Get the information you need to design, coordinate and improve your company's QMS as per ISO 13485:2016. Understand and implement a best-practice Quality Management System as per requirements for the medical industry. You can learn what the requirements are, and be aware of best practice guidelines that are beneficial to your operations.įurthermore, you can begin preparing your relevant set of documents (Quality Manual, SOPs, etc) for immediate implementation of your SOPs. Show how it relates to business processes In this course, we will walk through the ISO 13485:2016 standard to: ISO 13485 evaluates whether your Quality Management System is appropriate and effective while emphasizing the safety and efficacy of medical devices. The purpose of this course is to clarify the application of ISO 13485:2016 standards for medical device companies and development of the medical device. ISO 13485 Certified means an organization has implemented an ISO 13485 Quality Management System and has successfully met all of the requirements in ISO 13485. With this need for implementation, comes a need for understanding of the requirements. Global regulatory requirements emphasise this and make it mandatory for such standards to be adhered to by companies worldwide. Having a proper QMS in place is essential for medical device-related companies. Cytiva’s business has more than 50 years of experience in the biotechnology industry. Implementation of ISO 13485 helps an organization to keep the quality and consistency of medical devices, moreover it is an assurance to their clients. Throughout the design and manufacturing process, every aspect of your Cytiva product must meet stringent quality requirements and achieve a high level of performance. ISO 13485 is a quality management system specifically designed for medical device manufactures, designers and developers which is similar to US FDA 21 CFR 820. ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.The ISO 13485:2016 standard specifies requirements for the Medical Device Development and Quality Management System (QMS) that should be used by medical device-related companies. At Cytiva, quality is simply ingrained into who we are. Why was ISO 13485 revised and what are the main improvements?Īll ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace. Read more about certification to ISO’s management system standards. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard. Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organizations can reap many benefits from implementing the standard without undergoing the certification process. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.
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