Medical devices play a crucial role in healthcare, from diagnostic equipment to implantable devices that can improve quality of life or even save lives. However, if medical devices are poorly designed or manufactured, they can also put patients at risk. That is why quality management and regulatory compliance are so important for medical device companies. ISO 13485 is an internationally recognized standard that sets out comprehensive quality management system (QMS) requirements for organizations involved in medical device design, production, installation and servicing. By attaining ISO 13485 certification, a company demonstrates its commitment to quality and regulatory compliance. This in-depth guide explains what ISO 13485 is, why it matters and how certification works.
What is ISO 13485?
ISO 13485 is a quality management system standard published by the International Organization for Standardization (ISO) that contains requirements for a comprehensive QMS focusing on the lifecycle of medical devices. ISO standards are voluntary, but certification to ISO 13485 has become expected or even required by medical device regulators and customers worldwide.
Key Elements of ISO 13485
ISO 13485:2016, the current version of the standard, includes a number of important requirements:
- A documented QMS meeting regulatory requirements and ISO 13485 itself
- Risk-based approach to QMS processes
- Documented procedures and controls
- Management commitment and resource provision
- Infrastructure for quality and regulatory compliance
- Product and process planning
- Purchasing controls
- Production process controls
- Validation of processes
- Product traceability
- Control of nonconforming product
- Corrective/preventive actions
- Measurement, analysis, and improvement
Some key clauses of ISO 13485:2016 include:
Management Responsibility
Top management must demonstrate commitment to the QMS by defining responsibilities and providing needed resources. A management representative is appointed to oversee the system.
Resource Management
Resources like staff, infrastructure and work environment must support product quality and regulatory compliance. Staff must be competent for their roles.
Product Realization
Extensive requirements cover planning, design, purchasing, production, installation, servicing, traceability, customer communication and handling of nonconforming product.
Measurement, Analysis and Improvement
The QMS and processes must be monitored, measured, analyzed and improved. Data analysis guides corrective and preventive actions.
The Importance of ISO 13485 Certification
There are several reasons ISO 13485 certification has become essentially mandatory for medical device companies:
- Regulatory compliance – Most medical device regulators either recommend or require ISO 13485 certification. It demonstrates a commitment to quality and regulatory requirements.
- Access to markets – Certification facilitates access to markets worldwide. Some countries legally mandate it for selling medical devices.
- Customer confidence – Hospitals, healthcare providers and group purchasing organizations prefer to work with certified suppliers.
- Risk reduction – The QMS requirements of ISO 13485 reduce risks and support product safety.
- Consistent processes – Certification ensures consistent processes and helps prevent product defects.
- Legal necessity – In the EU and Canada, ISO 13485 is required for regulatory compliance.
Simply put, ISO 13485 certification is the expected norm across the medical device industry. For most companies, achieving certification is necessary to remain competitive.
How Does ISO 13485 Certification Work?
Here is an overview of how organizations get certified to ISO 13485:
- A company establishes a QMS meeting ISO 13485 requirements. This is thoroughly documented.
- Evidence of compliance comes from records, procedures, process measurements and more.
- An accredited certification body audits the QMS to verify conformance to ISO 13485.
- If successful, the certification body issues an ISO 13485 certificate. Certification is valid for 3 years.
- Periodic surveillance audits occur to ensure ongoing compliance and recertification after 3 years.
A few key points about ISO 13485 certification:
- The auditors who assess a QMS to grant certification must be accredited and fully qualified.
- Certification is site-specific – each location producing or supplying medical devices needs its own certification.
- The scope of certification lists the types of devices covered under the QMS.
- Any major changes to the QMS require notification of the certification body.
Achieving ISO 13485 certification takes commitment, but doing so demonstrates a dedication to quality that benefits medical device companies, healthcare providers, regulators and most importantly, patients.
Conclusion
ISO 13485 is the internationally recognized QMS standard specifically for organizations involved in medical devices. By providing comprehensive quality management requirements and risk management principles, ISO 13485 helps ensure medical devices are safe and fit for purpose. Although voluntary, certification has become a necessity for medical device companies to meet regulatory compliance, access global markets, reduce risk, and provide customer assurance. With stringent auditing by accredited bodies, ISO 13485 certification validates to stakeholders worldwide that certified organizations excel at medical device quality management.