- Benchtop High Speed Centrifuge
- Floor high speed centrifuge
- High speed refrigerated centrifuge
- Tabletop Low Speed Centrifuge
- Low speed refrigerated centrifuge
- Free-standing Low Speed Centrifuge
- Laboratory centrifuges
- Medical centrifuge
- Automatic decapping centrifuge
- Petroleum centrifuge
- Large capacity centrifuge
- Hematology Centrifuge
- PRP centrifuge
- Refrigerated Centrifuge
- Blood Bank Centrifuge
- Mini centrifuge
- Special centrifuge
- Centrifuge rotors
- Electronic Balance
- Vacuum Centrifugal Concentrator
- Moisture Analyzer
Hunan Herexi Instrument Equipment Co., Ltd. recently received the ISO13485: 2016 quality management system certification certificate (certificate code: 47241) issued by Shanghai Enkeai Certification Co., Ltd. It is December 12, 2019, and the expiration date is December 12, 2022.
By obtaining the ISO13485: 2016 certification, we will improve and improve our company's management level, avoid legal risks, and increase the visibility of the company; improve and guarantee the quality level of the product, so that the company can obtain greater economic benefits; and help to eliminate trade barriers To obtain a permit to enter the international market; it is conducive to enhancing the competitiveness of the product and increasing the market share of the product; through effective risk management, it effectively reduces the risk of product quality accidents or adverse events; and improves the sense of responsibility, motivation and dedication of employees .
The acquisition of the ISO13485: 2016 quality management system certification certificate indicates that the design, development and production of the company's centrifuge products meet the requirements of the ISO13485: 2016 quality management system, which will help the centrifuge products to be legally placed on the market within the EU and promote the company's overseas Steady business development.
The successful passing of the ISO13485: 2016 certification has given the company more confidence in product quality and safety regulations. Here, Hunan Herexi Instrument and Equipment Co., Ltd. will continue to take refined management as the basis for guarantee, continuously improve internal control, and strive to achieve faster, better, and more sustainable development! It will continue to strengthen medical device production management, strengthen enterprise quality control, provide users with stable quality medical centrifuge products, and make greater contributions to China's medical device business.Thanks also to every Hessian for their efforts and sweat in the Hessian family to achieve higher quality goals!Knowledge points of ISO 13485:The ISO 13485 international standard, or "Medical device-Quality management system-requirements for regulatory", was developed by the ISO / TC210 Medical Device Quality Management and General Requirements Technical Committee, and is based on ISO 9001 Based on independent standards applied in the medical device industry and operating in a regulatory environment. Since its first release in 1996, the standard has been widely recognized and applied worldwide.The current implementation version is ISO13485: 2016 "Requirements for Medical Device Quality Management System for Regulations". The new version of ISO 13485: 2016 medical device quality management system runs through medical devices such as product approval, design and development, sample preparation, registration testing, clinical evaluation, product registration, production, storage, installation or service, use, post-market surveillance feedback, and disposal. Every link in the entire life cycle places higher requirements on the quality management of the medical device industry.ISO13485 is an important standard in the field of medical devices. The guarantee of quality system has become the main means for pre-market control and post-market supervision of medical device products.
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