QUALITY MANAGEMENT SYSTEM
KORVIS QUALITY MANAGEMENT SYSTEM
Consistent with our overall business strategy, the Korvis manufacturing quality management system takes a pragmatic approach to assuring our customers receive consistent, reliable equipment that will perform at the highest level—from the first day of service—through its entire lifecycle.
Korvis is proud to carry dual registrations for ISO 9001:2015 and ISO 13485:2016. These registrations come from the international auditing company TÜV and is maintained through two audits every year. We employ 9001:2015 QMS and 13485:2016 QMS designations in our work areas and assure our people are trained to operate in accordance with the QMS level within which they are working.
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Along with our ISO 9001:2015 and 13485:2016 certifications, Korvis supports specific customer audits and collaborates with our customers’ quality organizations regularly. We have been audited and successfully passed audits by customers from many industries including Semiconductor, Disk Drive, Bio-Medical, and Alternative Energy. As required, Korvis products are compliant and certified to SEMI (most frequently S2 and S8), UL, CE (we commonly self mark), NFPA, RoHS, ANSI, ASME, and many more.
Our QMS is true, a company-wide system that addresses our processes, from our handling of customer inquiries and RFQ’s through all phases of quote, design, development, procure, build, test, ship, and post delivery support. Korvis’ QMS is defined through an overarching Quality Manual for our ISO 9001:2015 and 13485:2016 QMS. These manuals are consistent with the standards and specifically call out our procedures and forms which, as the ISO standards mandate, are implemented and followed to ensure that at the conclusion of each process, if given the required input, the desired output will be achieved.
Our operations follow an overall Korvis process map that specifically delineates how we do our business. The process map addresses specific procedures and forms that get used regularly while also serving as a baseline process map to be tailored for projects, products or customer with special requirements.
Procedures to manage change control, non-conformances, corrective and preventive actions, internal audits, test and measuring equipment calibration, process validation, risk assessment, etc. are all included and followed within our QMS. The data derived from these processes is discussed during our semi-annual management reviews and real and/or potential issues are identified and addressed.
- Delineates how we do our business
- Addresses specific procedures and forms and serves as baseline for operations
- Standard process map gets tailored for projects, products or customer with special requirements
QUALITY MANUAL FOR OUR ISO 9001:2015 AND ISO 13485:2016 QMS
- Manuals consistent with ISO standards
- Procedures and forms that ensure the desired output is achieved
- RFQ handling and quotations
- Design and development
- Build and test
- Packaging and shipping
- Post delivery support
- Change control
- Corrective and preventive actions
- Internal audits
- Test and measuring equipment calibration
- Process validation
- Risk assessment