Our mission is to guarantee a quality of production and service systematically in line with our customer’s expectations.
Leading continuous improvement methods such as Six Sigma and 5S are baked into our strategy and implemented throughout product development and manufacturing.
SCT’s Quality Management System outlines the qualification processes to meet our clients’ regulatory and contractual requirements. We ensure that our suppliers, our products and all our production steps have been qualified for use in their respective high-reliability markets. Our internal auditing allows us to assess the Compliance and Effectiveness of our QMS.
We apply Statistical Process Control (SPC) tools to monitor and control our key manufacturing processes. This lean and upstream control of our operations allows us to proactively offer personalized solutions to our customers.
Quality in medical and industrial applications
AIMD Quality Control Measures
- Process Validation: For our markets such as cardiac, cochlear and neurostimulation our Process Validation Plan includes IQ, OQ and PQ phases in the product development cycle all the way up to series production. To do this, we use validated flowcharts and regular quality documents in accordance with ISO 13485 standards.
- Medical Device Regulation: We follow our client’s specifications to meet their national agency requirements (FDA, CE, CFDA).
- Development Cycle: SCT has adopted its own PES (Prototype — Engineering – Series) process to accompany our clients throughout their development from idea to market.
Industrial Applications Quality Control Measures
- Many of our clients operate in markets with tough industrial requirements. For industries such as Energy, Aerospace and Electron Tubes, SCT complies with industry regulations and provides traceability of our ceramic brazed insulators.
- For the aerospace market, SCT uses qualified processes to manufacture brazed sensor components. Our documentation protocols ensure compliance with EN9100 (FAI), Delta FAI and DVI.
Our nuclear quality assurance includes :
- Nuclear safety awareness training using internal referral.
- Configuration management (CM).
- Transparent documentation (PQR, DTR, RFF).
- 2 COFREND certified operators for leak testing (LT).
- RCCE, RCCM.
SCT abides by strict IOS standards and maintains the above certifications
SCT is compliant with the following :
- Restriction of the Use of certain Hazardous Substances in Electrical and Electronic Equipment
- European Union’s Directive 2002/95/EC
- Guarantees that our products do not exceed the allowable amounts of the following restricted materials: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), with some limited exemptions.
- EU REACH regulation (EC) No 1907/2006.
- Registration, Evaluation, Authorisation and Restriction of Chemicals
- Guarantee that the chemicals used in production are rigorously regulated and risk managed and that, when possible, we opt to use the least harmful substances in our operations.