How to meet UDT requirements and obtain a product certificate of conformity with the PED

Conformity assessment procedure under the Pressure Equipment Directive (PED)

Conformity assessment as a process preceding the placing of a product on the market, carried out by the manufacturer, is an activity whose purpose is to verify that the product complies with the law within the scope defined by the EU directives applicable to that product. In this process, the task of the notified body is to demonstrate that a given product and its manufacturing process comply with the requirements set out in standards and legal provisions. As a result of the conformity assessment process, the product manufacturer receives a certificate of conformity or a certificate of compliance confirming that the product meets specified requirements. To carry out the assessment process, the notified body should ensure uniform rules for assessing the conformity of products subject to CE marking with essential and specific requirements and technical specifications for all applicants (manufacturers or authorised representatives of manufacturers). When assessing products within the scope of its notification, the body should have established rules and procedures for the product conformity assessment process, in accordance with legal requirements and standard PN-EN ISO/IEC 17065. For products subject to Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (abbreviated as PED – Pressure Equipment Directive), the implementing national legislation is currently the Regulation of the Minister of Development of 11 July 2016 on requirements for pressure equipment and assemblies of pressure equipment.

The conformity assessment procedures to be applied to a given item of pressure equipment are determined on the basis of the category to which the equipment has been assigned in accordance with the above Regulation. The procedures that may be applied to the various categories of pressure equipment are as follows: 1) for category I – internal production control (module A), referred to in Part I of Annex 2 to the Regulation; 2) for category II:

1. a) internal production control plus supervised pressure equipment checks at random intervals (module A2), referred to in Part II of Annex 2 to the Regulation,
2. b) quality assurance of the production process (module D1), referred to in Part VI of Annex 2 to the Regulation,
3. c) quality assurance of final pressure equipment inspection and testing (module E1), referred to in Part VIII of Annex 2 to the Regulation;

3) for category III:

1. a) EU type examination (design type) – module B (design type) in combination with module D (conformity to type based on quality assurance of the production process), referred to respectively in Parts III and V of Annex 2 to the Regulation,
2. b) EU type examination (design type) – module B (design type) in combination with module F (conformity to type based on pressure equipment verification), referred to respectively in Parts III and IX of Annex 2 to the Regulation,
3. c) EU type examination (production type) – module B (production type) in combination with module E (conformity to type based on pressure equipment quality assurance), referred to respectively in Parts III and VII of Annex 2 to the Regulation,
4. d) EU type examination (production type) – module B (production type) in combination with module C2 (conformity to type based on internal production control plus supervised pressure equipment checks at random intervals), referred to respectively in Parts III and IV of Annex 2 to the Regulation,
5. e) conformity based on full quality assurance – module H, referred to in Part XI of Annex 2 to the Regulation;

4) for category IV:

1. a) EU type examination (production type) – module B (production type) in combination with module D (conformity to type based on quality assurance of the production process), referred to respectively in Parts III and V of Annex 2 to the Regulation,
2. b) EU type examination (production type) – module B (production type) in combination with module F (conformity to type based on pressure equipment verification), referred to respectively in Parts III and IX of Annex 2 to the Regulation,
3. c) conformity based on unit verification – module G, referred to in Part X of Annex 2 to the Regulation,
4. d) conformity based on full quality assurance plus design examination – module H1, referred to in Part XII of Annex 2 to the Regulation.

The conformity assessment process carried out by a notified body comprises: – submission and review of the application – conclusion of a contract – assessment – review and decision – issue of a document confirming conformity – surveillance

Personnel assigned to perform conformity assessment tasks are appointed according to their competencies and the requirements of PED 2014/68/EU for the tasks entrusted to them in the conformity assessment process. The purpose of the application review is to ensure that information about the client and the product is sufficient to conduct the certification process and that all known differences of understanding between the certification body and the client, including agreement on standards or other normative documents, have been resolved. As part of the application review, the notified body should define the scope of the requested assessment, ensure the availability of resources to carry out all assessment-related activities, and confirm competence and capability to perform those activities. Where products are identified with which the body has no prior experience, products may be treated as being of the same type if knowledge of the requirements, characteristics and technology relating to one product is sufficient to understand the requirements, characteristics and technology of another product. In such cases the body ensures that it has the competence and capability to undertake all required conformity assessment activities and maintains a record of the justification for the decision to undertake conformity assessment, or refuses to undertake a particular conformity assessment if it lacks any of the competencies or capabilities required for that activity. The notified body may also rely on conformity assessments previously carried out for that client or other clients; it then refers to the existing conformity assessment and, at the client’s request, provides justification for omitting certain activities. Signature of the contract by the supplier is a condition for continuing the procedure. The contract contains conformity assessment requirements relating only to matters within the scope of the requested assessment. A positive assessment and fulfilment of the contract conditions form the basis for issuing the certificate. If the notified body finds that the manufacturer has not met the requirements laid down in the relevant harmonisation legislation or in the relevant harmonised standards or technical specifications, it requires the manufacturer to take appropriate corrective measures, which must be completed before a certificate of conformity is issued. The assessment is carried out by designated competent personnel (in accordance with the adopted plan) who are given access to the information and documents necessary to perform the assessment tasks, and the client is informed of the adopted assessment plan. A review of all information and assessment results is carried out, in accordance with the adopted review plan, by a person who was not involved in the assessment processes. The review covers analysis of documentation and assessment results as well as records relating to the body’s use of previously conducted conformity assessments for other clients. The scope of the review includes in particular assessment of:

• the application, with particular regard to identification of the product enabling its identification,
• the design and technical documentation,
• the standards or other normative documents adopted in the conformity assessment process,
• sampling for testing,
• conformity of the adopted test method with the standard or other normative documents, and assessment of the tests performed and the results obtained,
• the course and results of inspections carried out,
• the inspection, measuring and test equipment used by the supplier and the competence of its personnel,
• conformity of the product marking with the requirements.

The result of the review enables a decision to be taken on granting or refusing a certificate of conformity. The manufacturer affixes the CE marking to each item of pressure equipment that meets the requirements set out in the regulation and draws up an EU declaration of conformity in writing. The procedure described above for the conformity assessment process is also applied by the notified body COCH Kraków (notified body No. 1462 EU), which operates in the assessment of conformity of refrigeration, air-conditioning and heat-pump products with the PED. The body holds accreditation from the Polish Centre for Accreditation (accreditation certificate AC036 – Photo 1), including as a conformity assessment body for notification purposes, and is authorised to conduct conformity assessments under the following assessment modules: