Questions for quoting
Please send the completed questionnaire (4 pages) to:
TÜV Rheinland LGA Products GmbH
Branch Medical Devices
Am Grauen Stein
51105 Köln
Germany
TÜV Rheinland LGA Products GmbH
Branch Medical Devices
Alboinstraße 56
12103 Berlin
Germany
Mr. Gerald Breuninger
Phone: +49 221 806-1545
E-mail: Gerald.Breuninger@de.tuv.com
Mr. Sandro Holl
Phone: +49 30 7562-1320
E-mail: Sandro.Holl@de.tuv.com
Ms. Nina Bilk
Phone: +49 221 806-2984
E-mail: Nina.Bilk@de.tuv.com
You may also contact our customer service center:
Phone: +49 221 806-1400
Fax: +49 221 806-2095
http://www.tuv.com/
E-mail: service@de.tuv.com
The information in the attachment supports you when completing this questionnaire. If you have any
questions, please contact us! Challenge us – we take care of you!
1. Details about the company and contact persons
Company:
Contact person:
Street:
ZIP-Code, Place:
Phone no.:
E-mail:
Fax no.:
Homepage:
2. List of the specified products with classification (please refer to page 2-5 of the attachment)
EC-directive
Products
MDD, IVDD or
AIMD
Classification
+ rules (for products
acc. to MDD)
1
2
3
4
5
Please inform us about the categorization of your medical devices in subcategories (class IIa) and/or
generic device groups (class IIb) as per directive 2007/47/EC in the attachment to questions for
quoting.
Do you sell products under your own company name, which are produced
by other companies?
yes
no
If yes, did the original equipment manufacturer (OEM) already carry out a
conformity assessment procedure?
yes
no
Do any QA system certificates for your company already exist?
yes
no
Questions for quoting-GB.doc
Rev. 10; 2010-03-03
Page 1 of 4
Questions for quoting
3. Desired conformity assessment procedure
(please refer to page 5 of the attachment)
MDD (93/42/EEC)
IVDD (98/79/EC)
AIMD (90/385/EEC)
EC directive on
medical devices
EC directive on
In vitro diagnostics
EC directive on active
implantable medical devices
Quality Management
System certificates
Annex II.3
Annex III.6
Annex 2
No certificate
Annex II.3 + II.4
Annex IV.3
EN ISO 9001
Annex III + IV
Annex IV.3 + IV.4 + IV.6
EN ISO 13485
Annex III + V
Annex V + VI
EN ISO 15378
Annex III + VI
Annex V + VII
ISO 13485 under
CMDCAS
Annex IV
Annex V + VII.3 + VII.5
Further international
approvals:
Annex V
PAL GMP (Japan)
FDA Mock audit
Annex VI
TCP Taiwan
Do you wish a Pre-audit (Recommended in case of certification for the first time)?
yes
In which language can audits be carried out?
German
English
In which language is your QM system described?
German
English
In which language is your technical documentation written?
German
English
no
4. Details about your quality management system
Please specify the scope of your Quality Management System
(QMS), as stated in your Quality Manual:
Activities excluded from the scope of the QMS:
Production
(Please mark if applicable)
Design and development
Did you receive consultancy regarding the implementation of
your QMS?
yes, by:
no
Questions for quoting-GB.doc
Rev. 10; 2010-03-03
No. of shifts
Sum
Other
Service
Sales
Warehouse
Production
Purchasing
Name and address of the headquarters,
as well as of the possible subsidiaries/branches
Design and
Development
Please specify the (approximate) number of employees
in the particular departments
Quality
assurance
departments
Page 2 of 4
Questions for quoting
Processes
Name and location of subcontractors, which perform outsourced processes
Design and
Development
Production
Packaging
Sterilisation
Warehouse
Service
5. Controlled environmental conditions / specification about your products
Do you manufacture under defined environmental conditions?
yes
no
yes
no
yes
no
If yes, which parameters or certain areas are controlled and monitored ?
temperature
ESD controlled areas
humidity
radiation protected areas
total particle counts
others:
microbial counts
Do you maintain “clean room” conditions?
If yes, please specify classification according to EN ISO 14644:
Do you produce sterile products?
If yes, to which sterilisation procedure?
by ethylene oxide according to EN ISO 11135
by moist heat according to EN ISO 17665-1
by irradiation according to EN ISO 11137
others:
Is the sterilisation process validated with the specified products?
yes
no
Are the devices manufactured utilising tissues of animal origin according to
directive 2003/32/EC?
yes
no
6. Time scale/scheduling:
Please specify your desired dates for:
the product test/product documentation review:
the Pre-audit (voluntary):
Stage 1 audit:
Stage 2 (Certification) audit:
• Please consider that the interval between stage 1 and stage 2 should be > 10 days and < 3 months.
Questions for quoting-GB.doc
Rev. 10; 2010-03-03
Page 3 of 4
Questions for quoting
7. Additional information:
7.1 International approvals:
The global Network of TÜV Rheinland Group provides services which allow a fast world-wide market access for your
products. Please mark for which country you would like to receive additional information.
Canada: cTUV
Australia:
MRA
Canada: CMDCAS
New Zealand:
MRA
USA:
TUVus
Japan:
Certification service under PAL
USA:
FDA 510(k)
Participation of CB-procedure (CB = Certification Body), the world-wide recognised testing procedure
7.2 Product tests:
Please mark for which product tests we may offer additional information to you.
Safety test
Biocompatibility test
EMC test
Ergonomic test
GM mark test (voluntary tested medical product)
Possible criteria for the performance of a stage 1 audit as “off-site” audit (desk audit):
•
Existing valid or recently expired QM certification, issued by an accredited certification body
•
Pre-audit performed
•
Limited company size (e.g. < 65 employees)
•
Simple structure of the organization and its process landscape
•
Limited number of product groups involved
•
Low risk classification of products (e.g. class I products according to MDD 93/42/EEC)
•
Reasonable exclusions of quality management system activities (refer to the QMS scope, stated in section 4)
•
Limited product or manufacturing complexity
Are you ready?
Checklist
Please attach the following information:
•
Company brochure
•
Relevant product information/brochures/instructions for use
•
Copies of any valid EC Directive approval
•
Copies of any valid QMS certificate
•
Organization chart of the headquarter as well as of subsidiaries/branches (if applicable)
•
Copies of any valid QMS and regulatory certificates of the subcontractors
•
Copies of existing EC directive approvals of OEMs (QM system as well as product-related
approvals, if applicable)
Place,
Date
Questions for quoting-GB.doc
Name
Rev. 10; 2010-03-03
Legally binding signature
Page 4 of 4
Additional information about the
questions for quoting
Which EC directive covers your product?
Is your product a medical product?
Art.1(2)a [93/42/EEC]
‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in
combination together with any accessories, including the software intended by its manufacturer to be used specifically for
diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for
human beings for the purpose of:
•
diagnosis, prevention, monitoring, treatment or alleviation of disease,
•
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
•
investigation, replacement or modification of the anatomy or of a physiological process,
•
control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or
metabolic means, but which may be assisted in its function by such means.
... or is your product an accessory of a medical product?
Art.1(2)b [93/42/EEC]
'accessory' means an article which whilst not being a device is intended specifically by its manufacturer to be used together with
a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.
Is your medical product an in vitro diagnostic medical device?
Art.1(2)b [98/79/EC]
‘in vitro diagnostic medical device´ means any medical device which is a reagent, reagent product, calibrator, control
material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the
manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the
human body, solely or principally for the purpose of providing information:
•
concerning a physiological or pathological state, or
•
concerning a congenital abnormality, or
•
to determine the safety and compatibility with potential recipients, or
•
to monitor therapeutic measures.
Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles´ are those devices,
whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of
specimens derived from the human body for the purpose of in vitro diagnostic examination. Products for general laboratory
use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended
by their manufacturer to be used for in vitro diagnostic examination.
Is your medical product an active implantable medical device?
Art.1(2)b+c [90/385/EEC]
'active medical device'
means any medical device relying for its functioning on a source of electrical energy or any source of power other than that
directly generated by the human body or gravity;
'active implantable medical device'
means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the
human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure;
Internet link:
List of relevant EC directives:
http://www.newapproach.org/Directives/DirectiveList.asp
Questions for quoting-GB.doc
Rev. 10; 2010-03-03
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Additional information about the
questions for quoting
How is your medical product classified?
