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| More information on shared audit methodology : 6 key steps |
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Identification of suppliers |
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- Signature of confidentiality agreement
- Sharing information related to audit supplier needs
- Identification by HCS-QA of potential shared audits
- Information to the relevant customers |
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Establish a Quality Agreement with customers |
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This Quality Agreement is signed between HCS-QA and each customer concerned for confidentiality reasons and should include :
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- The scope of the audit
- The objectives of the audit
- The standard and products
- The name and qualification of the auditor
- Commitment of the auditor related to the absence of
conflict of interest with the auditee |
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Audit agenda |
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| The agenda takes into account potential specific items to consider during the audit. |
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Audit on site |
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| The audit is performed according to the agenda. The audit includes the review of product processes, Quality Management system and
specific customer items. |
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Audit report |
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| The report is issued to each customer and to the supplier asking for the action plan. Specific customer items are included into the relevant
audit report. |
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Evaluation of CAPA plan |
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| The action plan is provided to HCS-QA for an evaluation before being issued to customers. |
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HealthCare Services - Quality - Audits
1 rue Paul Séjourné - 75006 Paris - mckrief@hcs-home.com - Tél : +33 (0)6 09 64 68 21 |
