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What is ISO 13485? |
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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. |
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Created by the International Organization for Standardization, ISO 13485:2003 is
based on eight quality management principles: customer focus, leadership, involvement
of people, process approach, system approach to management, continual improvement,
fact based decision-making and mutually beneficial supplier relationships. When
fully adopted, these principles have been proven to enhance organizational performance. |
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Benefits of Registration to ISO 13485:2003 |
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- Provides international recognition.
- Enables your organization to become more cost-effective.
- Improves internal communications, efficiency and resilience to change.
- Improves product and process quality and provides a basis for meeting regulatory
requirements.
- Requires your organization to monitor and improve key business and customer satisfaction
measures.
- Certification to ISO 13485 satisfies a significant portion of the EU Directive requirements
for marketing medical devices in Europe.
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Click here for Application Form |
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