Magna Laboratories (Gujarat) Pvt. Ltd.
5/6 Shreyas, 2nd Hasnabad Lane,
Santa Cruz (West),
Mumbai 400 054.
Maharastra, India.
Document Review Report
For
ISO 9002 Certification
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
Quality Manual & Procedures
Pages
QM
Issue
No
Rev
Issue
Date
QM Containing 28 Section
along with 7 functional
procedures issue 01
01
00
01.06.2000
Quality Manual - General Comments
One control copy of the Quality Manual along with 7 functional procedure Manual was
provided to ISC for review.
The present system of signing each page of the Manual is a time consuming matter may be
reviewed. Introduction of a build in status page of Similar Technique may reduce the activity.
4.1
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
National or International Standard as applicable has been
Contract Review
Seems to comply. However further verification needed.
4.4
Design Control
Not Applicable.
But no statement has been made on Quality Manual Level 1 why not applicable ?
4.5
Documents and Data Control
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
Control of Customer Supplied Product
Page 2 of 3
By: N. Bhattacharya
Seems to comply.
4.8
Product Identification and Tracebility
Seems to comply.
4.9
Process Control
Seems to comply.
4.10
Inspection and Testing
Positive recall system has not been addressed.
4.11
Control of Inspection Measuring and Test Equipment
No reference of procedure is made in Quality Manual.
4.12
Inspection and Test Status
Seems to comply.
4.13
Control of Nonconforming Product
Seems to comply.
4.14
Corrective and Preventive Action
Procedure on handling customer complaint is not at all clear. Non-involvement of any
Management personal in this procedure does not support the Quality Policy.
4.15
Handling, Storage, Packaging, Preservation and Delivery
Seems to comply.
4.16
Control of Quality Records
Seems to comply.
4.17
Control of Internal Quality Audit
Seems to comply.
Magna Laboratories (Gujarat) Pvt. LTd.,
Documentation Audit Report Number QAC/A/91/
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