Jenitek is committed to supplying products and services that meet the needs of customers, comply with statutory and regulatory requirements, increase customer satisfaction and maintain the effectiveness of the quality management systems through continuous improvement in products, processes and services.
Compliant with ISO 13485:2016, ISO 9001:2015, and FDA 21 CFR Part 820 quality system, we have established complete quality system documents, including manuals, procedures, work instructions and recorded documents.
Our quality activities such as production, inspection, product development, process validation, supply chain management and continuous improvement are well controlled.
6 Sigma Quality Team
Jenitek quality team understands the system are not only the foundation of quality management but also paramount to the importance of our customers, product development, production, and process improvement. Our 6 Sigma black belt engineers have extensive experience with quality management and use a range of methods and tools, including IQ/OQ/PQ, FMEA, and DOE to support in product development and process improvement.
When NPI goes into the pre-production phase, process validation is carried out. Through the IQ/OQ/PQ, we validate product & process design, equipment, tooling, material, environment, personnel, inspection plan, and measurment system to ensure the products meet the customer's requirements.
Material ComplianceBesides special medical grade materials, we utilize non-hazardous materials which comply with REACH and RoHS directives.
If there are questions as to whether or not a potential change may impact the quality of a finished device, we require prior written notification and approval from our customer to review and update any changes to our entire supply chain providing materials, critical components, assemblies or services.
Device History Records
We establish Device History Records (DHR) for each lot of products. Each DHR contains documentation of the processes, material certifications, certification of outside processes, finishing certifications and lot inspection records. This includes in-process and final inspections along with any other quality assurance documents pertinent to a particular lot.