Dear customer

-Before the formal mass production of BQ products, according to the requirements of laws and regulations and the necessary design and development process, the product's material, structure, intended use, performance indicators and other technical requirements as well as the production process are designed and verified, and the relevant technical documents are issued through the quality management system and implemented.

-BQ+ implements Total Quality Management. Products in the production process, including material feeding, injection molding, extrusion, assembly, bonding, packaging, sterilization and inspection all links, there are corresponding production records and inspection records, each process is in accordance with the corresponding drawings, operating procedures, inspection procedures and other technical documents for operation. Keep a detailed record of the traceability information of each project, the operation content and technical parameters of each process, and the inspection results of each technical requirement.

-Total Quality Management is also reflected in the quality awareness and training level of all staff. BQ+ production and inspection personnel must undergo corresponding skill training and pass the examination before they officially take up their posts.

-The non-conforming products in the production process shall be confirmed by the quality personnel or reviewed by the responsible departments according to the document requirements and shall be repaired, reworked,

-scrapped and other disposal measures to ensure that all products meet the quality requirements.

-Each customer feedback and complaint case will be carefully investigated and actions taken. BQ+ quality engineers on complaint handling and CAPA ability will ensure a smooth cooperation with every clients.

-We promise a safe usage of BQ+ products by devote our sustained engagement in continuous improvement. Not only the improvement identified by our own QMS, but also the chances of improvement from our treasured clients. Every voice from you will be appreciated and considered as a valuable source of our improvement!

BQ+ possesses an independent Ethylene Oxide Sterilization Center besides its production lines. The sterilization validaiton and routine contorl procedures have been well established according to ENISO11135 standard and additional local requirements from China FDA.

As ENISO13485/ENISO11135 certificates holder, We are supervised by routine audit of notified body TUV Rheinland and also the national authority CFDA.

We also accept audit from domestic and foreign customers. Our service on process validaiton ranks top level in China and we provid routine sterilization service for hundreds of enterprises both domestic and abroad of China.

BQ+ provides sterile products which meets EN556-1 defination on sterility, with a SAL=10-6.At the same time, BQ+ also provides commercial EO sterilization service aimed at lower down bioburden or product disinfection.

Our quality is assured with ISO13485 quality management system and traceability is well established. Each sterilization Service with be provided with the following documents:

-Sterilization batch record

-Sterilization certificate

-Results of BI culture

-EO residue test result

BQ has set up a special warehouse to store all raw materials and products. The warehouse is equipped with pest control facilities and the environment temperature is monitored.

The warehouse implements partition management for raw materials and finished products. Place raw materials or finished products according to their respective product names, specifications, models, etc., and register the traceability information of raw materials and products such as product names and batch Numbers through identification cards. The warehouse keeps information for incoming and outgoing materials and products, and carries out dynamic management.

All products shall be inspected by quality personnel and confirmed to be qualified before being put into storage. The warehouse arranges the delivery according to the shipping instructions of the sales department.

BQ+ sales team is base in factory, and they keep interaction with production, quality and logistic team. They are following your medical device order status and quality controlling, in case there is any issue, you will know it immediately.

BQ+ sales representative will send you photos/videos to keep you posted.

FQC will be done before releasing goods from BQ+ factory, COC/COA will be issued by BQ+ laboratory. You could do “remote video inspection before shipment” and see container loading through sales representative’s mobile phone camera.

Don't worry, BQ+ Guarantees：

• Sales responds in 24hours Investigation in 3 days

• Proposal of Compensation in 7 days

• Corrective and preventive action plan in 30 days

• CAPA close in 90 days.

The following support needed from your side:Please do inspections within 30 days after shipment arrives.If there is any quality issue,

• It is helpful to provide photos or videos.

• Please describe the scenario as detailed as possible.

• Please provide your inspection result, test method and sampling standard.

• Please let us know the current disposition status of the problem products.