At a glance
- There is no general file checklist: each module in Annex III describes its own documentation. Four blocks always return: design, materials, fabrication, final assessment.
- The EU declaration of conformity (Annex IV, eight points) is the keystone, not the starting point — you sign on your sole responsibility.
- Collect during fabrication what cannot be made afterwards: calibration records, batch numbers of consumables, heat treatment records.
There is no single list — there is a list per module
The PED has no general article listing what a technical file contains. Each module in Annex III describes its own technical documentation. What you must deliver therefore depends on the module you choose, and that depends on your category.
What returns in every case is the core: the design with its substantiation, the material with its traceability, the fabrication with its qualifications, and the final assessment with its evidence.
The four blocks every file rests on
Design
The design calculation with the PS, TS and load cases applied; the drawings of the pressure-bearing parts; the hazard analysis showing which hazards of Annex I point 1 were considered and how they are covered; and the standard or design rule applied, with its edition.
Materials
Material certificates of the pressure-bearing parts, traceable to the part. Annex I point 4.2 allows three routes: materials complying with harmonised standards, materials covered by a European approval for pressure equipment materials under Article 15, or a particular material appraisal. For categories III and IV that particular appraisal is assessed by the notified body — not a formality, and it costs lead time.
Fabrication
Welding procedure and welder qualifications, the welding plan, the qualification of NDT personnel, heat treatment records and the inspection and test plan. From category II, procedures and personnel for permanent joints must be approved (Annex I point 3.1.2); for categories III and IV, NDT personnel must be approved by a recognised third-party organisation (point 3.1.3).
Final assessment
The final inspection report, the NDT report and the evidence of the proof test. Annex I point 3.2.2 requires a test of the pressure containment aspect, normally a hydrostatic pressure test, at no less than the value of point 7.4 — see the page on the minimum test pressure.
The EU declaration of conformity
Annex IV prescribes what the declaration contains. Eight numbered points, plus the signature:
- identification of the equipment or assembly: product, type, batch or serial number;
- name and address of the manufacturer and, where applicable, the authorised representative;
- the statement that the declaration is issued under the sole responsibility of the manufacturer;
- the object of the declaration, with the information for traceability, the conformity assessment procedure followed and, for assemblies, the constituent equipment;
- the statement that the object conforms to the relevant Union harmonisation legislation;
- the harmonised standards used or the other technical specifications conformity is declared against;
- name, address and number of the notified body, the certificate number and references to the EU certificates issued;
- additional information.
Plus place and date of issue, and name, function and signature of the signatory. Point 7 is the one most often left empty although a body was involved, and point 6 usually misses the edition of the standard.
The law is the floor — client requirements come on top
In oil and gas and heavy industry the PED is rarely the whole story. Clients impose their own specifications on top of the legal requirements and the harmonised standards: stricter NDT scope, additional material requirements, their own documentation demands. Those requirements are nowhere in the directive, but contractually they weigh just as much: a file that satisfies the PED but not the client specification is simply not accepted.
Also expect the client to attend fabrication at fixed points — not only the notified body. Large clients send their own inspector or a hired inspection agency, and want their own hold and witness points. Put those client points in the same inspection and test plan as the body's points, and agree the notification period per point. Two separate inspection regimes side by side is the fastest way to derail a schedule.
Statements of contract practice, not requirements of the directive.
Rather not start from a blank page: custom templates
This page tells you what goes into the file; the templates give you the documents themselves. SWQC supplies them fully fill-in-ready and in your own house style — logo, company details and document coding — matched to your category and conformity module: file structure, deliverables list, inspection and test plan and register sheets. Delivered as editable files, from € 395 excl. VAT.
Mail info@swqc.nl with your category and module; you will receive a fixed quote within one working day.
Where files founder in practice
The following items come from practice, not from the directive. They are rarely the reason a design is unsound, and often the reason a delivery stalls:
- Welding consumables and shielding gases without traceability to the batch actually used.
- Calibration evidence of the welding power source and of the measuring instruments at the proof test, missing or expired on the day of the test.
- The particular material appraisal requested only after the plate has been cut.
- Heat treatment records without thermocouple positions.
- The inspection and test plan not agreed beforehand, so that supervision points turn out to be hold instead of witness and fabrication stands still.
- The instructions for use, never in the schedule and a hard requirement at delivery (Annex I point 3.4).
The pattern is always the same: items that must be collected during fabrication and cannot be reconstructed afterwards. A welding report can be written up later; a calibration certificate from six months ago cannot.
Frequently asked questions
What must a technical file under the PED contain?
There is no general list; each module in Annex III describes its own technical documentation. In every case four blocks return: the design with calculation, drawings and hazard analysis; the materials with certificates and traceability; the fabrication with welding and NDT qualifications and the inspection and test plan; and the final assessment with NDT report and proof test evidence.
What goes into the EU declaration of conformity?
Annex IV names eight points: identification of the product, name and address of the manufacturer, the sole-responsibility statement, the object with the procedure followed, the conformity statement itself, the standards or specifications used, the notified body details with certificate number, and additional information. Plus place, date, name, function and signature.
Who draws up the declaration of conformity?
The manufacturer, under its sole responsibility. A notified body issues certificates on what it assessed, but it does not sign the declaration of conformity. Those two are often confused.
When is a particular material appraisal needed?
When you use material that is not covered by a harmonised standard and no European approval for materials under Article 15 exists. Annex I point 4.2 then allows the particular material appraisal as the third route. For categories III and IV that appraisal is assessed by the notified body, which costs lead time.
Which proof test belongs in the file?
Annex I point 3.2.2 requires a test of the pressure containment aspect, normally a hydrostatic pressure test. The value follows from point 7.4: at least the higher of 1.25 times the maximum in-service loading, corrected for the allowable stress ratio, and 1.43 times the maximum allowable pressure PS. Harmonised standards can add requirements of their own.
What do you have to deliver?
The full report works out the file items for your category and module, with the reference per item and a fill-in deliverables list.
Run the free check or see the full report