FORM - Supplier Self-Evaluation
eDoc No.: CD-0000169 eDoc Vers.: 9
Identifier: K1042145 Revision: J
Page: 1/5
The information given herein is confidential and proprietary to Dornier MedTech Company and shall remain confidential for as long as
entitled in law. The information is not to be used or disclosed to any party without express written consent of Dornier MedTech Company
All latest approved revisions are available in the enaio ECM System. All printed hardcopies are for information only.
Dornier MedTech is a manufacturer of medical devices. To fulfill the requirements according to
ISO 13485 in evaluation of suppliers, we created this questionnaire. By this questionnaire we
want to keep the number of audits as low as possible for mutual benefit.
However we depend on your support. Please fill in the questionnaire and indicate questions which
are not applicable with NA.
A) Company Information
Company Name
Street and house number
Zip and City
SRN (Single Registration number) from EUDAMED, if
applicable
Name, Quality Management Representative
Phone
Fax
Email
Founding year
Average Number of Employees at this site during the last
3 years:
Thereof how many Employees work actually in the
production and the quality assurance
Average Sales Volume for last 3 year
FORM - Supplier Self-Evaluation
eDoc No.: CD-0000169 eDoc Vers.: 9
Identifier: K1042145 Revision: J
Page: 2/5
The information given herein is confidential and proprietary to Dornier MedTech Company and shall remain confidential for as long as
entitled in law. The information is not to be used or disclosed to any party without express written consent of Dornier MedTech Company
All latest approved revisions are available in the enaio ECM System. All printed hardcopies are for information only.
B) Scope Manufacturing and Services
☐ Turning / Milling part
☐ Welding / molding / bonding
☐ Electrical Assembly
☐ Mechanical Assembly
☐ Painting
☐ Boards Assembly
☐ Contract Development Electrical
☐ Contract Development Mechanical
☐ Contract Development Optics
☐ Service Provider of :
☐ etc. – please specify :
C) QMS Part 1
Is your Quality Management System certified by an
external party?
☐ Yes
If “Yes”, please indicate the relevant
certificate and skip Part D):
☐ (EN) ISO 13485:2012
☐ (EN) ISO 13485:2016
☐ (EN) ISO 9001:2008
☐ (EN) ISO 9001:2015
☐ other standard (please specify) :
Please provide a copy of Certificate.
☐ No
If “No”, please answer additionally “D) QMS
Part 2”
If Dornier MedTech wants to conduct an audit, How
much lead time do you need for planning?
Are any process steps / services subcontracted? If Yes,
please list the provided in detail
☐ Yes ☐ No
Are there any Quality Agreements with the
subcontractors?
☐ Yes ☐ No
☐ Not applicable
FORM - Supplier Self-Evaluation
eDoc No.: CD-0000169 eDoc Vers.: 9
Identifier: K1042145 Revision: J
Page: 3/5
The information given herein is confidential and proprietary to Dornier MedTech Company and shall remain confidential for as long as
entitled in law. The information is not to be used or disclosed to any party without express written consent of Dornier MedTech Company
All latest approved revisions are available in the enaio ECM System. All printed hardcopies are for information only.
How long is the documentation of production, trading
and quality system stored?
How is the documentation done, paper based or
electronical?
☐ paper based
☐ electronical
Remarks:
Are the products checked and released prior to sale?
☐ Yes ☐ No
☐ Not applicable
Are the delivered products labeled with name, material
number, lot and manufacturing date?
☐ Yes ☐ No
☐ Not applicable
Remarks:
Is the traceability given
a) from the product to the source of material or
manufacturer
b) from the product to the customers?
a) ☐ Yes ☐ No
☐ Not applicable
b) ☐ Yes ☐ No
☐ Not applicable
Are the customers informed about changes to the
product in advance?
☐ Yes ☐ No
Are the customers informed about deficiencies which are
detected after the sale?
