KEMA Quality Registrar
KEMA Quality Management System
KEMA Quality Registrar: ISO Certification
KEMA Quality Registrar
Quality Management System Free Quote
Services

Certification - How it Works

System certification
Process Audits since 1987

+ ISO 14064
 

Regulatory Services

+ ISO 13485:2003
+ CMDCAS - Health Canada
+ ATEX

Other Services

+ Supplier Audits
+ National Biosolids
Free Quote
KEMA Registered Quality, Inc.
Filter Type:
Thank you for considering KEMA as your Notified Body and Registrar. To best serve you and provide you with the most accurate quotation for certification services, please complete the questionnaire below. If you need assistance to complete this form, please do not hesitate to contact the KEMA medical team now. Any information provided to KEMA will remain strictly confidential.
Date
How did you find KEMA?
Other
Section I - Type of Request
(check all that apply)
 New Certification
 Assumption of Certificate
 Management System Certification
 Management System Certification
 Sterilization Certification
 Not Sure
Section II - Company Information
Legal Company Name
Main Location Address
P.O. Box
City
State
Zip
Country
Website
Primary Contact
Position
Phone
Fax
Email
Secondary Contact
Phone
Email
 I agree to the following (not required)
KEMA has our permission to send us promotional updates and marketing information via e-mail. KEMA agrees to maintain the email address for private use only and will not sell the address for outside use.
 I would like KEMA to contact me
I would like KEMA to contact me to complete the remainder of this request for quote form.
Section III - Additional Company Information
Is your company part of a larger organization?
 Yes No
If yes, please explain
Will the legal company name and address, as stated earlier, be used as the only name on the labels of products with CE?
 Yes  No
If no, please give more details if available (e.g. distributor name in addition, trade name used other then company name, labeled with another company's name).
Does your company consist of more than one manufacturing/support location, all of which contribute to the overall scope of the quality system and product family that you intend to certify?
 Yes  No
If yes, please give more detail (what occurs at what location). This should include all relevant manufacturing sites covered be the Quality System under your responsibility.


Please list the facilities you wish to include in your certification:
Site Name
State
Zip
Number of Employees
Number of Shifts
Site Name State Zip Employees Shifts
Do you make use of subcontractors for the manufacturing?
 Yes  No
Is the product sterilized? (A contract sterilizer must be considered a subcontractor)
 Yes  No

Subcontractor Information Form
If yes, please fill in the Subcontractor Information Form below. This information is essential for us have in order to provide you with an quote. If you have more than one subcontractor, you may wish to download the Subcontractor Information Form and return it to us via postal mail or fax at 215.997.9736. Please complete a new form for each subcontractor.
Name and address of subcontractor:
What activity/manufacturing steps are performed by this subcontractor?
To what quality control standard(s) does this subcontractor comply
 QSR (GMP) ISO13485:2003
 ISO 9001:2000 None of these standards
Is the quality system registered/certified
 Yes  No
If yes, year of registration
Registration body
Section IV - Quality System Information
Please check the standard(s) you wish to be registered to
 ISO 9001:2000 QS9000 ISO 14001
 AS9100B TL-9000 TS16949
 ISO 17799 OHSAS 18001 2nd Party Audit
Have you ever previously been certified to any of these standards?
 Yes No
If yes, which standard(s) -
By whom?
Do you presently have a fully documented Quality System?
 Yes  No
If no, please explain
If yes, have you completed a full cycle of Internal Audits?
 Yes  No
If no, please explain
Have you completed a full cycle of Management Reviews?
 Yes  No
If no, please explain
When will your documentation be ready for review?
What is your target date for certification?
Have any external audits been performed?
 Yes  No
If yes, please explain
Section V - Product Related Questions
Product Information Form
If yes, please fill in the Product Information Form below. This information is essential for us have in order to provide you with an quote. If you have more than one product, you may wish to download the Product Information Form and return it to us via postal mail or fax at 215.997.9736. Please complete a for each product family that you wish to CE mark.
Model/reference number(s) of the product for which you require CE marking
Description of the product (please send product brochures)
Intended use of the product (please send instructions)
Accessories are provided with the product
Will the accessories be sold separately?
 Yes  No
Materials are used (only for non-active devices: animal tissue, metals, plastics, etc.)
Major sub-assemblies are used (active devices)
Classification of the product
MDD
 Class I Sterile
 Class I Measuring
 Class IIa
 Class IIb
 Class III
AIMD
 Active Implantable
IVDD
 List A
 List B
 Self-Testing
How long has the product been on the market?
 New Product  Existing Product
Existing how many years
In what countries?
Are there test reports of accredited testing bodies available?
 Yes  No
If yes, the following reports by accredited bodies are available
Is the product sterilized? Yes
If yes, where is the sterilization performed (name, address and method)
If yes, does the sterilization facility have any certifications (quality system or sterilization)?
 Yes  No
If yes, please indicate what type and forward us copies of documentation of their certification
Please also submit the following items as applicable:
A. Brochures describing your company and products
B. Product(s) Information Forms (if applicable)
C. ISO9001:2000 and/or ISO13485 quality system certificates of your manufacturing site(s) or subcontractors relating to the product(s) to be CE marked
D. CE certificates that may be relevant to the products for which CE certification is sought
E. Any other information which you think would be helpful in processing the quotation
Section VI - CE Conformity Assessment
Is this the starting point for CE registration for your company's products or does your company currently have products registered with another Notified Body?
 This is the first time we start with
CE registration of our products.
 I am currently with another
Notified Body. Please specify which Notified Body and send copies of your current CE certificates.
Notified Body
When will the product dossiers be ready for notified body review?

Which CE conformity procedure(s) do you wish to follow?
MDD (Medical Devices)
 Annex II Annex III/IV
 Annex III/V Annex III/VI
 Annex VII/IV Annex VII/V
 Annex VII/VI Unknown
AIMD (Active Implantable)
 Annex II Annex III/V
 Annex III/VI Unknown
IVDD (In-Vitro Diagnostics)
 Annex IV Annex V/VII
 Annex III (Self-testing) Unknown

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