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Baianda Successfully Passed the CE Certification Factory Audit.

2024-04-12 15:19

Baianda Successfully Passed the CE Certification Factory Audit.


Baianda has held CE certification for nearly ten years. At the end of March 2024, Baianda once again smoothly passed the strict CE certification factory audit.

half mask respirator factory

The factory received Module D certification (production process quality control), and the product passed Module B certification (EC type examination). The "CE" mark is a safety certification mark considered as a passport for manufacturers to enter the European market. In the EU market, the "CE" mark is a mandatory certification mark, and only products that comply with EU requirements and are affixed with the "CE" mark can circulate freely in the EU market.

 

The CE certification conducts strict audits and controls on various aspects of the applicant entity, such as safety design documents, product technical conditions, operating manuals, design details, operational descriptions, lists of key components or raw materials, and the theoretical basis of testing, including all necessary items to meet basic requirements for health and safety. For high-risk Class III protective equipment, factory audits and at least annual product quality assurance capability supervision and audits are also required.

 

There are nine basic models of CE certification, among which Module D focuses on the production process and final product control. The factory produces in accordance with the methods approved by the testing organization, and on this basis, declares that the product is consistent with the certified type. Module B involves the factory sending samples and technical documents to the testing organization for review, and the testing organization issues a certificate. Module B alone is not sufficient for the use of CE; protective masks must obtain both Module B and Module C2 certificates (internal quality control + product random monitoring spot checks) or a Module D certificate before they can be legally sold in the EU.

silicone half mask

The factory audit of Baianda was conducted by the renowned British certification body INSPEC (International Safety Products Certification Ltd.,UK). INSPEC is authorized and recognized by the United Kingdom Accreditation Service (UKAS) as a personal protective equipment testing organization, and it is empowered to grant CE certification for respiratory protection products and production systems. UKAS is the only national accreditation body authorized by the British government, responsible for assessing and accrediting certification, testing, inspection, and calibration entities according to international standards. It is also theUKsignatory to the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC). It is important to note that each Personal Protective Equipment (PPE) certification body has different scopes of authorization; if it does not have the sub-category for respiratory protection, it cannot engage in CE certification activities for protective masks.

 

As of now, Baianda has obtained ISO9001:2015 Quality Management System certification and ISO45001:2018 Occupational Health and Safety Management System certification. It has received factory and product certifications fromChina's LA,America's NIOSH, Europe's CE, andRussia's EAC, and has obtained dozens of national patents for its products.

 

As a Chinese national brand enterprise engaged in research on respiratory safety protection technology, manufacturing of respiratory protective equipment, and respiratory safety protection services, Baianda will remain true to its original aspiration and mission. It aims to play a leading role as a Chinese national brand, safeguarding the respiratory occupational safety and health of workers.



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