Adapt Management Consulting's internal audit for ISO 13485 is a systematic examination of an organization's quality management system (QMS) to ensure compliance with the requirements of the ISO 13485 standard for medical devices. Here's what our auditor typically includes in an ISO 13485 internal audit:
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Planning: Our internal audit begins with planning, which involves defining the scope, objectives, and criteria for the audit. This includes determining which processes, procedures, and areas of the QMS will be audited and establishing a timeline for the audit activities.
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Preparation: Before conducting the audit, the auditor reviews relevant documentation, such as the ISO 13485 standard, the organization's quality manual, procedures, work instructions, and records. We familiarize themselves with the organization's QMS processes and gather any additional information needed for the audit.
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Conducting the Audit: Our Auditor conducts on-site or remote audits, depending on the organization's preferences and circumstances. During the audit, the auditor interviews personnel, observe processes, and review documentation to assess compliance with ISO 13485 requirements. We may use checklists or audit tools to guide their assessment and ensure thorough coverage of audit criteria.
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Documentation and Reporting: AMC documents the findings, including any non-conformities or areas of concern identified during the audit. We also note any positive practices or areas of strength within the QMS. The audit report typically includes details such as audit objectives, scope, methodology, findings, observations, and recommendations for improvement.
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Follow-Up and Corrective Action: After the audit, the organization is responsible for addressing any non-conformities identified during the audit. This may involve implementing corrective actions to resolve the root causes of non-conformities and prevent recurrence. If requested, the Auditor may follow up to verify the effectiveness of corrective actions taken by the organization.
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Continuous Improvement: Internal audits play a crucial role in driving continuous improvement within the organization's QMS. Auditors may identify opportunities for process improvements, efficiency gains, or enhancements to the QMS to better meet ISO 13485 requirements and organizational objectives.
Overall, an ISO 13485 internal audit helps organizations identify strengths and weaknesses in their QMS, ensure compliance with ISO 13485 requirements, and drive continual improvement in quality and performance.
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