ISO ����� can help organizations involved in any part o a medical device’s lie cycle : What benefits will it bring to my organization ? Safety and performance of medical devices are paramount in i n this highly regulated industry this is why quality management systems systems are a regulatory or legal requirement in many countries. Moreover, the standard is compatible with an organiorganization’s other management systems.
For this reason, ISO ����� does not set detailed requirements, but asks a medical devices organization to identiy those regulatory requirements that are relevant to its individual situation and incorporate them into its QMS. Regulations differ widely from one country It is also flexible enough eno ugh to meet the individual needs of different types o medical devices organizations organizations.
Sistently provide safe and effective effective medicalĭevices and fulfil customer and regulatory requirements. ISO ����� enables an organization to con. In the medical devices industry, a QMS is required by regulators in most countries. It is based on the Plan-Do-Check-Act cycle, a our-step management method used in business or the control and continual improvement o processes and products. What is a quality management system ? A quality management system (QMS) is a set o policies, processes and procedures that help an organization meet the require. These include simple devices like wound dressingsĪnd scalpels durable devices like wheelchairs and dentist chairs implantable devices like cardiac pacemakers and monitors, prosthetic limbs and prosthetic joints life-supporting life-supporti ng devices like respirarespirators and lung ventilators sophisti-Ĭated, sofware-controlled devices like CT scanners and MRI machines Īnd in vitro diagnostic reagents and test kits. There is a huge variety o medical devices, ranging rom basic hand tools to complex computercontrolled machines. What is a medical device ? A medical device is an instrument,Īpparatus, implement, machine, implant, in vitro reagent, or other similar article, that is intended or use in the diagnosis, prevention prevention and treatment o disease or other medical conditions.
It reflects a strong commitment to continual iimprov mprovement ement and gives custom-Įrs confidence in its ability to bring br ing sae and effective products to market. ISO ����� helps an organization design a quality man-Īgement system that establishes and maintains the effectiveness o its processes. Them with their certification processes, processes, or by supply chain organizations that are required by contract to conorm. In addition, the standard can be used by other internal and external parties, such as certification bodies, to help It also covers aspects such as storage, distribution, installation and servicing, servici ng, and the provision o associated services. It is designed to be used by organizations throughout the lie cycle o a medical device, rom initial conception to production and post-production, including final decommission and disposal. ISO ����� ISO �����, Medical devices – Quality management systems – Requiremen Requirementts for regulatory regulatory purposes purposes, is an internationally agreed standard that sets out the requiremen requirements ts for a qualit qualityy management system specific to the medical devices industry. ISO ����� Quality management for medical devices