NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/7.

0
QUALITY
MANAGEMENT STANDARD OPERATING PROCEDURE- ISSUE NO: 01
SYSTEM
PRODUCTION ISSUE DATE:-15/07/10
Combine Dressing 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:

Mount the non-woven rolls of 25cm width on the roller of equipment no.
Place at the centre of non-woven the cotton roll of 10cm 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 pad should be 10.5 + 0.6 cm
Pass the strip of pad through cutting machine equipment no. Set the Cutting length for 10cm
10.5cm + 0.6 cm for 20cm 20.5cm + 0.6 cm. Check the sealing of overlap.
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
 NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/7.0
QUALITY
MANAGEMENT STANDARD OPERATING PROCEDURE- ISSUE NO: 01
SYSTEM
PRODUCTION ISSUE DATE:-15/07/10
Combine Dressing PAGE 2 OF 2

PREPARED APPROVED ISSUED

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