1. According to MDD
Annex IX directive 93/42/EEC amended by directive 2007/47/EC
Rule 1
Rule 5
All non-invasive devices are in Class I, unless one of the rules All invasive devices with respect to body orifices, other than
set out hereinafter applies.
surgically invasive devices and which are not intended for
connection to an active medical device or which are intended for
connection to an active medical device in Class I:
•
are in Class I if they are intended for transient use,
Rule 2
•
are in Class IIa if they are intended for short-term use,
All non-invasive devices intended for channelling or storing
except if they are used in the oral cavity as far as the
blood, body liquids or tissues, liquids or gases for the purpose
pharynx, in an ear canal up to the ear drum or in a nasal
of eventual infusion, administration or introduction into the body
cavity, in which case they are in Class I,
are in Class IIa:
•
are in Class IIb if they are intended for long-term use, except
•
if they may be connected to an active medical device in
if they are used in the oral cavity as far as the pharynx, in an
Class IIa or a higher class,
ear canal up to the ear drum or in a nasal cavity and are not
•
if they are intended for use for storing or channelling blood
liable to be absorbed by the mucous membrane, in which
or other body liquids or for storing organs, parts of organs
case they are in Class IIa.
or body tissues,
in all other cases they are in Class I.
All invasive devices with respect to body orifices, other than
surgically invasive devices, intended for connection to an active
medical device in Class IIa or a higher class, are in Class IIa.
Rule 3
All non-invasive devices intended for modifying the biological
or chemical composition of blood, other body liquids or other
liquids intended for infusion into the body are in Class IIb,
unless the treatment consists of filtration, centrifugation or
exchanges of gas, heat, in which case they are in Class IIa.
Rule 6
All surgically invasive devices intended for transient use are in
Class IIa unless they are:
•
intended specifically to control, diagnose, monitor or correct
a defect of the heart or of the central circulatory system
through direct contact with these parts of the body, in which
Rule 4
case they are in Class III,
All non-invasive devices which come into contact with injured
•
reusable surgical instruments, in which case they are in
skin:
Class I,
•
are in Class I if they are intended to be used as a
•
intended specifically for use in direct contact with the central
mechanical barrier, for compression or for absorption of
nervous system, in which case they are in Class III,
exudates,
•
intended to supply energy in the form of ionising radiation in
•
are in Class IIb if they are intended to be used principally
which case they are in Class IIb,
with wounds which have breached the dermis and can only •
intended to have a biological effect or to be wholly or mainly
heal by secondary intent,
absorbed in which case they are in Class IIb,
•
are in Class IIa in all other cases, including devices
•
intended to administer medicines by means of a delivery
principally intended to manage the micro-environment of a
system, if this is done in a manner that is potentially
wound.
hazardous taking account of the mode of application, in
which case they are in Class IIb.
Questions for quoting-GB.doc
Rev. 10; 2010-03-03
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Additional information about the
questions for quoting
Rule 7
Rule 9
All surgically invasive devices intended for short-term use
are in Class IIa unless they are intended:
•
either specifically to control, diagnose, monitor or correct a
defect of the heart or of the central circulatory system
through direct contact with these parts of the body, in
which case they are in Class III,
•
or specifically for use in direct contact with the central
nervous system, in which case they are in Class III,
•
or to supply energy in the form of ionizing radiation in
which case they are in Class IIb,
•
or to have a biological effect or to be wholly or mainly
absorbed in which case they are in Class III,
•
or to undergo chemical change in the body, except if the
devices are placed in the teeth, or to administer medicines,
in which case they are in Class IIb.
All active therapeutic devices intended to administer or
exchange energy are in Class IIa unless their characteristics are
such that they may administer or exchange energy to or from the
human body in a potentially hazardous way, taking account of the
nature, the density and site of application of the energy, in which
case they are in Class IIb.
All active devices intended to control or monitor the performance
of active therapeutic devices in Class IIb, or intended directly to
influence the performance of such devices are in Class IIb.
Rule 8
All implantable devices and long-term surgically invasive
1
devices are in Class IIb unless they are intended:
•
to be placed in the teeth, in which case they are in Class
IIa,
•
to be used in direct contact with the heart, the central
circulatory system or the central nervous system, in which
case they are in Class III,
•
to have a biological effect or to be wholly or mainly
absorbed, in which case they are in Class III,
•
or to undergo chemical change in the body, except if the
devices are placed in the teeth, or to administer medicines,
in which case they are in Class III.
Rule 10
Active devices intended for diagnosis are in Class IIa:
•
if they are intended to supply energy which will be absorbed
by the human body, except for devices used to illuminate the
patient's body, in the visible spectrum,
•
if they are intended to image in vivo distribution of
radiopharmaceuticals,
•
if they are intended to allow direct diagnosis or monitoring of
vital physiological processes, unless they are specifically
intended for monitoring of vital physiological parameters,
where the nature of variations is such that it could result in
immediate danger to the patient, for instance variations in
cardiac performance, respiration, activity of CNS in which
case they are in Class IIb.
Active devices intended to emit ionizing radiation and intended for
diagnostic and therapeutic interventional radiology including
devices which control or monitor such devices, or which directly
influence their performance, are in Class IIb.
