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)