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NB-CPD/11/476br2 Issued by GNB-CPD: 12 December 2011 TF ……… 21 September 2011 CONSTRUCTION STANDARDIZATION GUIDANCE DOCUMENT Implementation of the Construction Product Regulation (CPR) in harmonized standards Content Part 1 – Drafting the Annex ZA Part 2 – Drafting the Assessment and Verification of Constancy of Performance (AVCP) Incorporating detailed comments from the GNB-CPD In this revised version (revision 2) of the document, comments that were broadly met in CEN’s subsequent PDF document TF N 530, 2011-11-22, have been deleted, so that this document can serve as a source of comments on TF N 530. Proposed additions are indicated by green text Proposed deletions are indicated by struck through red text 1

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Page 1: NB-CPD/11/476br2 11... · Web viewIssued by GNB-CPD: 12 December 2011 TF ……… 21 September 2011 CONSTRUCTION STANDARDIZATION GUIDANCE DOCUMENT Implementation of the Construction

NB-CPD/11/476br2Issued by GNB-CPD: 12 December 2011

TF ………21 September 2011

CONSTRUCTION STANDARDIZATION

GUIDANCE DOCUMENT

Implementation of the Construction Product Regulation (CPR) in harmonized standards

ContentPart 1 – Drafting the Annex ZA

Part 2 – Drafting the Assessment and Verification of Constancy of Performance (AVCP)

Incorporating detailed comments from the GNB-CPDIn this revised version (revision 2) of the document, comments that were broadly met in CEN’s subsequent PDF document TF N 530, 2011-11-22, have been deleted, so that this document can serve as a source of comments on TF N 530.

Proposed additions are indicated by green text

Proposed deletions are indicated by struck through red text(Struck through text can be deleted in Microsoft Word 2007 by using [Replace] in the Editing tab of the ribbon. In Word 2003 use ‘Edit’ ‘Replace…’.With the cursor in the “Find what:” box <Click> [More] [Format] ‘Font…’ and under “Effects” check StrikethroughLeave the “Replace with:” box untouched<Click> [Replace All])

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PART 1

Drafting the Annex ZA

ForewordThe Annex ZA is the part of the standard which is mandatory for the CE marking of construction products* and transforms all or part of a European product standard into a harmonised European product standard for construction products.

Only product standards include Annex ZAs; supporting standards do not.

The Annex ZA identifies those clauses of the a standard (or refers to clauses in another standard) which cover are relevant for the essential characteristics of a construction product in respect of the CE marking, included in the mandate to which it responds, considered in the answer to the mandates prepared by the TC and accepted by the Commission.

Moreover, it reproduces the Assessment and Verification of Constancy of Performance (AVCP) system(s) of product(s) established by Commission acts, to which the concerned relevant construction product(s) need(s) to be submitted before the manufacturer is entitled to draw up the a Declaration of Performance (DOP) and to affix the CE marking.

* The use of harmonized standards is only mandatory for construction products according to the CPD and the CPR, as the requirements of both are not related to the construction products themselves but to the works, as controlled the building regulations of the Member States. For some directives or regulations the use of harmonized standards is voluntary.

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IntroductionThis document has been prepared taking into account the experience gained in the drafting of Annex ZA under Council Directive 89/106/EEC and the adoption of the Regulation (EU) No. 305/20111

Clause 1 of this document provides the general guidance including explanations regarding the meaning of the different parts of clause 2.

Clause 2 of this document provides the template that new, revised or amended harmonized standards shall contain when made available (DOA) from the 1st July 2013 onwards.

In the template given in clause 2 of this document:

- the text in [blue characters] represents items to be filled in;

- the text in [black italics] represents notes or other comments not to be included in the standard.

1 General guidance1.1Meaning of the Annex ZA1.1.1 GeneralThe Annex ZA is the part of the standard which, without prejudice to the simplified measures envisaged by the CPR, needs to be applied for CE marking purposes and transforms all or part of a European product standard into a harmonised European product standard.

Only product standards include Annex ZA; supporting standards do not.

It identifies those clauses of the standard (or refers to clauses in another standard) which cover are relevant for the essential characteristics of a construction product in respect of the CE marking, included in the mandate to which it responds and considered in the answer to it, as prepared by the TC and accepted by the Commission.

Moreover, it reproduces the AVCP system(s) of product(s) established by EC Decisions, to which the concerned relevant construction product(s) need(s) to be submitted before the manufacturer is entitled to draw up the a DOP and to affix the CE marking.

Although informative from CEN/CENELEC’s point of view, Annex ZA has a regulatory mandatory effects for CE marking.

1.1.2 Clause ZA.1 - Scope and relevant characteristicsThis clause of Annex ZA indicates, in its Tables ZA.1.1 to ZA.1.n, its scope, and shall refer to the Scope (Clause 1) of the standard. Usually the coverage of Annex ZA will be the same as the scope of the standard itself, although in some cases it may be more limited.

It is not possible, however, for Annex ZA to have a wider coverage than the scope of the standard itself.

1 Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC. (OJEU L88 of 4.4.2011)

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Tables ZA.1.1 to ZA.1.n have to list all essential characteristics (including their durability) identified in the mandate, considered as relevant in the TC’s answer to the mandate and accepted by the Commission as being appropriate, and the clause(s) of this (or another) standard which cover each of them.

Requirement clauses in the body of the standard shall be sufficiently well differentiated so that reference to a clause does not bring other requirements, not covered by the mandate, into the harmonised part of the EN.

In general, one clause should refer to one characteristic only. The table(s) need only refer to requirement clauses, not to test methods (although these may be given in the column “Notes” in Tables ZA.1.1 to ZA.1.n), because the test/assessment/calculation method to be used should be uniquely identifiable from the requirement clauses.

Where the requirement clause includes the test/assessment/calculation method, reference to the former will also be a reference to the latter, and this is permitted. Where the requirement clause does not include or refer to the test/assessment method, this should be referred to in the Notes of Table(s) ZA.1.1 to ZA.1.n.

The third column in Tables ZA.1.1 to ZA.1.n, entitled "Levels and/or classes of performance", is limited to levels and classes of performance defined by CPR article 27 and included by the Commission in an entirely new mandate or in amendments/revisions of those existing.

The last column in Tables Z.1.1 to ZA.1.n entitled "Notes", should be used to indicate how results are to be expressed (e.g. the units, values, etc.) and may also be used to indicate where the standard establishes a threshold value (which was requested in the original/revised answer to the mandate as accepted by the Commission), or classes of performance established as indicated in the paragraph above.

The clauses to which Tables ZA.1.1 to ZA.1.n refers should allow the test/assessment/calculation method used to be unambiguously identified. This will usually be done by the requirement text in Clause 4 “Requirements” of the standard referring to test/assessment/calculation method in Clause 5 “Testing, assessment and sampling methods” or to another standard (see the model standard).

Tables ZA.1.1 to ZA.1.n may, however, refer to clauses in another standard, if necessary.

If an EN covers only harmonised essential characteristics, Tables ZA.1.1 to ZA.1.n will then refer to all of the requirement clauses in the standard (but has nevertheless to identify them against essential characteristics).

More often, however, it will refer to only some of the clauses, where the standard includes other non-harmonised requirements.

Where a product covered by the standard has distinctly different end uses (i.e. having different characteristics), or where it covers products subject to more than one mandate, Tables ZA.1.1 to ZA.1.n shall be subdivided accordingly.

1.1.2.1 Clause ZA.2 - Procedure(s) for the AVCP

1.1.2.1.1 ZA.2.1 AVCP system(s)Annex ZA shall contain a sub-clause, ZA.2.1, which identifies the relevant AVCP system(s) and the tasks of the different parties, i.e. who will do is obliged to perform the assessment and the verification.

4

Autor, 03/01/-1,
Earlier the document states “It is not possible, however, for Annex ZA to have a wider coverage than the scope of the standard itself.” WARNING! If Annex ZA refers to another standard that is not harmonised, no control is exercised over its contents and updates. This may produce disruption in the use of Annex ZA of the harmonised standard, unless the CEN instructions specify that reference to another standard shall be made only by dated reference.
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Only Annex ZA can contain details about third party tasks, the main body of the standard has to be written in a way that is neutral.

ZA.2.1 shall reproduce the relevant AVCP system(s) as any other prescriptions established by the Commission given in the text of the EC Decision and in the mandate, such as “Regarding products under systems 1 and 3, for the determination of the product-type the tasks for the notified body shall be limited to the following characteristics:…”.

When the AVCP system established by the Commission by means of Decisions or delegated acts covers several products and/or several intended uses, those covered by the standard can be extracted together with the relevant text or footnotes, but without changing the wording used. This must be done carefully to ensure that the standard does not inadvertently change the AVCP system or its details. However, where the reference to products included in the above-mentioned acts is too generic, TCs may complement the wording used for making specific reference to product(s). If this is the case, it shall be done outside the Table extracted from the Commission acts.

The responsibility for different tasks related to the AVCP shall be presented as in Tables ZA.3.1 to ZA.3.5 in clause 2 of this document. This presentation has been agreed by the European Commission because it represents the roles for different parties given in Annex V of the CPR.

The CPR requires “Testing/Further testing of samples taken at the factory in accordance with a prescribed test plan” for AVCP systems 1+, 1, 2+. This is generally assumed to cover FPC testing of finished products.

The TC should liaise with the group of notified bodies body coordination group to establish what is necessary to satisfy this requirement on the basis of the provisions included in the AVCP clause of the standard.

Clause ZA.2.1 shall also require that the product be subject to the determination of the product-type against the essential characteristics listed in Table ZA.1 for which the manufacturer intends to declare the performance.

Annex ZA shall not give requirements on the qualifications or accreditation of notified bodies. This is a legal matter which remains the responsibility of Member States.

1.1.2.1.2 Clause ZA.2.2 - Certificate of constancy of performance and Declaration of performance (DOP)

To ensure a level playing field for manufacturers, Annex ZA has to contain a clause detailing the specific content of the DOP (see clause ZA.2.3 “Model of the Declaration of performance”) and Part 3 of this document.

If relevant, it shall also detail the specific content that will have to be included in the certificate of constancy of performance.

1.1.2.1.3 Clause ZA.3 - CE marking and labellingThis clause shall provide details regarding the information associated with the CE marking on the basis of the provisions of Article 8 and 9 of the CPR.

TCs should be aware of the need to permit the use of the “No performance determined” (NPD) option when a characteristic is not regulated for a given end use required by the Member State where the product will be made available.

5

Autor, 03/01/-1,
The GNB-CPD welcomes this statement in principle. However, we consider it would be better to use the formal name of the coordination group as stated in Article 55 of the CPR.
Autor, 03/01/-1,
In this paragraph, the expression « EC Decision » is used in the singular. But for some products several decisions are applicable including a few horizontal decisions related to particular intended use and then applicable only to selected essential characteristic(s). A note should specify how this table shall be prepared with as much clarity/precision in this respect as is possible.
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In order to ensure that all manufacturers of similar products apply the CE marking in the same way, clause ZA.3 needs to be specific about where the CE marking symbol and the information associated with it is to be placed.

According to articles 9.1 and 9.2 of the CPR, the CE marking shall be affixed visibly, legibly and indelibly:

- to the construction product or

- to a label attached to it.

Where this is not possible or not warranted on account of the nature of the product:

- it shall be affixed to the packaging or

- to the accompanying documents.

The CE marking shall be followed by:

- the two last digits of the year in which it was first affixed (this refers to marking the individual product; normally a product will be marked during or immediately after its manufacture),

- the name and the registered address of the manufacturer, or the identifying mark allowing identification of the name and address of the manufacturer easily and without any ambiguity,

- the unique identification code of the product-type,

- the reference number of the declaration of performance,

- the level or class of the performance declared,

- the reference to the harmonised standard applied,

- the identification number of the notified body, if applicable, and

- the intended use as laid down in the harmonised standard applied.

All ZA.3 clauses shall give example(s) of CE marking. If the TC intends to have more than one location (e.g. the CE marking symbol followed by the identification number of the body involved, on the product, with all other information (including the CE marking symbol again) on the accompanying commercial documentation), this shall be explicitly stated.

Where a standard covers more than one type of product and the test/assessment/calculation method depend on the type, the type of product must be indicated.

Where the standard provides for more than one method of test/assessment/calculation or of test conditions, and the method or conditions affect the result, the test/assessment/calculation/calculation method and conditions used need to be identified together with the stated result. ZA.3 may refer to the "Marking and labelling" clause in the body of the standard, as long as this does not bring into the CE marking any non-harmonised aspects.

In some cases, the "Product description" may include some factual information (e.g. dimensions) where a TC wishes, but it cannot contain non-harmonised product performance information.

Information regarding the essential characteristics may not be given without this being accompanied by the CE marking symbol. This means, for example, that if such information is given on the product, the CE marking symbol is also required to appear near to it on the product.

6

Autor, 03/01/-1,
Remember that dimensions and other essential characteristics can be relevant for fulfilling the enlarged basic requirement No. 4 "Safety and accessibility in use" concerning accessibility and use for disabled persons.
Autor, 03/01/-1,
Under the CPD there was confusion over the meaning of ‘the year when CE marking was affixed’ . Eventually the Commission clarified that the date relates to the physical activity of putting the CE marking on a particular product. It would be helpful to prevent the same confusion arising under the CPR.
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Part or all of the CE marking information may be given in the form of a designation or symbols, but only if such a designation system or symbols are defined in the standard. When using a designation, care has to be taken to ensure that only information concerning essential characteristics is included in it.

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2 Template for Annex ZA

Annex ZA(informative)

Clauses of this European Standard addressing the provisions of the EU Construction Products Regulation

ZA.1 Scope and relevant characteristics

This European Standard has been prepared under Mandate M [insert here the number and the title of the mandate] given to CEN by the European Commission and the European Free Trade Association.

The clauses of this European Standard shown in this annex meet the requirements of the mandate to be considered as being given under the Regulation (EU) No. 305/2011.

Compliance with these clauses, drawing up the declaration of performance and affixing the CE marking, indicate that the manufacturer of the [insert here the name of product A as given in the title of the standard] takes the responsibility for the conformity of the construction product with the declared performance as well as the compliance with all applicable requirements laid down in the Regulation (EU) No. 305/2011 and in other relevant European Union harmonisation legislation providing for its affixing.

WARNING: Other requirements and other EU Directives can be applicable to the [insert here the name of the construction product as given in the title of the standard] falling within the scope of this European Standard.

NOTE 1 [1] In addition to any specific clauses relating to dangerous substances contained in this standard, there may be other requirements applicable to the products falling within its scope (e.g. transposed European legislation and national laws, regulations and administrative provisions). In order to meet the provisions of the Regulation (EU) No. 305/2011, these requirements need also to be complied with, when and where they apply.

NOTE 2 An informative database of European and national provisions on dangerous substances is available at the Construction web site on EUROPA (accessed through:

http://ec.europa.eu/enterprise/construction/cpd-ds/.

[NOTE 1: These notes are the subject of a BT Resolution and have to be incorporated in every hEN.]

This annex establishes the conditions for the CE marking of the [insert here the name of the construction products as given in the title of the standard] intended for the uses indicated in Table(s) ZA.1.1 to ZA.1.n and shows the relevant clauses applicable.

This annex has the same scope as in Clause 1 of this standard related to the aspects covered by the mandate and is defined by Table(s) ZA.1.1 to ZA.1.n.

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Table ZA.1.1 — Relevant clauses for product [A] and intended use [1]

Product: [insert here the name of product A as given in the scope of the standard]Intended use: [insert here the intended use 1]

Essential Characteristics [2]Requirement clauses in this and other European

Standard(s) [3]

Levels and/or classes of

performance [4]Notes [5]

[name of essential characteristic 1 as given in the accepted answer to the mandate]

[name of essential characteristic 2 as given in the accepted answer to the mandate]

[name of essential characteristic n as given in the accepted answer to the mandate]

[durability of essential characteristic 1]

[durability of essential characteristic 2]

[durability of essential characteristic n]

Table ZA.1.2 — Relevant clauses for product [A] and intended use [2]

Product: [insert here the name of product A as given in the scope of the standard]Intended use: [insert here the intended use 2]

Essential Characteristics [2]Requirement clauses in this and other European

Standard(s) [3]

Levels and/or classes of

performance [4]Notes [5]

Name of essential characteristic 1 as given in the accepted answer to the mandate

Name of essential characteristic 2 as given in the accepted answer to the mandate

Name of essential characteristic n as given in the accepted answer to the mandate

durability of essential characteristic 1

durability of essential characteristic 2

durability of essential characteristic n

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Table ZA.1.3 — Relevant clauses for Product [B] and intended use [1]

Product: [insert here the name of product A as given in the scope of the standard]Intended use: [insert here the intended use 1]

Essential Characteristics [2]Requirement clauses in this and other European

Standard(s) [3]

Levels and/or classes of

performance [4]Notes [5]

Name of essential characteristic 1 as given in the accepted answer to the mandate

Name of essential characteristic 2 as given in the accepted answer to the mandate

Name of essential characteristic n as given in the accepted answer to the mandate

durability of essential characteristic 1

durability of essential characteristic 2

durability of essential characteristic n

Table ZA.1.n — Relevant clauses for Product [n] and intended use [n]

Product: [insert here the name of product n as given in the scope of the standard]Intended use: [insert here the intended use n]

Essential Characteristics [2] Requirement clauses in this and other European

Standard(s) [3]

Levels and/or classes of

performance [4]Notes [5]

Name of essential characteristic 1 as given in the accepted answer to the mandate

Name of essential characteristic 2 as given in the accepted answer to the mandate

Name of essential characteristic n as given in the accepted answer to the mandate

durability of essential characteristic 1

durability of essential characteristic 2

durability of essential characteristic n

The requirement on a certain essential characteristic is not applicable in those Member States (MSs) where there are no regulatory requirements on that essential characteristic for the intended use of the product. In this case, manufacturers placing their products on the market of these MSs are not obliged to determine nor declare the performance of their products with regard to this essential characteristic and the option “No performance determined” (NPD) in the information accompanying the CE marking and in the declaration of performance (see ZA.3) may be used. However, the NPD option may not be used for durability of essential characteristics that have been declared, and where essential characteristics are subject to a threshold level.

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[NOTE 2: Each of the essential characteristics for the product and the intended use should be listed here, including their durability.NOTE 3: Requirement clauses (normally under Clause 4) should be referred to here. Requirement clauses in which reference to the determination method is given are recommended, although where these methods are not included in the clause, they can be referred to under "Notes" in the table. See NOTE 5.NOTE 4: Threshold levels and classes of performance, if any, referred to under these requirement clauses in the standard, if any, are not to be listed here except if they are recognized as classes and levels of performance according to Article 27 of the CPR, as specified in the revised mandate, following a CEN proposal or determined by the Commission. NOTE 5: In the column "Notes", the method of expressing the characteristic should be mentioned i.e. units, accuracy, steps. If an essential characteristic is subject to a threshold value or class of performance, this must be clearly indentified in the "Notes" column of each table ZA.1. This column may also indicate the test/assessment/calculation method and refer to threshold levels or classes of performance , where these have been defined in the standard.]

ZA.2 Procedure for AVCP of [insert here the name of product A as given in the scope of the standard]

ZA.2.1 System(s) of AVCP

The AVCP system(s) of [insert here the name of the construction products as given in the scope of the standard] indicated in Table(s) ZA.1.1 to ZA.1.n, established by EC Decision [insert here the number of the EC Decision] [(insert here the No. of OJEU)] is shown in Table ZA.2 for the indicated intended use(s) and relevant level(s) or class(es) of performance.

Table ZA.2 — System(s) of AVCP

Product(s) [6] Intended use(s) [7] Level(s) or class(es) of performance [8] AVCP system(s) [9]

[insert here the name of the construction

products as given in the EC Decision or delegated acts]

[insert here the intended use of the construction products as given in the

EC Decision or delegated acts]

[insert here the level(s) or class(es) of

performance as given in the EC Decision or

delegated acts]

[insert here the AVCP system as given in the

title of the EC Decision or delegated

acts]

System 1+: See Regulation (EU) No. 305/2011 (CPR) Annex V, 1.1 with audit testing of samples taken before placing the product on the market.System 1: See Regulation (EU) No. 305/2011 (CPR) Annex V, 1.2 System 2+: See Regulation (EU) No. 305/2011 (CPR) Annex V, 1.3 including certification of the factory production control by a notified production control certification body on the basis of initial inspection of the manufacturing plant and of factory production control as well as of continuous surveillance, assessment and evaluation of factory production control.System 3: See Regulation (EU) No. 305/2011 (CPR) Annex V, 1.3System 4: See Regulation (EU) No. 305/2011 (CPR) Annex V, 1.4 [10]

[NOTE 6: The products shall appear as in EC Decision or delegated act. All products not covered by the scope of Annex ZA can be omitted. However, where the reference to products included in the above-mentioned acts is too generic, TCs may complement the wording used for making specific reference to product(s). If this is the case, it shall be done outside the Table extracted from the Commission acts.NOTE 7: The intended use shall appear as in EC Decision or delegated act. All intended uses not covered by the scope of Annex ZA may be omitted.NOTE 8: The level(s) or class(es) of performance shall appear as in EC Decision or delegated act. All level(s) or class(es) of performance not covered by the scope of Annex ZA may be omitted.NOTE 9: The AVCP systems for the products covered shall appear as in EC Decision or delegated act.NOTE 10: Any reference to non-relevant AVCP system(s) shall be removed.]

11

Autor, 03/01/-1,
A note should specify how this table shall be prepared with as much clarity/precision in this respect as is possible.
Autor, 03/01/-1,
This note is difficult to interpret. Does it mean ‘For an essential characteristic with a threshold level or class of performance, the entry in the column “Levels and/or classes” shall be “None” unless the threshold level or class is recognized according to Article 27 of the CPR, as specified in the revised mandate.’?
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The AVCP of the [insert here the name of the construction products as given in the scope of the standard] in Table(s) ZA.1.1 to ZA.1.n shall be according to the AVCP procedures indicated in Table(s) ZA.3.1 to ZA.3.n resulting from application of the clauses of this or other European Standard indicated therein. The content of tasks of the notified body shall be limited to those essential characteristics as provided for, if any, in Annex III of the relevant mandate.

Table ZA.3.1 — Assignment of AVCP tasks for [insert here the name of the construction products as given in the scope of the standard] under system 1+ [11]

Tasks Content of the task [12*] AVCP clauses to apply [13]

Tasks for the manufacturer

Factory production control (FPC)

Parameters related to essential characteristic of Table ZA.1 relevant for the intended use which are declared

Further testing of samples taken at factory according to the prescribed test plan

essential characteristic of Table ZA.1 relevant for the intended use which are declared

Tasks for the notified product certification body

determination of the product-type on the basis of type testing (including sampling), type calculation, tabulated values or descriptive documentation of the product

[essential characteristic of Table ZA.1 relevant for the intended use indicated in Annex III of the mandate]

Initial inspection of the manufacturing plant- and of FPC

Parameters related to essential characteristic of Table ZA.1, relevant for the intended use which are declared, namely [those indicated in Annex III of the mandate]. Documentation of the FPC.

Continuous surveillance, assessment and evaluation of FPC

Parameters related to essential characteristic of Table ZA.1, relevant for the intended use which are declared, namely [those indicated in Annex III of the mandate]

Audit testing of samples taken before placing the product on the market

[essential characteristic of Table ZA.1 relevant for the intended use which are declared], namely [those indicated in Annex III of the mandate]

Table ZA.3.2 — Assignment of AVCP tasks for [insert here the name of the construction products as given in the scope of the standard] under system 1 [11]

Tasks Content of the task [12*] AVCP clauses to apply [13]

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Tasks for the manufacturer

Factory production control (FPC)

Parameters related to essential characteristics of Table ZA.1 relevant for the intended use which are declared

Further testing of samples taken at factory according to the prescribed test plan

Essential characteristics of Table ZA.1 relevant for the intended use which are declared

Tasks for the notified product certification body

determination of the product type on the basis of type testing (including sampling), type calculation, tabulated values or descriptive documentation of the product

[essential characteristics of Table ZA.1 relevant for the intended use indicated in Annex III of the mandate]

Initial inspection of manufacturing plant and of FPC

Parameters related to essential characteristics of Table ZA.1, relevant for the intended use which are declared, namely [those indicated in Annex III of the mandate]. Documentation of the FPC.

Continuous surveillance, assessment and evaluation of FPC

Parameters related to essential characteristics of Table ZA.1, relevant for the intended use which are declared, namely [those indicated in Annex III of the mandate] and documentation of FPC

Table ZA.3.3 — Assignment of AVCP tasks for [insert here the name of the construction products as given in the scope of the standard] under system 2+

Tasks Content of the task [12*] AVCP clauses to apply [13]

13

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Tasks for the manufacturer

Factory production control (FPC)

Parameters related to essential characteristics of Table ZA.1 relevant for the intended use which are declared

determination of the product-type on the basis of type testing (including sampling), type calculation, tabulated values or descriptive documentation of the product

Parameters related to essential characteristics of Table ZA.1 relevant for the intended use which are declared

Further testing of samples taken at factory according to the prescribed test plan

Essential characteristics of Table ZA.1 relevant for the intended use which are declared

Tasks for the notified factory production control certification body

Initial inspection of the manufacturing plant and of FPC

Parameters related to essential characteristics of Table ZA.1, relevant for the intended use which are declared, namely [those indicated in Annex III of the mandate]. Documentation of the FPC.

Continuous surveillance, assessment and evaluation of FPC

Parameters related to essential characteristics of Table ZA.1, relevant for the intended use which are declared, namely [those indicated in Annex III of the mandate]. Documentation of the FPC.

Table ZA.3.4 — Assignment of AVCP tasks for [insert here the name of the construction products as given in the scope of the standard] under system 3

Tasks Content of the task [12*] AVCP clauses to apply [13]

Tasks for the manufacturer

Factory production control (FPC)

Parameters related to essential characteristics of Table ZA.1 relevant for the intended use which are declared

Tasks for a notified testing laboratory

Determination of the product-type on the basis of type testing (based on sampling carried out by the manufacturer), type calculation, tabulated values or descriptive documentation of the product

[essential characteristics of Table ZA.1 relevant for the intended use indicated in Annex III of the mandate]

Table ZA.3.5 — Assignment of AVCP tasks for [insert here the name of the construction products as given in the scope of the standard] under system 4

Tasks Content of the task [12] AVCP clauses to apply [13]

14

Autor, 03/01/-1,
The CPR Annex V (2) defines bodies involved in the assessment and verification of constancy of performance, including “(2) factory production control certification body”.
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Tasks for the manufacturer

Factory production control (FPC)

Parameters related to essential characteristics of Table ZA.1 relevant for the intended use

Determination of the product-type on the basis of type testing, type calculation, tabulated values or descriptive documentation of the product

Essential characteristics of Table ZA.1 relevant for the intended use which are declared

[NOTE 11: for products having more than one intended uses specified in the following families, the tasks for the notified body, related to the applicable systems of AVCP, are cumulative.NOTE 12: The text within inverted commas and in italics shall be replaced by the actual list of relevant characteristics or parameters established for the relevant limited task in 3.1, 3.2, 3.3 or 3.4 of Annex III of the mandate. When the product has more than one intended use it is recommended, where practicable, that the assignment of tasks is brought together in one or more of the tables above. “relevant” in this column relates to the fact that some characteristics of Table ZA.1 may not be assessed, depending on the intended use of the product.NOTE 13: The relevant sub-clauses of the clause on AVCP (Clause 6 of the standard) should be referred to herein. Reference to specific parts of the tables likely to be in these sub-clauses may be made if considered necessary for the correct application of the sub-clause.]

ZA.2.2 Declaration of performance (DOP)

ZA.2.2.1 General

When compliance with the conditions of this annex is achieved, manufacturer shall draw up the DOP and affix the CE marking on the basis of:

In case of products under system 1+

- the factory production control and the further testing of samples taken at the factory according to the prescribed test plan, carried out by the manufacturer; and

- the certificate of constancy of performance issued by the notified product certification body on the basis of determination of the product type on the basis of type testing (including sampling), type calculation, tabulated values or descriptive documentation of the product; initial inspection of the manufacturing plant and of factory production control; continuous surveillance, assessment and evaluation of factory production control and audit-testing of samples taken before placing the product on the market.