Rule 11
All active devices intended to administer and/or remove
medicines, body liquids or other substances to or from the body
are in Class IIa, unless this is done in a manner:
•
that is potentially hazardous, taking account of the nature of
the substances involved, of the part of the body concerned
and of the mode of application in which case they are in
Class IIb.
Rule 12
All other active devices are in Class I.
1
Consider COMMISSION DIRECTIVE 2003/12/EC of 3 February 2003
on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices and
COMMISSION DIRECTIVE 2005/50/EC of 11 August 2005
on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC
concerning medical devices
Questions for quoting-GB.doc
Rev. 10; 2010-03-03
Attachment: Page 3 of 5
Additional information about the
questions for quoting
Rule 13
Rule 16
All devices incorporating, as an integral part, a substance
which, if used separately, can be considered to be a medicinal
product, as defined in Article 1 of Directive 2001/83/EC, and
which is liable to act on the human body with action ancillary to
that of the devices, are in Class III.
All devices incorporating, as an integral part, a human blood
derivative are in Class III.
Devices specifically intended for recording of X-ray diagnostic
images are in Class IIa.
Rule 17
All devices manufactured utilizing animal tissues or derivatives
rendered non-viable are Class III except where such devices are
intended to come into contact with intact skin only.
Rule 14
All devices used for contraception or the prevention of the
transmission of sexually transmitted diseases are in Class IIb,
unless they are implantable or long term invasive devices, in
which case they are in Class III.
Rule 18
By derogation from other rules, blood bags are in Class IIb.
Rule 15
All devices intended specifically to be used for disinfecting,
cleaning, rinsing or, when appropriate, hydrating contact
lenses are in Class IIb. All devices intended specifically to be
used for disinfecting medical devices are in Class IIa unless
they are specifically to be used for disinfecting invasive devices
in which case they are in Class IIb.
This rule does not apply to products that are intended to clean
medical devices other than contact lenses by means of physical
action.
2. According to IVDD
Annex II [98/79/EC]
IVD devices according to list A:
IVD devices according to list B:
Reagents and reagent products, including related calibrators
and control materials,
for determining the following blood groups:
• ABO system,
• rhesus (C, c, D, E, e)
• anti-Kell,
Reagents and reagent products, including related calibrators and
control materials,
for determining the following
• blood groups: anti-Duffy and anti-Kidd,
• irregular anti-erythrocytic antibodies,
• HLA tissue groups: DR, A, B,
for the detection and quantification in human samples of
• congenital infections: rubella, toxoplasmosis,
for diagnosing of
• hereditary disease: phenylketonuria,
• human infections: cytomegalovirus, chlamydia,
• tumoral marker: PSA,
designed specifically for evaluating the risk of
• trisomy 21 (also software),
for the detection, confirmation and quantification in human
specimens of markers of
• HIV infection (HIV 1 and 2),
• HTLV I and II
• hepatitis B, C and D.
Device for self-diagnosis, including its related calibrators and
control materials:
•
device for the measurement of blood sugar.
IVD devices for self-testing:
Art.1(2)d [98/79/EC]:
‘device for self-testing´ means any device intended by the manufacturer to be able to be used by lay persons
in a home environment;
IVD devices for performance evaluation:
Art.1(2)e [98/79/EC]: ‘device for performance evaluation´ means any device intended by the manufacturer to be subject to one or
more performance evaluation studies in laboratories for medical analyses or in other appropriate
environments outside his own premises;
Other in vitro diagnostic medical devices
Questions for quoting-GB.doc
Rev. 10; 2010-03-03
Attachment: Page 4 of 5
Attachment to questions for quoting
What are the conformity assessment procedures?
