ISO 13485 Medical Devices Management Systems
Organizations that develop, produce, or maintain medical devices and related services fall within the scope of ISO 13485 compliance.
The current version, ISO 13485:2016, aligns with modern quality standards like ISO 9001:2015 and addresses the dynamic regulatory landscape and rapid innovations in the medical device sector.
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Meet Regulatory Compliance
ISO 13485:2016 offers a comprehensive quality management framework that enables medical device organizations to meet global regulatory requirements effectively. Adhering to ISO 13485 signifies an organization’s dedication to producing medical devices that are safe, dependable, and of consistently high quality.
Expand Global Market Access
ISO 13485 enables organizations to gain international market access by proving their ability to meet both customer expectations and regulatory mandates. Implementing ISO 13485 enhances your organization’s credibility and facilitates smoother entry into regulated markets around the world.
Enhance Operational Efficiency
Aligning your quality management system with your business strategy is essential for boosting performance and reducing risks. ISO 13485 supports this alignment by embedding quality principles into core operations, enabling better decision-making, reduced waste, and increased organizational agility.
Strengthen Patient Safety and Product Quality
In the highly sensitive field of healthcare, protecting patients is paramount. ISO 13485 promotes a lifecycle approach that incorporates risk-based thinking and preventive action to ensure product safety and regulatory conformity, ultimately supporting improved patient outcomes.
What Is It?
ISO 13485 is an internationally recognized standard that defines the requirements for a robust quality management system (QMS) in the medical device industry. It strengthens a process-based approach to quality by helping organizations maintain compliance, ensure device effectiveness, and consistently improve performance.
- Increase patient safety and product quality
- Ensure regulatory compliance
- Align with strategic business goals
- Improve operational processes and reduce costs
- Enable international market entry
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:
