Quality Management System (QMS)
Carville are certified to the latest ISO9001: 2015 standard and were first certificated with ISO 9001 in 1992. Our QMS has been continuously improved over these twenty-eight years supported by many different audit types including internal, external checks, re-certification, client audits and un-announced notified body audits. Carville has a culture of actively seeking ways to improve our systems and embrace any recommendations from external sources to help this. The result is a very robust QMS system that supports many different industries including medical, life sciences, defence and automotive.
ISO13485 Medical Devices & IVD
Carville supply many clients in the medical device and In-Vitro Diagnostics markets, who are very often producing the highest safety class of products (such as Class III medical devices). Carville’s parts are often classed as “critical to function and safety” for these end products, so we support all our clients’ ISO13485 requirements with our QMS including full traceability, testing, measurement and vigilance support. As a designated “Critical Supplier” we are also subject to unannounced notified body audits including the FDA as part of our support for clients and have performed exceptionally well with all of these audits.
We use a range of tools and processes for the quality assurance of our parts including the following:
- Coordinate Measuring Machines (CMM)
- Optical measuring systems
- Pressure checking
- Digital callipers
- Digital optical analysis
- Visual inspection templates and processes
- Bespoke fixtures
- Bespoke functional testing equipment
We can support our clients’ specific needs by developing bespoke testing and measurement systems and procedures, to eliminate any incoming inspection or testing for them. We can also provide material certificates of conformity for certain materials.