SIST-TP CR 14245:2004
(Main)Guidelines for the application of EN 197-2 "Conformity Evaluation"
Guidelines for the application of EN 197-2 "Conformity Evaluation"
EN 197-2 specifies the scheme for the evaluation of conformity of cements to their corresponding product specification standards, including certification of conformity by a certification body.
The standard provides technical rules for factory production control by the manufacturer, including autocontrol testing of samples, and for the tasks of the certification body. It also provides rules for actions to be followed in the event of non-conformity, the procedure for the certification of conformity and requirements for dispatching centres.
In EN 197-2 the word "cement" is used to refer both to common cements as defined in EN 197-1 and to other cements and binders for which the relevant product specification standard makes reference to EN 197-2 and which are submitted for certification. Such a cement is produced at a given factory and belongs to a particular type and a particular strength class, as defined and specified in the relevant product specification standard. ?
Smernice za uporabo EN 197-2 "Ovrednotenje skladnosti"
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TP CR 14245:2004
01-januar-2004
Smernice za uporabo EN 197-2 "Ovrednotenje skladnosti"
Guidelines for the application of EN 197-2 "Conformity Evaluation"
Ta slovenski standard je istoveten z: CR 14245:2001
ICS:
91.100.10 Cement. Mavec. Apno. Malta Cement. Gypsum. Lime.
Mortar
SIST-TP CR 14245:2004 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST-TP CR 14245:2004
---------------------- Page: 2 ----------------------
SIST-TP CR 14245:2004
CEN REPORT
CR 14245
RAPPORT CEN
CEN BERICHT
July 2001
ICS
English version
Guidelines for the application of EN 197-2 “Conformity
Evaluation”
This CEN Report was approved by CEN on 13 March 2001. It has been drawn up by the Technical Committee CEN/TC 51.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2001 CEN All rights of exploitation in any form and by any means reserved Ref. No. CR 14245:2001 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST-TP CR 14245:2004
CR 14245:2001 (E)
Introduction to this Guidelines Document
Purpose
The purpose of this Guidelines Document is to provide explanatory detail on points not
fully elaborated in EN 197-2. It is intended for use by manufacturers and by
certification bodies involved in the certification of cement following EN 197-2, in
particular for the issuing of an EC Certificate of Conformity.
This Document does not deal with the necessary internal procedures that the
certification bodies will have.
It is an objective of this Guidelines Document that its use will assist in the
establishment of equivalent procedures for certification of cement. It is expected that,
following this Document, traditional good procedures and practices that may be
different can continue to be used, provided that they are not in contradiction with EN
197-2 and the relevant product specification standard. Such existing good procedures
and practices, applied in conjunction with these Guidelines, are not considered to be
an impediment to the achievement of the uniform level of certification throughout
Europe, and by different certification bodies, that is expected from the application of
EN 197-2 together with these Guidelines.
This Guidelines Document is based on existing situations for production, evaluation of
conformity and certification of cements. It may happen that certification bodies be
confronted by a situation different to those included in this document. In such a case,
specific procedures should be elaborated on a case by case situation and be approved
and fully recorded by the Certification Body. These specific procedures should always
fulfil the requirements of EN 197-1 and EN 197-2 and lead to the same level of
confidence in product conformity that would be achieved by application of this
Guidelines Document.
Arrangement
The clause numbering system of EN 197-2 is followed. The text of each of the clauses
of the Standard is reproduced in full and is followed by guidance, which is provided
only for those clauses where clarification or elaboration is needed.
CLAUSES OF EN 197-2
Foreword
1 Scope
2 Normative references
3 Definitions
4 Factory production control by the manufacturer
5 Tasks for the certification body
6 Actions in the event of non-conformity
7 Procedure for third party certification of conformity
8 Certificate of conformity and conformity mark
9 Requirements for dispatching centres
Tables 1 and 2
Annexes A and B
2
---------------------- Page: 4 ----------------------
SIST-TP CR 14245:2004
CR 14245:2001 (E)
Foreword
This European Standard has been prepared by Technical Committee CEN/TC 51
"Cement and building limes", the secretariat of which is held by IBN.
