New Accreditation Programme for ISO 13485 Certification

The Singapore Accreditation Council (SAC) has launched a new accreditation programme for Medical Devices Quality Management System Certification on 14 August 2017.

This programme is to accredit Certification Bodies (CBs) certifying companies to ISO 13485: Medical Devices – Quality Management Systems – Requirements for regulatory purposes. ISO 13485 provides a practical foundation for manufacturers and distributors to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. Accreditation provides a higher level of confidence in the ability to consistently comply in line with regulatory requirements. ISO 13485 can help to minimize unexpected situations and failures which might adversely affect patients’ health and safety, through ensuring effectiveness, control and maintenance of a manufacturer/ distributor’s quality management system.

CBs accredited by SAC will be assessed to ensure that a CB is competent through validation of its operations and implementation of its quality system. SAC accreditation will provide added public confidence, level playing field among the CBs and assurance of integrity, credibility and transparency of certification services. In addition, SAC has a good track record of accrediting certification programmes that gain increasing acceptance from industry and government agencies.

Application for accreditation of the Medical Devices Quality Management System Certification: ISO13485 can be done through SACiNet.