ISO 13485 Medical devices – Requirements for regulatory purposesISO 13485? ISO 13485:2016 (BDS EN ISO 13485:2016, with applicable amendments) is an international standard that specifies requirements for quality management systems of organizations involved in one or more stages of the life cycle of medical device...
QualityISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes specifies requirements for quality management systems for organizations involved in the design, production, installation and servicing of medica...
Latest issue of The ISO Survey shows 16% rise in ISO 9001 and ISO 14001 certificationsCertification to ISO 9001 (for quality management) and to ISO 14001 (for environmental management) increased in both cas...
Implementation of management standards
CONSEJO Ltd. is a consulting company with over 20 years of practical experience in the development, implementation and maintenance of management systems in accordance with international standards and regulatory requirements. The company provides consulting services in the areas of quality management, environmental management, occupational health and safety, food safety, information security, cybersecurity, risk management and sustainable development. Our expertise covers standards and schemes such as ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO/IEC 27001, IFS Food, BRCGS and HACCP, as well as consulting services related to NIS2, DORA, GDPR and EcoVadis.
The CONSEJO team has been involved in over 1,500 projects for organizations across various sectors of the economy, including manufacturing, construction, energy, information technology, transport, trade, the food industry and services. Our approach focuses on developing management systems that work effectively in practice, tailored to the specific characteristics and needs of each organization. We work closely with our clients, providing consulting support, staff training and assistance during implementation. We strive to deliver high-quality services within the agreed deadlines and solutions that support successful certification and create long-term value for businesses.
