processes, and offered services.
- Complying with applicable statutory and regulatory requirements.
- Maintaining the effectiveness and suitability of our Quality Management System.
Steps
- Validation and Verification (V & V)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Process Validation (PV)
- Process Capabilities Studies
- First Article of Inspection
- Control Plan
- PFMEAs
- PPAP
Frameworks & Requirements
ISO Quality Management Systems (QMS)
To fulfill our commitment to quality, we use the framework and requirements of ISO 13485 and 9001 respectively.
View ISO Certificates or verify independently with Perry Johnson Registrars, Inc.
ISO 13485:2016
Quality Management Systems – Medical Devices
Requirements for Regulatory Purposes
ISO 9001:2015
Quality Management Systems - Requirements
Class 8 Cleanrooms
There’s Clean, and then there’s Cavist Clean.
Monitoring & 3rd Party Lab Audits
Internal monitoring is performed monthly at minimum with external 3rd party lab audits conducted Annually.
Engineered for Compliance
Cavist cleanrooms have been engineered to support medical device manufacturing requirements, ensuring compliance with regulatory laws. Our capability and expertise extends to each and every project requiring cleanliness at the highest standard.
Held to ISO Standards
ISO-8 cleanrooms mandate 20 air changes per hour with HEPA-filtered air, maintaining particle levels below 29,300 particles/meter³ equal to or greater than 5 microns. These standards are established by ISO14644-1.
Quality Documentation
Performance Monitoring
We monitor the performance of suppliers within our network to guarantee that orders adhere to our quality standards. Certifications and reports are available upon request.
- Certificate of Conformance
- Reach and RoHS
- First Article Inspection (FAI)
- Dimensional Inspection Report
- Certificate of Assurance
Metrology
Advanced Tools & Equipment
Using state-of-the-art tools and equipment for metrology and material analysis ensures precision and reliability in every aspect of our work.
Vision Measurement Systems
The Keyence LM1100 and VR6200 provide high-precision measurement solutions for industrial applications. Both systems offer automated inspection capabilities with advanced imaging technology, ensuring accuracy to within +/- 0.7 μm for the LM1100 and capturing data with a resolution of 0.1 µm for the VR6200, thus enhancing productivity, minimizing waste, and upholding quality standards in manufacturing processes.
Moisture Analyzer
The Mettler Toledo HX204 Excellence series high-performance moisture analyzer offers a 200-gram capacity with a 0.001% moisture content readability, meeting the rigorous requirements of research, quality control, and production. Featuring rapid testing, powerful graphics, and full compliance, it’s ideal for highly regulated industries, delivering outstanding measurement performance for precise moisture analysis.
Rheometer
The DVNXLV Rheometer offers a wide viscosity range from 1 to 6 million centipoise (cP) or millipascal-seconds (mPa·s), with speeds ranging from 0.1 RPM to 250 RPM (or 2.6K RPM). It’s equipped with different internal springs for measuring viscosity, catering to materials ranging from low to high viscosity, making it an invaluable tool for material science and fluid mechanics research, development, and quality assurance.
High Accuracy Weight Scale
The Ohaus scale, boasting a 120-gram capacity and a readability of 0.0001 gram (0.1 milligram), provides versatile weighing units and supports applications such as parts counting and density determination. Its precision in measuring weight, facilitated by advanced load cell technology and precise calibration mechanisms, ensures reliable and consistent readings, crucial for quality control, manufacturing processes, and research applications, thereby optimizing efficiency, minimizing waste, and upholding stringent standards.