Infrastructure [ISO 13485 Cl 6.3]
Clause 6.3 of ISO 13485:2016 emphasizes the importance of identifying, providing, and maintaining the necessary infrastructure to support the quality management system and ensure product conformity. This infrastructure encompasses the physical and technical resources needed to support your entire medical device development and manufacturing process. The standard emphasizes the importance of managing infrastructure effectively to achieve several objectives:
Key Elements:
Determining Infrastructure Needs: Organizations must determine the infrastructure that impacts product quality and compliance.
Provision of Infrastructure: This includes buildings, workspace, associated utilities, process equipment (hardware and software), and supporting services (transportation, communication, and information systems).
Maintenance of Infrastructure: Regular maintenance must be performed to ensure the infrastructure remains suitable for its intended purpose and should prevent degradation and ensure ongoing compliance with product requirements.
Preparing an Infrastructure Audit as per ISO 13485 Cl 6.3
When preparing for an audit of ISO 13485, audit as per section 6.3 for the maintenance process, there are several key elements to implement and few are detailed below
Maintenance Procedures and Schedules
Ensure documented procedures for maintaining the infrastructure, which includes buildings, workspace, process equipment (both hardware and software), and supporting services. Maintenance schedules should be well-documented and adhered to. These schedules should include preventive maintenance plans as well as procedures for addressing unplanned maintenance.
Records of Maintenance Activities
Keep detailed records of all maintenance activities performed covering preventive maintenance, corrective maintenance, and calibration records. Records should show that maintenance is performed at regular intervals as per the defined schedule and procedures.
Qualification and Training of Personnel:
Ensure that personnel responsible for maintenance are adequately trained and qualified. Training records should be maintained and easily accessible.
Calibration of Equipment:
Calibration activities should be included in the maintenance procedures, and calibration records should be maintained. Ensure that calibration is performed by qualified personnel and according to the defined schedule. Implement monitoring and measurement methods to ensure that maintenance activities are effective.
Supplier and External Services Management:
If maintenance activities are outsourced, ensure that suppliers and service providers are adequately controlled. Maintain records of supplier qualifications and performance evaluations.
During an audit, auditors will look for evidence of compliance in these areas. Proper documentation, adherence to procedures, and effective implementation of maintenance activities are crucial for passing the audit successfully.