ISO 14971: Definition, Compliance, Tools, and Certifications
ISO 14971 is a critical standard for medical device manufacturers and their suppliers. The standard defines the requirements for risk management and provides a framework for assessing and controlling safety risks associated with medical devices. ISO 14971 is widely adopted, and compliance is mandatory in many regions. In this blog post, we will provide an overview of ISO 14971, including a definition of the key terms, compliance requirements, and some common certification schemes.
What is Risk Management?
Risk management is the process of identifying, assessing, and controlling safety risks associated with medical devices. The goal of risk management is to protect patients, users, and other stakeholders from unacceptable risks.
Each organization faces slightly different risks, which could stem from many different sources and include everything from strategic management errors to IT security threats to natural disasters. For this reason, organizations must conduct periodic risk assessments and implement a plan to mitigate the possible disruptions.
What is ISO 14971?
ISO 14971 is an international standard that provides a framework for the risk management of medical devices. The standard defines the requirements for risk management and provides a framework for assessing and controlling safety risks associated with medical devices. ISO 14971 is widely adopted, and compliance is mandatory in many regions.
Today, there are three versions of ISO 14971: ISO 14971:2007, EN ISO 14971:2012, and ISO 14971:2019. The European market is covered by the EN standard. Outside of Europe, the most recent standard is ISO 14971:2019. The EN version of the standard adds three new appendices that have their own numbering system, which is not included in the ISO standard.
- Appendix A (Informative) – Overview of risk management
- Appendix B (Informative) – Illustrative examples
- Appendix C (Normative) – Guidance on the application of ISO 14971:2007 to software aspects of medical devices
Everywhere else across the globe, the ISO 14971:2019 version remains the current standard.
What are the key terms in ISO 14971?
There are four key terms in ISO 14971: risk, hazard, safety, and efficacy.
- Risk: The probability of occurrence of a hazardous event and the severity of the resulting injury or damage.
- Hazard: A source of potential harm or adverse health effect on a patient, user, or another person.
- Safety: The state in which the risks associated with the use of a medical device are reduced to an acceptable level.
- Efficacy: The ability of a medical device to achieve its intended purpose.
How is ISO 14971 compliance important?
ISO 14971 compliance is important because it helps ensure that medical devices are safe for patients and users. The standard provides a framework for assessing and controlling safety risks associated with medical devices. ISO 14971 is widely adopted, and compliance is mandatory in many regions.
To fulfill ISO 14971, a manufacturer must first assess the risks of medical devices and develop a plan to address these risks. The process begins with identifying the hazards associated with in vitro diagnostic (IVD) medical devices to:
- Estimate and evaluate the associated risks;
- Control these risks, and
- Monitor the effectiveness of the controls.
The medical device risk management standard covers the medical device from its inception to its decommissioning and disposal throughout the product lifecycle, as risks may (and frequently do) occur at various stages.
What are the compliance requirements for ISO 14971?
Organizations that implement ISO 14971 must establish a risk management process that includes the following steps:
- Identify hazards associated with the medical device.
- Estimate the risks associated with those hazards.
- Evaluate the risks and decide on controls to mitigate them.
- Implement controls to mitigate risks.
- Monitor the effectiveness of controls.
How are ISO 14971 and ISO 13485 related?
ISO 14971 is closely related to ISO 13485, the international quality management standard for medical devices. ISO 13485 provides requirements for a quality management system that can be used by organizations that design, develop, manufacture, and/or provide medical devices. The standard covers risk management activities such as hazard identification, risk analysis, and risk control.
ISO 14791 and ISO 13485:2016 are linked because they form a QMS that is operational and protects against risk. Medical devices must meet regulatory and customer standards set forth in ISO 13485. Because any risk necessitates a risk analysis and record-keeping as stipulated by ISO 13485, it looks to ISO 14971 for assistance. When it comes to risk analysis, ISO 14971 provides a process to identify hazards, assess risks, and control risks.
The new ISO 13485 version improves risk management by including procedures such as purchasing and training. “The organization shall apply a risk-based approach to the control of the required processes for the quality management system,” reads section 4.2.1 in part.” In other words, anything that has an impact on the quality system’s performance needs to be assessed in light of this risk. This is not anything new, but it serves as a reminder that risk is an essential component of your QMS and must be addressed in order to obtain ISO 13485:2016 certification.
Visure Requirements ALM Platform:
The Visure Requirements ALM platform is a tool that helps organizations manage the requirements in accordance with ISO 14971. The platform includes risk analysis and management features that help organizations comply with ISO 14971.
The platform includes a risk register that allows users to track and manage risks throughout the product lifecycle. The risk register includes fields for hazard identification, risk estimation, risk evaluation, and risk control. The platform also includes a hazard log that allows users to track and manage hazards throughout the product lifecycle.
The Visure Requirements ALM platform is ISO 14971:2019 compliant and helps organizations manage the requirements of ISO 14971.
ISO 14971 is a regulatory standard for medical device manufacturers. The benefits of certification to this standard are many and include reducing the risk of product recalls, improving communication between departments within a company, and protecting patients from harm. Visure Requirements ALM Platform is a tool that can help companies achieve ISO 14971 certification. Request a free 30-day trial at Visure Requirements ALM Platform today to see how our software can help your business meet the requirements of this important regulatory standard.