Number of edition: 01
Number of version: 08
Valid from: 25 Sept 2017
REQUEST FORM
(1) Data of the company
Name of the company:
Headquarters:
Phone: / Fax:
E-mail: / Web:
Name of official representative: / Position:
(2) Data of contact person
Name: / Position:
Phone: / E-mail:
(3) Necessary information for price offer
Certification standard:
MSZ EN ISO 9001:2015 (ISO 9001:2015) MSZ EN ISO 13485:2012 (ISO 13485:2003)
MSZ EN ISO 13485:2016 (ISO 13485:2016)
Exclusions: Design and development (7.3) Other:
Activity area:
Product range:
Scope (this will be on the certificate): / MSZ EN ISO 9001:2015 (ISO 9001:2015):
MSZ EN ISO 13485:2012 (ISO 13485:2003) or MSZ EN ISO 13485:2016 (ISO 13485:2016):
You are kindly requested to mark which scope(s) is applicable for your company!
ISO 9001
Textiles / Machinery and equipment
Chemicals / Electrical and optical equipment
Pharmaceuticals / Manufacturing not elsewhere classified (like medical device))
Rubber and plastic products / Wholesale and retail trade: Repair of motor vehicles, motorcycles and personal and household goods
Basic metals and fabricated metal products / Health and social work
ISO 13485
Non-active, non-implantable devices / Active (non-implantable) medical devices other than specified above
Non-active, implantable devices / Active implantable devices
Devices of wound care / IVD reagents and reagent products, calibrators and control materials
Dental devices / In Vitro Diagnostic Instruments and software
Other, non-active medical devices / IVD medical devices other than specified above
General, active medical devices / Medical devices incorporating medicinal substances
Monitoring devices / Medical devices utilizing biological active coatings and/or materials or being wholly or mainly absorbed
Devices for radiation therapy and thermo therapy / Sterile medical devices
Sterilization method:
Applied technologies:
Critical subcontracted processes:
Statistical number of employees
concerned in the area of the certification:
Organisational structure: / (Please, enclose a copy of your organogram.)
Number of sites:
Only in case of more sites! Fill out for each site:
Headquarter/
Site 1 / Site2 / Site 3
Name and address of site:
Activity area:
Product range:
Applied technologies:
Main equipment:
Statistical number of employees concerned in the area of the certification:
Language of the audit: / Language of the documentation:
Requested deadline
of the offer: / Requested deadline
of the certification process:
Number and language of requested certificates:
(4) Other information
Do you have a certified system?
Certification standard: / Certification body:
Start date of the quality management system:
Do you have a consultant? / Name of the consultant (person/company):
(5) Any other information, remark or request concerning the offer:
Date: / Signature:
Signatory:
Please, send back this request form to one of these addresses:
E-mail:
Fax: +36 23880831
Postal address: 2040 Budaörs, Gyár u. 2., Hungary
CE Certiso Ltd. reserves the right to call for additional data.
File name:RTK-M-03 Árajánlatkérő adatlap v08_en / Page / Number of pages: 1 / 3