In case of products under system 1

- the factory production control and further testing of samples taken at the factory according to the prescribed test plan, carried out by the manufacturer; and

- the certificate of constancy of performance issued by the notified product certification body on the basis of determination of the product type on the basis of type testing (including sampling), type calculation, tabulated values or descriptive documentation of the product; initial inspection of the manufacturing plant and of factory production control and continuous surveillance, assessment and evaluation of factory production control.

In case of products under system 2+

15

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- the determination of the product-type on the basis of type testing (including sampling), type calculation, tabulated values or descriptive documentation of the product; the factory production control and the testing of samples taken at the factory according to the prescribed test plan, carried out by the manufacturer; and

- the certificate of conformity of the factory production control, issued by the notified factory production control certification body on the basis of initial inspection of the manufacturing plant and of factory production control and continuous surveillance, assessment and evaluation of factory production control.

In case of products under system 3

- :the factory production control carried out by the manufacturer; and

- The determination of the product-type on the basis of type testing (based on sampling carried out by the manufacturer), type calculation, tabulated values or descriptive documentation of the product, carried out by the notified testing laboratory:.

In case of products under system 4

- The determination of the product-type on the basis of type testing, type calculation, tabulated values or descriptive documentation of the product and the factory production control, carried out by the manufacturer.

ZA.2.2.2 Content

The DOP shall contain, in particular the following information:

- the reference of the product-type for which the declaration of performance has been drawn up;

- the AVCP system or systems of the construction product, as set out in Annex V of the CPR;

- the reference number and date of issue of the harmonised standard (not the date of the national version of the EN) which has been used for the assessment of each essential characteristic;

- where applicable, the reference number of the Specific Technical Documentation used and the requirements with which the manufacturer claims the product complies.

The DOP shall in addition contain:

(a) the intended use or uses for the construction product, in accordance with the applicable harmonised technical specification;

(b) the list of essential characteristics, as determined in the harmonised technical specification for the declared intended use or uses;

(c) the performance of at least one of the essential characteristics of the construction product, relevant for the declared intended use or uses;

(d) where applicable, the performance of the construction product, by levels or classes, or in a description, if necessary based on a calculation in relation to its essential characteristics determined in accordance with the Commission determination

16

Autor, 03/01/-1,
Under the CPD, for AoC System 3, GP ‘K’ acknowledges that different tests may be undertaken by different laboratories.
Autor, 03/01/-1,
The CPR Annex V (2) defines bodies involved in the assessment and verification of constancy of performance, including “(2) factory production control certification body”.
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regarding those essential characteristics for which the manufacturer shall declare the performance of the product when it is placed on the market or the Commission determination regarding threshold levels for the performance in relation to the essential characteristics to be declared.

(e) the performance of those essential characteristics of the construction product which are related to the intended use or uses, taking into consideration the provisions in relation to the intended use or uses where the manufacturer intends the product to be made available on the market;

(f) for the listed essential characteristics for which no performance is declared, the letters "NPD" (No Performance Determined);

The DOP shall be drawn up using the model shown in clause ZA.2.3.

A copy of the DOP of each product which is made available on the market shall be supplied either in paper form or by electronic means. [14]

However, where a batch of the same product is supplied to a single user, it may be accompanied by a single copy of the DOP either in paper form or by electronic means [14].

A paper copy of the DOP shall be supplied if the recipient requests it.

The DOP shall be supplied in the language or languages required by in the Member State in which the product is made available.

NOTE 14: the copy of the DOP may be made available on a web site in accordance with conditions to be established by the Commission by means of delegated acts in accordance with Article 60 of the CPR. Such conditions shall, inter alia, guarantee that the DOP remains available at least for 10 years after the construction product has been placed on the market.

The information referred to in Article 31 or, as the case may be, in Article 33 of Regulation (EC) No 1907/2006, (REACH) shall be provided together with the DOP.

ZA.2.2.3 DOP model

The manufacturer shall draw up the declaration of performance using the following model:

Declaration of performance

No. .................. [to be given by the manufacturer]

1. Unique identification code of the product-type: [to be given by the manufacturer]

2. Type, batch or serial number or any other element allowing identification of the construction product as required under Article 11(4) of the CPR: [to be given by the manufacturer in accordance with the provisions included in its FPC ]

3. Intended use or uses of the construction product, in accordance with the applicable harmonised technical specification, as foreseen by the manufacturer: [to be taken from clause 1 “Scope” of the harmonized standard]

17

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4. Name, registered trade name or registered trade mark and contact address of the manufacturer as required under Article 11(5): [to be given by the manufacturer and shall correspond to the same information that will be given in the CE marking box]

5. Where applicable, name and contact address of the authorised representative whose mandate covers the tasks specified in Article 12(2): [to be given by the manufacturer]

6. System or systems of assessment and verification of constancy of performance of the construction product as set out in Annex V: [to be taken from the last column of Table ZA.2 of Annex ZA of the harmonized standard]

7. In case of the declaration of performance concerning a construction product covered by a harmonised standard: [the dated reference of the harmonized standard is to be given here, followed by the name and identification number of the notified body if the concerned product is covered by AVCP system 1+, 1 or 2+]

Performed: [the description of the tasks performed by the notified body in relation to the applicable AVCP system is to be taken from the relevant paragraph of clause ZA.2.2 of Annex ZA of the harmonized standard, which corresponds to the third party tasks as set out in Annex V of the CPR]

under system [this information is to be taken from the last column of Table ZA.2 of Annex ZA of the harmonized standard]

and issued: [certificate of constancy of performance, certificate of conformity of the factory production control, test/calculation reports - as relevant]

8. Declared performance

Essential characteristics(see Note 1)

Performance(see Note 2)

Harmonised technical specification(see Note 3)

Notes to the table:

1. Column 1 shall contain the list of essential characteristics as determined in the harmonised technical specifications for the intended use or uses indicated in point 3 above [this information is to be taken from Table ZA.1 of Annex ZA of the harmonized standard. The full list of the essential characteristics has to appear maintaining the same sequence and the same wording indicated in Table ZA.1];

2. For each essential characteristic listed in column 1 and in compliance with the requirements of Article 6 of the CPR, column 2 shall contain the declared performance, expressed by level or class, or in a description, related to the corresponding essential characteristics [this information is to be taken from the last column of Table ZA.1 of Annex ZA of the harmonized standard] . The letters "NPD" (No Performance Determined) shall be indicated where no performance is declared;

3. For each essential characteristic listed in column 1, column 3 shall contain dated reference of the corresponding harmonised standard and, where relevant, the reference number of the Specific or Appropriate Technical Documentation used;

Where pursuant to Article 37 or 38 the Specific Technical Documentation has been used, the requirements with which the product complies [where the mentioned simplified procedures are not applicable to the manufacturer responsible for the DOP or where the concerned product is individually manufactured or custom-made or made for heritage purposes in accordance with National rules in a non-series process in response to a specific order, and which are installed in a single identified construction work, this information shall be omitted];

18

Autor, 03/01/-1,
In Article 5 of the CPR there are three derogations fr5om drawing-up a DOP.
Autor, 03/01/-1,
The text does not clarify how the issue of a certificate should be acknowledged. The text should require the certificate number. Accepting a statement that a certificate has been issued would be very weak and would not provide traceability.
Autor, 03/01/-1,
The description of the task of the notified body should be omitted. A reference to the relevant AVCP-system would be sufficient.
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910. The performance of the product identified in points 1 and 2 is in conformity with the declared performance in point 8.

This declaration of performance is issued under the sole responsibility of the manufacturer identified in point 4.

Signed for and on behalf of the manufacturer by:

…………………………………………………………………………………………………………(name and function)

………………..……………… ……………………………… (place and date of issue) (signature)

NOTE 16: The number of the declaration of performance shall be assigned by the concerned manufacturer

NOTE 17: The number of the notified body is the number assigned by the Commission following the notification procedure.

The following gives an example of a filled-in DoP for vertical air/flue terminals:

DECLARATION OF PERFORMANCENo. 001CPR2013-07-14

1. Unique identification code of the product-type: Positive pressure air/flue terminal with metal flue duct for C62- and C63-type gas appliances

T120- P1- D-Vm-L40045- O502 Type, batch or serial number or any other element allowing identification of the construction product as required under Article

11(4) of the CPR:[to be given by the manufacturer]

3. Intended use or uses of the construction product, in accordance with the applicable harmonised technical specification, as foreseen by the manufacturer:

convey air for combustion, and the products of combustion from appliances to the outside atmosphere.4. Name, registered trade name or registered trade mark and contact address of the manufacturer as required under Article

11(5):AnyCo Ltd,PO Box 21

B-1050 Brussels5. Where applicable, name and contact address of the authorised representative whose mandate covers the tasks specified in

Article 12(2):[to be given by the manufacturer]

6. System or systems of assessment and verification of constancy of performance of the construction product as set out in CPR, Annex V:

System 2+7. In case of the declaration of performance concerning a construction product covered by a harmonised standard:

EN 14989-1: 2007Notified factory production control certification body No. 5678 performed the initial inspection of the manufacturing plant and of factory production control and the continuous surveillance, assessment and evaluation of factory production control. and issued the certificate of constancy of conformity of the factory production control.

8. Declared performanceEssential characteristics Performance Harmonised technical

specificationCompressive strength PassResistance to fire 050

19

Autor, 03/01/-1,
Point 7 of the DoP form given above includes, in the blue text to be completed, “name and identification number of the notified body”, in line with the CPR Annex III point 7. However, the NB name is not included in this example.
Autor, 03/01/-1,
This DoP has a different format to those used in the example declarations of CE marking, figures ZA.1 to ZA.5. In any case, it would be helpful to reduce the risk of stakeholder confusion by differentiating the format of this number further from the format of certificate numbers, for instance by using “001-DoP-CPR-2013/Jul/14”. See document NB-CPD/11/476a for further detail.
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EN 14989-1: 2007

Gas tightness/leakage:- of the flue

- of the air supply duct

≤ 0,006 l s-1 m-2

(under a positive pressure of 200 Pa)≤ 0,28 l s-1 m-2

(under a positive pressure of 40 Pa)Flow resistance coefficient:- of the flue- of the air supply duct

1,5 (declared)2,5 (declared)

Thermal resistance of air/flue terminal:- with separate air/flue configuration- with concentric air/flue configuration

0,5 m2K/W (declared)0,35 m2K/W (declared)

Thermal shock PassFlexural tensile strength PassDurability:- against chemicals- against corrosion- freeze thaw

PassPassPass

910. The performance of the product identified in points 1 and 2 is in conformity with the declared performance in point 8.This declaration of performance is issued under the sole responsibility of the manufacturer identified in point 4.Signed for and on behalf of the manufacturer by:………………………………………………………………………………………………………………………………

(name and function)…………………………………..…………… …………………………………..……………

(place and date of issue) (signature)

ZA.3 CE marking and labelling

The manufacturer or his authorized representative established within the EEA is responsible for the affixing of the CE marking. The CE marking symbol shall be in accordance with the general principles set out in Article 30 of Regulation (EC) No 765/2008 and shall be affixed visibly, legibly and indelibly [see clause 1.1.2.1.3]:

- to the [insert here the name of the construction products as given in the title of the standard]

or

- to a label attached to it.

Where this is not possible or not warranted on account of the nature of the product, it shall be affixed:

- to the packaging

or

- to the accompanying documents.

NOTE: in addition to the above, the information could be split in different places according to the provisions to be given in clause ZA.3 of the Annex ZA of the standard.

The CE marking shall be followed by:20

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- the last two digits of the year in which it was first affixed,

- the name and the registered address of the manufacturer, or the identifying mark allowing identification of the name and address of the manufacturer easily and without any ambiguity,

- the unique identification code of the product-type

- the reference number of the declaration of performance [see note 16]

- the level or class of the performance declared [18 see examples of the declaration in annex]

- the dated reference to the harmonised technical specification applied [19]

- the identification number of the notified body(ies), [17; only for products under systems 1+, 1, 2+ and 3],

- the intended use as laid down in the harmonised technical specification applied.

The CE marking shall be affixed before the construction product is placed on the market. It may be followed by a pictogram or any other mark notably indicating a special risk or use.

The “No performance determined” (NPD) option may not be used for durability of essential characteristics that have been declared and where the essential characteristic is subject to a threshold level. Otherwise, the NPD option may be used when and where the essential characteristic, for a given intended use, is not subject to regulatory requirements in the Member State of destination.

NOTE 18: Reference shall be made to the list of essential characteristics as they appears in Table ZA.1 of the standard, which shall be included in the table appearing in the declaration of performanceNOTE 19: In case of harmonized standards, the reference to be used shall be the same as appeared in the OJEU.Examples:

- EN 450-1:2005+A1:2007- EN 671-1:2001; EN 671-1:2001/AC:2002- EN 1155:1997; EN 1155:1997/A1:2002; EN 1155:1997/A1:2002/AC:2006- EN 1457:1999; EN 1457:1999/A1:2002; EN 1457:1999/AC:2006; EN 1457:1999/A1:2002/AC:2007- EN 13241-1:2003; EN 13242:2002+A1:2007In case of Specific Technical Documentation (STD), the reference to be used shall be the number assigned to the STD by the manufacturer

Figures ZA.1 to ZA.5 give examples of the information related to products subject to AVCP under each of the different systems to be given on the [to be specified as decided in clause ZA.3] [see clause 1.1.2.1.3].

0123

CE marking, consisting of the “CE”-symbol

Identification number of the product certification body (see note 17)

21

Autor, 03/01/-1,
Under the CPD, for AoC System 3, GP ‘K’ acknowledges that different tests may be undertaken by different laboratories.
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AnyCo Ltd, PO Box 21, B-1050

13

00001-CPR-year/month/day

name and the registered address of the manufacturer, or identifying mark

Last two digits of the year in which the marking was first affixed

reference number of the DOP (see note 16)

EN nnnn - p:yy - year

Product A

intended to be used in X applications

essential characteristic 1: Unitsessential characteristic 2: Passessential characteristic 3: Class A1essential characteristic 4: RE 60essential characteristic n: xxxDurability of essential characteristic 1: expressed as indicated in the DOPDurability of essential characteristic n: expressed as indicated in the DOPDangerous substance X : Less than 0,2 ppm

No. of European standard applied, as referenced in OJEU (see note 19)

Unique identification code of the product-type

Intended use of the product as laid down in the European standard applied

Level or class of the performance declared

Figure ZA.1 — Example CE marking information of products under AVCP system 1+ [to be specified as decided in ZA.3] [see clause 1.1.2.1.3].

22

Autor, 03/01/-1,
It would be helpful to reduce the risk of stakeholder confusion by differentiating the format of this number further from the format of certificate numbers, for instance by using “nnn-DoP-CPR-yyyy/Mmm/dd”. See document NB-CPD/11/476a for further detail.
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0123

CE marking, consisting of the “CE”-symbol

Identification number of the product certification body (see note 17)

AnyCo Ltd, PO Box 21, B-1050

13

00001-CPR-year/month/day

name and the registered address of the manufacturer, or identifying mark

Last two digits of the year in which the marking was first affixed

Reference number of the DOP (see note 16)

EN nnnn - p:yy - year

Product Aintended to be used in X applications

essential characteristic 1: Unitsessential characteristic 2: Passessential characteristic 3: Class A1essential characteristic 4: RE 60essential characteristic n: xxxDurability of essential characteristic 1: expressed as indicated in the DOPDurability of essential characteristic n: expressed as indicated in the DOPDangerous substance X : Less than 0,2 ppm

No. of European standard applied, as referenced in OJEU (see note 19)

Unique identification code of the product-typeIntended use of the product as laid down in the

European standard appliedLevel or class of the performance declared

Figure ZA.2 — Example CE marking information of products under AVCP system 1 [to be specified as decided in ZA.3] [see clause 1.1.2.1.3].

23

Autor, 03/01/-1,
It would be helpful to reduce the risk of stakeholder confusion by differentiating the format of this number further from the format of certificate numbers, for instance by using “nnn-DoP-CPR-yyyy/Mmm/dd”. See document NB-CPD/11/476a for further detail.
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4567

CE marking, consisting of the “CE”-symbol

Identification number of the notified factory production control certification body (see note 17)

AnyCo Ltd, PO Box 21, B-1050

13

00001-CPR-year/month/day

name and the registered address of the manufacturer, or identifying mark

Last two digits of the year in which the marking was first affixed

Reference number of the DOP(see note 16)

EN nnnn - p:yy - year

Product Aintended to be used in X applications

essential characteristic 1: Unitsessential characteristic 2: Passessential characteristic 3: Class A1essential characteristic 4: RE 60essential characteristic n: xxxDurability of essential characteristic 1: expressed as indicated in the DOPDurability of essential characteristic n: expressed as indicated in the DOPDangerous substance X : Less than 0,2 ppm

No. of European standard applied, as referenced in OJEU (see note 19)

Unique identification code of the product-typeIntended use of the product as laid down in the

European standard appliedLevel or class of the performance declared

Figure ZA.3 — Example CE marking information of products under AVCP system 2+ [to be specified as decided in ZA.3] [see clause 1.1.2.1.3].

24

Autor, 03/01/-1,
It would be helpful to reduce the risk of stakeholder confusion by differentiating the format of this number further from the format of certificate numbers, for instance by using “nnn-DoP-CPR-yyyy/Mmm/dd”. See document NB-CPD/11/476a for further detail.
Autor, 03/01/-1,
The CPR Annex V (2) defines bodies involved in the assessment and verification of constancy of performance, including “(2) factory production control certification body”.
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1234, 4567 ?

CE marking, consisting of the “CE”-symbol

Identification number(s) of the notified testing laboratory(ies) ?

(see note 17)AnyCo Ltd, PO Box 21, B-1050

13

00001-CPR-year/month/day

name and the registered address of the manufacturer, or identifying mark

Last two digits of the year in which the marking was first affixed

Reference number of the DOP (see note 16)

EN nnnn - p:yy - year

Product Aintended to be used in X applications

essential characteristic 1: Unitsessential characteristic 2: Passessential characteristic 3: Class A1essential characteristic 4: RE 60essential characteristic n: xxxDurability of essential characteristic 1: expressed as indicated in the DOPDurability of essential characteristic n: expressed as indicated in the DOPDangerous substance X : Less than 0,2 ppm

No. of European standard applied, as referenced in OJEU (see note 19)

Unique identification code of the product-typeIntended use of the product as laid down in the

European standard appliedLevel or class of the performance declared

Figure ZA.4 — Example CE marking information of products under AVCP system 3 [to be specified as decided in ZA.3] [see clause 1.1.2.1.3].

CE marking, consisting of the “CE”-symbol

AnyCo Ltd, PO Box 21, B-1050

13

00001-CPR-year/month/day

name and the registered address of the manufacturer, or identifying mark

Last two digits of the year in which the marking was first affixed

Reference number of the DOP (see note 16)

EN nnnn - p:yy - year

Product Aintended to be used in X applications

essential characteristic 1: Unitsessential characteristic 2: Passessential characteristic 3: Class A1essential characteristic 4: RE 60essential characteristic n: xxxDurability of essential characteristic 1: expressed as indicated in the DOPDurability of essential characteristic n: expressed as indicated in the DOPDangerous substance X : Less than 0,2 ppm

No. of European standard applied, as referenced in OJEU (see note 19)

Unique identification code of the product-typeIntended use of the product as laid down in the

European standard appliedLevel or class of the performance declared

25

Autor, 03/01/-1,
It would be helpful to reduce the risk of stakeholder confusion by differentiating the format of this number further from the format of certificate numbers, for instance by using “nnn-DoP-CPR-yyyy/Mmm/dd”. See document NB-CPD/11/476a for further detail.
Autor, 03/01/-1,
It would be helpful to reduce the risk of stakeholder confusion by differentiating the format of this number further from the format of certificate numbers, for instance by using “nnn-DoP-CPR-yyyy/Mmm/dd”. See document NB-CPD/11/476a for further detail.
Autor, 03/01/-1,
Under the CPD, for AoC System 3, GP ‘K’ acknowledges that different tests may be undertaken by different laboratories.
Autor, 03/01/-1,
Should this information include the identification number(s) of the notified testing laboratory(ies)? The CPD asked only for “the number of the EC certificate of conformity” but the CPR Article 9 asks for “the identification number of the notified body, if applicable”.
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Figure ZA.5 — Example CE marking information of products under AVCP system 4 [to be specified as decided in ZA.3] [see clause 1.1.2.1.3].

In addition to any specific information relating to dangerous substances shown above, the product should also be accompanied, when and where required and in the appropriate form, by documentation listing any other legislation on dangerous substances for which compliance is claimed, together with any information required by that legislation.

NOTE 1 European legislation without national derogations need not be mentioned. [20]

[NOTE 20: This text is the subject of a BT Resolution and has to be incorporated in every Harmonized standards]

NOTE 2 Affixing the CE marking symbol means, if a product is subject to other directive(s) or European legislation(s), that it complies with all those applicable .

26

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PART 2How to draft clauses on Assessment and verification of the constancy

of performance (AVCP)

ForewordThis document has been updated to take account of the adoption of the Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC.

This document gives the principles behind writing clause 6 as “Evaluation of conformity” in the mandated harmonised standardization works carried out in the framework of Council Directive 89/106/EEC repealed by the above-mentioned Regulation.

Clause 2 of this document provides the template that all Technical Committees have to use from the 1st July 2013 when drafting the AVCP clause (previously defined in the CPD as “Evaluation of conformity”) in new standards or when revising/amending existing harmonized standards.

The numbering of paragraphs in clause 2 of this document follows the framework indicated in the model standard.

NoteIn the template:

- the text in [blue characters] represents items to be filled in;

- the text in [black italics] represents notes not to be included in the standard, or other comments.

27

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1 DefinitionsFor the purposes of this document, the principles, the provisions, the terms and the definitions given in the Regulation (EU) No. 305/2011 apply.

The attention is particularly drawn on the definition of the following terms used in this document:

- Factory Production Control (FPC) means the documented, permanent and internal control of production in a factory, in accordance with the relevant harmonised technical specifications;

- Product-type means the set of representative performance levels or classes of a construction product, in relation to its essential characteristics, produced using a given combination of raw materials or other elements in a specific production process;

- Essential characteristics means those characteristics of the construction product which relate to the basic requirements for construction works;

- Performance of a construction product means the performance related to the relevant essential characteristics, expressed by level or class, or in a description;

- Level means the result of the assessment of the performance of a construction product in relation to its essential characteristics, expressed as a numerical value;

- Class means a range of levels, delimited by a minimum and a maximum value, of performance of a construction product;

- Threshold level means a minimum or maximum performance level of an essential characteristic of a construction product;

- Classified Without Further Testing (CWFT) means the classification assigned to construction products showing a stable behavior of a given characteristic in a given levels and/or class of performance related to characteristics other than fire and dangerous substances defined by CPR article 27, adopted by the Commission or established by CEN/CENELEC Technical Committees ad and included by the Commission in a revised mandates.

- Product range means group of products produced by one manufacturer for which the test results for one or more characteristics from any one product within the range are valid for all other products within this range.

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2 Template for the clause “Assessment and Verification of Constancy of Performance – (AVCP)””

6 Assessment and verification of constancy of performance - (AVCP) relevant for the CE marking

6.1 GeneralThe compliance of [insert here the name of the products as it appears in the title of the standard] with the requirements of this standard and with the declared values shall be demonstrated by:

- determination of the product type

- factory production control by the manufacturer, including product assessment.

The manufacturer shall always retain the overall control and shall have the necessary means to take responsibility for the product.[NOTE: The assignment of tasks to the notified body(ies) and the manufacturer is shown in Annex ZA, Table ZA.3.]

6.2 Product type6.2.1 GeneralThe determination of the product type shall be performed for all the performances related to essential characteristics defined in this standard included in the declaration of performance drawn up by the manufacturer.

All the performances related to characteristics included in this standard other than the essential characteristic may be determined when the manufacturer claims compliance with them, unless the standard gives provisions for declaring them without performing tests. (e.g. use of previously existing data, CWFT and conventionally accepted performance).

Tests previously performed in accordance with the provisions of this standard, may be taken into account provided that they were made to the same or a more rigorous test method, under the same AVCP system on the same product or products of similar design, construction and functionality, such that the results are applicable to the product in question.

Note: Same AVCP system of means testing by an independent third party [only for products covered by system 1+, 1 and 3], under the responsibility of a notified product certification body [only for products covered by system 1+ and 1].

For the purposes of testing, the manufacturer's products may be grouped into families, where it is considered that the results for one or more characteristics from any one product within the family are representative for that same characteristics for all products within that same family.

Note 1: Products may be in grouped different families for different characteristics.

Note 2: Reference to the test method standards should be made to allow the selection of a suitable representative sample.

In addition, the determination of the product type shall be performed for all characteristics included in the standard for which the manufacturer declares performances:

29

Autor, 03/01/-1,
How should users of the standard decide whether one test method is more or less rigorous than another with regard to a particular characteristic, and whether one design is similar to another? Standards should define in more detail, on a case by case basis, when “tests previously performed” may be taken into account. For example, accepting a test on a construction material (e.g. gravel) is very different to accepting a test performed on a finished product made by assembling different manufactured components (e.g. a building kit).
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- at the beginning of the production of a new or modified [insert here the name of the products as it appears in the title of the standard] (unless a member of the same family), or

- at the beginning of a new or modified method of production (where this may affect the stated properties); or

they shall be repeated for the appropriate characteristic(s), whenever a change occurs in the [insert here the name of the products as it appears in the title of the standard] design, in the raw material or in the supplier of the components, or in the production process (subject to the definition of a family), which would affect significantly one or more of the characteristics.

Where components are used whose characteristics have already been determined, by the component manufacturer, on the basis of compliance with other product standards, these characteristics need not be re-assessed. Retaining the full responsibility for the performance of the product, the manufacturer may take account of testing and assessments performed by suppliers of components. The specifications of these components shall be documented.

Products bearing the CE regulatory marking in accordance with appropriate harmonized European specifications may be presumed to have the performances declared in the DoP, although this does not replace the responsibility on the [insert here the name of the products as it appears in the title of the standard] manufacturer to ensure that the [insert here the name of the products as it appears in the title of the standard] as a whole is correctly manufactured and its component products have the declared performance values.

6.2.2 Test samples, testing and compliance criteria [this clause is optional. Its possible inclusion should be decided by each WG depending on the kind of products covered by the standard they are drafting]

The number of samples of [insert here the name of the products as it appears in the title of the standard] to be tested/assessed shall be in accordance with Table A.

Table A — Number of samples to be tested and compliance criteria [insert here the appropriate number of the table]

Characteristic[name of the

characteristic]

Requirement[clause where

requirement is given. Usually, clause 4

“Requirements” of the standard]

Assessment method

[clause where the method is given]

No. of samples

[number of samples to be

assessed]

Compliance criteria[clause where criteria are given. Usually they should

appear in clause 4 “Requirements” of the

standard]

6.2.3 Test reportsThe results of the determination of the product type shall be documented in test reports. All test reports shall be retained by the manufacturer for at least 10 years after the last date of production of the [insert here the name of the products as it appears in the title of the standard] to which they relate.

30

Autor, 03/01/-1,
CE-marking is the only marking in accordance with harmonized standards. Therefore, products ‘marked in accordance with appropriate harmonized standards’ could mean nothing else than CE-marking. It should be emphasized that there is no requirement for components to be CE-marked.
Autor, 03/01/-1,
This is contrary to the basic principle that the manufacturer is fully responsible for the finished product. From a technical viewpoint, it is less important who carries out the testing and assessments. What is important is that testing and assessing is done competently and under the control of the manufacturer. Alternative wording is proposed.
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6.2.4 Shared other party results [This clause is optional depending on the kind of products covered by the standard]

It is in principle applicable to all systems of assessment and evaluation of constancy of performance.

A manufacturer may use the results of the product type determination obtained by someone else (e.g. by another manufacturer, as a common service to manufacturers, or by a product developer), hereafter called “other party ITT results”, to justify his own declaration of performance regarding a product that is manufactured according to the same design (e.g. dimensions) and with raw materials, constituents and manufacturing methods of the same kind, provided that:

– the results are known to be valid for products with the same characteristics relevant for performance;

– in addition to any information essential for confirming that the product has such same characteristics, the other party who has carried out the determination of the product type concerned or has had it carried out, has expressly accepted1 to transmit to the manufacturer the results and the test report to be used for the latter’s product type determination, as well as information regarding production facilities and the production control process that can be taken into account for FPC;

– the manufacturer using other party results accepts remaining responsible for the product being in compliance with the declared performances;

– he ensures that the product has the same characteristics relevant for performance as the one that has been subjected to the determination of the product type, and that there are no significant differences with regard to production facilities and the production control process compared to that used for the product that was subjected to the determination of the product type; and

– he keeps available a copy of the determination of the product type report that also contains the information needed for verifying that the product is manufactured according to the same design and with raw materials, constituents and manufacturing methods of the same kind.

