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ISO 13485 Certification
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ISO 13485 Certification

ISO 13485 is an international standard, recognized throughout the world for establishing a business management system specific to the medical device industry. Borrowing the structure of ISO 9001:2008. ISO 13485 is applicable to organizations that manufacture private label medical devices, in vitro diagnostic medical devices and medical components.

Created by the International Organization for Standardization, ISO 13485:2003 is based on eight quality management principle:

1.       Customer focus

2.       Leadership

3.       Involvement of people

4.       Process approach

5.       System approach to management

6.       Continual improvement

7.       Fact based decision-making

8.       Mutually beneficial supplier relationship

When fully adopted, these principles have been proven to enhance organizational performance.