The foundation of the risk management process must be top management. This is a standard technique used to assess and evaluate potential risks in the design development phase, which continues during production process controls. Although this may not be new, it is a reminder that risk is a major part of your QMS and needs to be addressed to achieve ISO 13485:2016 certification.Īnother tool to help manage risk is a Failure Mode Effect Analyses (FMEA). Section 4.2.1 states that, “The organization shall apply a risk-based approach to the control of the appropriate processes needed for the quality management system.” In other words, anything that affects the quality system needs to be viewed from that risk perspective. The new revision of ISO 13485 expands risk management to include processes such as purchasing and training. ISO 14971 is more detailed when it comes to risk management requirements. As ISO 13485 requires risk analysis and record keeping pertaining to any risk, ISO 13485 looks to ISO 14971 for guidance. ISO 13485 is focused on regulatory and customer requirements and for medical devices. ISO 14791 and ISO 13485:2016 are related because they work together to create a QMS that is functional and addresses risk. The requirements of this standard are applicable to all stages of the life-cycle of a medical device.” Regardless of which standard you are looking at, the abstract describes both standards the same: “ISO 14971 is a key standard specifying a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. If you align your risk management process with the EU version, you will also meet the requirements for ISO 14971:2007. If you are doing business in the EU, then you should purchase this version of the standard. The EN version of the standard introduces three new annexes which have their own set of requirements. Everywhere else in the world ISO 14971:2019 remains the current standard. EN is the ISO standard for the European market. It is paramount for your organization to guarantee that your products are safe and effective, and having a risk management system in place is crucial. Additionally, ISO 14971 provides a thorough explanation of terms and definitions. This standard defines the best practices throughout the entire life cycle from design to distribution and maintenance. ISO 14971 addresses risk management and is the international standard designed for the medical device industry. ISO 13485 PowerPoint Training Materials.ISO 13485 Online Training Course Listing.ISO 13485 Internal Auditor Training Courses.ISO 13485 Lead Auditor Training Courses.Simple Steps to ISO 13485 Certification Follow our proven and manageable step-by-step process for a successful ISO implementation project.
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