Quality

At Caroba, each item undergoes strict quality control at all stages of manufacturing by our In-Process Quality department and Metrology Lab.  Our Quality teams are staffed with professional ASQ Certified Quality Inspectors who measure and monitor our manufacturing operations to ensure consistent productivity and quality. These controls support Caroba's ability to meet even the most stringent delivery schedules while meeting or exceeding ISO and QS standards as well as customer expectations.

Our world-class results are assured by employing progressive quality systems with superb quality management principles.  This is reflected in our ISO 9001:2008 certification as well as compliance to ISO 13485, cGMP's, SPC (Statistical Process Control), FMEA (Failure Mode and Effects Analysis) and Six Sigma methodologies. 

Supported by professional engineering and documentation specialists, Caroba is very familiar with the ever increasing regulatory requirements of the medical device and high technology industries.  We have experience in product, packaging, and sterilization validation requirements of many leading medical OEM validation protocols (IQ, OQ & PQ), which can also include Process Validation, Measurement System Analysis (MSA), Design of Experiments (DOE), and Process Capability.

 At Caroba, we recognize that our success depends on the success of our customer with the devices that we manufacture for them. Our management staff can offer personalized services in everything from design assistance through delivery in an effort to reduce manufacturing costs to their lowest uncompromised level.

 

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