Pressure Equipment Directive (2014/68/AB)
Our scope is:
Annex III - Module E1
Annex III - Module E
Annex III - Module D1
Annex III - Module D
Annex III - Module F
Annex III - Module B
Annex III - Module G
Annex III - Module B
Annex III - Module H1
Annex III - Module H
Annex I, 3.1.2
CE Marking Conformity Assessment Procedures for Pressure Equipment Directive
Application process is completed when the documents in the following list have been sent to TSE. If the documents are not incomplete after they have been checked, inspection date(s) is/are determined by coming to an agreement with the applicant in the consequent week and the inspection is implemented. If no non-conformity is found after the inspection has been carried out, the applicant is entitled to a certificate. In case the documents are not incomplete and there is no non-conformity, certification process is fulfilled in approximately 1 week.
The applicants are obliged to inform TSE concerning the significant amendments they have made in their system by means of "Technical File Amendment Notification Form."
Application Documents
1) Conformity Assesment Application Form
and Agreement (must be filled 2 copies)
2) Pressure Equipment Directive Information Form
3) A copy of Trade Registry Gazette which indicates the title, legal tender and the managers having representative and binding authority of the Applicant Firm. For foreign applicants: an equivalent legal document is required (original or notarized document)
4) Authorised Signatory List of the authorised persons of the Applicant
5) In case the Applicant and Manufacturing Place are different; confirmed document presenting the agreement between them
6) A copy of the registration of trademark document
7) Document manifesting the application advance payment
Prepayment Receipt (3000 USD)
8) Quality System File (The documents which Quality System File must contain are: Quality Manual, Procedures, Test Instructions and List of Forms, EC Type Examination Certificate (if exists), EC Design Examination Certificate (if exists)
9) Technical File
10) Technical File must contain at least the following documents:
10.1) Presentation of the Applicant Firm (Name and Address of the manufacturer, if the application is lodged by the Authorised Representative then Name and Address of the Authorised Representative)
10.2) Full description, Category and Class (Group 1 - Group 2) of the Pressure Equipment
10.3) Conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, etc. of the Pressure Equipment
10.4) Mechanical Strength Calculations of the Pressure Equipment
10.5) Inspection and Testing Reports
10.6) Technical characteristics of the Pressure Equipment
10.7) Users and assembling guides of the Pressure Equipment
10.8) Assembling and Maintenance Instructions of the Pressure Equipment
10.9) EC Declaration of Conformity for each Pressure and Safety Accessory bearing CE Marking (if exists)
10.10) User / Maintenance / Assembling Guides of the products bearing CE Marking
10.11) Quality Management System Certificate - ISO 9001 (if exists)
10.12) EC Declaration of Conformity
10.13) Records and approvals concerning the permanent joining operations (if exist)
10.14) Inspection and Testing Records concerning Non-Destructive Testing (if exist)
10.15) Certificates belonging personnel (Approvals of permanent joining personnel (welders) and Non-Destructive Testing Personnel) (if exist)
10.16) A list of the specified standards applied in full or in part
10.17) Descriptions of the solutions adopted to meet the Essential Requirements of the directive where the specified standards have not been applied
10.18) Risk Analysis
10.19) A written declaration concerning the application has not been lodged through the channel of any other Notified Body.
In order to get TS EN ISO 9000 Quality Management System Certificate together with CE Marking Conformity Assessment Certification, Quality Management System Application Forms are required to be filled as well. These forms can be obtained from www.tse.org.tr
Responsible of Pressure Equipment Directive
Sezai DOĞAN/FATİH KAYA
Tel: 90 - 312 416 65 68
Fax: 90 - 312 416 62 82
fkaya@tse.org.tr