This European Standard supersedes ENV 197-2:1995.
Annex A of EN 197-2 is normative, annex B is informative.
According to the CEN/CENELEC Internal Regulations, the national standards
organisations of the following countries are bound to implement this European
Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany,
Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain,
Swede, Switzerland and the United Kingdom.
1 Scope
EN 197-2 specifies the scheme for the evaluation of conformity of cements to their
corresponding product specification standards, including certification of conformity by
a certification body.
The standard provides technical rules for factory production control by the
manufacturer, including autocontrol testing of samples, and for the tasks of the
certification body. It also provides rules for actions to be followed in the event of non-
conformity, the procedure for the certification of conformity and requirements for
dispatching centres.
In EN 197-2 the word “cement” is used to refer both to common cements as defined in
EN 197-1 and to other cements and binders for which the relevant product
specification standard makes reference to EN 197-2 and which are submitted for
certification. Such a cement is produced at a given factory and belongs to a particular
type and a particular strength class, as defined and specified in the relevant product
specification standard.
„
Guidance
EN 197-2 deals with the evaluation of conformity of cements and binders that are
submitted for certification. It deals in particular with cases where “further testing”
of the product is undertaken, as is the case for attestation system 1+ under the
Construction Products Directive. The products for which EN 197-2 is applicable
are: the 27 common cement products, refer EN 197-1, and masonry cements,
refer prEN 413-1. It will also be applicable for low heat cements, sulfate resisting
cements and calcium aluminate cements when the corresponding product
specification standards are adopted.
“ 2 Normative references
EN 197-2 incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the
text and the publications are listed hereafter. For dated references, subsequent
amendments to or revisions of any of these publications apply to EN 197-2 only when
incorporated in it by amendment or revision. For undated references the latest edition
of the publication referred to applies.
EN 196-1, Methods of testing cement - Part 1: Determination of strength.
3
---------------------- Page: 5 ----------------------
SIST-TP CR 14245:2004
CR 14245:2001 (E)
EN 196-7, Methods of testing cement - Part 7: Methods of taking and preparing
samples of cement.
EN 197-1, Cement - Part 1: Composition, specifications and conformity criteria for
common cements.
ENV 413-1, Masonry cement - Part 1: Specification.
EN ISO 17025, General requirements for the competence of testing and calibration
laboratories.
EN 45004, General criteria for the operation of bodies performing inspection.
EN 45011, General criteria for certification bodies operating product certification
(ISO/IEC Guide 65:1996).
ISO 2854, Statistical interpretation of data - Techniques of estimation and tests
relating to means and variances.
3 Definitions
For the purposes of EN 197-2, the following definitions apply:
3.1 Specific definitions
3.1.1
certificate of conformity
document issued under the rules of this scheme for the evaluation of conformity
indicating that adequate confidence is provided that cement is in conformity with the
relevant product specification standard „
Guidance
The term “certificate of conformity” refers to certificates of conformity issued by a
certification body under the rules of EN 197-2. This includes an EC Certificate of
Conformity issued in relation to the CPD.
“ 3.1.2
conformity mark
protected mark applied on the basis of the certificate of conformity (see 3.1.1) „
Guidance
The term “protected mark” includes registered mark, regulated mark and CE
marking.
