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Our company fully implements the ISO9001 quality management system and ISO13485 medical device quality system, and strictly implements three inspections in production: raw material inspection, process inspection and factory inspection; measures such as self-inspection, mutual inspection, and special inspection are also adopted during production and circulation to ensure product quality. Ensure that unqualified products are prohibited from leaving the factory. Organize production and deliver products in strict accordance with user requirements and relevant national standards, and ensure that the products provided are new and unused products, and are made with corresponding raw materials and advanced technology to ensure product quality, specifications and performance. The goods are transported in an appropriate manner.

Quality policy, Quality goals, Commitment

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Quality policy

Customer first; quality first, strict control process control, to create a first-class brand.

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Quality goals

Customer satisfaction reaches 100%; timely delivery rate reaches 100%; customer opinions are processed and feedback 100%.

Quality Control

Quality system

In order to effectively control the factors that affect product technology, management and personnel, and prevent and eliminate substandard products, the company has planned and systematically formed quality system documents and strictly implemented them to ensure quality assurance. The system continues to work.

Design control

Plan and execute product design and development in accordance with the design control program to ensure that the product meets relevant national standards and user requirements.

Control of documents and materials

In order to maintain the integrity, accuracy, uniformity and effectiveness of all quality-related documents and materials of the company, and to prevent the use of invalid documents, the company strictly controls documents and materials.


In order to meet the quality requirements of the company's final products, the company strictly controls the procurement of raw and auxiliary materials and external parts. Strictly control supplier qualification verification and procurement procedures.

Product identification

In order to prevent raw and auxiliary materials, purchased parts, semi-finished products and finished products from being mixed in production and circulation, the company has stipulated the method of product identification. When traceability requirements are specified, each product or batch of products should be uniquely identified.

Process control

The company effectively controls each process that affects product quality in the production process to ensure that the final product meets the specified requirements.


In order to verify whether each item in the production process meets the specified requirements, inspection and testing requirements are specified, and records must be kept.

Control of inspection and measurement equipment

In order to ensure the accuracy of inspection and measurement and the reliability of value, and meet production requirements, the company stipulates that inspection and measurement equipment should be controlled and inspected. And repair in accordance with regulations.

Quality awareness is integrated into all aspects of HMKN

The company's experienced quality control team follows the highest industry inspection standards of IQC, IPQC and OQC to ensure the high quality of products.

Control of substandard products

In order to prevent the release, use and delivery of substandard products, the company has strict regulations on the management, isolation and treatment of substandard products.

Corrective and preventive measures

In order to eliminate actual or potential unqualified factors, the company strictly stipulates corrective and preventive measures.

Transportation, storage, packaging, protection and delivery

In order to ensure the quality of foreign purchases and finished products, the company has formulated strict and systematic documents for processing, storage, packaging, protection and delivery, and strictly controlled them.