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BSI Group Singapore Pte. Ltd.
Accredited by: SAC
BSI Group Singapore Pte. Ltd. is a certification body based in Singapore that specializes in the certification of medical devices quality management systems. They provide accreditation for a wide range of medical devices, including non-active and active medical devices, in vitro diagnostic devices, and various sterilization methods. BSI Group Singapore operates under the ISO 13485:2016 standard, ensuring compliance with regulatory requirements for medical device manufacturers.
77 Robinson Road, #28-03,Robinson 77, Singapore , 068896
Certification Scopes (7)
ISO 13485
Management Systems Certification Bodies
Singapore Accreditation Council
Singapore
BSI Group Singapore Pte. Ltd. certifies organizations involved in the design, development, production, and servicing of medical devices under ISO 13485. This includes a wide range of products such as non-active and active medical devices, in vitro diagnostic devices, and various sterilization methods, ensuring compliance with quality management system requirements for regulatory purposes.
ISO/IEC 27001
Management Systems Certification Bodies
Singapore Accreditation Council
Singapore
BSI Group Singapore Pte Ltd certifies organizations under ISO 27001 for their information security management systems, ensuring that they effectively manage sensitive information and maintain data security. This certification is particularly relevant for sectors involved in information technology and cloud computing, helping organizations demonstrate their commitment to protecting data and managing risks associated with information security.
ISO 9001
Management Systems Certification Bodies
Singapore Accreditation Council
Singapore
BSI Group Singapore Pte Ltd certifies organizations across various sectors under ISO 9001, focusing on quality management systems. Their accreditation encompasses a wide range of industries, including agriculture, food production, construction, manufacturing, healthcare, and information technology, ensuring that these organizations meet international quality standards.
ISO 13485
Management Systems Certification Bodies
Singapore Accreditation Council
Singapore
BSI Group Singapore Pte Ltd certifies organizations under ISO 13485 for their compliance with quality management systems specifically tailored for the medical device sector. This certification ensures that companies involved in the design, production, and distribution of medical devices meet stringent regulatory requirements and maintain high standards of quality and safety.
ISO 22301
Management Systems Certification Bodies
Singapore Accreditation Council
Singapore
BSI Group Singapore Pte Ltd certifies organizations across various sectors, including aerospace, agriculture, healthcare, and information technology, under ISO 22301. This standard focuses on Business Continuity Management Systems, ensuring that certified entities can effectively prepare for, respond to, and recover from disruptive incidents.
ISO/IEC 17021-1
Management Systems Certification Bodies
Singapore Accreditation Council
Singapore
BSI Group Singapore Pte. Ltd. certifies organizations involved in the medical devices sector under ISO 17021-1, focusing on quality management systems. Their certification encompasses a wide range of medical devices, including both active and non-active devices, in vitro diagnostic devices, and various sterilization methods, ensuring compliance with regulatory requirements and quality standards.
ISO 45001
Management Systems Certification Bodies
Singapore Accreditation Council
Singapore
BSI Group Singapore Pte Ltd certifies organizations under ISO 45001, focusing on Occupational Health and Safety Management Systems. Their certification spans various sectors, including fabricated metal products, machinery and equipment, construction, chemicals, and information technology, ensuring that organizations implement effective health and safety practices to protect employees and improve workplace safety.
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