In addition, important terms have been defined including: medical device, active. The standard is based on ISO 9001, but includes additional requirements specific to this business sector. ISO 13485 is the most accepted standard worldwide for manufacturers of medical. PJR is accredited by ANAB to register companies to ISO 13485. The ISO 13485 standard concerns manufactures and suppliers of medical devices. Food and Drug Administration (FDA)’s Current Good Manufacturing Practices (CGMP), maintenance of documentation, and traceability of products.
#Iso 13485 registrars registration#
Registration to ISO 13485 requires accountability, compliance with regulations such as the U.S. Companies that establish and implement an ISO 13485 quality system are taking a world-class approach to the design, development, manufacture, distribution and servicing of medical devices. ISO 13485 A Complete Guide to Quality Management in the Medical Device Industry. Although both are in the same QMS family of standards, ISO 9001 is a general set of requirements that necessitates greater focus on continual improvement and customer satisfaction.
Medical devices come in close contact with patients and range from minor support for medical conditions to lifesaving capability. ISO 13485 is a stand-alone document, but it was based on and is directly related to ISO 9001, the world’s leading quality management standard. ISO 13485, Medical Devices – Quality Management Systems - Requirements for Regulatory Purposes. BSB Registrars is a Facilitating Body for Systems Certifications against International Standards of ISO 9001(Quality Management System), ISO 14001(Environmental Management System), OHSAS / ISO 18001(Occupational Health & Safety Assessment Series), ISO 22000(Food Safety Management System), ISO 20000(IT Service Management), ISO 27001(Information Security Management.
#Iso 13485 registrars verification#
ISO 13485 is a sector-specific quality standard for the medical device industry. Are you looking for a registrar to help you with your certification Find the right registrar for. British Accreditation Registrars accredits Certification Bodies for compliance against ISO 1385:2016 through verification of their existing ISO 17021 system.