ISO 13485 2003 in Lucknow

What is an ISO 13485 Quality Management System? ISO 13485:2003 specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services. This is a process-based system and contrasted to the procedure-based system of QSR and ISO 9001.Manufacturers of Medical Devices are subject to specific legislative fulfilments. Medical Devices intended for diagnostic or therapeutic use, must comply with stringent requirements for safety and effectiveness .The medical device industry throughout the world will move toward adopting the new ISO 13485:2003 as the preferred quality system standard.Another important aspect of ISO 13485:2003 is the inclusion of risk management throughout the quality system process, thus providing for a risk-based approach for determining a level of rigor when implementing the standards.ISO 13485 is based on ISO 9001, there are some key differences and additional requirements, in addition to product-specific demands and more stringent documentation requirements. ISO 13485 calls for risk management to be in place for all stages of product realization, training and supervision of staff, project site specs, and prevention of contamination. Clinical evaluation must be carried out as part of design and development evaluation in line with regulatory requirements. The cleanliness of products and contamination control must be considered, as must the status of the product with respect to monitoring and measurement.In brief, ISO 13485 provides system where the experience, clear point of view and judgement are applied systematically in order to manage the risks related to medical device use. This system was specially developed for medical device manufacturers that use principles based on risk management. For all other participants for example, the ones from the health industry, this standard can be used as informative guidance in the development and maintenance of the system and the risk management processes. This standard manages the risk management processes primarily to patient/user, but also to the operator, other equipment and the environment.According to the International Standards Organization, from 2004 through 2013 a total of 22,950 ISO 13485 certificates were issued worldwide throughout 93 countries.   What are the benefits of being certified to ISO 13485?   Companies with this certification communicate a commitment to quality to both customers and regulators. Improved stakeholder relationships Guarantees high quality of provided services and products. Is recognized globally as the best quality management practices within the medical device industry. Increase efficiency, cut costs and monitor supply chain performance. Demonstrate that you produce safer and more effective medical devices. Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty and widen market opportunities. Meet regulatory requirements and customer expectations.  

The iso 13485 standard was designed in 2016 to respond the latest quality management system practices to be used by organization engaged in designing process, production and supply of medical devices and related services .iso 13485:2016 standard was established by iso organization with greater emphasis on risk based decision making and continual improvement in process with using best practices to fulfill the regulatory requirement for medical devices and ensure safe usage of medical devices. Iso 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations of customers.iso 13485:2016 specifies requirements for a quality management system where an organization needs to achieve their safety objective for medical devices that consistently meet customer and applicable regulatory requirements. Iso 13485 certification in india provides a crucial advantage for medical device manufacturing organization to assure stakeholder that the organization is committed to comply the regulatory requirement of mdqms standard with organizations have adopted the process approach which follows pdca (plan–do–check–act) for continuous perfection in the process of organization. It’s emphasizing on managing foreseeing risk and control plan to resolve problem before they occur. The most recent update to the standard was published in february of 2016, migrating previously published versions from 2003 and 1996. To avail the standard benefit, organization required iso 13485 certification process consultant for design the framework of mdqms standard and he also assist to management department for design and implementation of standard with amended principles that help organization in sustainable development of quality product to face the competitive market and lead in international market.

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