In order to maintain an certification obtained, the healthcare organisation shall permanently and fully comply with the of ISO 9001:2015, ISO 7101:2023, and/or EN 15224:2016 standard requirements.
To ensure sustained compliance with all applicable of ISO 9001:2015, ISO 7101:2023, and/or EN 15224:2017 Standards, certified healthcare organizations are subject to annual periodic audits. These audits serve as a structured mechanism to monitor continued adherence, address previous findings, and support ongoing performance improvement. The focus of each audit will vary based on the organization’s scope, site(s), and services. For multi-site certification, audits are designed to provide a comprehensive and balanced evaluation across all operational units.
Audit Frequency and Scheduling
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Annual Requirement: At least one periodic audit shall be conducted every calendar year.
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First Periodic Audit:
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Must occur within 12 months of the initial accreditation decision date
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Postponement beyond 12 months is not permitted
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Organizations will be informed of this requirement and should plan the audit well in advance to ensure timely compliance
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Second Periodic Audit:
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May be scheduled ± 3 months from the target date
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However, it is recommended not to schedule it too close to the next re-certification audit, allowing sufficient time to address any findings
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Key Requirements of Periodic Audits
Each periodic audit will include:
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A targeted review of departments or functions with previously identified critical or major nonconformities
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Verification that all minor nonconformities from earlier audits have been adequately addressed
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Confirmation of corrective actions with documented evidence supporting the closure of each nonconformity, referenced in the prior audit report
This structured and proactive approach ensures that certified organizations:
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Maintain continuous compliance with of ISO 9001:2015, ISO 7101:2023, and/or EN 15224:2016 standards
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Strengthen their quality and safety systems
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Foster a culture of continuous improvement
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Resolve any prior findings in a timely and transparent manner