Quality Management System
We understand that more than 1 million diagnostic tests are performed in your laboratory, each year; and many of these have a direct impact on final outcome and medical decisions. Lack of quality control can render many of these tests unusable.
At Advancells Diagnostics, we are maintaining our own Quality Management System, under ISO 13485:2016 to ensure that every batch of products is passing through stringent quality check processes; before being released into the market. We follow all the guidelines proposed by Medical Rule 2017, under CDSCO; with proper documentation, SOPs, internal as well as an external audit for quality assessments. These safety parameters can further promote accurate lab results with minimum variations.
Here is a quick checklist to ensure performance consistency with quality
- All the raw materials are compliant with laid down specifications with AR grade
- Every batch is being monitored on a real-time basis for sterility, fungal/microbial contamination, performance outcome, stability outcome, and performance consistency.
- This performance evaluation report is created and maintained by QA and is reviewed on a monthly basis.
- All the incoming and packaging material has to pass through a stringent quality control process
- Accelerated stability studies are conducted for all the batches
- All the batches are being reviewed for real-time stability studies
- We are maintaining proper documentation with reference to our post-marketing surveillance, vigilance report and CAPA.
Awards and Accreditations
The quality and precision of our products is absolutely paramount to us. We are honored to be recognized for our accomplishments, quality, and technical expertise