MDD
Class
I
I (S)
Design
phase
Production
phase
Annex
Annex
Vll *)
VII
Class I (S)
Class I sterile medical product
Class I (M)
Class I medical product with measuring function
Annex II
Full QA system without annex II.4
V (S) **)
Annex II.4
EC design-examination (“Design dossier review”)
V (M) **)
Vl (M) **)
IV (M) **)
Annex III
EC type-examination
II **)
I (M)
VII
II **)
IIa
Annex IV
EC verification
Annex IV (M)
EC verification referring to measuring function
Annex V
QA system production
Annex V (S)
QA system production referring to sterilisation
Annex V (M)
QA system production referring to measuring
function
Annex VI
QA system product
Annex VI (M)
QA system product referring to measuring
function
Annex VII
EC conformity declaration
Annex III
Annex III.6
EC conformity declaration
Examination of the design
Annex
IV.3 + IV.6
VII.3 + VII.5
Annex IV.3
Annex IV.4
Annex IV.6
Full QA system
EC design-examination (“Design dossier review”)
Verification of manufactured products
IV.3
Annex V
EC type-examination
Annex VII.3
Annex VII.5
QA system production
Verification of manufactured products
Annex VI
EC verification
Annex VIII
Statement and procedures concerning devices for
performance evaluation
VII
V
Vl
IV
II
IIb
III
V
Vl
IV
II
III
III
V
IV
II (incl. annex II.4)
IVDD
Product list
Annex II, list A
Design
phase
Annex
IV.4
+
V
Annex II, list B
Production
phase
V
VII.3
VI
III.6
Self-testing
V
IV.3
III +VIII *)
Dev. for performance
evaluation
Other IVD
AIMD
active
implantable
medical
device
VlI.3
VI
III *)
Design
phase
Productionphase
Annex
Annex
2
3
5
Annex 2
Full QA system and EC design-examination (“Design
dossier review”)
Annex 3
EC type-examination
Annex 4
EC verification
Annex 5
QA system production
4
*) for assessing the Technical Documentation of products of Class I (MDD), devices for performance
evaluation (IVDD) and „other IVD“ (IVDD), the involvement of a Notified Body is not required. On your
request we can offer you a voluntary review of your Technical Documentation.
**) for aspects of sterilisation or metrological requirements (see Annex VII (5))
Questions for quoting-GB.doc
Rev. 10; 2010-03-03
Attachment: Page 5 of 5
General Terms and Conditions of Business of TÜ V Rheinland Korea Ltd
.
Valid from January 1st , 2013
1.
Scope
4.5
1.1
The followi ng terms and conditions appl y to
agreed s ervices including cons ultanc y
services , infor mation, deliveries and similar
services as well as ancillary ser vices and
other sec ondar y obligations pr ovided within
the scope of contract performance.
In the c ase of ins pec tion wor k, TÜ V
Rheinland Korea Ltd. shall not be
responsi ble for the accurac y or c hec king of
the safety pr ogrammes or safety regulations
on whic h the ins pec tions are bas ed, unless
otherwise expressly agreed in writing.
4.6
Exc ept as may be expressly provided in
writing, TÜ V Rheinland Korea Ltd. makes no
other express or implied warranties
regarding its ser vices or deli ver ables to the
client, and TÜ V Rheinland Korea Ltd.
hereby disclai ms any and all i mplied
warranties or warranties impos ed by law,
including warranties of merchantability or
fitness for a particular purpose.
1.2
2.
The client‟s general ter ms and c onditi ons of
business, including the client‟s ter ms and
conditi ons of purchasing, if any, shall not
appl y and shall her eby be expressl y
excl uded. No c ontr actual terms and
conditi ons of the client shall form part of the
contract even if TÜ V Rhei nland Korea Ltd.
does not explicitly object to them.
Quotations
5.
Performance periods/dates
Unless otherwis e agreed, all quotations
submitted by TÜ V Rheinl and Korea Ltd.
shall be subject to change without notice.
5.1
The contractuall y agreed periods and dates
of performanc e are based on es timates of
the wor k i nvol ved which are prepared i n line
with the details provided by the client. They
shall onl y be binding if confirmed as bi nding
by TÜ V Rheinland Korea Ltd. in writing.
3.
Coming into
contracts
effect
and
duration
of
3.1
The contract s hall come into effect for the
agreed term upon the quotation letter of
TÜ V Rheinland Korea Ltd. or a separate
contractual document being signed by both
contracti ng parties , or upon the wor ks
requested by the client being c ommenced
by TÜ V Rheinland Korea Ltd. If the client
instructs TÜ V Rheinl and Korea Ltd. without
receivi ng a prior quotation from TÜ V
Rheinland Korea Ltd. (quotati on), TÜ V
Rheinland Korea Ltd. is – in its s ole
discretion – entitled to acc ept the or der by
giving written notice of s uch acc eptanc e
(including notice s ent via electronic means)
or by performing the requested services.
5.2
3.2
The c ontrac t term s tarts upon the coming
into effect of the contract in accor danc e with
article 3.1 and shall c onti nue for the ter m
agreed in the contract , or if no term is
specified then until TÜ V Rhei nland Korea
Ltd.„s performanc e of the contract is
complete.
3.3
If the contract provi des for an extension of
the contract term, the c ontract ter m will be
extended by the ter m provided for in the
contract unless terminated i n writing by
either party with a si x-week notic e to the end
of the contractual term.
