What is ISO 13485?
Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a products life cycles, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. ISO 13485 is the best international accepted model for medical devices. ISO 13485 is a stand alone QMS standard, derive from the internationally recognized and accepted ISO 9000 quality management series. ISO 13485 adapts the ISO 9000 process based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. Thus it is more prescriptive in nature and requires a more thoroughly documented quality management system.it aid medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes.it ensures consistent design, development, production, installation and delivering of medical devices that are safe for their intended purpose.
Why seek ISO 13485 Certification
It helps demonstrate compliance to laws and regulations of the medical device industry. Adopting 13485 provide a practical foundation for manufacturers to address the responsibilities as well as demonstrating commitment to the safety and quality of medical devices. The regulatory requirements are intended to ensure that manufacturers consistently design, produce, and place onto the market, medical devices that are safe and fit for their intended purpose.
Benefit ISO 13485 Certification
- Potentially gain entrance into international markets since certification to ISO 13485 is seen as a first step toward achieving compliance with European requirements.
- Meet regulatory requirements
- Meet customer expectations
- Moreover, ISO 13485 will help your organization monitor the effectiveness of supply chain and impart improved risk management & design controls to assist you in the development and improvement of your products
- Get ensure compliance with the requirements of the standard and more
