Laboratory Management System
Laboratory Management System
ISO 13485:2016 establishes requirements for a quality management framework under which organizations must demonstrate their ability to provide remedial equipment and related controls that reliably meet customer needs and corresponding control requirements. Such organizations may be involved in one or more stages of the life cycle. This includes planning and improvement, generation, capacity and distribution, establishment or refurbishment of recovery equipment, and planning and further development or ordering of related exercises (such as specialized bolsters).
ISO 13485:2016 can also be used by vendors or external parties who provide items, including quality management system related controls to such organizations. Meet ISO 13485 compliance and regulatory requirements. Our quality management system is designed to meet the specific needs of the medical device industry and ensure best practices at every stage of the product life cycle. From design to delivery to service, ISO 13485 provides an effective framework for continuous improvement and customer satisfaction.ISO 15189:2022
ISO 15189 can be used by medical laboratories in developing their quality management systems and assessing their own competence. This standard establishes a strict set of quality management requirements specific to laboratories at every level of the healthcare system. Some of the standard objectives for laboratory operations include ensuring the quality and traceability of patient information, maintaining the safety and integrity of laboratory materials, monitoring the environmental conditions of the facility, and supporting public health decision making.
This standard can also be used by laboratory customers, regulators, and accreditation bodies to confirm or recognize the capabilities of medical laboratories. ISO 15189 encourages the full participation and use of skills of all employees at all levels to improve the organization. For ISO 15189 accredited laboratories, continuous improvement is the goal, ensuring that employees know exactly what and how they do it, who is responsible for the process, and where all the information they need to do their job can be found.ISO 17025:2017
ISO 17025 enables laboratories to demonstrate that they operate competently & generate valid results, thereby promoting confidence in their work both nationally & around the world. It also helps facilitate cooperation between laboratories & other bodies by generating wider acceptance of results between countries. Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, improves international trade. ISO 17025 is useful for any organization that performs testing, sampling or calibration & wants reliable results. This includes all types of laboratories, whether they be owned & operated by government, industry or, in fact, any other organization. The standard is also useful to universities, research centers, government, regulators, inspection bodies, product certification organizations & other conformity assessment bodies with the need to do testing, sampling or calibration.