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By
International Standards Certifications (S.A.) Pvt. Ltd.
File Ref.QAC/A/91/
Date 21st October 2000
Magna Laboratories Pvt. Ltd.,
Documentation Audit Report Number QAC/A/91/
Page 1 of 3
By: N. Bhattacharya
Document Reviewed
Pages
QM
Issue
No
Rev
Issue
Date
QM Containing 28 Section
along with 7 functional
procedures issue 01
01
00
01.06.2000
Management Responsibility
The Organisation chart does not show the position of Managing director it shows director.
The position of Management Representative is not clear in the Organisation chart as regards to
Quality System. It is a better practice to show this function separately.
4.2
Quality System
Quality Planning has not been addressed in the Level 1 Quality Manual.
No regulatory requirement/
addressed in this section.
4.3
Contract Review
Design Control
Not Applicable.
But no statement has been made on Quality Manual Level 1 why not applicable ?
4.5
Procedure does not state how the documents of external origin are up dated.
4.6
Purchasing
Seems to comply.
Magna Laboratories (Gujarat) Pvt. Ltd.,
Documentation Audit Report Number QAC/A/91/
4.7
Page 2 of 3
By: N. Bhattacharya
Seems to comply.
4.8
Seems to comply.
4.9
Process Control
Seems to comply.
4.10
Seems to comply.
4.13
Seems to comply.
4.14
Seems to comply.
4.16
Seems to comply.
4.17
Seems to comply.
Page 3 of 3
By: N. Bhattacharya
4.18 Training
Procedure does not state clearly who is going to identify the Training need of HOD and above
level position.
4.19
Servicing
Not Applicable.
4.20 Statistical Techniques
Seems to comply.
N. Bhattacharya
Lead Auditor