4.
Scope of services
4.1
The sc ope of the s ervices shall be decided
solely by a unanimous declarati on issued by
both parties. If no suc h declaration exists,
then the written confirmation of order by
TÜ V Rheinland Korea Ltd. shall be decisive.
4.2
The agreed s ervic es shall be performed in
compliance with the regulations in force at
the time the contract is entered into.
4.3
Furthermore, TÜ V Rheinland Korea Ltd. is
entitled to deter mine (in its s ole discreti on)
the method and nature of the ass ess ment
unless otherwise agreed i n writing or if
mandator y pr ovisions require a s pecific
procedure to be followed.
4.4
On execution of the wor k ther e shall be no
simultaneous ass umption of any guarantee
of the correctness (proper quality) and
wor king order of either tes ted or examined
parts nor of the i nstallation as a whole and
its upstream and/or downs tream pr ocess es,
organisations, use and applicati on in
accordance with regulations, nor of the
systems on which the installation is based;
in particular, no res ponsibility shall be
assumed for the c onstruc tion, s election of
materials and assembl y of installations
examined, nor for their use and application
in accordanc e with regulati ons unless thes e
questions are expressl y c overed by the
contract.
If bi nding periods of performance have been
agreed, thes e periods shall not commenc e
until the client has submitted all required
documents to TÜ V Rheinl and Korea Ltd.
This also applies , even without express
approval by the client, to all extensi ons of
agreed dates for perfor mance not c aused by
TÜ V Rheinland Korea Ltd.
6.
The client’s obligation to cooperate
6.1
The client s hall guarantee that all
cooperation required on its part, its agents
or third parties will be provided in good time
and at no cost to TÜ V Rheinland Korea Ltd.
6.2
Design doc uments, s upplies, auxiliar y s taff,
etc. nec essar y for perfor mance of the
services shall be made availabl e free of
charge by the client . Moreover, collaborative
action of the client must be undertaken in
accordance with legal provisions , s tandar ds,
safety regulations and accident prevention
instructions.
6.3
The client s hall bear any additional c ost
incurred on account of wor k having to be
redone or being delayed as a res ult of late,
incorrect or incompl ete information or l ac k of
proper cooperation. Even where a fi xed or
maxi mum price is agreed, TÜ V Rhei nland
Korea Ltd. shall be entitled to c harge extra
for such additional expense.
7.
Invoicing of work
7.1
If the scope of performance is not l aid down
in writing when the order is placed, invoicing
shall be based on costs inc urred. If no
payment is agreed i n writing, invoicing shall
be in accordanc e with the TÜ V Rhei nland
Korea Ltd. price list valid at the ti me of
performance.
7.2
Unless other wise agreed, wor k s hall be
invoiced acc ording to the progress of the
work.
7.3
If the exec ution of an order extends over
more than one month and the val ue of the
contract or the agreed fi xed price exc eeds
€2,500.00, TÜV Rheinl and Korea Ltd. may
demand payments on account or in
instalments.
8.
Payment terms
8.1
All invoic e amounts shall be due for
payment without deduction on rec eipt of the
invoice. No discounts shall be granted.
8.2
Payments shall be made to the bank
account of TÜ V Rheinland Korea Ltd. with
immediatel y available funds as indic ated on
the invoice, stating the invoic e and cus tomer
numbers.
8.3
In c ases of default of payment, TÜ V
Rheinland Korea Ltd. shall be entitl ed to
claim default interest at a rate of 8% above
the base interest rate of the German central
bank (Deutsc he Bundesbank). At the s ame
time, TÜ V Rheinland Korea Ltd. res erves
the right to claim further damages.
8.4
Should the client default in payment of the
invoice des pite being granted a reasonable
grace period, TÜ V Rheinland Korea Ltd.
shall be entitl ed to cancel the c ontrac t,
withdraw the c ertificate, cl aim damages for
non-perfor mance and refuse to c ontinue
performance of the contract.
8.5
The provisions set forth in article 8.4 s hall
also appl y i n cas es invol ving canc elled or
dishonour ed cheques, inc omplete or partial
payment,
c essation
of
payment,
commencement of ins ol venc y proceedings
against the client‟s ass ets or cases in which
the
commenc ement
of
i nsol venc y
proceedings has been dis missed due to lac k
of assets.
8.6
Objections to the i nvoices of TÜ V Rhei nland
Korea Ltd. s hall be s ubmitted in writing
within two weeks of rec eipt of the invoic e.
