Skip to content
HTC
ertSystem
QMS Certification
Sign In
"
*
" indicates required fields
Step
1
of
12
8%
This offer request application contains all necessary fields for HTCert to understand the structure of your company. It will take approximately 30 minutes and you will have the option to move forward and backwards.
Company Information
Company Name
*
Company Address
*
Street Address
Address Line 2
City
ZIP / Postal Code
Afghanistan
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antarctica
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bonaire, Sint Eustatius and Saba
Bosnia and Herzegovina
Botswana
Bouvet Island
Brazil
British Indian Ocean Territory
Brunei Darussalam
Bulgaria
Burkina Faso
Burundi
Cabo Verde
Cambodia
Cameroon
Canada
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos Islands
Colombia
Comoros
Congo
Congo, Democratic Republic of the
Cook Islands
Costa Rica
Croatia
Cuba
Curaçao
Cyprus
Czechia
Côte d'Ivoire
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Eswatini
Ethiopia
Falkland Islands
Faroe Islands
Fiji
Finland
France
French Guiana
French Polynesia
French Southern Territories
Gabon
Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Heard Island and McDonald Islands
Holy See
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Isle of Man
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
Korea, Democratic People's Republic of
Korea, Republic of
Kuwait
Kyrgyzstan
Lao People's Democratic Republic
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
Macao
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia
Moldova
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Netherlands
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
North Macedonia
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestine, State of
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn
Poland
Portugal
Puerto Rico
Qatar
Romania
Russian Federation
Rwanda
Réunion
Saint Barthélemy
Saint Helena, Ascension and Tristan da Cunha
Saint Kitts and Nevis
Saint Lucia
Saint Martin
Saint Pierre and Miquelon
Saint Vincent and the Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Sint Maarten
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Georgia and the South Sandwich Islands
South Sudan
Spain
Sri Lanka
Sudan
Suriname
Svalbard and Jan Mayen
Sweden
Switzerland
Syria Arab Republic
Taiwan
Tajikistan
Tanzania, the United Republic of
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkmenistan
Turks and Caicos Islands
Tuvalu
Türkiye
US Minor Outlying Islands
Uganda
Ukraine
United Arab Emirates
United Kingdom
United States
Uruguay
Uzbekistan
Vanuatu
Venezuela
Viet Nam
Virgin Islands, British
Virgin Islands, U.S.
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe
Åland Islands
Country
Phone
*
Fax
Company Email
*
Website
Billing Details
Legal Entity Name
*
Tax Identification Number
*
Billing Address
*
Street Address
Address Line 2
City
ZIP / Postal Code
Afghanistan
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antarctica
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bonaire, Sint Eustatius and Saba
Bosnia and Herzegovina
Botswana
Bouvet Island
Brazil
British Indian Ocean Territory
Brunei Darussalam
Bulgaria
Burkina Faso
Burundi
Cabo Verde
Cambodia
Cameroon
Canada
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos Islands
Colombia
Comoros
Congo
Congo, Democratic Republic of the
Cook Islands
Costa Rica
Croatia
Cuba
Curaçao
Cyprus
Czechia
Côte d'Ivoire
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Eswatini
Ethiopia
Falkland Islands
Faroe Islands
Fiji
Finland
France
French Guiana
French Polynesia
French Southern Territories
Gabon
Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Heard Island and McDonald Islands
Holy See
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Isle of Man
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
Korea, Democratic People's Republic of
Korea, Republic of
Kuwait
Kyrgyzstan
Lao People's Democratic Republic
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
Macao
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia
Moldova
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Netherlands
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
North Macedonia
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestine, State of
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn
Poland
Portugal
Puerto Rico
Qatar
Romania
Russian Federation
Rwanda
Réunion
Saint Barthélemy
Saint Helena, Ascension and Tristan da Cunha
Saint Kitts and Nevis
Saint Lucia
Saint Martin
Saint Pierre and Miquelon
Saint Vincent and the Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Sint Maarten
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Georgia and the South Sandwich Islands
South Sudan
Spain
Sri Lanka
Sudan
Suriname
Svalbard and Jan Mayen
Sweden
Switzerland
Syria Arab Republic
Taiwan
Tajikistan
Tanzania, the United Republic of
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkmenistan
Turks and Caicos Islands
Tuvalu
Türkiye
US Minor Outlying Islands
Uganda
Ukraine
United Arab Emirates
United Kingdom
United States
Uruguay
Uzbekistan
Vanuatu
Venezuela
Viet Nam
Virgin Islands, British
Virgin Islands, U.S.
