Benefits of ISO 13485 Certification

04 May 2012

By Christine Forcier, Program Manager, Medical

For medical manufacturers seeking access to new markets, conformity with regulatory requirements is most often a prerequisite. Those who want to compete effectively also should have a properly implemented and maintained quality management system (QMS). To satisfy these conformity and QMS needs, many manufacturers are discovering the benefits of working with a third-party testing company.  

The benefits of management systems certification:
Your management system’s conformity with ISO 9001, ISO 13485, ISO 14971, or ISO14001 can help your company open doors to untapped domestic and international business opportunities, and 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 management 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. 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 performance – Based on a uniform and widely-accepted system of process control, your company’s certified management system helps you improve your products and processes. This can foster improved relationships with your suppliers, business partners, and customers, and give you a real advantage in the marketplace.

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