ISO 13485 Medical Devices Management Systems
Organizations involved in the design, development, production, installation, and servicing of medical devices, as well as related services.
ISO 13485:2016 is the latest version of the standard for medical device quality management systems. It was updated to align with other quality management system standards, such as ISO 9001:2015, and to address the evolving regulatory landscape and advancements in the medical device industry.
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Meet Compliance Requirements
ISO 13485:2016 provides organizations in the medical device industry with a practical framework to meet regulatory requirements for a quality management system. By adhering to the standard’s requirements, organizations can demonstrate their commitment to producing safe and effective medical devices.
Gain Market Access
The international recognition for quality management systems in the medical device industry. It establishes a set of requirements that organizations can implement to demonstrate their ability to consistently meet customer and regulatory requirements.
Drive Business Performance
Align your management system with the strategic direction of your organization is crucial for achieving operational efficiency and minimizing reputational risks. ISO 13485 provides a framework that helps organizations integrate quality management practices into their overall business strategy.
Improve Patient Safety and Quality
Protecting consumer safety is a fundamental aspect of the medical device industry. ISO 13485 emphasizes the importance of robust risk management practices throughout the entire lifecycle of a medical device.
What Is It?
The internationally recognized standard that brings a strengthened process approach to quality management in the medical device industry. It provides a framework for organizations to establish and maintain a quality management system that complies with regulatory requirements.
- Increase patient safety and quality, protecting your brand
- Achieve regulatory compliance requirements
- Achieve organizational strategic objectives
- Improve process efficiency and lower costs
- Gain market access
Following the requirements of ISO 9001, ISO 13485 follows the structure to implement a quality management system including the requirements to document processes for the highly regulated medical device industry. Expands the terms of the Standard to include areas such as clinical evaluation, software, medical device families, post-market surveillance, Distributors and Importers.
Top management sit at the center of the organization’s success, and are therefore required to establish the quality processes and objectives, as well as conduct reviews to ensure the business is meeting customer expectations.
Only applicable if relevant, implement the right people and infrastructure to foster a positive work environment that sets the organization up to succeed.
The ISO 13485 standard includes specific requirements for planning, designing, developing, purchasing, and monitoring medical devices. These requirements ensure that organizations follow a systematic and controlled approach throughout the entire lifecycle of a medical device.
performance indicators, setting targets, and collecting data to evaluate the performance of processes. By monitoring and measuring key metrics, organizations can identify areas for improvement, track progress, and take corrective actions when necessary.
Next Steps
We can help your organization to implement or optimize ISO 9001.
Start
- Purchase the ISO 13485 Standard
- Undertake optional training to build expertise
- Implement the Standard
Implement
- Contact QCI Global to discuss requirements, timeframes and costs
- Review and accept proposal to book audit dates
- Take an optional pre-assessment
- Perform a gap analysis
Certify
- Undertake a Stage 1 audit
- Complete a detailed Stage 2 audit
- Upon successful certification, display the ‘Five Ticks’ StandardsMark™
Maintain
- Conduct Surveillance Audits annually
- Recertify to ISO 13485 every three years
- Establish a continuous improvement culture
Optimize
- Market for brand and promotional benefits
- Optimize commercial teams
- Ensure shareholder and stakeholder awareness
Maximize Your Certification to ISO 13485:2016
ISO 13485:2016 offers medical device manufacturers a quality management system that translated into greater consistency, improved quality and less risk.
Watch NowMedical Devices Courses & Training
Explore the range of Medical Devices courses we have on offer through QCI Global Assurance Learning.
Related Services
In addition to the services mentioned earlier, there are several related services that can further support improving business excellence maturity and sustainable business practices. These services include:
