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Manufacturers across the globe, including in the US, Japan, Canada, EU, accept the ISO 13485 standard as the quality standard for medical devices. This standard consists of requirements which are specific to the medical devices business sector and provides definition for terms such as medical device, active medical device, implanted medical device, sterile medical device, etc.
The ISO 13485 ensures the minimisation of unexpected risks for companies who design, manufacture or use medical devices and services, including during fabrication and beyond. The goal of this standard is to enhance your reputation with authorities and customers. One aspect to highlight is that this is an independent standard that can be implemented without ISO 9001, provided your company works only in the medical industry.
ISO 45001 provides a clear direction to an occupational health and safety management system. It is not a legislative requirement or an implementation guide. Rather, it is a certification or audit specification. The ISO 45001 does not set specific performance criteria, or offer any specifications for management system design. Instead, the system is focused towards reducing and preventing accidents and the loss of lives, resources and time due to accidents.
The ISO 45001 standard is compatible with the ISO 9001 quality standards and ISO 14001 environmental standards. The aim of ISO 45001 standard is that any organisation that implements this standard can seamlessly integrate it with other management systems like quality, environmental or occupational health and safety. ISO 45001 follows the Plan-Do-Check-Act approach, with an emphasis on continuous improvement. This model aligns easily with the structure of other management systems standards such as the ISO 14001, thereby assisting the progress of integrated management systems.
The components of ISO 45001 standard includes hazard identification, risk assessment & risk controls, objectives and programs, organization and personnel, policy and commitment, communication and consultation, training, documentation and records, legal requirements, measurement and monitoring, operational controls, accident and incident investigation, emergency readiness, audit and review, corrective and preventive action, and application and relevance in the industry.