NB-CPD/SG02/07/044r1

GNB-CPD

SG02

Guidance from the Group of Notified Bodies

for the Construction Products Directive
89/106/EEC

Issued: 20 April 2012

APPROVED GUIDANCE

GNB-CPD position paper from SG02 - EN 13263-1:2005+A1:2009

Certification of silica fume for concrete
General scope, limitations and aim of this guidance for notified bodies
This position paper contains guidance for notified bodies (NBs) involved in the certification of silica
fume for concrete according to EN 13263-1:2005+A1:2009. The purpose is to help NBs work
equivalently and come to common judgments. This guidance contains informative material (which
NBs should or may follow) and/or normative guidance (which NBs shall follow or at least work
equivalently to as circumstances demand).
The primary document for NBs is the edition of the relevant harmonized standard that is currently
cited in the Official Journal of the EU to which the manufacturer works. This guidance is thought
necessary to provide clarity and completeness for NBs so that they can work equivalently. It
supplements and makes practical for NBs the harmonized standard EN 13263-1:2005+A1:2009,
approved AG guidance, and Standing Committee guidance in the form of GPs, which also apply unless otherwise explicitly stated in this guidance. This position paper should not contradict nor
extend the scope of the work and role of a NB, nor impose additional burdens on the manufacturer,
beyond those laid down in the CPD and EN 13263-1:2005+A1:2009.
This guidance should be considered valid until the relevant standards are amended to include the
guidance (as thought fit by the CEN/TC); or until guidance from Commission, SCC or AG has
changed on relevant matters. Whereupon, the paper should be considered for withdrawal/revision
and be replaced by new guidance as necessary.
This position paper was considered approved in its original form by SG02 on 13 September 2006
and by Advisory Group on 2 January 2007, and in its revised form by SG02 on 2 November 2011
and by Advisory Group on 1 April 2012.

Paragraphs that have been changed from NB-CPD/SG02/07/044 are indicated as follows:
modified text or paragraph by a broken left border line;
new paragraph by a solid left border line, and;
where previous paragraphs have been removed by .
Also Annexes 1 and 3 from the previous edition have been deleted.

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Contents
1

Foreword ..................................................................................................................................................... 3

Scope and field of application ..................................................................................................................... 3

Reference list .............................................................................................................................................. 3

Terminology ................................................................................................................................................ 4

EC silica fume certification process (for a new factory) .............................................................................. 5

Starting / application / acceptance - 1st Phase............................................................................................ 6

Initial inspection of the factory and factory production control - 2nd Phase ................................................. 6

Initial Audit Sampling/Type testing and issue of EC certificate of conformity - 3rd Phase .......................... 8

Initial period - 4th Phase .............................................................................................................................. 9

10 Maintaining the EC certificate of conformity ............................................................................................. 10

11 Continuous surveillance, assessment and approval of factory production control ................................... 11
12 Quality records .......................................................................................................................................... 12
13 EC certificate of conformity ....................................................................................................................... 12
14 Proficiency testing ..................................................................................................................................... 12
Annex A Example of a reference checklist.................................................................................................... 13

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Foreword
0B

Sector Group 02 of the Group of Notified Bodies for the Construction Products Directive
89/106/EEC has prepared this document to assist NBs in following equivalent procedures in
certifying the conformity of silica fume with Annex ZA of EN 13263-1.
The scope of this document is to supplement this standard and EN 13263-2 taking into
consideration the necessary internal procedures of the certification bodies. All the activities of the
notified certification body, necessary to achieve the EC certificate of conformity, are reported and
explained in the sequence of the certification activity. In preparing this edition of the position paper
SG02 has taken into consideration the experience of certification/inspection bodies and testing
laboratories notified in the field of silica fume of working to the documents in the reference list.
It is emphasized that only the silica fume manufacturer/authorized representative is responsible for
ensuring that silica fumes bearing the CE Marking have all the characteristics required by Annex ZA
of EN 13263-1.
To maintain equivalent use and interpretation of this document, notified bodies are strongly invited
to raise any questions, remarks, or problems related to the use of this document with the secretariat
of NB-CPD/SG02. The address of the secretariat can be found on the CIRCA website
http://www.forum.europa.eu.int/Members/irc/nbg/cpdgnb/library.
H

Scope and field of application

1B

This document defines and describes the sequence of the main operational procedures to be
followed by a notified certification body in granting EC certificate of conformity for silica fume on the
basis of the requirements of Annex ZA of EN 13263-1. In case of undated references the latest
version (including amendments and corrigenda) cited in the Official Journal of the European Union
applies, as per 3.2 and 3.3 of NB-CPD/AG/08/009.
EN 13263-1 covers silica fume intended for use as a type II addition for the production of concrete
including in particular cast-in-situ or prefabricated structural concrete conforming to EN 206-1.
Silica fume according to EN 13263-1 may also be used in mortars and grouts.