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe
Åland Islands
Country
Contact Person
The first contact person will receive all communication
Contact Person
*
Position in the company
*
Phone
*
Contact Person Email
*
Extra Contact Persons
Name
Position in the company
Phone
Email
Add
Remove
Employee Status
Total number of employees
*
(full and part time)
Number of Shifts
*
Number of Part-Time employees
Number of employees Performing Same or Similar Repetitive Task
*
Please enter a number greater than or equal to
0
.
Activities considered for estimation of the number of employees performing same or similar repetitive task shall be of low risk and low complexity (e.g. cleaners, security, transport, sales, call centers, etc)
Other Sites
If the quality management system includes Additional Facilities, please complete the following table. In case there are more than 1 facilities, please make a copy of this table and provide details for all facilities
Additional Facilities
Location
Contact Person
Number of Shifts
Total number of employees (full and part time)
Number of Part-Time Employees
Number of employees Performing Same or Similar Repetitive Task
Activities performed in the facility
Add
Remove
Subcontractors
If there are more than one subcontractors, please make a copy of this table and provide details for all. Please describe in which way outsourced processes are monitored and controlled (e.g. by auditing of subcontractors, by in-coming inspection, subcontractors are certified to MDD, ISO 13485 or ISO 9001) Please attach copies of any relevant certificates.
Subcontractor's List
Company Name
Address
Devices concerned
Services Provided
Control of Processes
Design / Development
Production
Product Testing
Packaging
Sterilization
Critical components
OEM manufacturer
Add
Remove
to add more services provided, please write the service you want and hit enter
Company activities
Company's Activities
Please give a short description of the company's activities specifying the range of products or services and avoiding generalized expressions.
Scope of Certification
Standard(s) applied for
*
ISO 9001:2015
ISO 13485:2016
1348/04 Greek M.D.
Required Certification Scope
Desired date of the audit
DD slash MM slash YYYY
Is a pre-audit requested?
*
No
Yes
Current Certification Status
Is this a new application or an extension to an existing Certification?
New
Extention of Existing
Is this a transfer from another Certification Body?
No
Yes
In this case please attach copies of all current certificates
Drop files here or
Select files
Max. file size: 256 MB.
Is Certification for another standard held?
No
Yes
Certification for another standard held List
Certification Body
Certificate No
Standard
Add
Remove
External consultants
*
Did you receive consultancy services regarding the implementation of the quality management system?
No
Yes
by:
Quality System Documentation/Structure
*
One quality manual/set of procedures covers all facilities
Separate quality manual/procedures for each facility
Other
Attachments
Company brochure
*
Drop files here or
Select files
Max. file size: 256 MB.
Organization chart of the headquarter
*
Drop files here or
Select files
Max. file size: 256 MB.
Organization chart of subsidiaries / branches
Drop files here or
Select files
Max. file size: 256 MB.
Company’s current certificates
Drop files here or
Select files
Max. file size: 256 MB.
Certificates of subcontractors
Drop files here or
Select files
Max. file size: 256 MB.
Finalize
Submitted by
*
enter your name as signature
Position in the company
*
Privacy
*
I agree to the
Privacy Policy
.
Terms of Service
*
I agree to the
Terms of Use
Hidden
Final Certifications (Deprecated Field)
Drop files here or
Select files
Max. file size: 256 MB.
Please use the field below. Slowly everything will be migrated to the new format below and the field will be deleted
Email
This field is for validation purposes and should be left unchanged.
Helpdesk
For any problem please send an email using the link below
Send Issue Report
Sign In
Sign In
Username or Email Address
Password
Remember Me
Sign In
Lost your password?