Failure to objec t in writing withi n two weeks
of receipt of the invoice s hall be deemed an
acceptance of the invoice without objection.
8.7
TÜ V Rheinl and Korea Ltd. shall be entitled
to demand appropriate advance payments in
amounts reas onabl y determined by TÜ V
Rheinland Korea Ltd.
8.8
TÜ V Rheinl and Korea Ltd. shall be entitled
to raise its fees at the beginning of a month
if overheads and/or purc hase costs have
increased. In this cas e, TÜ V Rhei nland
Korea Ltd. shall notify the client in writing of
the rise i n fees. This notificati on shall be
issued one month prior to the date on which
the rise in fees s hall c ome i nto effect (period
of notic e of changes in fees). If the rise in
fees remains under 5% per c ontr actual year,
the client shall not have any special right of
termination. If the rise in fees exc eeds 5%
per contractual year, the client shall be
entitled to ter minate the contractual
relations hip by the end of the period of
notice of changes i n fees. If the c ontrac t is
not termi nated, the changed fees s hall be
deemed to have been agreed upon expir y of
the above period.
8.9
Only legall y established and undisputed
claims may be offset against clai ms by TÜ V
Rheinland Korea Ltd.
8.10 Title to the goods delivered or s ervic es
render ed by TÜ V Rhei nland Kor ea Ltd will
pass to the client onl y when TÜ V Rhei nland
Korea Ltd. has rec eived payment from the
client in full.
9.
Acceptance
9.1
Any part of the wor k ordered which is
complete in its elf may be presented by TÜ V
Rheinland Korea Ltd. for acc eptanc e as an
instalment . The client shall be obliged
to accept it immediately.
9.2
If the client fails to fulfil its acceptanc e
obligation immediatel y, acceptance shall be
deemed to have taken plac e 4 cal endar
weeks after performance of the wor k if TÜ V
Rheinland Korea Ltd. has specifically made
the client aware of the aforementioned
deadline upon performance of the service.
10.
Confidentiality
10.1 For the purpos e of this agreement,
“confidential
information”
means
all
information, doc uments , images, drawings,
know-how, data, sampl es and proj ect
documentation which one party (the
“disclosing party”) hands over, trans fers or
otherwise discloses to the other party (the
“receiving party”). C onfidential information
also i ncludes paper copies and electr onic
copies of such information.
10.2 The disclosing party shall mar k all
confidenti al infor mati on disclos ed in written
form as c onfi dential before passing it on to
the rec ei ving party. T he s ame applies to
confidenti al infor mati on transmitted by email. If confidential information is disclosed
orally, the recei ving party s hall be
appropriately informed in advance.
receivi ng
party
hereby
agrees
to
immediatel y (i) return all confi dential
information, including all copies, to the
disclosing party, and/or, on request by the
disclosing party, to (ii) destroy all
confidenti al infor mati on, incl uding all copi es,
and c onfir m the des truction of this
confidenti al information to the disclosing
party in writing, at any time if s o requested
by the disclosing party but at the latest and
without s pecial reques t after termination or
expiry of this contract. This does not extend
to i nclude reports and certificates prepared
for the client solel y for the purpos e of
fulfilling the obligations under this c ontrac t,
which s hall remain with the client. However,
TÜ V Rhei nland Korea Ltd. is entitled to
make file copi es of suc h reports, certificates
and c onfi dential information that for m the
basis for preparing thes e reports and
certificates i n order to evidence the
correctness of its results and for general
documentation purpos es and to ens ure
adherenc e with statutor y retenti on periods to
the extent applicable.
10.3 All confidential i nfor mati on which the
disclosing party transmits or other wise
discloses to the recei ving party in
accordance with this agreement:
a)
may onl y be us ed by the recei ving party
for the purposes of performi ng the
purpos e of the contract, unl ess
expressl y other wise agreed in writing
with the disclosing party;
b)
may not be c opied, distributed,
published or other wise disclosed by the
receivi ng party, unless this is nec essar y
for fulfilling the purpos e of the c ontrac t
or TÜ V Rheinland Korea Ltd. is
required to pass on c onfi dential
information, i nspection reports or
documentation to the authorities or third
parties that are invol ved in the
performance of the contract;
c)
must be treated by the rec ei ving party
with the same level of confidenti ality as
the rec ei ving party uses to protec t its
own c onfidential information, but never
with a l esser level of c onfi dentiality than
that which is objectively required.
10.4 The rec ei ving party shall disclose any
confidenti al information recei ved from the
disclosing party only to those of its
employees who need this information to
perfor m the ser vices required for the s ubj ect
matter of this contrac t. The rec eivi ng party
undertakes to oblige thes e employees to
obser ve the s ame level of secrec y as s et
forth in this confidentiality clause.
