Scribd Logo
Upload

Welcome to Scribd!

  • 76 views

    Neptune Orthopaedics Standard Operating Procedure-Production

    Uploaded by

    dhir.ankur
    This standard operating procedure outlines the production process for elasticated tubular bandages at Neptune Orthopaedics. It defines critical production activities to comply with ISO 13485:2003. The procedure involves cutting stockinet cloth to specified lengths, spooling it onto tubes, applying labels with batch data, sealing in plastic pouches and shrink wrapping batches of 10 for shipping. The production manager prepared and the CEO approved and issued the procedure, which can only be amended by the CEO.

    Copyright:

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

    Neptune Orthopaedics Standard Operating Procedure-Production

    Uploaded by

    dhir.ankur
    76 views2 pages
    This standard operating procedure outlines the production process for elasticated tubular bandages at Neptune Orthopaedics. It defines critical production activities to comply with ISO 13485:2003. The procedure involves cutting stockinet cloth to specified lengths, spooling it onto tubes, applying labels with batch data, sealing in plastic pouches and shrink wrapping batches of 10 for shipping. The production manager prepared and the CEO approved and issued the procedure, which can only be amended by the CEO.

    Original Description:

    sop

    Original Title

    S 10

    Copyright

    © © All Rights Reserved

    Available Formats

    DOC, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This standard operating procedure outlines the production process for elasticated tubular bandages at Neptune Orthopaedics. It defines critical production activities to comply with ISO 13485:2003. The procedure involves cutting stockinet cloth to specified lengths, spooling it onto tubes, applying labels with batch data, sealing in plastic pouches and shrink wrapping batches of 10 for shipping. The production manager prepared and the CEO approved and issued the procedure, which can only be amended by the CEO.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    76 views2 pages

    Neptune Orthopaedics Standard Operating Procedure-Production

    Uploaded by

    dhir.ankur
    This standard operating procedure outlines the production process for elasticated tubular bandages at Neptune Orthopaedics. It defines critical production activities to comply with ISO 13485:2003. The procedure involves cutting stockinet cloth to specified lengths, spooling it onto tubes, applying labels with batch data, sealing in plastic pouches and shrink wrapping batches of 10 for shipping. The production manager prepared and the CEO approved and issued the procedure, which can only be amended by the CEO.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    You are on page 1of 2

    NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/10

    QUALITY
    MANAGEMENT STANDARD OPERATING PROCEDURE- ISSUE NO: 01
    SYSTEM
    PRODUCTION ISSUE DATE:-15/07/10
    ELASTICATED TUBULAR BANDAGE B.P PAGE 1 OF 2

    1.0 PURPOSE:
    The purpose of this procedure is to define and control critical activities in production as per the
    requirement of ISO 13485: 2003.

    2.0 SCOPE:
    This procedure covers standard operating procedure of the concerned area in production.

    3.0 RESPONSIBILITY:
    Refer Responsibility & authority chart NO/QSM/AX04.

    4.0 APPROVAL:
    This procedure is approved by CEO and can be amended only by him.

    5.0 DEFINITIONS: Nil

    6.0 PROCEDURE:

    Cutting &spooling
    1.0 Ensure cleaning of working tables, Equipments along with room.
    2.0 All materials used for should be issued by stores. And ensuring that the materials
    released by Q.C.
    3.0 The stockinet cloth is allowed to cut exactly to the cutting length instructed by QC
    Instruction:
    Visual inspection by supervisor/ skilled work mens shall be carried for any types of
    weaving defect, crease, loose threads, any marking of shade etc.

    4.0 Then cut straight one after one at specified length. Incase of any defects the bandage
    shall be discard
    5.0 Move the cut stockinet to spooling assembly. And spool it by opening the tube in
    upward and folded about 4-8 cm towards inside
    6.0 Packing: Wrap the rolled stockinet in printed label having batch data over printed on it.
    Insert it into plastic pouch.& seal
    7.0 Insert 10 of the seal pouch into a pvc shrink bag.
    8.0 Gun/shrink machine by maintaining temp about 130-1350C.
    9.0 Arrange such 10 unit in a shipper.

    PREPARED APPROVED ISSUED


    REVISION HISTORY
    BY BY BY
    REV.NO
    ISO 13485:2003
    DATE
    PM CEO MR
    NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/10
    QUALITY
    MANAGEMENT STANDARD OPERATING PROCEDURE- ISSUE NO: 01
    SYSTEM
    PRODUCTION ISSUE DATE:-15/07/10
    ELASTICATED TUBULAR BANDAGE B.P PAGE 2 OF 2

    PREPARED APPROVED ISSUED


    REVISION HISTORY
    BY BY BY
    REV.NO
    ISO 13485:2003
    DATE
    PM CEO MR

    You might also like