BS EN IEC 63077:2019 pdf download – Good refurbishment practices for medical imaging equipment.
4 General requirements for REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT 4.1 Quality management system R EFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT shall be conducted under a quality management system (QMS) of the REFURBISHER in compliance with ISO 1 3485:201 6. In addition to ISO 1 3485:201 6, the provisions in 4.2 to 4.1 1 shall be applied. 4.2 Resource management The REFURBISHER shall determine, and provide adequate resources, including: – trained and qualified personal; – maintained and calibrated equipment; – instructions, procedures, files, records, or documents to perform the REFURBISHMENT ; and – an environment for REFURBISHMENT that is in compliance with the applicable environmental, occupational health and safety requirements. 4.3 Corrective and preventive action The REFURBISHER shall implement a comprehensive corrective action and preventive action (CAPA) PROCESS , addressing the specific aspects of the REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT . In addition, in the event that the REFURBISHER identifies, through its CAPA system, safety related issues that are the responsibility of the original MANUFACTURER and not related to the REFURBISHMENT , it shall inform the original MANUFACTURER accordingly. 4.4 Customer complaints The REFURBISHER shall have in place a system for managing complaints. In addition, the REFURBISHER shall communicate to the original MANUFACTURER all customer complaints that are not related to the REFURBISHMENT of the MEDICAL IMAGING EQUIPMENT . 4.5 Production and service provision The REFURBISHER shall have documented procedures for REFURBISHMENT and service including but not limited to PROCESS validation, disinfection PROCESSES , identification, traceability and packaging.
4.6 Control of nonconforming PRODUCT The REFURBISHER shall ensure that a PRODUCT , that does not conform to PRODUCT requirements, is identified during REFURBISHMENT and controlled to prevent its unintended use or delivery. When a nonconforming PRODUCT is corrected during REFURBISHMENT , it shall be subject to re-verification to demonstrate conformity to the requirements of the original MANUFACTURER . 4.7 Post-market surveillance PROCESS The REFURBISHER shall collect feedback from customers and establish documented procedures to notify regulatory authorities of adverse events caused by the refurbished MEDICAL IMAGING EQUIPMENT . The PROCESS shall also determine if the adverse event is related to the REFURBISHMENT of the USED MEDICAL IMAGING EQUIPMENT or needs to be reported to the original MANUFACTURER . The REFURBISHER shall also establish its own post-market surveillance PROCESS to monitor whether the additional RISKS resulting from REFURBISHMENT have been adequately mitigated. The REFURBISHER shall enable monitoring of its installed base of refurbished MEDICAL IMAGING EQUIPMENT to allow for update management for safety and performance. NOTE To term installed base: All refurbished MEDICAL IMAGING EQUIPMENT provided by the REFURBISHER and installed, which meets all acceptance criteria for verification of installation. 4.8 Document control The REFURBISHER shall control all work instructions and procedures used to refurbish MEDICAL IMAGING EQUIPMENT . 4.9 Purchasing The REFURBISHER shall document procedures to ensure that purchased components, service parts and other materials such as packaging material, services as needed for REFURBISHMENT conforms to purchasing information as specified by the MANUFACTURER of the MEDICAL IMAGING EQUIPMENT . The REFURBISHER shall establish dedicated supplier management capabilities when components, services, or other materials such as packaging materials, services are purchased.
4.1 0 Control of design and design changes The REFURBISHER shall review, verify, and validate potential design changes to ensure that the safety and performance requirements of the MEDICAL IMAGING EQUIPMENT are not changed from its original or applicable valid registration. All changes, including parts, shall be evaluated to determine if the MEDICAL IMAGING EQUIPMENT needs new certification and the REFURBISHER needs registration, as it may become the legal MANUFACTURER . NOTE Control of design and design changes are not applicable to a REFURBISHER because this can result in the need of a new certification of the MEDICAL IMAGING EQUIPMENT and a legal MANUFACTURER status of the REFURBISHER . 4.1 1 RISK management PROCESS The REFURBISHER shall also establish a RISK management PROCESS that includes any RISK introduced by the REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT . This includes changes that would affect parts.