quality, process excellence, and reliability
The STRATEC Group is committed to continually enhancing its processes and service quality. One of STRATEC’s fundamental obligations is to structure its business processes so that it and its partners – diagnostics and life science companies operating in highly regulated worldwide markets – meet regulatory and legal requirements in a continually changing environment. STRATEC’s commitment to satisfying regulatory standards enhances its partners’ positions in their respective markets. STRATEC’s success is derived from the economic viability of its partners. Clearly defined processes throughout the value chain, from initial development steps through to serial production, play a crucial role in safeguarding permanent market success.
At the same time, a flexible quality management system also facilitates compliance with the necessary international requirements enabling STRATEC to work together with its OEM partners to access new markets rapidly and efficiently. STRATEC’s complaint handling system supports the service and vigilance process – as well as its partners’ risk management – by offering interdisciplinary error analyses and risk assessments. Additionally, STRATEC actively involves its partners in relevant control steps within the change process.
Quality Assurance
At STRATEC, Quality Assurance (QA) is integral to our operations, ensuring each product meets the highest standards. We implement rigorous QA processes throughout the product lifecycle, from initial design to final delivery. Our QA team performs comprehensive inspections, using state-of-the-art equipment to verify that all products adhere to precise specifications. Continuous monitoring and systematic audits are conducted to maintain quality and identify areas for improvement. We adhere to international standards, ensuring our products are reliable, safe, and effective. Our commitment to QA ensures that clients receive products that meet their exact requirements, fostering trust and long-term partnerships.
CONTINUOUS IMROVEMENT
Continuous Improvement (CI) is a core principle at STRATEC, one which drives us to continually enhance our processes. We employ Lean and Six Sigma methodologies to identify inefficiencies and implement effective solutions. Our CI initiatives involve regular training, employee engagement, and feedback loops to foster a culture of excellence. By leveraging advanced data analytics, we gain insights into performance metrics and trends, allowing us to make informed decisions. This proactive approach ensures that we stay ahead of industry advances, consistently delivering superior quality and value to our clients. Our commitment to CI translates into better processes, faster delivery, and increased customer satisfaction.
CUSTOMER SATISFACTION
Customer Satisfaction is at the heart of STRATEC. We strive to exceed client expectations by delivering exceptional products and services. Our dedicated customer support team works closely with clients, providing personalized assistance and addressing concerns promptly. By fostering open communication and collaboration, we build strong and lasting relationships with our clients. Our focus on quality, reliability, and innovation ensures that our clients can trust us as their partner in success.
SUPPLIER Quality MANAGEMENT
Supplier Quality Management (SQM) is crucial to maintaining STRATEC's high standards. We carefully select and evaluate our suppliers, ensuring they meet our stringent quality criteria. Our SQM process includes regular audits and performance reviews. By working closely with our suppliers, we ensure the integrity and consistency of materials and components used in our products. This collaborative approach helps us mitigate risks, reduce defects, and enhance overall quality. By maintaining strong relationships with reliable suppliers, we can guarantee that our products meet the highest standards of quality and reliability, ultimately benefiting our clients.
risk management
Risk Management is a vital component of our Quality Management system at STRATEC. We proactively identify, assess, and mitigate risks throughout the product development and manufacturing processes. Our risk management framework involves detailed risk assessments, failure mode and effects analysis (FMEA), and robust contingency planning. By anticipating potential issues, we can implement preventive measures to minimize their impact. This approach ensures the reliability and safety of our products, protecting our clients' investments and reputation. Our commitment to effective risk management enables us to consistently deliver high-quality products.
CERTIFICATES
QM System compliant with 21 CFR part 820
FDA registered establishment
NRTL registered (NEMKO)
Compliance with GMP requirements of Taiwan (TCP participation)
Foreign Manufacturer Accreditation in Japan
Compliance with QMS requirements in several other markets
Medical devices registered with UK MHRA
