Introduction of ISO 13485

ISO 13485 is an internationally recognized standard that outlines specific quality management system (QMS) requirements for organizations engaged in various aspects of the medical device industry, including the design, production, installation, servicing, and manufacturing of medical devices.

First published in 1996 and subsequently updated in 2003 and 2016, ISO 13485 continues to evolve to address the dynamic nature of the healthcare sector. Compliance with ISO 13485 is essential for organizations looking to demonstrate their commitment to producing safe and effective medical devices, adhere to stringent regulatory requirements, and maintain the highest levels of quality and patient safety.

What Is ISO 13485 Certification?

The ISO 13485 Certification is a harmonized ISO standard, which lays-down the needs for quality management systems for medical devices.

ISO 13485 Certifications offers manufacturers, suppliers and designers to the medical-device industry with a management system necessary to demonstrate compliance to regulatory need and mitigate hazard to stake-holders. It places more emphasis on hazard based thinking and decision making while it also provide stronger interoperability between the clauses & requirements.

Key Significance

• Boost the export advantage
• Clarification of Management Responsibilities
• ISO 13485 Boost customer satisfaction
• By help of ISO 13485 Certification integrate Risk Management
• ISO 13485 assures for good quality products and services
• Standard makes sure patient safety

Who Requires ISO 13485 Certification?

ISO 13485 certification is required for designers, suppliers and manufacturers of medical devices. However, ISO 13485 certification is relevant for a wide range of stakeholders in the medical device industry, including manufacturers, suppliers, regulatory authorities, healthcare institutions, and testing organizations and gain a competitive advantage by enhancing the organization brand’s credibility and recognition.

ISO 13485 certification is required by law in some countries like Australia, European Union, Japan, New Zealand, Russia, Singapore, South Korea, United States etc and it is also a requirement for many government and private sector contracts. ISO 13485 certification is relevant for a wide range of stakeholders in the medical device industry, including manufacturers, suppliers, regulatory authorities, healthcare institutions, and testing organizations.

Why choose SQC

• Expertise
• Reputation
• Global Recognition
• Client Centric Approach
• Results Driven
• No Middlemen

Choosing SQC Certification Services as your certification body ensures that you receive expert assessments and a streamlined certification process that paves the way for your organization to achieve ISO 13485:2016 certification.

Cost of ISO 13485:2016 Certification

Understanding the costs associated with ISO 13485:2016 certification is essential for organizations considering this endeavor. The cost of certification can vary depending on several factors, including the size of your organization, the complexity of your processes, and the Certification Body (CB) you choose. To know more about ISO 13485 certification cost, contact us.

Conclusions

By selecting SQC Certification Services as your certification body, you’re taking a significant step towards quality excellence, operational efficiency, and sustainable growth in the medical device industry.