Quality Management System (QMS)
Carville are certified to the latest ISO9001: 2015 standard and were first accredited 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
Supply Agreements and Stocking
Carville work in many fast paced and demanding industries and therefore understand the needs to a secure and reliable supply chain as well as guarantee lead times and stock availability. Carville have supply framework agrements with a range of customers in Europe, Asia and the USA. These are always tailored to the indivudal client’s needs including features such as stock holding at Carville, consignment stock on client’s site, kan ban systems, bespoke packaging guaranteed call-off windows.
“100% Quality, 100% Delivery – Category A Supplier” Purchase Department at Varian Medical, (medical oncology)
Design and Development Support
Carville has a successful track record in supporting new and established businesses to resolve engineering and manufacturing problems. When the precise knowledge is not available within Carville, we have working relationships with leading specialists who can support client’s design and development requirements.