The process of conducting an ISO 13485 supplier audit typically involves the following steps:
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Planning: Determine the scope and objectives of the audit, identify the suppliers to be audited, and establish a timeline for the audit.
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Pre-audit Preparation: Review relevant documentation, such as supplier contracts, quality agreements, and previous audit reports. Develop an audit checklist and gather any necessary audit tools or templates.
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On-site Audit: Visit the supplier's facility and conduct the audit according to the established checklist. This may involve interviewing personnel, reviewing records, observing processes, and assessing compliance with ISO 13485 requirements.
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Audit Findings: Document any non-conformities or areas of improvement identified during the audit. Classify the findings based on their severity and impact on product quality and safety.
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Corrective Actions: Provide the supplier with a detailed report of the audit findings and request them to develop and implement corrective actions to address any non-conformities.
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Follow-up: Monitor the supplier's progress in implementing corrective actions and verify their effectiveness through follow-up audits or other means of verification.
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Audit Closure: Once all non-conformities have been adequately addressed, close the audit and maintain records of the audit process and outcomes.
ISO 13485 Supplier Audit
The following sectors in scope:
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Diagnostic Devices: This sector includes devices used for diagnosing medical conditions and diseases, such as imaging equipment (X-ray machines, MRI scanners), diagnostic tests (blood glucose meters, pregnancy tests), and laboratory equipment.
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Therapeutic Devices: This sector focuses on devices used for therapeutic purposes, including implantable devices (pacemakers, artificial joints), surgical instruments, drug delivery systems, and rehabilitation equipment.
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Monitoring and Imaging Devices: This sector involves devices used for monitoring patients' vital signs and capturing medical images. Examples include patient monitors, ECG machines, ultrasound systems, and endoscopy equipment.
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In-vitro Diagnostic (IVD) Devices: This sector specializes in devices used for analyzing samples taken from the human body to diagnose diseases or monitor health conditions. Examples include laboratory analyzers, reagents, and test kits.
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Assistive Devices: This sector focuses on devices that assist individuals with disabilities or limitations in their daily activities. Examples include prosthetics, hearing aids, wheelchairs, and mobility aids.
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Healthcare IT and Digital Health: This sector involves the use of technology and software solutions to improve healthcare delivery, patient management, and data analysis. It includes electronic health records (EHR) systems, telemedicine platforms, health monitoring apps, and wearable devices.