Reference list
2B

EN 13263-1, Silica fume for concrete Part 1: Definition, requirements and conformity criteria,
including annex ZA
EN 13263-2, Silica fume for concrete Part 2: Conformity evaluation

EN ISO 9000, Quality management systems - Fundamentals and vocabulary (for definitions only)

NB-CPD/AG/03/001, Numbering of certificates of conformity

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NB-CPD/AG/03/002, Guidance to notified bodies on the attestation of conformity under the

Construction Products Directive 89/106/EEC
NB-CPD/AG/03/003, Examples of EC certificates of conformity
NB-CPD/AG/03/004, Checklists for initial inspection of factory and factory production control and
continuous surveillance of factory production control
NB-CPD/AG/07/008, Guidance to Notified Bodies in certifying own brand labelled product and those
involving significant subcontract manufacturing
NB-CPD/AG/08/009, The consequences for NBs of corrigenda, amendments and revisions to
harmonized European standards

Terminology
3B

For those terms that are not included in the documents listed in clause 3 and for those that needed
to be detailed, the definition is given below:
Applicant
Manufacturer applying for the EC certificate of conformity for silica fume produced in one factory,
directly or through its authorised representative.
Audit sample
Spot sample taken under the responsibility of the notified certification body at the point(s) of release
of silica fume from the factory and/or depot supplied with silica fume by the factory.
Authorised representative
Any natural or legal person, expressly designated by the manufacturer to act on his behalf. The
authorised representative must be established inside the EEA.
Brand name
A unique proprietary name owned and used by a manufacturer for a type of silica fume.
CIRCA
The European Commission Website dedicated to the Construct Products Directive (CPD) in which is
contained all the information concerning the general co-ordination (GNB-CPD Advisory Group ) and
the specific co-ordination (sector groups) of bodies under the CPD. Relevant information may be
found at any time by consulting:
http://forum.europa.eu.int/Members/irc/enterprise/cpdgnb/home.
H

EC certificate of conformity
A certificate which entitles the manufacturer to affix the CE marking.
EC certified silica fume
Silica fume for which an EC certificate of conformity has been issued.
EC declaration of conformity
Declaration by the manufacturer or its authorised representative in conformity with Annex ZA of
EN 13263-1.

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Manufacturer
Any natural or legal person who manufactures a construction product or who has such a product
designed or manufactured, and markets that product under his name or trademark. The
manufacturer is responsible for that product, and for the purposes of CE marking this includes
ensuring that it complies with the harmonised part of the standard and achieves the performance he
has declared.
Inspector
Person appointed under the responsibility of the notified certification body to perform the activities of
inspection and/or audit sampling.
Non-Conformity
For the CE certification of silica fume two types of non-conformities are possible:
a product non-conformity (PNC) in case the product does not fulfil the requirements of the
product when the test results are evaluated as described in EN 13263-2;
a system non-conformity (SNC) in case the factory production control system does not comply
with the requirements in EN 13263-2. The notified certification body may introduce different
levels of SNC combined with actions to be taken by the manufacturer.

EC silica fume certification process (for a new factory)

4B

The system to be followed by the notified certification body to grant the EC certificate (in the case of
a new factory) is divided into four main operative phases. A further phase concerns continuous
surveillance (see clause 11).

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Scheme of reference for the EC silica fume certification process

1st - Starting/Application/Acceptance (see clause 6):
Application receipt/acceptance
Acceptance of the application
Examination of the received documents

2nd - Initial inspection of the factory and factory production control (see clause 7):
Assessment of the quality documentation
Initial inspection of the factory and factory production control
Initial inspection of the laboratory of the factory
Report of the results of the initial inspection

3rd - Initial Audit sampling/Type testing and issue of EC certificate of conformity

(see clause 8):
Audit Sampling
Testing of the first audit sample
Evaluation of the results of the first audit sample
Issue of the EC certificate of conformity and information to the manufacturer
Additional identification of silica fume

4th - Initial period (see clause 9):

Subsequent audit samples
Testing of the subsequent audit samples
Receiving testing results
Evaluation of the auto-control results
Evaluation of the subsequent audit samples results
Decision that the EC certificate of conformity remains valid (and information to the manufacturer)

Starting / application / acceptance - 1st Phase

6
5B

For application procedure, see NB-CPD/AG/03/002.

Initial inspection of the factory and factory production control 2nd Phase
6B

For initial inspection procedure, see NB-CPD/AG/03/002.

During the initial inspection of the factory, the inspector should use a checklist, in addition to all of
the relevant document listed in clause 3, (see an example in Annex A).

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7.1

Assessment of the quality documentation

14B

During the initial inspection the manufacturer shall make available to the inspector the latest
controlled version of the works quality manual and of the related quality documents.
The inspector shall verify that the works quality manual and related quality documents are correctly
implemented and applied in compliance with EN 13263-2.

7.2

Initial inspection of the factory and factory production control

15B

The main actions to be taken are reported in EN 13263-2 5.5.1, 5.5.2, and 5.5.3.
The inspector, among others, shall verify that each silica fume silo bears the information concerning
the type or other indications necessary for a unique identification of the silica fume (brand name,
etc.).
A unique identification of the silica fume/silos shall be available for sampling, process control and
loading.
During the initial inspection, the first audit samples could be taken and the manufacturer shall state
which cement (ref. EN 13263-1 3.30) to be used when testing activity index according to
EN 13263-1 5.3.3.
The assessment of depot(s) should be included in the initial inspection.

7.3

Initial inspection of the laboratory of the factory

16B

The main actions to be taken are reported in EN 13263-2 5.5.4.

In the case where some auto-control tests are performed by an external laboratory as mentioned in
the works quality manual, the notified body shall inspect this external laboratory to verify the
records, competency and confidentiality at least once per year.
Annex A.3.3 gives requirements for the equipment that shall be functioning in the laboratory for
autocontrol testing.

7.4

Report of the initial inspection

17B

The main actions to be taken are reported in EN 13263-2 5.5.5 and 5.2.3. General information on
initial inspection for product certification is given in NB-CPD/AG/03/002.

In the event of non-conformity of the factory production control system (SNC) or a product nonconformity (PNC), the certification body should take appropriate decisions/actions to ensure that the
factory production control is correctly applied by the manufacturer and/or corrective actions are
taken to ensure product conformity as per document NB-CPD/AG/03/002.

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Initial Audit Sampling/Type testing and issue of EC certificate of

conformity - 3rd Phase

8.1

7B

Audit sampling
18B

The main actions to be taken are reported in EN 13263-2 5.4.1, 5.4.2, 5.4.4, and 5.6.1.

8.2

Testing of the first audit sample

19B

The actions to be taken are reported in EN 13263-2 5.4.3 and 5.4.4.

8.3

Evaluation of the results of the first audit sample

20B

The main actions to be taken are reported in EN 13263-2 5.6.2, 5.6.3.

The manufacturer shall inform the notified certification body of the results of the testing on audit
samples as soon as they are available.
The test results of the testing laboratory shall be sent to the manufacturer only by the notified
certification body, and in any case always after the receipt of the correspondent internal test results.
At the end of the tests of the first audit sample the notified certification body shall send a test report
to the manufacturer.
The test results of the testing laboratory and the manufacturer have to be equivalent (taking into
consideration the reliability of the test method) and both must comply with the requirements of
EN 13263-1.

8.4

Issue of the EC certificate of conformity and information to the manufacturer

21B

It is recommended that each EC certificate of conformity should refer only to one silica fume
produced in a specific factory.
NOTE

An advantage of issuing separate certificates for different plants and products is that it may be
easier to withdraw one certificate, if problems arise with one type of product (or the product is not
produced anymore), than to revise a complex certificate covering multiple products and sites.

The notified certification body shall issue the EC certificate of conformity after the positive results of
the 2nd and 3rd phases and shall immediately inform the applicant.
At this time some results of the autocontrol for that silica fume will be available. They shall also be
compared with the requirements of EN 13263-1 in order to make the conclusion of the notified
certification body as reliable as possible. In this case all available results of the autocontrol should
comply with the requirements of EN 13263-1.

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8.5

Additional identification of silica fume

2B

A manufacturer may produce different silica fumes complying to the same standard designation.
Additional identification is required to distinguish between these silica fumes, which shall be used by
the manufacturer and all documents relating to marking and shall be given in the certificate.
For this purpose, these products receive an additional identification in the form of a number or of
two lower case letters, between parentheses. For the numbering system this number should be 1
for the second certified silica fume, 2 for the next, and so on. For the lettering system the letters
shall be chosen in such a way to avoid confusion with letters used for cement and concrete
standard and regulation indications across the EEA countries.
Example: The designation (1) or (st) is given to a silica fume produced in a factory that already
has a certificate for a silica fume with different (additional) properties, but complying with the
requirements for that product in EN 13263-1.
This indication must always accompany the CE-marking information of the silica fume to which it is
given even if other silica fumes are no longer produced. This enables backward traceability of this
silica fume and its test results. Once an indication is used for a certain silica fume it may never be
used again for another silica fume produced by the same factory.
When this additional identification is given to a silica fume the following note shall be added in the
CE certificate of conformity under additional identification:
The indication between parentheses is added to distinguish this silica fume from another
certified silica fume produced by this factory. This indication must for this reason be added to
the standard designation of this silica fume.

Initial period - 4th Phase

9
9.1

8B

Subsequent audit samples

23B

The actions to be taken are reported in EN 13263-2 4.3.1, 5.4.1, and 5.4.2.
The notified certification body should devise an audit sample programme that takes into account all
points of release including depots and the amount of testing should be based on the proportion of
each product dispatched, but having regard to the overall practicality and effectiveness of the
autocontrol testing specified in the product standard EN 13263-1. To enable this, the notified
certification body should request the manufacturer to inform it in advance of the proportions of each
silica fume that it expects to sell directly from the factory, and through each individual depot.
In this case, the manufacturers auto-control sample programme could be organised in the same
way, and evidence of it could be given in the quality documents of the factory.

9.2

Testing of the subsequent audit samples

24B

The actions to be taken are reported in EN 13263-2 5.4.3.

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9.3

Receiving testing results

25B

The manufacturer shall inform the notified certification body of the results of the testing on audit
samples and autocontrol as soon as they are available.
The test results of the testing laboratory shall be sent to the manufacturer only by the notified
certification body, and not before receipt of the correspondent internal test results.

9.4

Evaluation of the auto-control results

26B

The actions to be taken are reported in EN 13263-2 5.6.

9.5

Evaluation of the subsequent audit samples results

27B

The actions to be taken are given in EN 13263-2 5.6.

It is within the responsibility of the notified certification body to take immediate action in the case of
doubts concerning the test results. The manufacturer shall be informed about these actions.

9.6

Decision that the EC certificate of conformity remains valid (and information to

the manufacturer)
28B

When the evaluation of the first initial period of autocontrol results is confirmed, as well as the
results of the external tests and all the aspects related to factory production control, at the end of the
initial period the notified certification body should inform the manufacturer of the confirmation of
validity of the first issue of the EC certificate of conformity.

10

Maintaining the EC certificate of conformity

9B

The scheme to be followed by the notified certification body to maintain the validity of the EC
certificate is shown below.

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Overview of actions in relation to EC certification of conformity continuous

surveillance, assessment and approval of factory production control (see clause 11)
Annual inspection to the factory, FPC and laboratory
Management of the non conformities/corrective actions following the annual inspection to the
factory, FPC and laboratory
Evaluation of the results of autocontrol testing of samples
Management of the non conformities/corrective actions following the evaluation of the results
of autocontrol testing of samples
Audit sample results
Management of the non conformities/corrective actions following the evaluation of the results
of audit testing
Decision that the EC certificate of conformity remains valid (and information to the
manufacturer)

11

Continuous surveillance, assessment and approval of factory

production control

11.1

10B

Annual inspection to the factory, FPC and laboratory

29B

The actions to be taken are reported in EN 13263-2 5.2.1, 5.2.2, and 5.2.3.

11.2

Management of the non conformities/corrective actions following the annual

inspection to the factory, FPC and laboratory
30B

The actions to be taken are reported in EN 13263-2 6.2.1.

11.3

Evaluation of the results of auto-control testing of samples

31B

The actions to be taken are reported in EN 13263-2 5.3.

11.4

Management of the non conformities/corrective actions following the

evaluation of the results of auto-control testing of samples
32B

The actions to be taken are reported in EN 13263-2 6.2.1.

11.5

Audit sample results

3B

The actions to be taken are reported in EN 13263-2 5.4.5, and 5.4.6.

Each sample shall be tested for all the required properties.

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11.6

Management of the non conformities/corrective actions following the

evaluation of the results of audit testing
34B

The actions to be taken are reported in EN 13263-2 6.2.2.

11.7

Validity of the EC certificate of conformity

35B

Following evaluation of the results of the autocontrol and audit samples as per table 1 of
EN 13263-2, and audit of factory production control, the certification body should consider the
validity of the EC certificate.
During the period of validity of the certificate, the notified certification body may re-issue the EC
certificate of conformity, maintaining the same number. This re-issue shall contain also the date of
the first issue.

12

Quality records
1B

The actions to be taken are reported in EN 13263-2 4.1.4.2.

13

EC certificate of conformity
12B

The format of the certificate should follow the latest examples given in NB-CPD/AG/03/003.
Examples for attestation of conformity system 1+ in languages other than English may be available
on GNB-CPD CIRCA, in subfolders of AG Guidance - Horizontal Guidance & Information.
However, these might not have been translated from the current version. Certificates derived from
translations of earlier versions should be modified to match the latest English language version.
(http://circa.europa.eu/Members/irc/nbg/cdpgnb/library?l=/pendingsreferencesinsoj/guidance_horizo
ntal&vm=detailed&sb=Title).
H

The proposed numbering system for EC certificates is set out in NB-CPD/AG/03/001.

An EC certificate must always show the organization placing the silica fume on the market as the
manufacturer. In cases where that organization has the silica fume manufactured for it by a
separate organization, the factory(ies) shown on the certificate shall be all those where the silica
fume may have been made, although the factory details may be given in a coded format. For
further details see NB-CPD/AG/07/008.

14

Proficiency testing
13B

The requirements are reported in EN 13263-2 5.4.7.

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Annex A

Example of a reference checklist

There is a generic checklist given in NB-CPD/AG/03/004 for purposes of inspecting factory and
FPC, however the checklist given below is more specific to silica fume production.
The numbers of the relevant clauses of EN 13263-2 are given in brackets at the end of each
heading.
Each notified body conducting certification of silica fume should prepare its own checklist. The
following checklist is an example of the issues which may be relevant.

A.1
A.1.1

General requirements (4.1)

Works quality manual (4.1.2)

Does the factory have a controlled copy of the works quality manual?
Is the year of the first issue of the works quality manual recorded?
Is there a distribution list of the works quality manual and related quality documents?
Is there evidence of receipt of the copies (controlled or not) of the works quality manual (and related
quality documents) by the persons indicated in the distribution list?

A.1.2

Management system (4.1.3)

Does the works quality manual show the organisation structure?

A.1.3

Quality policy statement (4.1.3.1)

Does the works quality manual show the quality objectives of the manufacturer/factory?
Are there defined responsibilities concerning quality?
Are the resources required to reach and maintain the quality objectives available?

A.1.4

Management representative (4.1.3.2)

Is there an appointed management representative?

A.1.5

Internal audits and management review (4.1.3.3)

Is there any list of persons charged with internal audit?

Are the members of this list independent of the area to be audited?

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A.1.6

Training (4.1.3.4)

Is there evidence of the competence of the personnel involved in the quality production/control
process?

Is there a defined programme for the training of the personnel involved in the quality
production/control process?
Are there personal sheets/files for recording the experience/training of each person involved in the
quality production/control process?

A.1.7

Document control (4.1.4.1)

Does a control ensure that the appropriate issue of all documents are available at essential
locations?
Does a control ensure that the changes or modifications to any document are effectively
introduced?
Has a master list been established to identify the current version of documents in order to prevent
the use of non-applicable documents?

A.1.8

Quality records (4.1.4.2)

Are the Factory Production records kept for a minimum period of three years?
Are the factory production records for the products kept for a minimum period of ten years?
Is there suitable back-up of electronic records?

A.2
A.2.1

Internal quality control (4.2)

Process control (4.2.1 and 4.2.1.1)

Are the steps of the production process described in a flow chart?

Are targets and control limits defined for each production step?
Are corrective measures set if control limits are exceeded?
Are there procedures for controlled proportioning of the silica fumes to achieve required target
properties?
What are the method(s) and frequencies adopted to collect process control data. Are these
methods made available to the factory managers?
Are there procedures intended to avoid contamination:
of silica fume (through separate, adequate storing facilities)?

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 during production, handling and at point of dispatching?

Are there silos for stocking products in bulk before dispatch?

A.2.2

Provisions for processing plants (4.2.1.2)

Are there procedures to ensure each consignment of incoming silica fume is documented and
controlled as required?
Are there procedures for the controlled processing of the silica fume?

A.2.3

Control of off-specification production (4.2.1.3)

Are there procedures for controlling the silica fume produced that does not comply with the control
limits set by the manufacturer?
Are there procedure aimed at avoiding the dispatch of silica fume that proves not to be in
compliance with the specifications provided in EN 13263-1?

A.2.4

Measuring and testing (4.2.2)

Do the quality documents define the equipment required for control and test activities during
production?

A.2.5

Inspection, measuring and test equipment (4.2.2.1)

Are there procedures to control and calibrate the test equipment used during production?
Are there records of the control and calibration of the test equipment used during production?
Is there an inspection/testing plan for all the steps of the production process?

A.2.6

Handling, storage, packaging and delivery (4.2.3)

Are there procedures for assuring that the silica fume does not become contaminated whilst being
conveyed inside the works to the silo?
Are there procedures for assuring that the silica fume does not become contaminated whilst being
conveyed inside the depots from the unloading point to the silo?
Is the silica fume contained in each silo uniquely and clearly identified, in conformity with the
complete name that will appear on the EC Certificate of conformity?
For the external depot(s) only, if applicable: Is the silica fume contained in each silo of the depot
uniquely and clearly identified, in conformity with the complete name that will appear on the EC
certificate of conformity and also with the identification of the factory in which it was produced?
Is there a diagram showing handling and feeding lines to the silos, deviations, dispatching and
sampling points?
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Are there procedures aimed at ensuring that the loaded silica fume complies with the customers
specifications?
Does the Works Quality Manual contain the list of the Depots of the Factory?
Have the weighing machines at the gate been approved and certified?

A.3
A.3.1

Autocontrol testing of samples (4.3)

Sampling and testing (4.3.1)

Is there a procedure describing the autocontrol plan for each silica fume?
Do these controls and tests frequencies comply with the requirements of EN 13263-1?
For silica fumes sold discontinuously, are the test frequencies and sampling points specified in the
works quality manual and agreed with the notified certification body?
Is the sampling plan in proportion to the production of bulk silica fume and production from depots
according to the relevant sale quantities?
Is autocontrol data transmitted to the certification body in due time?
Do the test procedures comply with the test methods given in EN 13263-1?
For which tests does the silica fume factory use an external laboratory? Is this recorded in the
works quality manual?
Has the manufacturer agreed for inspections of the external laboratory by the notified certification
body?
Are the test procedures for possible alternative test methods for determining the silica fume
properties reported in the quality documents?
Are the registers containing the autocontrol data correctly completed, updated and made available?
Are working/technical instructions available for the repetition of test results in the event of failure?
Are there instructions for repeating tests which have failed? Are the above recorded?
What is the frequency of the statistical assessment according to the criteria provided in
EN 13263-1?
Are records concerning the autocontrol data retained for at least 10 years?

A.3.2

Corrective actions (4.3.2)

Does the works quality manual provide corrective actions procedures to be carried out in order to
eliminate the causes of non-compliance?
In case of non-compliance with the single results limit values conformity criteria, does the works
quality manual provide a procedure for a review of the factory production control?

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In such cases, is the notified certification body informed?

In case of non-compliance of a sample taken at the delivery point:
has the manufacturer determined the quantity of non-complying materials?
has the manufacturer taken all the necessary precautions to avoid dispatch of the product?
has the manufacturer informed the customers that they could have been given non-complying
silica fume?
Are the corrective measures taken due to a non-compliance recorded and traceable?
Is the efficacy of the corrective measures controlled and recorded?

A.3.3

Measuring and test equipment for autocontrol testing (4.3.3)

Is there a list of the measuring equipment used for autocontrol tests?

Is there a procedure for controlling and calibrating the test equipment?
Do the control and calibration procedures include:
equipment identification?
equipment supplier and model?
location of the equipment?
control frequency?
control method?
approval criteria?
reference samples/instruments?
measures to be taken in case the results of the control/calibration are not satisfactory?
Is each item of equipment identified by a label reporting:
dates of the last and next control/calibrations?
authorised signature?
Is non-calibrated equipment identified with a label indicating that it is out of service?

A.3.4

Quality records (4.3.4)

Are autocontrol results recorded and traceable?

Is the documentation relevant to the control and calibration of test equipment recorded and
traceable?
Does the works quality manual show that autocontrol results and control/calibration documentation
are kept for at least 10 years?

NB-CPD/SG02/07/044r1

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