“ 3.1.3
certified cement
cement for which a certificate of conformity (see 3.1.1) has been issued
3.1.4
initial period
immediate period after the first issuing of the certificate of conformity for a cement
4
---------------------- Page: 6 ----------------------
SIST-TP CR 14245:2004
CR 14245:2001 (E)
3.1.5
certification body
impartial body, governmental or non-governmental, possessing the necessary
competence and responsibility to carry out conformity certification according to given
rules of procedure and management
3.1.6
factory production control
permanent internal control of cement production exercised by the manufacturer
consisting of internal quality control complemented by autocontrol testing
3.1.7
factory
facility used by a manufacturer for the production of cement using equipment which is
suitable for continuous mass production of cement including, in particular, equipment
for adequate grinding and homogenization and the necessary silo capacity for the
storage and dispatch of each cement produced. This equipment and the production
control applied allow the control of production with sufficient accuracy to ensure that
the requirements of the relevant product specification standard are met „
Guidance
According to clause 4 of EN 197-1, common cements (CEM cements) consist of
different materials and are statistically homogeneous in composition resulting
from quality assured production and material handling processes. A high degree
of uniformity in all cement properties is obtained through continuous mass
production processes, in particular, adequate grinding and homogenisation
processes. Similar considerations apply for other cements.
Three categories of “factory” are recognised:
- Traditional full cement factories, where clinker and cement are produced on the
same site;
- Grinding plants, where cement is produced by grinding supplied cement
constituents;
- Blending plants, where ground cement constituents, which may be received
already combined as cement, are blended to produce finished cement.
The following operating steps, which apply for all of these types of factory, are
essential in the manufacturing process. These steps are needed to ensure the
necessary uniformity, continuity and suitability of the cement properties as well as
the ability to meet the other requirements of the relevant product specification
standard:
- Use of separate and adequate storage for the cement constituents;
- Controlling the cement constituents – including, where relevant, their fineness
and particle size distribution, and therefore their grinding – to achieve a
performance of the cement compatible with the requirements of the product
specification standard;
- Proportioning the cement constituents in order to achieve the target
composition of the cement;
- Homogenisation of the cement constituents by grinding, or by mixing where
relevant;
- Storage of finished product, in silos of adequate capacity, allowing proper
identification of mass quantities of product and giving the possibility of taking
spot samples at any time without prior notice.
Factories can only be operated by manufacturers which have personnel with
sufficient experience and knowledge in all operating steps important for cement
5
---------------------- Page: 7 ----------------------
SIST-TP CR 14245:2004
CR 14245:2001 (E)
quality and which have the people and test equipment to test, evaluate and
correct the cement being produced. The definition of factory in EN 197-2 takes it,
therefore, for granted that all operating steps listed above are carried out in effect
under the same quality responsibility.
“ 3.1.8
new factory
factory which is not already producing cement(s) certified under this scheme
3.1.9
existing factory
factory which is already producing cement(s) certified under this scheme
3.1.10
depot
bulk cement handling facility (not located at the factory) used for the dispatch of
cement (whether in bulk or bagged) after transfer or storage where the manufacturer
has full responsibility for all aspects of the quality of the cement
„
Guidance
It is important to point out the difference between a depot and a dispatching
centre. The difference consists essentially of the linkage to the factory and the
responsibility for the quality of the cement. In the case of a depot the facility is
strictly linked to the factory and is included in the factory Works’ quality manual.
The manufacturer has full responsibility for the quality of the cement released
from the depot. In a dispatching centre, in contrast, the facility is not at all linked
to the factory and it is an intermediary (an entity taking certified cement, acting
independently and operating between the manufacturer and a subsequent
customer) who has full responsibility for the quality of the cement dispatched. A
dispatching centre, being independent from the factory cannot be included in a
Works’ quality manual, but it has to ensure, using appropriate rules, that the
quality of an already certified cement does not undergo any change.
Depots are included in the Works’ quality manual. An entity other than the
manufacturer may own and operate the depot but it does this on behalf of and
under the strict quality management responsibility of the manufacturer.
“ 3.1.11
dispatching centre
bulk cement handling facility (not located at the factory) used for the dispatch of
cement after transfer or storage where an intermediary has full responsibility for all
aspects of the quality of the cement „
Guidance
See guidance under 3.1.10 and 9.1.
