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1. Details about the company and contact persons

Company:
Address:

Phone no.:

E-mail:

Web homepage:

Contact person:
Phone no.:

Fax no.:

E-mail:

QM representative:
Phone no.:

Fax no.:

E-mail:

2. List and classification of the specified products

Model/Variant to Classification
No. Product type and description EC-directive
be CE marked according to rules

Please enclose product information/brochures/instructions for use

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3. Desired conformity assessment procedure

Directive No.: 93/42/EEC* Directive No.: 98/79/EC* Directive No.: 90/385/EEC*

Medical Devices (MD) In Vitro Diagnostics (IVD) Active Implantable Medical Devices

Annex II.3 Annex III.6 Annex 2

Annex II.4 + II.3 Annex IV.3 Annex 3 + 4
Annex III + IV Annex IV.3 + IV.4 + IV.6 Annex 3 + 5
Annex III + V Annex V + VI
Annex III + VI Annex V + VII
Annex IV Annex V + VII.3 + VII.5
Annex V
Annex VI
Check relevant Annexes. For more information visit http://www.newapproach.org
Please enclose copies of already existing EC directive approvals

To which standards would you like to certify your QA system?

EN ISO 9001:2000 EN ISO 13485:2003* EN ISO 13488:2000* No certificate
Do you have already your QA system certificated? yes no
Please enclose copies of already existing QM system certificates

4. Details about your quality management system

Name and address of the headquarters

Departments Sum
and subsidiaries / branches
Please fill the number of employees (approximately) W Ot
QC DD PU PR SL SE 
in the relevant departments H h

Please enclose an organisation structure of the headquarter as well as of the possible subsidiaries/branches
QC - Quality control DD - Design/Development PU - Purchasing WH -
Warehouse
PR - Production SL - Sales SE - Service Oth - Other

Do you sell products under your own company name, which are produced by other yes no
companies?

If yes, did the original equipment manufacturer (OEM) already carry out a conformity yes no
assessment procedure?
Please enclose copies of already existing EC directive certificates

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Please specify which companies took over activities for you

Processes Name and location of the companies which took over activities
Design/
Development

Production

Packaging

Sterilisation

Warehouse

Service

Do you wish a pre-audit (Recommended in case of certification for the first time)? yes no

5. Additional specification about sterile products*

Do you produce sterile products? yes no

If yes, which sterilisation procedure is used?
by ethylene oxide according to EN 550 by moist heat according to EN 554
by irradiation according to EN 552 others:

Is the sterilisation process validated with the specified products? yes no

6. Time scheduling:
Please specify your desired dates for:
the product test / product documentation review: the audit:

Completed on:
from:

Please send the completed questionnaire (3 pages) to:

ICL CERTIFICATIONS LIMITED

502 Opal Square, B/h. Hotel Express, R.C.Dutt road, Alkapuri Vadodara 390007 INDIA.
Tel.: +91-265-5523458, 5523459 Fax: +91-265-5523457
email: vadodara@iclcertifications.com , smallapur@iclcl.com
web: www.iclcertifications.com

* - Mainly applicable for Medical Devices

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