NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/14

QUALITY
MANAGEMENT STANDARD OPERATING PROCEDURE- ISSUE NO: 01
SYSTEM
PRODUCTION ISSUE DATE:-15/07/10
WOW BANDAGE 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 cotton gauze type 1 is allowed to Slit exactly to the required width and form to
slitted rolls. instructed

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 slitted rolls are allowed to folding machine for forming ply and wind into a roll.
After repetition of the folding and winding up to the required ply and form in roll.
5.0 Place the pre cut x-ray detectable thread straight in corner to corner
6.0 Stitch the thread as well as pad in such away that no loose threads shall expose to out
side.
7.0 Then stitch the tape at the corne of the pad just in the direction in which x-ray thread
stitched.
8.0 Packing:

PREPARED APPROVED ISSUED

REVISION HISTORY
BY BY BY
REV.NO
ISO 13485:2003
DATE
PM CEO MR
 NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/14
QUALITY
MANAGEMENT STANDARD OPERATING PROCEDURE- ISSUE NO: 01
SYSTEM
PRODUCTION ISSUE DATE:-15/07/10
WOW BANDAGE PAGE 2 OF 2

1. Insert the pad into previously coded glass in poly pouch and allow to seal.
2. Arrange 20 such pouch into a inner. And 10such inner packed into the shipper.

PREPARED APPROVED ISSUED

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