“ 3.1.12
intermediary
natural or legal person who takes from the manufacturer bulk cement certified
according to EN 197-2 and bearing the conformity mark, who undertakes full
responsibility for maintaining in a bulk handling facility all aspects of the quality of the
cement and who supplies the cement onwards to a further person
3.1.13
6
---------------------- Page: 8 ----------------------
SIST-TP CR 14245:2004
CR 14245:2001 (E)
confirmation autocontrol testing
continual testing carried out by an intermediary which consists of testing of samples
taken by the intermediary at the point(s) of release from the dispatching centre
3.1.14
works’ quality manual
document that provides information on the factory production control which is applied
by a manufacturer at a particular factory to ensure conformity of the cement with the
requirements of the relevant product specification standard
3.2 General definitions
See annex B (informative).
4 Factory production control by the manufacturer
4.1 General requirements
4.1.1 Concept
Factory production control means the permanent internal control of cement production
exercised by the manufacturer and consists of internal quality control (see 4.2)
complemented by autocontrol testing of samples of cement taken at the point of
1)
release (see 4.3).
NOTE The requirements of EN 197-2 as regards factory production control take
account of those clauses of EN ISO 9002 which are relevant to the production,
process control and testing of cement. „
Guidance
The purpose of factory production control is to ensure that the cement is
manufactured in a controlled way to meet all of the requirements of the relevant
product specification standard. In order that a certification body can verify such a
system it has to be documented in a structured way. This is carried out in a
Works’ quality manual supported and cross-referenced by a series of procedures,
work instructions and other associated and relevant documents. These need to be
clear, concise and adopt recommended good practices where applicable. The
factory production control system may form part of a wider, integrated
management system provided it can be demonstrated that all applicable
EN 197-2 requirements are addressed. See also the Note in 4.1.2 of the
Standard.
As depots are under the direct responsibility of the cement manufacturer, the
factory production control system must include them and appropriate procedures
should be produced, where relevant.
“ 4.1.2 Works' quality manual
1)
This testing corresponds also to the “further testing of samples” mentioned in Annex III
Section 2 point (i) of the Construction Products Directive 89/106/EEC.
7
---------------------- Page: 9 ----------------------
SIST-TP CR 14245:2004
CR 14245:2001 (E)
The manufacturer's documentation and procedures for factory production control shall
be described in a Works' quality manual, which shall adequately describe, among
other things:
a) the quality aims and the organisational structure, responsibilities and
powers of the management with regard to product quality and the means to
monitor the achievement of the required product quality and the effective
operation of the internal quality control (see 4.1.3);
b) the manufacturing and quality control techniques, processes and
systematic actions that will be used (see 4.2.1, 4.2.3 and 4.3.2);
c) the inspections and tests that will be carried out before, during and after
manufacture, and the frequency with which they will be carried out (see 4.2.2,
4.3.1 and 4.3.3).
The Works' quality manual prepared by the manufacturer for each factory shall include
an adequate system of documentation (see 4.1.4 and 4.3.4).
The Works' quality manual shall address and document the procedures operated to
ensure that the manufactured cement conforms to the technical specifications. The
manual may reference associated documents which provide further details of the
autocontrol testing of samples and the internal quality control. For the purpose of this
scheme, the term Works' quality manual shall be considered to include these
associated documents.
NOTE In the case of an existing quality management system according to EN
ISO 9002, the certification body may examine if the corresponding quality manual
meets all the requirements of EN 197-2 which are relevant to the factory production
control of cement. Provided all the requirements are included, this quality manual
may also be applied for product certification. „
Guidance
The Works’ quality manual is the fundamental document that describes the
factory production control system operated by the cement factory. It should clearly
state the scope of the factory production control system and must describe how
each of the elements of the system, as outlined in clauses 4.1 to 4.3.4, are
controlled and maintained.
The Works’ quality manual normally comprises a main document together with
associated documents and technical procedures. All these documents are written
in the current language of the factory’s country.
