Directorate of Device Testing and Clinical Engineering

Reference №
(to be completed EMKI)

Quotation Request Questionnaire for the certification

of Quality Management System according to standards EN ISO 9001, ISO 13485

and

for the Conformity Assessment according to the Regulation of the Minister of Health

4/2009. (III. 17.), (Council Directive 93/42/EEC)

1.) Data of manufacturer’s registered office:

Name
Address
E-mail address
Phone/Fax
Postal address (if diff.)
Tax identification number
Registration №
Activity (See section 2. for more than one sites)
Contact person (I) / Contact person (II)
Name
Position
when different / Address
E-mail address
Phone / Fax

2.) Authorized representative:

(Authorized by manufacturers OUTSIDE the EU):

Name
Address
E-mail address
Phone number/Fax
Postal address (if diff.)
Contact person (I) / Contact person (II)
Name
Position
when different / Address
E-mail
Phone /fax

3.) Details of further manufacturing sites:

Cert.¹ / Address / Activity / № of staff

¹Please sign with X if the site is requested to be included in the certificate.

4.) Outsourced activities (key subcontractors, critical suppliers):

Name of the contractor / Address / Activity / Type of certification possessed

5.) Details of processes / technologies of production (flow chart can be attached):

Process / Applied technology / Name of supplier / manufacturing site (with number of employees) / Number of employees

6.) Details of products

Product(family) (Type code) / Versions of product / Denomination (application, where appropriate introduction sheet is to be attached)

7.) Previous certification (Please, also indicate certifications expired):

Notified Type
(e.g. ISO 9001) / Certification / Notified Body / Certification Scope / Validity period

8.) Details of Requested Certification:

Required deadline of quotation
Intended date of certification: (only systems operated at least for 3 months previously can be certified)
Application of external consultant for introducing management system:*
Firm / Name
How did you get any information about certification activity of EMKI:* / □ Internet □ Media □ Business partner
□ Other: ...... …………………………………….

*It is not compulsory to fill in.

9.) System certification according to EN ISO 9001:2008:

Scope of certification:
Exclusions: (only from chapter 7. of the standard)
Number of employees under certification scope per shifts: / Shift 1. / Shift 2. / Shift 3.
Number of copies and the languages of required certificates:

10.) System certification according to EN ISO 13485:2012:

Scope of certification:
Exclusions: (only from chapter 7. of the standard)
Sections “Not Applied” of the standard
Number of employees under certification scope per shifts: / Shift 1. / Shift 2. / Shift 3.
Number of copies and the languages of required certificates:


11.) CE certification:

Classification / Name of product / According to the Council Directive 93/42/EEC
Annex 2. / Annex 3.
Type assessment / Annex 4.
Product review / Annex 5.
Production quality assurance / Annex 6.
Product quality assurance
Full quality assurance / Product design assessment according to section 4.
Class I
sterile or measuring function
Class IIa
Class IIb
Class III
Number of employees under certification scope:
Number of copies / language / Language / № of copies

Date:

official signature

Name and position of signatory (print, please):

* OGYÉI-EMKI 1372 Budapest P.O.B. 450. ¨1097 Budapest, Albert Flórián út 3/a ((+36) 20268 7595

¨Fax: (+36 1) 886-9460 ¨E-mail:

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Internal ID №: EMKI_MIR_M9_MDD_eng_v2.3_20160706