ISO 13485 is the internationally recognised standard for quality management systems in the medical device industry. It specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices, and that related services consistently meet customer requirements and applicable regulatory requirements. It is designed and intended for use by organisations for the design and development, production, installation, servicing and sales of medical devices.
The primary objective of ISO 13485 is to facilitate harmonised medical device regulatory requirements for quality management systems. ISO 13485 is a standalone standard. It is largely based on the structure of ISO 9001, but includes some particular requirements for medical devices such as risk analysis, sterile manufacturing and traceability. Organisations being certified to ISO 13485 can not claim conformity to ISO 9001.
The primary objective of ISO 13485 is to facilitate harmonised medical device regulatory requirements for quality management systems. ISO 13485 is a standalone standard. It is largely based on the structure of ISO 9001, but includes some particular requirements for medical devices such as risk analysis, sterile manufacturing and traceability. Organisations being certified to ISO 13485 can not claim conformity to ISO 9001.
Benefits of ISO 13485 Certification
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:
- 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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