To ensure an effective factory production control system, there needs to be a well
defined organisational structure within the cement factory, showing very clearly
the lines of reporting and this is best achieved by one or more simple diagrams.
The manual should list all personnel who can affect quality within the
manufacturing process together with their job titles and refer to a description of
their tasks and responsibilities within the quality function. These should pay
particular attention to the level of authority to check, assess, verify and pass
conforming product during the stages of clinker and cement and, if appropriate
under the selected scope of factory production control, of raw materials, raw meal
and/or kiln feed.
Illustrative Example of Responsibilities - For Information Only
8
---------------------- Page: 10 ----------------------
SIST-TP CR 14245:2004
CR 14245:2001 (E)
Quality Manager
The Quality Manager has two overall responsibilities: to ensure that adequate
quality procedures exist and to ensure that the procedures are carried out. The
Quality Manager is responsible to the Factory Manager for:
The co-ordination, monitoring and updating of the Works’ quality manual
procedures.
Ensuring all personnel at every level are kept informed of working methods,
procedures, specifications and quality targets.
Setting the requirements for process control and supervising their written
transmission to the appropriate personnel.
Assessing the conformity of raw materials to the relevant specifications.
Controlling of off-specification constituents and non-conforming cements.
The identification and resolution of non-conformities in the factory production
control system.
Supervising the recording and processing of relevant data and consequent
approval.
Provide senior personnel with periodic reports on the compliance status of the
cement.
There needs to be a quality plan for the production of conforming cement and
whilst it must be recognised that the plan can take on one of many forms and
include such things as process flow charts and control tables, it must show how
each of the parts of the process are connected. There must be a clear indication
of where samples are taken and at what frequency, together with the tests to be
applied. Targets and acceptability criteria should also be documented.
Regarding the NOTE at the end of 4.1.2, in the case of an existing quality
management system in accordance with EN ISO 9002 it should be clearly stated
in the Works’ quality manual that the system is also used for factory production
control according to EN 197-2 and the relevant product specification standard. EN
ISO 9002 is currently under revision and will be incorporated in EN ISO 9001.
“ 4.1.3 Management systems
4.1.3.1 Quality policy statement
The Works' quality manual shall include a statement by management defining its
quality policy, objectives and commitments to the attainment of product quality. „
Guidance
The quality policy statement is a document signed normally by the managing
director of the company or by the manager of the factory, depending on the
organisation of the company, or by both. It should include the quality aims and its
commitment to meeting the requirements of standards and/or of its customers
and to ongoing improvement, both internally and externally. It should indicate
approval of the factory production control system as outlined in the Works’ quality
manual and that it is mandatory.
The system by which all personnel are informed of the quality policy should be
documented. A route for feedback should be established to aid understanding of
the policy.
9
---------------------- Page: 11 ----------------------
SIST-TP CR 14245:2004
CR 14245:2001 (E)
In the case of an existing quality management system in accordance with EN ISO
9002 (see comment in the guidance under 4.1.2 regarding the revision of this
standard), the quality policy statement should include a commitment to the
attainment of cement quality in relation to the relevant product specification
standard.
The Quality Policy should be reviewed periodically to ensure changes in aims are
incorporated.
“ 4.1.3.2 Management representative
The manufacturer shall appoint a management representative who, irrespective of
other responsibilities, shall have defined authority and responsibility for ensuring that
the requirements of EN 197-2 for the evaluation of conformity are implemented and
maintained. „
Guidance
The Management Representative should be clearly shown to have the necessary
dedication, time and authority to ensure that cement continues to conform to the
relevant product specification standard by the adoption of the requirements of the
documented factory production control system. As he has the ultimate
responsibility for the effective operation of factory production control his
responsibilities should at least include maintenance of the Works’ quality manual,
the operation of process and autocontrol and the evaluation of the cement data to
the relevant product specification standard requirements. Effective and
unrestricted communication channels to other affected departments must be open
to the management representative to discuss possible problems.
