>What Is ISO 13485?
ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
ISO 13485 requirements :
In order to achieve ISO 13485 certification, you must develop written policies for the following functions:
- Document and record controls
- Internal auditing procedures
- Controls for non-conformance
- Corrective and preventative actions
- Process and design controls
- Record retention
- Accountability and traceability
ISO 13485 Benefits
Here is what medical device manufacturers can hope to gain from having an ISO 13485 certification:
- Access to markets that recognize or require the certification including Canada and Europe.
- Reduce operational costs by highlighting process deficiencies and improving efficiency
- Increase customer satisfaction by consistently delivering quality products and systematically addressing complaints
- Proven commitment to quality through an internationally recognized standard
- Adds transparency to the way complaints, surveillance or product recalls are handled
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