☐ Yes ☐ No
☐ Not applicable
Does the QM-department investigate and resolve quality
complaints
☐ Yes ☐ No
Is there a process for corrective and preventive actions
(CAPA) or a continuous improvement process (CIP)
installed?
☐ Yes ☐ No
Are periodic self-inspections or management reviews be
performed?
☐ Yes ☐ No
D) QMS Part 2 (edit only if you answered C) QMS Part 1 Question 1 with "No")
Does your company plan to be certified according to one
of the mentioned standards? Please indicate the
standard.
☐ Yes ☐ No
☐ (EN) ISO 13485:2016
☐ (EN) ISO 9001:2015
☐ other standard (please specify)
When do you plan the certification?
Remarks:
FORM - Supplier Self-Evaluation
eDoc No.: CD-0000169 eDoc Vers.: 9
Identifier: K1042145 Revision: J
Page: 4/5
The information given herein is confidential and proprietary to Dornier MedTech Company and shall remain confidential for as long as
entitled in law. The information is not to be used or disclosed to any party without express written consent of Dornier MedTech Company
All latest approved revisions are available in the enaio ECM System. All printed hardcopies are for information only.
Is your Quality Management System documented by a
Quality Manual and/or written procedures?
☐ Yes ☐ No
Remarks:
Please provide a list of procedures:
Has your Quality Management System already been
audited by other companies?
☐ Yes ☐ No
Are staff trainings performed?
☐ Yes ☐ No
Is there any system for staff training?
☐ Yes ☐ No
Is there any access control to critical premises,
documents and data?
☐ Yes ☐ No
Are the processes executed documented?
☐ Yes ☐ No
E) Environmental Compliance
Has your company/site implemented a system for
monitoring regulated substances in your products?
☐ Yes ☐ No
☐ Not applicable
Does your company comply with the DIN EN IEC 63000
or DIN EN 50581?
☐ Yes ☐ No
☐ Not applicable
Does your company perform risk assessments or
chemical tests for bought-in semi-finished products or
materials?
☐ Yes ☐ No
☐ Not applicable
Does your company have a Material-Compliance or
Product Compliance Officer position?
☐ Yes ☐ No
☐ Not applicable
Are you complying with the Directives/Standards/Acts below
Directives/Standards/Acts
Awareness
Applicable to your
products/Process
es
Do you comply
with these?
Can you provide a
Certificate of
conformity?
Yes No
Yes No
Yes No
Yes No
ISO 14001
☐ ☐
☐ ☐
☐ ☐
☐ ☐
RoHS 2 2011/65/EU
☐ ☐
☐ ☐
☐ ☐
☐ ☐
WEEE 2012/19/EU
☐ ☐
☐ ☐
☐ ☐
☐ ☐
REACH EC 1907/2006
☐ ☐
☐ ☐
☐ ☐
☐ ☐
Packaging and Packaging
waste Directive 94/62/EC
☐ ☐
☐ ☐
☐ ☐
☐ ☐
FORM - Supplier Self-Evaluation
eDoc No.: CD-0000169 eDoc Vers.: 9
Identifier: K1042145 Revision: J
Page: 5/5
The information given herein is confidential and proprietary to Dornier MedTech Company and shall remain confidential for as long as
entitled in law. The information is not to be used or disclosed to any party without express written consent of Dornier MedTech Company
All latest approved revisions are available in the enaio ECM System. All printed hardcopies are for information only.
Thank you for your support!
F) CE marking
Are your products CE marked?
☐ Yes ☐ No
☐ Not applicable
If yes, under which directive
If yes, provide CE marking certificate
G) References – please fill if providing service
Does your company work for other medical device or
pharma customers?
☐ Yes ☐ No
Does your company work for other regulated industries
like aerospace, defence industry, nuclear power?
☐ Yes ☐ No
Please provide 3 customer references
Company Name
Location
Sector
H) Name, Date, Signature
Name
Position
Date
Signature