6.2.5 Cascading determination of the product type results [This clause is optional. Its possible inclusion should be decided depending on the kind of products covered by the standard]

For some construction products, there are companies (system houses) which supply or ensure the supply of, on the basis of an agreement2 some or all of the components (e.g. in case of windows: profiles, gaskets, weather strips)3 to an assembler who then manufactures the finished product (referred to below as the “assembler”) in his factory.

______________________

1 - The formulation of such an agreement can be done by licence, contract, or any other type of written consent.

2 - This can be, for instance, a contract, license or whatever kind of written agreement, which should also contain clear provisions with regard to responsibility and liability of the component producer (system house, on the one hand, and the assembler of the finished product, on the other hand.

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3 - These companies may produce components but they are not required to do so.

Provided that the activities for which such a system house is legally established include manufacturing/assembling of products as the assembled one, the system house may take the responsibility for the determination of the product type regarding one or several essential characteristics of an end product which is subsequently manufactured and/or assembled by other firms in their own factory.

When doing so, the system house must submit an “assembled product” using components manufactured by it or by others, to the determination of the product type and then make the determination of the product type report available to the assemblers, i.e. the actual manufacturer of the product placed on the market.

To take into account such a situation, the concept of cascading determination of the product type might be taken into consideration in the technical specification, provided that this concerns characteristics for which either a notified product certification body or a notified test laboratory intervene, as presented below.

The determination of the product type report that the system house has obtained with regard to tests carried out by a notified body, and which is supplied to the assemblers, may be used for the regulatory marking purposes without the assembler having to involve again a notified body to undertake the determination of the product type of the essential characteristic(s) that were already tested, provided that:

– the assembler manufactures a product which uses the same combination of components (components with the same characteristics), and in the same way, as that for which the system house has obtained the determination of the product type report. If this report is based on a combination of components not representing the final product as to be placed on the market, and/or is not assembled in accordance with the system house’s instruction for assembling the components, the assembler needs to submit his finished product to the determination of the product type;

– the system house has notified provided to the manufacturer the instructions for manufacturing/assembling the product and installation guidance;

– the assembler (manufacturer) assumes the responsibility for the correct assembly of the product in accordance with the instructions for manufacturing/assembling the product and installation guidance notified provided to him by the system house;

– the instructions for manufacturing/assembling the product and installation guidance notified provided to the assembler (manufacturer) by the system house are an integral part of the assembler’s Factory Production Control system and are referred to in the determination of the product type report;

– the assembler is able to provide documented evidence that the combination of components he is using, and his way of manufacturing, correspond to the one for which the system house has obtained the determination of the product type report (he needs to keep a copy of the system house’s determination of the product type report);

– regardless the possibility of referring, on the basis of the agreement signed with the system house, to the latter’s responsibility and liability under private law, the assembler remains responsible for the product being in compliance with the declared performances, including both the design and the manufacture of the product, which is given when he affixes the regulatory marking on his product

32

Autor, 03/01/-1,
Use of the word “notified” is to similar to “notified body” and suggests a notified body should be involved.
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6.3 Factory production control (FPC)6.3.1 GeneralThe manufacturer shall establish, document and maintain an FPC system to ensure that the products placed on the market comply with the declared performance of the for their essential characteristics.

The FPC system shall consist of procedures, regular inspections and tests and/or assessments and the use of the results to control raw and other incoming materials or components, equipment, the production process and the product. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic manner in the form of written policies and procedures.

This factory production control system documentation shall ensure a common understanding of the evaluation of the constancy of performance and enable the achievement of the required product performances and the effective operation of the production control system to be checked. Factory production control therefore brings together operational techniques and all measures allowing maintenance and control of the compliance of the product with the declared performances of the essential characteristics.

6.3.2 Requirements6.3.2.1 GeneralThe manufacturer is responsible for organizing the effective implementation of the FPC system. Tasks and responsibilities in the production control organization shall be documented and this documentation shall be kept up-to-date.

The responsibility, authority and the relationship between personnel that manages, performs or verifies work affecting product constancy shall be defined. This applies in particular to personnel that needs to initiate actions preventing product non-constancies from occurring, actions in case of non-constancies and to identify and register product constancy problems.

Personnel performing work affecting product constancy of performance shall be competent on the basis of appropriate education, training, skills and experience for which records shall be maintained.

In each factory the manufacturer may delegate the action to a person having the necessary authority to:

identify procedures to demonstrate constancy of performance of the product at appropriate stages;

identify and record any instance of non-constancy;

identify procedures to correct instances of non-constancy.

The manufacturer shall draw up and keep up-to-date documents defining the factory production control. The manufacturer's documentation and procedures should be appropriate to the product and manufacturing process. The FPC system should achieve an appropriate level of confidence in the constancy of performance of the product. This involves :

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a) the preparation of documented procedures and instructions relating to factory production control operations, in accordance with the requirements of the technical specification to which reference is made;

b) the effective implementation of these procedures and instructions;

c) the recording of these operations and their results;

d) the use of these results to determine whether the product conforms with its product-type, and may be placed on the market or, if necessary, withdrawn;

e) the use of these results to correct any deviations, repair the effects of such deviations, treat any resulting instances of non-conformity and, if necessary, revise the FPC to rectify the cause of non-constancy of performance.

Where subcontracting takes place, the manufacturer shall retain the overall control of the product and ensure that he receives all the information that is necessary to fulfil l his responsibilities according to this European standard.

If the manufacturer has part of the product designed, manufactured, assembled, packed, processed and/or labelled by subcontracting, the FPC of the subcontractor may be taken into account, where appropriate for the product in question.

The manufacturer who subcontracts all of his activities may in no circumstances pass these responsibilities on to a subcontractor.

NOTE - Manufacturers having an FPC system, which complies with EN ISO 9001 series standard and which addresses all the provisions of the present European standard are considered as satisfying the FPC requirements of the Regulation (EU) No 305/2011.

6.3.2.2 Equipment6.3.2.2.1 TestingAll weighing, measuring and testing equipment shall be calibrated and regularly inspected according to documented procedures, frequencies and criteria.

6.3.2.2.2 ManufacturingAll equipment used in the manufacturing process shall be regularly inspected and maintained to ensure use, wear or failure does not cause inconsistency in the manufacturing process. Inspections and maintenance shall be carried out and recorded in accordance with the manufacturer’s written procedures and the records retained for the period defined in the manufacturer's FPC procedures.

6.3.2.3 Raw materials and componentsThe specifications of all incoming raw materials and components shall be documented, as shall the inspection scheme for ensuring their compliance. In case supplied kit components are used, the constancy of performance system of the component shall be that given in the appropriate harmonised technical specification for that component.

34

Autor, 03/01/-1,
The meaning of “supplied kit components” is unclear. CPR Article 2 (2) defines “kit” as “a construction product placed on the market by a single manufacturer as a set of at least two separate components that need to be put together to be incorporated in the construction works”. Is “supplied kit components” a reference to the complete kit, to individual components that will form part of a kit, or simply to components that will form part of a construction product? Is it necessarily the case that a component part of a construction product must conform to a harmonised standard if it falls within the scope of that standard? Or would that be the case only if the standard for the complete product specifies that the component must conform with the relevant standard? For example, EN 13830: 2010 ‘Curtain walling - Product standard’ defines a curtain walling kit. Such a kit is likely to include windows amongst its component parts, but EN 13830: 2010 does not refer to EN 14351-1, the windows and doors product standard. So presumably there is no requirement for windows supplied as component parts of a curtain walling kit, but not placed on the market as windows, to meet the EN 14351-1 constancy of performance system for windows. As components are not considered construction products, there are no harmonised standards for components. However, it should be recognised that products placed on the market as construction products and CE-marked accordingly are often used as components of other construction products or kits. It is obvious that the manufacturer need not necessarily repeat tests or inspections already carried out. However, being the responsible party, the manufacturer should retain the freedom to decide whether or not to apply more severe requirements to his suppliers of components.
Autor, 03/01/-1,
Calibration shall be traceable to international references. Equipment shall be inspected and calibrated before being placed into service, regularly when in service, when taken out of service, and after any adjustment or repair. In the case of deficient equipment or equipment out of calibration, an assessment of the possible impact on product conformity / performance shall be made, and nonconforming products dealt with accordingly.
Autor, 03/01/-1,
Making an ISO 9001 compliant system specific to a harmonised standard is not ensuring compliance with CPR. As ISO 9001 obliges the organization to identify and take account of any relevant regulatory requirement, and as the CPR itself is important in that regard, ISO 9001 compliant systems must also be made specific to the harmonised standard and to the CPR to meet the requirements of CPR.
Autor, 03/01/-1,
The terminology regarding products not meeting the declaration is unclear. Even though the CPR has introduced the term ‘constancy of performance’, referring to ‘non-constancy’ is not likely to make much sense to the users of harmonised standards. The well-known terms ‘non-conformity’ and ‘non-conforming products’ should be preferred. The clause should take account of CPR Article 11 (7) and describe the manufacturers responsibilities with regard to non-conforming products placed on the market, possibly by direct reference to that clause. The first priority for the manufacturer interpreting the FPC results should be decisding whether the products should be or remain placed on the marked. Possible text is proposed.
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6.3.2.4 Design processThe factory production control system shall document the various stages in the design of products, and identify the checking procedure and those individuals responsible for all stages of design. During the design process itself, a record shall be kept of all checks, their results, and any corrective actions taken.

