ISO 14971

ISO 14971 is a state-of-the-art, international standard that is quickly being recognized as the best process to ensure that all aspects of risk management are considered throughout the product lifecycle for medical devices.

ISO 14971 for the application of risk management is designed to help manufacturers introduce safe medical devices into the market place. The manufacturer is responsible for identifying and controlling not only the risks associated with their medical device, but evaluating interactions with other devices.  The standard also allows for other healthcare manufacturing organizations to use the process and obtain certification.  This might include human tissue, animal care products, pharmaceutical manufacturers, etc., who may choose to use this standard.

The standard requires that top management demonstrate its commitment to risk management by:

• Establishing the process
• Setting the policy for acceptable risk
• Reviewing the effectiveness of the process at determined intervals

The risk management certification program by BSI will bring focus to this aspect of the process, and ensure that the manufacturer understands any significant gaps in the organization’s process.

The BSI ISO 14971 Risk management certification program was created by a team of healthcare experts specializing in the needs of medical device manufacturers and meets the latest 2007 requirements. The standard recognizes that even though medical devices are never without some level of risk, manufacturers still need a structured discipline to ensure that product benefits outweigh the risk, and that all risks have been reduced to an acceptable level.  In addition it provides an excellent risk management model that focuses on entire life cycle of the medical device.

For more information, please visit our Healthcare and medical device ISO 14971 page.

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• First Certification Program developed to the ISO 14971 standard
• Provides independent third party validation and objective evidence of compliance
• Suppliers can gain a competitive advantage which is recognized by manufacturers and regulatory authorities
• Demonstrates that risk process conforms to ISO 13485 and IEC 60601-1 for electromedical devices
• Increase speed-to-market with the establishment of robust risk
• High profile process with FDA, Japan PAL, Health Canada, Australia and other regulatory agencies' management processes for new product development
• Process-Centered Approach can enable manufacturers to improve internal auditing and control processes

For more information, please visit our Healthcare and Medical Device ISO 14971 page.

Request a quote, find out more about training courses or contact us for more details.

From a one-day introductory course to implementation training or lead auditor courses, our network of public and onsite training can help you at every stage of the process. Our experience of how organizations of all types and sizes relate to the standard is unequalled - and we can deliver the training you need for understanding, implementing, assessing and certifying your risk management systems.

We offer a comprehensive program of training courses covering every aspect of ISO 14971 for:

Students who are new to risk management systems

• Courses in understanding and implementing a new system

Students who need to audit and improve an existing system

• Courses in auditing, assessing and improving an existing system

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There are six steps to achieving certification with BSI.

1. Establish a quality management framework as identified in the appropriate standard (ISO 14971).
2. BSI will then provide an estimate of costs and time-scales for formal assessment.
3. Submit a formal application to BSI. Consider an optional pre-assessment.
4. BSI will undertake a pre-certification review of the Quality Manual and the Quality Systems.  This will then identify any weaknesses and omissions in your quality management system that need to be resolved and your readiness for the main assessment.
5. BSI will then conduct an on-site initial assessment and make recommendations.
6. On successful completion of the audit, a certificate of registration is issued which clearly identifies the scope of the Registered Management System. This certificate is supported by continual assessment visits.

Request a quote, find out more about training courses or contact us for more details.