Medical Consumables and Lab Consumables OEM Manufacturer
Medical Consumables and Lab Consumables OEM Manufacturer

Quality Assurance

IS013485:2016 Quality Management System

With IS013485:2016 Quality System Certification, SHENTEK show steadfast dedication to providing standardized and customized quality control products that meet customer requirements and pharmacopeia regulations.

The whole product lifecycle - from design and development to production, distribution, and after-sales support - is covered by our solid quality management system. In order to enhance customer satisfaction, SHENTEK employs quality policies, quality objectives, audit results, data analysis, corrective actions, preventive measures, internal audits and management reviews to carry out essential improvements.

SHENTEK-ISO13485   SHENTEK-ISO13485


Product Quality Management

Design and Development

We provide our customers with standardized and customized solutions, that adhere to international bioindustry standards to ensure compliance and satisfaction.


Logistics Management

Efficient order processing, handling, packaging, warehousing, and delivery for seamless logistics.


Production and Release

Extensive production pipelines have been developed, validated and monitored on the entire production process from material to delivery and the products met specifications.


Facility and Environment

Facilities operations and maintenance encompasses the day-to-day activities and cleaning, maintain systems, contamincation control with approved procedures and instructions.


Customer-centric Service

To deliver value to our customers, we deeply understand customer needs and shape our business.

Personnel and Expertise

We ensure appropriate training and guidance to staff, pursue the best way to ensure compliance.

Laboratory Management System

SHENTEK Testing Center has established registered microbiology laboratories and PCR laboratories, which are used to conduct non-clinical sample microorganism-related testing and residual host cells DNA detection services.

The laboratories are equipped with biosafety cabinets, clean benches, sterilization equipment, biochemical incubators, CO2 incubators, quantitative PCR instruments, etc., and possess comprehensive testing standards and technical data.

Our strong organizational framework and dedicated staff guarantee the provision of dependable and superior services, upholding the utmost professionalism and integrity to deliver quality services to our customers promptly.


Laboratory Management System  QC Lab Instruments List

Ensuring Testing Excellence

Testing Facility

The optimized layout and efficient workflow ensure the seamless execution of testing procedures.


Sample Managemen

The appointment of dedicated personnel and implementation of stringent control measures safeguard the integrity and confidentiality of all testing samples.


Method Validation

The employment of rigorously validated methodologies and procedures ensures the effectiveness and feasibility of our tests and improves the comprehensive quality of our testing services.

Result Analysis

Systematic result analysis and verification program is implemented to ensure the precision and reliability of test results.

Certificate of Analysis
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