/ Preliminary questionnaire
for potential client
INSTITUTE FOR TESTING AND CERTIFICATION, Inc.
Czech State Authorized Body No. 224  EU Notified Body No. 1023  Accredited Testing Laboratory No. 1004  Accredited Product Certification Body No. 3020

1. Details about the company and contact persons (potential client)

Company: / .
Address:
Phone no.:
E-mail:
E-mail 2:
Web homepage:
Contact person:
Phone no.:
Fax no.:
E-mail:
QM representative:
Phone no.:
Fax no.:
E-mail:
E-mail 2:

2. List and classification of the specified products

No. / Product type and description / EC-directive / Clasification + rules / NANDO Code

Please enclose (for each product)

-product information

-brochures

-instructions for use

For more information visit: ;

Do you possess Certificates issued by NB1023? yes no

If yes, specify numbers of Certificates:

If yes, indicate the earliest date for the next surveillance:

3. Desired conformity assessment procedure

Directive No.: 93/42/EEC
Medical Devices (MD) / Directive No.: 98/79/EC
In Vitro Diagnostics (IVD) / Directive No.: 90/385/EEC
Active Implantable Medical Devices
Annex II, excl. point 4 / Annex III, point 6 / Annex 2
Annex II, point 4 / Annex IV, excl. points 4+6 / Annex 3
Annex III / Annex IV, point 4 / Annex 4
Annex IV / Annex V / Annex 5
Annex V / Annex VI
Annex VI / Annex VII
Check relevant Annexes. For more information visit

Please enclose copies of already existing EC directive approvals/certificates.

Please enclose copies of already existing authority approvals for other than European market(s).

Do you have already your QA system certificated? / yesno
If no, to which standards would you like to certify your QA system?
EN ISO 9001:2008 / EN ISO 13485:2012/ISO13485:2003 / GMP / No certificate

For QA system certification, please, see website

Please enclose copies of already existing QM system certificates

4. Details about your quality management system

Name and address of the headquarters
and subsidiaries / branches / Departments / Sum
Please fill the number of employees (approximately)
in the relevant departments / QC / DD / PU / PR / WH / SL / SE / Oth / 

Please enclose an organigram 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 companies? / yesno
If yes, did the original equipment manufacturer (OEM) already carry out a conformity assessment procedure? / yesno

Please specify which companies for which specific device took over activities for you (critical subcontractor, supplier)

Processes / Name and location of the companies which took over activities
Design/
Development
Production
Packaging
Sterilisation
Warehouse
Service
Do you wish a preaudit (Recommended in case of certification for the first time)? / yesno

5. Additional specification about sterile products

Do you produce sterile products? / yesno
If yes, which sterilisation procedure is used?
by ethylene oxide according to EN ISO 11135-1
by irradiation according to EN ISO11137-1 / by moist heat according to EN ISO 17665-1
others: (describe)
Is the sterilisation process validated with the specified products? / yesno

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 (5 pages) to:

Dipl. Ing. Václav Kahánek
Institut pro testovani a certifikaci, a.s.
trida Tomase Bati 299, Louky
763 02 Zlin
Czech Republic / Phone: +420-577-601357, -601269,-601266
Fax: +420-577-104855
e-mail: , ,

Significant notes:

  1. All the information in this questionnaire and all the delivered attached documents are considered as classified documents.
  2. Completing this form does not mean that ITC is obliged to issue any certificate and/or that conformity assessment procedure has started.
  3. If the corresponding conformity assessment procedure will not start for any reasons, ITC will either send the submitted information back to the potential client at his own cost or destroy the submitted informationaccording to potential client written demand.
  4. Potential client is conscious that conformity assessment process could start only if dully signed application form will be submitted to ITC in paper form (see
  5. Potential client is conscious that for issuing of the certificate(s) is necessary to sign General framework agreement (will be send on potential client demand). This GFA shall be signed and send to ITC together with duly filled in application.

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