There’s Quality, and then
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


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.


  1. Validation and Verification (V & V)
  2. Installation Qualification (IQ)
  3. Operational Qualification (OQ)
  4. Performance Qualification (PQ)
  5. Process Validation (PV)
  6. Process Capabilities Studies
  7. First Article of Inspection
  8. Control Plan
  9. PFMEAs
  10. 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

Requirements to create the systems used to better understand and control our quality practices.

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


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

Vision Measurement Systems

Moisture Analyzer

Moisture Analyzer



High Accuracy Weight Scale

High Accuracy Weight Scale

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.


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.