MEDICAL DEVICES – QUALITY MANAGEMENT SYSTEM

ISO 13485 Certification

The processes required by ISO 13485:2016 are applicable to the organization. Still, the organization does not perform its responsibility and does not account for the quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls. This can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches to address the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.

Suppose any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied. In that case, the organization does not need to include such a requirement in its quality management system. For any clause that is not applicable.

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.

BENEFITS OF MEDICAL DEVICES – QMS

Management system’s conformity with ISO 9001, ISO 13485 or ISO14001 can help company open doors to untapped domestic and international business opportunities and the benefits.

Expanding 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. Investing in such a system speeds access into those countries that require it and expedites market entry into others.

Reducing 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.

Improving 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 improve relationships with your suppliers, business partners, and customers and give you a real advantage in the marketplace.