10.5 Infor mati on for which the rec eivi ng party can
furnish proof that:
a)
b)
it was generall y known at the ti me of
disclosure or has become general
knowledge without vi olation of this
agreement; or
it was disclos ed to the rec eivi ng party
by a third party entitled to disclose this
information; or
c)
the rec ei ving party already poss essed
this information prior to disclos ure by
the disclosing party; or
d)
the rec ei ving party developed it itself,
irrespective of disclos ure by the
disclosing party, shall not be deemed to
constitute “confidential i nfor mati on” as
defined in this agreement.
10.6 All confidential i nfor mati on shall remain the
property of the disclosing party. The
10.7 From the start of this contract and for a
period of three years after termination or
expiry of this contract, the r ecei ving party
shall maintain strict s ecrec y of all
confidenti al information and shall not
disclose this infor mati on to any third parties
or use it for itself.
11.
Copyrights
11.1 TÜ V Rhei nland Korea Ltd. s hall retain all
excl usive and joint copyrights and any other
intellectual property rights in the expert
reports,
test
results,
calcul ations,
presentati ons etc. prepared by TÜ V
Rheinland Korea Ltd. and except for the
limited use right provided i n articles 11.2 and
11.3, nothi ng in this contract nor arising out
of the contractual rel ationship s hall be
interpreted as TÜ V Rheinland Korea Ltd.
having granted the client any expr ess or
implied right or licens e to s uch c opyrights
and other intellectual property rights.
11.2 The client may only use expert reports, test
results, c alculations, presentations etc.
prepar ed within the sc ope of the c ontr act for
the contractually agreed purpose.
11.3 The client may us e test reports, test results ,
expert r eports , etc . onl y compl ete and
unshortened. Any publicati on or duplication
for advertising pur pos es needs the prior
written approval of TÜ V Rheinl and Korea
Ltd.
12.
Liability of TÜ V Rheinland Korea Ltd.
12.1 Irrespecti ve of the l egal basis and in
particular in the event of a br each of
contractual obligations and tort, the liability
of TÜ V R heinl and Korea Ltd. for all damage,
loss and rei mburs ement of expens es
caused by l egal repres entati ves and/or
employees of TÜ V R heinland Korea Ltd.
shall be limited to: (i) in the case of contr act
with a fi xed overall fee, fi ve ti mes the overall
fee for the entire contract; (ii) in the c ase of
contracts for annuall y rec urring services , to
the agreed annual fee; (iii) in the cas e of
contracts expressl y charged on a time and
material basis to a maximum of 20,000 Euro
and (iv) in the c ase of framewor k
agreements that provide for the possibility of
placing indivi dual orders, to an amount
equal to two ti mes the fee for the i ndi vidual
order under which the damage occurred.
The maxi mum liability of TÜ V Rhei nland
Korea Ltd. is li mited in any event of damage
or loss to 1.0 mil. Euro.
12.2 The limitation of liability accor ding to article
12.1 above s hall not appl y to all damage
and loss es caused by gross negligence or
wilful misconduct on the part of any of the
legal representatives of TÜ V Rhei nland
Korea Ltd. or their vicarious agents.
12.3 TÜ V Rheinl and Korea Ltd. shall not be liable
for personnel made available by the client to
support TÜ V Rheinland Korea Ltd. in the
perfor manc e of its s er vices regulated under
this c ontrac t. If TÜ V R heinl and Korea Ltd. is
not liable for pers onnel made availabl e by
the client under the foregoing provision, the
client shall indemnify TÜ V R heinl and Korea
Ltd. against any clai ms made by third parties.
12.4 The limitation periods for claims for
damages shall be based on statutor y
provisions.
12.5 None of the provisions of this article 12
changes the burden of proof to the
disadvantage of the client.
13.
Partial invalidit y, written form, place of
jurisdiction
13.1 No ancillary agreements to this contr act
have been concluded.
13.2 All amendments and supplements must be
in writing in order to be effec ti ve; this also
applies to amendments and supplements to
the requirement for the written form.
13.3 Should one or s everal of the provisions
under this contract be or bec ome i neffecti ve,
the c ontrac ting parti es shall replace the
invalid provision with a legall y valid provision
that c omes clos est to the content of the
invalid pr ovision i n legal and commercial
terms.
13.4 The plac e of jurisdiction for all dis putes
arising in connection with this contract s hall
be C ologne. This c ontr act is governed by
German substantive law.