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Quality Assurance System for Clinical Diagnostic Solutions
PT. Sintech Manunggal Sejahtera implements a comprehensive Quality Assurance (QA) system as an integral part of the development, production, and service of clinical diagnostic products. This system is designed to ensure that every instrument, reagent, and service provided meets quality, safety, and applicable medical device regulatory requirements.
Quality Assurance forms the foundation for maintaining consistent product performance and reliable test results used in routine clinical laboratory practice.
Quality Assurance Approach
Technical Validation and Verification
Every product undergoes technical validation and verification to ensure compliance with design specifications and clinical usage requirements. This process includes performance evaluation, system stability assessment, and functional verification before products are widely deployed.
Quality Control and Consistency
Quality control is conducted to maintain product consistency over time. This approach minimizes variability, ensures reproducibility of results, and supports the reliability of diagnostic systems in laboratory operations.
Documentation and Traceability
All QA activities are supported by structured and well-documented technical records. Process traceability is crucial for transparency, continuous evaluation, and compliance with applicable standards and regulations.
Quality Assurance Across the Product Lifecycle
QA is applied throughout the product lifecycle—from design, development, and production to usage and after-sales service. This approach ensures product quality is maintained not only at initial deployment but also throughout its operational lifespan.
Regulatory Compliance and Quality Standards
Sintech’s QA system is implemented in accordance with quality management principles and relevant medical device regulations. Adhering to these standards ensures the safety, effectiveness, and reliability of clinical diagnostic products used by laboratories.
Commitment to Continuous Improvement
Through ongoing evaluation and monitoring, PT. Sintech Manunggal Sejahtera is committed to continuously enhancing its QA system to adapt to technological advancements, user needs, and evolving regulations.
Learn More
For more information about our quality assurance system, technical validation, or compliance documentation, please contact our team via the contact page.