Application to Transfer an MED Module D or E CertificateBABT 789
Issue 6
Page 1 of 7
Section A:Applicant Details
A. 1Applicant Detail
Please note the certificate will be issued listing the applicant company details. This company must be the holderor authorised representativeof the Module B certificates referenced in this application
Title:First Name: / Last Name:
Job Title and/or Department Reference:
Company Name:
Address:
Postcode/Zip Code: / Country:
Telephone Number: / Fax Number:
Email Address:
The above Applicant is the
A. 2Other Contact/Company Information
If the above company name is a trading name which is different from the registered company name, please tick the box and supply, as a part of your application, full details of the registered company name (and number) and the relationship with the trading name.If the application is from anauthorised representative applying under their own company name, it is MANDATORY that you provide full contact details of the Manufacturer. Please tick the box and supply the full details as a part of your application.
If this application has been made in the name of a Manufacturer established outside the European Community, it isMANDATORYthat an authorised representative within the community is appointed. Please tick the box and supply full contact details and a copy of the mandate of the responsibilities of the authorised representative.
If this application has been made in the name of a manufacturer established within the European Community,you may opt to appoint an authorised representative(e.g. Brandname applicant appoints the original manufacturer as authorised representative). If you use this option, please tick the box and supply full contact details and a copy of the mandate of their responsibilities.
If you wish an agent to be involved with this application, please tick the box and supply an agent’s letter on letterhead signed by an employee/official of the applicant company.
© TUV SUD BABT 2017 /
A Certification Body of TÜV SÜD /
Section B:Your Certification Requirements
B. 1Type of Assessment:
B. 2Required Scope of Certification
What type(s) of product will be included in the scope of the certification and which Implementing Regulation (IR)?(If more than 3 types list in separate document)
Please note TUV SUD BABT are unable to accept transfers for product items outside our scope
IR Number / Sector / Item TypesselectLifesavingNavigation Radio CommsColRegs 72
selectLifesavingNavigation Radio CommsColRegs 72
selectLifesavingNavigation Radio CommsColRegs 72
.
Are all these item types on your current certificate? Choose an item.
If “No” Please list the new items: .
B. 3Please Identify the Products to be Included in the Scope of the Certification
Product Name / TEC Certificate number / No of issuing Notified Body / Expiry Date of the CertificateIf you have more than 6 products please provide the above details for all the products in a separate document and reference it in the first above product name
B. 4Number of Facilities to be included in this Certificate?
Section C:Applicant Company Details
C. 1Internal Quality
A copy of our Internal Audit Schedule and process is attached to this applicationChoose an item.
If you have selected “Will be included by date” ,please state the proposed dateClick here to enter a date.
Note: The Schedule should show the date/month when you plan to conduct the Audit of the fabricator,for compliance to the relevant requirements of the MED and BABT 340.
A copy of our PQC compliance plan is attached to this application / selectAttached with applicationWill be provided by dateIf you have not provided the documents indicate the date when they will be sent / Date / Click here to enter a date.
A copy of the manufacturing Test Plan for each Product is attached to this application / selectAttached with applicationWill be provided by date
If you have not provided the documents indicate the date when they will be sent / Date / Click here to enter a date.
Section D:About the Facility If the Production Phase Will Occur (the Fabricator) and Existing Certifications
Note: If you have more than one facility on your Module D certificate,please complete this section for each additional site and attach to the application.
D. 1Facility Information
Company name and address as you wish them to appear on your certificate; If same as applicant just state “as applicant”
Company Name:Address:
Postcode/Zip Code: / Country:
Telephone Number: / Fax Number:
Email Address:
D. 2Contacts at Facility
D.2.1Principal Contact
Title:First Name: / Last Name:
Job Title and/or Department Reference:
Telephone Number: / Fax Number:
Email Address:
D.2.2Alternative Contact
Title:First Name: / Last Name:
Job Title and/or Department Reference:
Telephone Number: / Fax Number:
Email Address:
D. 3Please tick/check box if this facility is the only site or the main (controlling) site
D. 4Employees
Note: FTE = Full Time Employees; 2 employees working ½ days = 1 FTE
Total FTE on site / Total FTE in fabrication / Total FTE in QAD. 5Shifts
Number of Shifts operating on Site / If this facility operates more than one shift, do all shifts perform the same operations? / selectYesn/aIfshifts differ, please provide details of the differences:
D. 6Manufacturing Process
Please indicate those stages of manufacture to be performed at this facility detailed in section A, by applying a tick/check in column A below.
Please indicate any stages of manufacture to be performed at a different facility within the Certification,byselecting column B or sub-contracted (column C) by applying a tick/check as appropriate below.
Note: If the holder is not also the fabricator please indicate in column B any activities are performed at the Holder’s premises.
Column A(this facility) / Column B
(at another facility within this Certification) / Column C
(sub-contracted)
Component Procurement
Goods Receiving
Incoming Component Inspection
Component Stores
Printed Board Assembly
Printed Board Test
Final Product Assembly
Functional Test
Safety Test
D. 7Readiness for Audit
Please indicate the earliest date by which the facility will be ready to demonstrate a compliant quality system (i.e. when ready for an audit). / Date / Click here to enter a date.(Note: While TUV SUD BABT normally follow the audit plan of the previous Notified Body, we reserve the right to require earlier audits).
D. 8Persons or Organisations Providing Consultancy or Acting on Your Behalf.
You are required to identify the details of any a person or organisation who has provided consultancy related to the QMS of the facility in the last 2 years. In addition, if you wish TUV SUD BABT to discuss your application with that named person/company or any other person you must formally authorise TUV SUD BABT to discuss your application with them.
I have included the contact details and brief description of the involvement of every consultant who has been involved with my QMS system over the last 2 years / Choose an item. /Section E:About your current Module D or E Certification
E. 1Current Certification
Please submit a copy of your current Module D/E Marine Equipment
certificate, inclusive of all relevant annexes, with this document. Tick Box to indicate it is supplied
E. 2 Status of your current certification
Our certification is currently Choose an item.
Has any request for transfer of this certification to any other Notified
Body (NB) been turned down or refusedChoose an item.
Note: If your certificate is not current, or a transfer request has been turned down or refused please provide an explanation of the circumstances:-
E. 3Details of Notified Body audit visits
Date / Number of Auditors / Duration(Days)
Our initial assessment/latest re-assessmentvisit was conducted on: / Click here to enter a date. /
Our latest surveillance visit was conducted on / Click here to enter a date. /
Next surveillance visit is expected / Click here to enter a date. /
Note: TUV SUD BABT will take into consideration your existing cycle of audits when planning our next audit. Audits are normally annual. Transfers,if audits were previously conducted at other intervals, would revert to annual unless otherwise agreed.
E. 4Status of Last Audit
Please submit a copy of your most recent audit report from your current,
Mod D/E NB with this document. Tick Box to indicate it is supplied
Are there any outstanding nonconformities that have not beenclosed out
by your current NB?Choose an item.
Are you in dispute with your current NB over theclassification or resolution
of anynonconformitiesChoose an item.
Please state the number of nonconformities not closed out or in dispute.
Note: Full details will be required for all the nonconformities identified above.
Any major nonconformities will need to be closed out by TUV SUD BABT prior to your acceptance for certification, and may require an audit visit if they can’t be fully addressed on a documentary basis.
E. 5Status of Complaints received and actions taken
Do you maintain an up-to-date record of all complaints received and
relevant corrective and preventive actions taken?Choose an item.
What is the number of complaints received since the last audit visit by your NB?
What is the number of outstanding complaints yet to be resolved?
Note: Full details of any outstanding complaints recorded or known to be in progress at the date of application must be provided to TUV SUD BABT with this application. Further information may also be requested regarding any of the complaints recorded above.
Section F:Agreement
The applicant named in A1 must complete this section:
I (We) hereby apply for a TUV SUD BABT Production Quality Certification for the Marine Equipment Directive Module D/ E (as applicable) in relation to the specified locations and agree to conform to the TUV SUD BABT Certification Regulations; (A copy can be found on
and
I (We) authorize TUV SUD BABT to discuss details related to this application with the Notified Body who issued my existing Module D/E Certificate and authorize TUV SUD BABT to receive copies of any supporting documentation held by that Notified Body;
and
I (We) declare that that we have the rights to make use of all trade names referenced in this application and supporting documentation;
and
I (We) agree to advise TUV SUD BABT of any significant change to the quality system of the holder and any listed facility;
Signed for and on behalf of the applicantAuthorised Signatory: / Date Click here to enter a date.
Title: / First Name: / Last Name:
Company name of the authorised signatory:
Please select this if you are an authorised representative applying on behalf of the manufacturer
- Certificates only relate to the holder and specific facilities listed in the certificate.
- Certificates are not transferable.
- Changes to the holders name or address must be notified to TUV SUD Customer Services in writing.
Please return your application to: your local TUV SUD office / If you do not know your local office please return your application to:
TUV SUD Product Service
Octagon House
Concorde Way
Segensworth North
Fareham
Hampshire
PO15 5RL
United Kingdom
National Tel:01489 558234;
International Tel: +44 (0)1489 558234;
Fax: +: +44 (0)1489 558101
Web Address:
Email:
Application to Transfer an MED Module D or E CertificateBABT 789
Issue 6
Page 1 of 7
Section G:Application Checklist
The completion of this is not mandatory
The application you are submitting should include: / Completed BABT 789 form (plus additional section D for additional facilities)
Company Registration details if the application is made in a trading name
Manufacturers details if the applicant is an authorised representative
Copy of applicants existing MED Module D/E certificate
Copy of applicants Internal Audit Process and audit schedule
Copy of most recent audit report from your current Notified Body
Status and corrective action plans for any open findings from that audit
Details of any complaints received related to any of the products to be manufactured under the TUV SUD BABT certificate
A copy of the QMS documentation of the fabricator’s facility (including the Quality Manual, identification of key personnel and key performance aspects of the QMS, the objectives and operation of the management system)
A copy of the PQC Compliance Plan showing how you ensure compliance to the requirements
A copy of all manufacturing test plans
Copy of TECS for all products to be included in the initial certification (or reference numbers if Module B is in progress)
A copy of the Technical Documentation of each listed Module B TEC which was issued by another Notified Body
Any additional sheets providing further information that you feel is of relevance to this application