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ISO 13485:2016 Certification

What is ISO 13485?

ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive "management system for the design and manufacture of medical devices". While it remains a stand-alone document, "ISO 13485" is generally harmonized with ISO 9001. A fundamental difference, however, is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 requires only that they demonstrate the quality system is implemented and maintained.

ISO 13485:2016 provides a harmonized set of quality management system requirements for medical device manufacturers. Based on a process approach to quality management, it focuses on what the manufacturer does to provide safe and effective medical devices.

Your ISO 13485 certificates can help you enter into EU market.

While it is based on ISO 9001:2015, ISO 13485 does not include the customer satisfaction and continual improvement clauses - so an organization certified to ISO 13485 does not automatically meet the requirements of ISO 9001 unless it is assessed against that standard separately. Compliance with ISO 13485 also does not equate compliance with regulatory requirements, although in many cases it can facilitate the audit process for those requirements.


Why should my organization become certified to ISO 13485?

Your quality system's conformity with ISO 13485 can help you reap the benefits of:
 
  • Expanded market access
    National regulatory authorities require, or strongly prefer, that manufacturers marketing medical products in their countries have a third-party audited and certified quality system in place. Investing in such a system speeds access into those countries that require it, and expedites market entry into the others.
  • Reduced cost of sales
    Your certification establishes your company's credibility and commitment to quality from day one. Because the task of explaining the specifics and demonstrating the effectiveness of your quality system is more straightforward, it takes less time to earn your prospective customers' trust and confidence.
  • Improved overall performance
    Based on a uniform and widely accepted system of process control, your certified QMS helps you improve your products and processes. This can faster improved relationships with your suppliers, business partners and customers, and give your business a real advantage in the marketplace.
 
 

Other specific differences include:

 
 
  • The promotion and awareness of regulatory requirements as a management responsibility. An example of market specific regulatory requirements is 21 CFR 820 Quality System Regulation for Medical Devices sold in the United States.
  • Controls in the work environment to ensure product safety
  • Focus on rick management activities and design transfer activities during product development
  • Specific requirements for inspection and traceability for implantable devices
  • Specific requirements for documentation and validation of processes for sterile medical devices
  • Specific requirements for verification of the effectiveness of corrective and preventive actions.

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