ISO13485      
 

ISO 13485

 


ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes is designed for the medical device industry. A number of changes from the ISO 9001 foundation have been made. These change include the following:

  
 

The emphasis on continual improvement has changed to maintaining your product and system. The emphasis on customer has taken a slightly different form. More documentation is required by this standard than in the ISO 9001 standard
Some of the key issues addressed by ISO 13485 are

  • Regulatory focus
  • Process approach
  • Focus on “meeting customer requirements”
  • Focus on “maintaining the effectiveness of the QMS”
 
  • Maintenance of procedural documentation
  • Clarification of specific differences between ISO 9001 and ISO 13485
 
Wenzhou GM Quality Technology Services Ltd.
   
     
 
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http://www.cnca.gov.cn/cnca/default.shtml：中国国家认证认可监督管理委员会
 
http://www.cqc.com.cn：中国质量认证中心
 
http://www.wzzl.cn：温州市质量技术监督局
 
http://www.zjbts.gov.cn：浙江省质量技术监督政务网
 
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