NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/8

QUALITY
MANAGEMENT STANDARD OPERATING PROCEDURE- ISSUE NO: 01
SYSTEM
PRODUCTION ISSUE DATE:-15/07/10
EYE PAD B.P PAGE 1 OF 1

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:

Mount the non-woven rolls of 25 cm width on the roller of equipment no.

Place at the centre of non-woven the cotton roll of 10 cm width & GSM (NLT 200)
Mount the Blue thread at the back of equipment roll it & pass it through the
Adhesive Box.
Adjust the folding assembly in such a way that the overlapping is 2.5 cm + 0.5 cm
& Blue thread is placed between the overlap.
Start the machine and let the pad pas through the roller.
The width of the eye pad should be 8.0 + 0.5 cm
Pass the strip of pad through Die-cut tools.
GSM of the pad should not be less than 370.

PREPARED APPROVED ISSUED

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