pedcertification rules issue2 2013-07-25

7/27/2019 PEDcertification Rules Issue2 2013-07-25

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PED certification rules, issue 2: 2013-07-25

P r o d u c t c e r t i f i c a t i o n b a s e d o n PED

Contents

1 Service description...................................................................................................... 2 2 Legal framework .......................................................................................................... 2 3 General conditions ...................................................................................................... 2 4 DNV certification procedures ................................................................................. 3

4.1 Application .................................................................................................................. 3 4.2 Activities .................................................................................................................... 3 4.3 Issuing of certificate .................................................................................................... 3

5 Refusal of certification ............................................................................................... 3 6 Maintaining the certificate ....................................................................................... 3 7 Changes in standards ................................................................................................ 4 8 Changes by the manufacturer ................................................................................ 4 9 Suspension or withdrawal of the Certificate ..................................................... 4 10 Cancelling of the Certificate from the manufacturer .................................. 4 11 Complaints and appeals ......................................................................................... 5

12 Publishing of certificates ........................................................................................ 5

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1 Service descriptionThis document describes the DNV conditions and certification processes for certification ofpressure equipment.

The document define Customer and DNV obligations additional to the ones fixed in the Product

Certification Agreement between the parties.The Customer is also called manufacturer in this document and is the person who is responsible

for designing and manufacturing a product with a view to placing it on the European Communitymarket on his own behalf.

2 Legal frameworkDNV will perform this service as a Notified Body in conjunction with the European productdirective 97/23/EC - PED.

Det Norske Veritas Italia S.r.l. is appointed by the Italian “Ministero dello Sviluppo Economico” as

Notified Body (0496) for the following PED activities:

Module A1

Module B Module B1

Module C1

Module D1

Module D

Module E1

Module E

Module F

Module G

Module H1

Module H

Annex I, 3.1.2

The appointment is based on an accreditation by Accredia.

Where DNV is mentioned in the following text, all DNV units providing the service is understood.The final certification is however done at the Notified Body uniquely.

3 General conditionsIn addition to the Section II – General terms and conditions - of the standard DNV Product

Certification Agreement (PCA), the following applies:

The certification will state compliance of the product to the relevant parts of the PED Annex IEssential Safety Requirements (ESR). The standards used by the manufacturer in order to achieve

this will be listed on the certificate.The legislation relevant to the product(s) is the PED, which is transferred to national legislation inall European Economic Area (EEA) member states.

DNV will not provide any consultancy services aiming to facilitate the certification.

All product information needed for the DNV evaluation of the product is treated as confidential.

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4 DNV certification procedures

ApplicationUpon a Request For Quotation sent by a manufacturer, DNV will draw up a Product Certification

Agreement (PCA) describing all activities involved in the certification process priced according to

valid price list. The formal application for certification is annexed to the PCA. An authorized

representative of the manufacturer shall sign and return both of the documents. The application

shall contain information about the applicant as well as information about the product and the

system subject for certification.

By completing and signing the “EC PRESSURE EQUIPMENT APPLICATION FORM” the manufacturer

and the Notified Body 0496 (Det Norske Veritas Italia S.r.l.) have signed a formal agreement with

each other where the manufacturer also declares that the same application has not been lodged

with any other Notified Body.

The application form covers the special conditions of certification for CE-marking of pressure

equipment. A signed application form is not a financial contract. This document shall be handled

by the concerned DNV Local Unit.

Activities

DNV has the overall responsibility to carry out the Notified Body services in accordance with the

regulation given by the legal Italian authorities and by Accredia. This also includes the work carried

out by the Local DNV Units.

Personnel engaged as auditors or technical experts shall fulfil the requirements as defined by DNV.

The manufacturer agrees to promptly supply to DNV, where duly justified, any relevant information

data, which is necessary for establishing and maintaining the attestation of conformity in view of the

chosen procedure.

The manufacturer will further ensure that DNV and its employees and other acting on behalf of DNVwill get all necessary work and access permits.

Issuing of certificate

DNV will issue all formal documents and certificates according DNV’s notification (see point 2 of this

document).

5 Refusal of certificationCertification shall be refused if the product or the quality system is found not to comply with PED.

DNV shall communicate refusal of certification to the applicant in writing. Information regardingthe appeal procedures shall be given.

DNV shall, with exception for modules A1, C1, F and G, make relevant information regarding the

certification it has refused available to other PED Notified bodies and the appropriate nationalauthorities.

6 Maintaining the certificate

The manufacturer must at all times ensure that the requirements of the standards under thecertification scope are complied with and undergo all DNV scheduled assessment activities and

visits. Corrective actions to identified findings must be implemented within the set time limit.

DNV is authorised by the manufacturer to pay unannounced visits to manufacturer’s premises

when foreseen by the directive or due to reasonably substantiated doubts regarding the

compliance of the product or the appropriate function of the approved quality system.

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The fees as stipulated in the PCA must be paid following the conditions for payment stated

therein.

The manufacturer is also obliged to keep a record of all complaints concerning the products underthe certification scope with regard to the standard requirements. DNV will verify that the

manufacturer has taken relevant corrective actions for these complaints in conjunction with thesurveillance visits.

7 Changes in standards

DNV will assess the products subject to certification to the valid versions of the standards underthe certification scope. The manufacturer is therefore obliged to keep the standards updated.

8 Changes by the manufacturer

Customer must report all changes in the product design and/or production (hereunder changes in

the organisation, ownership, new products, modifications to the factory and services, location

etc.), which may reasonably be considered to have an effect of the Certificate(s), to DNV within areasonable time and preferably before execution of such change.

The manufacturer is required to have informed DNV of any changes to the products and/or

modifications to the quality system under which the products are fabricated if relevant. Failure todo so may result in a non-compliance being raised by DNV.

It will be the decision of DNV whether or not a further inspection visit is necessary at the time ofthe announcement of any such changes.

9 Suspension or withdrawal of the Certificate

DNV reserves the right to withdraw or suspend the certificate if at the time when the certificatewas issued:

a) The requirements as set out in the Directive on which the conformity assessment procedure

has been based and which form the basis for issuing the certificate or the appendix were notfulfilled, or

b) The product was incorrectly defined as pressure equipment according to the Directive.

c) The product which has been subject to the conformity assessment procedure has been modified

without prior notification to DNV, or

d) The requirements for the quality system or the pressure equipment are no longer fulfilled, or

e) The product is no longer covered by the Directive, or

f) The pressure equipment is no longer in compliance with the Directive, and the shortcomings

observed are not corrected by the manufacturer within an appropriate time period as defined byDNV under consideration of the severeness and potential impacts of these shortcomings.

DNV shall communicate withdrawal of certification to the applicant in writing. Information

regarding the appeal procedures shall be given.

DNV shall, with exception for modules A1, C1, F and G make relevant information regarding thecertification it has withdrawn available to the other NB’s and the appropriate national authorities

10 Cancelling of the Certificate from the manufacturer The manufacturer may cancel the certificate at any time provided that DNV receives a written

communication at least 30 days before the wished cancellation date authorizing DNV to invoice allactivities up to that date.

11 Complaints and appeals

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All complaints from the manufacturer with regard to the DNV certification activities shall be

handled according to DNV internal routines. An acknowledgement of received complaint will besent without delay.

12 Publishing of certificatesDNV will publish DNV certificates listing product scope and relevant manufacturers on the external

website www.dnvba.com.

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pedcertification rules issue2 2013-07-25

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