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    SHERAZ
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    1) This is a non-compliance report form documenting an audit finding against ISO 13485:2016 standards. 2) It describes a non-compliance in a department, references the affected clause, and categorizes the issue as minor or significant. 3) The auditee must propose a corrective action plan and have follow-up to verify the issue was addressed by a specified close-out date.

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    Ncr

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    1) This is a non-compliance report form documenting an audit finding against ISO 13485:2016 standards. 2) It describes a non-compliance in a department, references the affected clause, and categorizes the issue as minor or significant. 3) The auditee must propose a corrective action plan and have follow-up to verify the issue was addressed by a specified close-out date.

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    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
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    Download as doc, pdf, or txt
    5 views1 page

    Non Compliance Report

    Uploaded by

    SHERAZ
    1) This is a non-compliance report form documenting an audit finding against ISO 13485:2016 standards. 2) It describes a non-compliance in a department, references the affected clause, and categorizes the issue as minor or significant. 3) The auditee must propose a corrective action plan and have follow-up to verify the issue was addressed by a specified close-out date.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
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    of 1

    Standard Operating Record

    Non Compliance Report


    Document No:
    Revision: 1.0 Issue# 01 Effective Date11/11/2023 Page: 1 of 1
    ABC.NCR-03

    NON-COMPLIANCE REPORT
    Audit # Reference Standard: ISO 13485:2016 Date:

    Department Name: Reference Clause: NCR #


    (A) Description of non-compliance:
    (See the potential impact of the NCR on the product/service) (Category________)

    Non-compliance categories:
    Cat II. A minor or single deficiency (ies)
    Cat I. A significant level of non-compliance with Quality System. Observation: A potential weakness

    Auditee Signature: Auditor Signature:

    (B) Proposed Corrective Action:

    Auditee Signature: Proposed Implementation Date:

    (C) Follow-up Audit: Accepted Not accepted (Raise new NCR)

    (D) Close out By: Date:

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