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Titel -Accreditation Procedure 2024 |
If you have any questions regarding the accreditation procedure, please do not hesitate to contact us.
Tabelle - Accreditation Procedure 2024 |
Requirements Specification |
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The Requirement Specification for an Accredited Laboratory of the SGRM and AGER have to be fully applied by the laboratory that wants to obtain accreditation.
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Procdure | |
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Preliminary meeting
Doc-Zert offers preliminary meetings for laboratories that wish support in assessing their current situation in terms of the requirement specifications. Laboratories that are interested in a preliminary meeting are kindly asked to contact us directly via Email. Preliminary meetings are mandatory. Laboratories who do not wish to have a preliminary meeting please directly submit a request for accreditation (see below).
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Request for accreditation
Laboratories that are interested in the accreditation are kindly asked to complete the request form for accreditation.
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Request form accreditation (DOC-File)
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Offer for accreditation
After Doc-Cert has received the request form, Doc-Cert issues an offer for the laboratory with information about the accreditation fee and the accreditation procedure in general. Questions regarding the offer and the accreditation procedure can be clarified at this stage.
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Assignment for accreditation Along with the offer Doc-Certs provides the laboratory with the assignment form. If the laboratory agrees with the offer the laboratory completes the assignment form and sends it to Doc-Cert. Thereby the accreditation process is started. At this stage the laboratory specifies its preferred date for the accreditation audit. |
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Confirmation of the assignment After Doc-Cert has received the assignment form, Doc-Cert confirms the assignment. |
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Examination of the SOPs and the KPIs At the latest 4 weeks before the accreditation audit the laboratory sends the SOPs of the to be accredited procedures and the Key Performance Indicators (KPIs) to Doc-Cert. Based on the SOPs and the KPIs Doc-Cert and the expert auditor assess whether the prerequisites for the accreditation are principally given. If relevant requirements are not fulfilled the accreditation audit will be cancelled. |
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Accreditation Audit The audit takes place on one day and is conducted by an expert auditor and a representative of Doc-Cert. The laboratory receives the audit plan at the latest 2 weeks before the audit. At the end of the audit the expert auditor and the Doc-Cert auditor will announce their assessment. The audit report is submitted to the accreditation committee. If the accreditation committee approves the accreditation, the certificate is issued, and the laboratory receives the certificate. The certificate is valid for 5 years and is signed by representatives of the medical associations SGRM and AGER. |
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Maintaining the Accreditation Every year the laboratory issues an annual report that includes amongst others the KPIs and hands it over to Doc-Cert. Doc-Cert evaluates the annual report. In case of deviations from the requirements the accreditation committee is informed. The accreditation committee can impose conditions. After five years the re-accreditation audit takes place. After 2-3 years a supervisory audit takes place. |
Form annual report German (DOC-File)
Form annual report English (DOC-File) Appendix KPIs based on V3.5 of the requirements specification (DOC-File) |
Procedure of QUARTS accreditation Please find an overview of the QUARTS accreditation procedure. |
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Terms and Conditions Accreditation Doc-Cert AG |