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    Quality Records: Neptune Orthopaedics

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    dhir.ankur
    This document lists 17 external origin documents that Neptune Orthopaedics maintains quality records for along with their required retention periods and designated custodians. These include ISO standards, statutory documents, customer specifications, quality management system documents, test reports, calibration certificates, material safety data sheets, and more. Retention periods range from 1 year to permanent, with most being 3.5 years. The list is approved by the Managing Director and specific documents are assigned custodians such as the Quality Assurance Manager.

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    Quality Records: Neptune Orthopaedics

    Uploaded by

    dhir.ankur
    25 views1 page
    This document lists 17 external origin documents that Neptune Orthopaedics maintains quality records for along with their required retention periods and designated custodians. These include ISO standards, statutory documents, customer specifications, quality management system documents, test reports, calibration certificates, material safety data sheets, and more. Retention periods range from 1 year to permanent, with most being 3.5 years. The list is approved by the Managing Director and specific documents are assigned custodians such as the Quality Assurance Manager.

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    MR 2.doc

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    This document lists 17 external origin documents that Neptune Orthopaedics maintains quality records for along with their required retention periods and designated custodians. These include ISO standards, statutory documents, customer specifications, quality management system documents, test reports, calibration certificates, material safety data sheets, and more. Retention periods range from 1 year to permanent, with most being 3.5 years. The list is approved by the Managing Director and specific documents are assigned custodians such as the Quality Assurance Manager.

    Copyright:

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

    Quality Records: Neptune Orthopaedics

    Uploaded by

    dhir.ankur
    This document lists 17 external origin documents that Neptune Orthopaedics maintains quality records for along with their required retention periods and designated custodians. These include ISO standards, statutory documents, customer specifications, quality management system documents, test reports, calibration certificates, material safety data sheets, and more. Retention periods range from 1 year to permanent, with most being 3.5 years. The list is approved by the Managing Director and specific documents are assigned custodians such as the Quality Assurance Manager.

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    NEPTUNE ORTHOPAEDICS Control No: NO/MR/02

    Quality
    Managemen
    QUALITY RECORDS Rev No: 00
    t System LIST OF EXTERNAL ORIGIN DOCUMENTS Rev Date:-
    WITH DISTRIBUTION LIST PAGE OF 01

    Retention Approved by
    Sl. No. Particulars
    period & Custodian
    Till next
    1 ISO 13485:2003 International standard MR
    revision
    2 ISO 9000: 2005 International standard Do MR

    3 ISO 19011: 2002 International standard Do MR


    ISO 14971: 2009 International standard MR
    4 Do

    5 ISO 2859 International standard Do MR

    6 Drugs & cosmetic act, 1940 Do PM


    Statutory documents applicable to
    organization:
    State pollution control board
    7 Local self government/GIDC Do CEO
    Factorys license
    Electrical inspectorate/Board
    Drugs license
    8 Customer specifications Do CEO

    9 QMS related documents 3.5 Years CEO

    10 Water quality test report 1 Year CEO


    Sterilization validation report/Sterilization
    11 3.5 Years QAM
    report
    12 Rodent control report 1 Year PM
    13 Hemolytic report Permanent QAM
    14 In-vitro cyto-toxicity report Do QAM
    15 Product bio-burden report 3.5 Years QAM
    16 Calibration certificate and traceability records I year QAM
    17 Test reports (External/Supplier generated) 3.5 Years QAM
    18 Raw material MSDS 3.5 Years QAM

    APPROVED BY (Sign)
    PREPARED BY (Sign)

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