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Product & Service Quality

IS013485:2016 Quality Management System

HZSKBio was certified with ISO 13485 quality system in 2019 and is committed to providing standardized and customized quality control products in accordance with pharmacopeia regulations and customer preferences.

This comprehensive system covers product design, development, manufacturing, delivery, and after-sles service. Our team of experts closely monitor and track the entire process to ensure the continuous enhancement of our quality system. Through the continuous improvement approach, we consistently pursue innovation and growth with a primary focus on fulfilling customer needs.

Quality Assurance Principles

Dedication & Professionalism

Design and Development

Standardized and customized solutions were designed and realized with the development processes in compliance with bioindustry and ISO regulations.

Logistics Management

We strive for flawless logistics management from order processing, material handling, packaging,warehousing, to transportation and delivery.

Production and Release

Hundreds of 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 must have a clear understanding of customer needs and shape our business.

Personnel Control

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


The CNAS accredited Laboratory Service

HZSKBio Testing Center, established in March 2021, is committed to providing comprehensive and high-quality testing services tailored to meet our customers' needs. Equipped with state-of-the-art P2 biosafety labs for microbiological testing of non-clinical samples, as well as a wide range of other advanced bioanalytical labs, we ensure accurate and reliable results. Our laboratories are equipped with essential equipment such as biosafety cabinets, laminar flow hoods, sterilizers, incubators, real-time PCR instruments, and microscopes. At HZSKBio Testing Center,we maintain rigorous operational procedures and testing protocols that are regularly updated in accordance with the latest regulations and technical guidelines. Our robust organizational structure and dedicated staff ensure the delivery of reliable and high-quality services. We take great pride in our work ethic,always adhering to the highest standards of professionalism and integrity, and delivering the quality service to our customers in a timely manner.

Quality Assurance Principles

Professionalism, Equity, Acuracy, Efficiency

Testing Facility

The layout and workflow effectively
ensure the smooth operation of the testing

Sample Management

Dedicated personnel and control measures
ensure the integrity and confidentiality of the
testing samples.

Method Validation

Validated methods and procedures guarantee the efficiency and feasibility of the tests.

Result Analysis

Systematic result analysis and verification program ensure the accuracy and reliability of test results.