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MEBO (Shanghai) Won ISO13485 International Quality Management System Certificate
2013年-11月-20日
来源：MEBO
MEBO (Shanghai) Won ISO13485 International Quality Management System Certificate
Recently, MEBO (Shanghai) won ISO13485 and received the international quality management system certificate issued by SGS.
Standard full name of ISO13485 in 2003: Medical Device – Quality Management System – Requirements for Regulator. The Standard was stipulated by SCA/TC221 Committee of Medical Device – Quality Management System – Requreiments for Regulatory, which is an independent standard based on ISO9001: 2000.
Since its stipulation in 1996, it has been widely applied and carried out around the world. The new version of ISO13485 standard was formally issued on July 3rd of 2003, serving as a management standard complying with laws and regulations. From its name, it is defined as a requirement suitable for laws and regulations.
Medical devices are usually not regular products sold on international markets. They are supervised and managed by national and local laws and regulations, e.g. FDA (USA), MDD (European Union) and Medical Device Supervision and Management Regulations (China). Therefore, the Standard shall be restricted by law and shall be operated under laws-abiding environment. At the same time, the risks shall be comprehensively taken into consideration, and the risk management shall be fulfilled in the whole process of realization of medical devices. So, ISO13485 can be regarded as the ISO9001 in the environment of medical device regulations, apart from its special requirements.
ISO9001, EN46001 or ISO13485 are usually adopted in US, Canada and Europe as a requirement for quality guarantee system. The establishment of medical device quality guarantee system shall follow this standard. Related laws and regulations shall be followed in order to promote medical devices in countries in North America, Europe or Asia.
In this April, MEBO (Shanghai) submitted applications for ISO13485 Quality Management System to SGS, a well-know international authentication company. Through inspections of documents and on-site observation, various index has been approved by UK. And, the ISO13485:2003/ENISO13485: 2012 certificate was issued on October 30th.
The smooth process of obtaining authentication represents that the research, development, production, management and quality control of products of MEBO (Shanghai) have reached to a new height and greatly improved the expertise and reputation of MEBO (Shanghai) in medical industry. At the same time, it helped lay foundation for the international development MEBO products.