ISO 13485: 2003 is a standard that sets out the steps required to implement a medical device management system. It concerns companies that design and produce medical devices, that market medical devices, that install and provide technical support for medical devices.
The implementation of ISO 13485 is a requirement of the legislation (National legislation, Ministry Decision 1348/2004 / Government Gazette 32B ').
ISO 22716: 2007 is the standard that describes the good practices of cosmetics production. The application of the standard is a requirement of the legislation (Regulation 1223/2009 / EC as in force).
The ISO 22716 standard ensures the companies that apply it the safety of the produced cosmetic products. This model takes special care in the implementation, documentation and improvement of measures and practices (procedures) that ensure the control of raw materials, intermediates and final products, good storage practice and the safety of the product for its life.
ISO 45001: 2018 that replaces the OHSAS 18001 standard is an integrated management system for health and safety at work. The occupational health and safety management system provides the company and its employees with a framework for managing risk and opportunities for improvement, with the aim of providing a safe work environment and preventing accidents and occupational diseases.
ISO 45001 is more compatible with standards for quality management (ISO 9001) and environmental management (ISO 14001). This makes it easier to implement a total quality system consisting of the above standards.
ISO 14001: 2015 is a quality system for environmental management that aims to improve the environmental objectives of an organization and their sustainable development with an environmental sign.
The implementation of ISO 14001: 2015 contributes to the more rational use of natural resources, Reduction of the environmental impact of the company's processes, improvement of environmental performance, fulfillment of compliance obligations, achievement of environmental objectives and proof to third parties (authorities, customers , other stakeholders) of the company 's environmental sensitivity.
Clinical laboratories are distinguished from other testing laboratories by their handling of human samples and sampling in humans. The requirements for sampling, sample handling, analysis and performance of the results to the interested party are described in ISO 15189: 2012.
The clinical laboratories with the accreditation according to ISO 15189: 2012 document the technical adequacy of the staff and the suitability of the laboratory in carrying out laboratory tests. It is indeed "vital" that the results are correct and with a certain measurement uncertainty, so that there is proper evaluation and further use by medical staff.