Preparing for Certification
The Stage 1 provides healthcare organizations with a preliminary evaluation of whether the key requirements of the ISO 9001:2015, ISO 7101:2023, and/or EN 15224:2016 have been adequately addressed. This assessment is offered as an optional service prior to the formal initiation of the certification process.
Stage 1 includes both a document review and a site visit, which may be conducted in parallel. It is not necessary to visit every department or unit, especially those providing complex care, unless they are critical to evaluating overall readiness.
Objectives of the Document Review and Initial Site Visit
The Stage 1 is conducted to:
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Determine the organization’s readiness for the Stage 2 Initial Certification Audit
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Evaluate the level of conformity of the management system processes and documentation with the applicable ISO standard(s)
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Assess the understanding and implementation of key standard requirements across the organization
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Gain sufficient knowledge of the organization’s context, services, processes, and customer base to support effective planning of the Stage 2 audit
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Review and confirm resource needs for Stage 2 and reach agreement with the client on audit details and logistics
Additional Purposes of the Initial Visit
The Initial Site Visit is also intended to:
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Ensure the client understands the certification process, including its goals, structure, and implications
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Confirm and finalize the scope of certification, including any exclusions or limitations
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Identify outsourced processes relevant to the certification scope and determine their impact on audit planning
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Verify critical organizational details used for project setup, such as information provided in the Application Form (e.g., site location, core processes, number of employees, number of shifts, etc.)
This preparatory stage plays a critical role in setting the foundation for a smooth and successful certification audit by identifying potential gaps early, facilitating informed planning, and establishing mutual clarity on expectations and scope.