This record shall be sufficiently detailed and accurate to demonstrate that all stages of the design phase, and all checks, have been carried out satisfactorily.

6.3.2.5 Traceability and marking [This clause is optional and may not be relevant for all standards]

Individual [to be indicated if products, product batches or packages] shall be identifiable and traceable with regard to their production origin. The manufacturer shall have written procedures ensuring that processes related to affixing traceability codes and/or markings are inspected regularly.

6.3.2.6 Controls during manufacturing processThe manufacturer shall plan and carry out production under controlled conditions.[Note: Where the CEN/TC identifies important stages during the production process where monitoring of the constancy of intermediate states of the product and/or at the main stages of its production, is necessary, it can introduce the necessary paragraphs here. This monitoring of constancy focuses, where necessary, on the product throughout the process of manufacture, so that only products having passed the scheduled intermediate controls and tests are dispatched. However, TCs cannot misuse this paragraph to define a particular manufacturing process, nor are they allowed to discriminate against certain production processes]

6.3.2.7 Product testing and evaluation [this part needs to be made specific for each EN]

The manufacturer shall establish procedures to ensure that the stated values of the characteristics he declares, are maintained. The characteristics, and the means of control, are:

- [insert here the name of the characteristic 1]: shall be subject to the tests indicated in clause [insert here the relevant clause number], at least [insert here the envisaged frequency];

- [insert here the name of the characteristic 2] shall be subject to the tests indicated in clause [insert here the relevant clause number], at least [insert here the envisaged frequency];

- [insert here the name of the characteristic 3]: shall be subject to the tests indicated in clause [insert here the relevant clause number], at least [insert here the envisaged frequency];

- [insert here the name of the characteristic n]: shall be subject to the tests indicated in clause [insert here the relevant clause number], at least [insert here the envisaged frequency].

6.3.2.8 Non-complying productsThe manufacturer shall have written procedures which specify how non-complying products shall be dealt with. Any such events shall be recorded as they occur and these records shall be kept for the period defined in the manufacturer’s written procedures.

35

Autor, 03/01/-1,
The title and much of the content of this paragraph seems inappropriate. Design has nothing to do with CE marking. But selection and identification of the product-type is a key point when launching a new product. (In particular the traceability with respect to current production. This is the task “determination of the product-type” in the CPR Annex V.)
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6.3.2.9 Corrective actionThe manufacturer shall have documented procedures that instigate action to eliminate the cause of non-conformities in order to prevent recurrence.[Note: Where TC agrees upon certain specific actions (e.g. downgrading a non-constant product to a product type of lower performance, e.g. from Type A to Type B), then this shall be expressly specified]

6.3.2.10 Handling, storage and packagingThe manufacturer shall have procedures providing methods of product handling and shall provide suitable storage areas preventing damage or deterioration.

6.3.3 Product specific requirementsThe FPC system shall address this European Standard and ensure that the products placed on the market comply with the declaration of performance.

The FPC system shall include a product specific FPC, which identifies procedures to demonstrate compliance of the product at appropriate stages, i.e.:

a) the controls and tests to be carried out prior to and/or during manufacture according to a frequency laid down in the FPC test plan,

and/or

b) the verifications and tests to be carried out on finished products according to a frequency laid down in the FPC test plan

If the manufacturer uses only finished products, the operations under b) shall lead to an equivalent level of compliance of the product as if FPC had been carried out during the production.

If the manufacturer carries out parts of the production himself, the operations under b) may be reduced and partly replaced by operations under a). Generally, the more parts of the production that are carried out by the manufacturer, the more operations under b) may be replaced by operations under a).

In any case the operation shall lead to an equivalent level of compliance of the product as if FPC had been carried out during the production.

NOTE: Depending on the specific case, it can be necessary to carry out the operations referred to under a) and b), only the operations under a) or only those under b).

The operations under a) refer to the intermediate states of the product as on manufacturing machines and their adjustment, and measuring equipment etc. These controls and tests and their frequency shall be chosen based on product type and composition, the manufacturing process and its complexity, the sensitivity of product features to variations in manufacturing parameters etc.

The manufacturer shall establish and maintain records that provide evidence that the production has been sampled and tested. These records shall show clearly whether the production has satisfied the defined acceptance criteria and shall be available for at least three years.

36

Autor, 03/01/-1,
This clause should take account of CPR Article 11 (2) and Article 11 (7).
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Where the product fails to satisfy the acceptance measures, the provisions for non-complying products shall apply, the necessary corrective action shall immediately be taken and the products or batches not complying shall be isolated and properly identified.

Once the fault has been corrected, the test or verification in question shall be repeated.

The results of controls and tests shall be properly recorded. The product description, date of manufacture, test method adopted, test results and acceptance criteria shall be entered in the records under the signature of the person responsible for the control/test.

With regard to any control result not meeting the requirements of this European standard, the corrective measures taken to rectify the situation (e.g. a further test carried out, modification of manufacturing process, throwing away or putting right of product) shall be indicated in the records.

Individual products or batches of products and the related manufacturing documentation shall be completely identifiable and retraceable.

6.3.4 Initial inspection of factory and of FPC Initial inspection of factory and of FPC [only for products covered by AVCP 1+, 1 and 2+] shall be carried out when the production process has been finalized and in operation. The factory and FPC documentation shall be assessed to verify that the requirements of clause 6.3.2 and 6.3.3 are fulfilled.

During the inspection it shall be verified:

a) that all resources necessary for the achievement of the product characteristics included in this European standard are in place and correctly implemented,

and

b) that the FPC- procedures in accordance with the FPC documentation are followed in practice,

and

c) that the product complies with the product type samples, for which compliance with this European standard has been verified.

All locations where final assembly or at least final testing of the relevant product is performed, shall be assessed to verify that the above conditions a) to c) are in place and implemented. If the FPC system covers more than one product, production line or production process, and it is verified that the general requirements are fulfilled when assessing one product, production line or production process, then the assessment of the general requirements does not need to be repeated when assessing the FPC for another product, production line or production process.

All assessments and their results shall be documented in the initial inspection report.

6.3.5 Continuous surveillance of FPC [only for products covered by AVCP system 1+, 1 and 2+]

Surveillance of the FPC shall be undertaken [insert here the frequency] (at least once) per year. The surveillance of the FPC shall include a review of the FPC test plan(s) and production processes(s) for each product to determine if any changes have been made since the last assessment or surveillance. The significance of any changes shall be assessed.

37

Autor, 03/01/-1,
The expectation within the GNB-CPD is that all the production lines that are used to manufacture the finished product (i.e. the entire manufacturing activity) shall be inspected by the notified body. This is specifically required by some of GNB-CPD’s AG and SG position papers.
Autor, 03/01/-1,
The manufacturer should set up his own FPC based on the manufacturing process and the plant/process characteristics. The attempt of this document to define the different phases of control may not be general enough to be helpful. Clause 6.3.3. might be deleted, or reworded in terms of guidance for CEN/TCs to write specific clauses applicable to the products covered by each standard.
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Checks shall be made to ensure that the test plans are still correctly implemented and that the production equipment is still correctly maintained and calibrated.

The records of tests and measurement made during the production process and to finished products shall be reviewed to ensure that the values obtained still correspond with those values for the samples submitted to the determination of the product type and that the correct actions have been taken for non-compliant devices.

6.3.6 Procedure for modificationsIf modifications are made to the product, production process or FPC system that could affect any of the product characteristics declared according to this standard, then all the characteristics for which the manufacturer declares performance, which may be affected by the modification, shall be subject to the determination of the product type, except as described in 6.2.1 and 6.3.7.

Where relevant, a re-assessment of the factory and of the FPC system shall be performed for those aspects, which may be affected by the modification.

All assessments and their results shall be documented in a report.

6.3.7 One-off products, pre-production products (e.g. prototypes) and products produced in very low quantity [this clause is optional. Its possible inclusion should be decided by each WG depending on the kind of products covered by the standard they are drafting]

The [insert here the name of the products as it appears in the title of the standard] produced as a one-off, prototypes assessed before full production is established, and products produced in very low quantities [to be specified] per year) shall be assessed as follows.

For type assessment, the provisions of 6.2.1, 3rd paragraph apply, together with the following additional provisions:

- in case of prototypes, the test samples shall be representative of the intended future production and shall be selected by the manufacturer;

- on request of the manufacturer, the results of the assessment of prototype samples may be included in a certificate or in test reports issued by the involved third party.

The FPC system of one-off products and products produced in very low quantities shall ensure that raw materials and/or components are sufficient for production of the product. The provisions on raw materials and/or components shall apply only where appropriate. The manufacturer shall maintain records allowing traceability of the product.

For prototypes, where the intention is to move to series production, the initial inspection of the factory and FPC shall be carried out before the production is already running and/or before the FPC is already in practice. The following shall be assessed:

- the FPC-documentation; and

- the factory.

In the initial assessment of the factory and FPC it shall be verified:

a) that all resources necessary for the achievement of the product characteristics included in this European standard will be available, and

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b) that the FPC-procedures in accordance with the FPC-documentation will be implemented and followed in practice, and

c) that procedures are in place to demonstrate that the factory production processes can produce a product complying with the requirements of this European standard and that the product will be the same as the samples used for the determination of the product type, for which compliance with this European standard has been verified.

Once series production is fully established, the provisions of clause 6.3 shall apply.

39