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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

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