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Social Responsibility
Customer Responsibility

Quality System

1. We use the following medical standards to protect you: ISO9001 & ISO 13485, the “Specifications for Quality Management of Medical Device Manufacturing (Revised Edition)”, QSR, MDD, CMDCAS and other QA systems.

2. As for industrial standards for the food industry and non-medical quality protection systems, we use: ISO9001 , BRC, NSF, and PPE.

3. In terms of social responsibility, the company strictly follows: SA8000, BSCI, and WCA standards.

Quality Control Methods

Bluesail Medical has established rigorous quality control test standards and methods for our products. Elements of this system include:

1. Meeting the latest product standards:

A. Chinese Standards: GB 24786 & GB 10213

B. US Standards: ASTM D5250 & ASTM D6319

C. EU Standards: EN 455, EN 374, EN 420, EN 1186, & RoHs

2. Systematic efforts quality control and quality improvement. Using lean Six Sigma theory and management tools, we have implemented comprehensive quality management covering the entire product testing process, including IQC, IPQC, OQC, and FQC. We have established and implemented standardized operations, including on-site 7s kanban management systems as well as QCC operational systems.

Customer Needs

Bluesail never loses its focus on the needs of its customers. The market and our customers are our very center, and we always listen to customer needs and try to satisfy our customers to the utmost.

1. We have established a market-based and customer-focused operation system.

2. We have established a collaborative mechanism to respond quickly to customer needs.

3. We actively listen to the voices of our customers and their feedback, and proactively communicate with our customers to help solve their problems.

4. We never stop improving our quality and taking steps to prevent quality risks.


  Preventing FDA Risks

International Experience

    We have introduced advanced international management experience.

International Standards

    We have become members of the Standards Committees of the EU and ASTM.

Six Quality Control Platforms

As a member of society, enterprises should not only pursue economic benefits, but also fulfill their own social responsibilities. Only in this way will our society be harmonious and our companies be respected and recognized by the outside world. In Bluesail’s long-term business development, we have always upheld a business philosophy of “equality and mutual benefit, cooperation and win-win” and has established long-term stable, reliable, and mutually beneficial strategic partnerships and relationships with distributors and customers in many countries and regions all over the world.