The authority and responsibility for the factory production control system and the
quality assurance of cement are not necessarily held by the same person.
The Works’ quality manual should state to whom the responsibility is transferred
in the absence of the management representative.
“ 4.1.3.3 Internal audits and management review
In order to ensure the continuing suitability and effectiveness of the Work’s quality
manual to meet the requirements of EN 197-2, the manufacturer shall perform at least
once per year:
a) internal audits covering the scope of this clause 4 and 6.1;
b) a management review of the factory production control, taking into
account records of the internal audits. „
Guidance
For audits to be of value there needs to be evidence that non-conformities raised
are progressed to a satisfactory conclusion and this must be assessed by
management during the review. Reviews should be conducted to an established
formal agenda by a management team and a record made of the findings,
showing actions to be taken and relevant responsibilities. Reviews will need to
take account of not only the internal audits but also of customer complaints.
Audits need to be carried out at an established frequency, procedures and plan,
by trained personnel independent of the area to be audited.
10
---------------------- Page: 12 ----------------------
SIST-TP CR 14245:2004
CR 14245:2001 (E)
It is essential that internal audits cover all aspects dealt with in the Works’ quality
manual, not forgetting compliance of cement constituents and cements with
standard requirements and in-process specifications.
“ 4.1.3.4 Training
The Works' quality manual shall describe the measures taken to ensure that all the
personnel involved in operations that can affect internal quality control and product
quality have appropriate experience or training. Appropriate records shall be
retained. „
Guidance
The adequate training of all personnel engaged in quality related matters and
forming part of the factory production control system is of prime importance. It
ensures that the exact skills and level of understanding are achieved to allow
tasks to be carried out correctly and efficiently.
A training plan, covering all the relevant personnel should be available, listing the
essential skills and education required for each element of the task/responsibility
to be covered. These need to cover both technical skills and an understanding of
the function and operation of quality systems. The training plan must be
supported by management and be continuous. It should indicate the minimum
educational level required for each role. Training can be external, as well as
internal - details of these should be recorded.
A separate training plan for new starters will be required to cover induction
training.
“ 4.1.4 System of documentation
4.1.4.1 Document control
The management representative shall be responsible for the control of all documents
and data related to factory production control and to this scheme for the evaluation of
conformity.
This control shall ensure that the appropriate issues of all documents are available at
essential locations, that obsolete documents are withdrawn and that changes or
modifications to any document are effectively introduced.
A master list shall be established to identify the current version of documents in order
to prevent the use of non-applicable documents. „
Guidance
The effectiveness of the factory production control system relies on the availability
and use of correctly updated documents and data which include the Works’
quality manual, procedures, operating instructions, technical specifications, plans,
flowcharts, test methods and data records; this list is not exhaustive. A procedure
must be available covering the issuing of amendments and updated documents.
All documents should be listed, giving proper identification, issue status
and approval, holders and locations and mode of disposal of previous issues.
If previous issues are to be retained they must be suitably marked to indicate that
they are obsolescent and withdrawn.
11
---------------------- Page: 13 ----------------------
SIST-TP CR 14245:2004
CR 14245:2001 (E)
The principles of the document control are the same as those of ISO 9002, which
can therefore be used as guidelines.
“ 4.1.4.2 Quality records
The manufacturer shall retain records of factory production control for at least the
period required to comply with relevant legislation. „
Guidance
All factory production control records should be kept for a minimum period of
three years and the Works’ quality manual will identify retention periods and
location of all records. Factory production control records that relate directly to the
finished cement should be retained for at least the period necessary to satisfy
product liability legislation and for at least a period of ten years.
All records must be legible, identifiable, retrievable and protected from damage,
deterioration or loss. Where records have been transferred to electronic or optical
storage media, suitable back up copies should be taken.
“ 4.2 Internal quality control
4.2.1 Process control
4.2.1.1 General
The Works' quality manual shall describe the parameters for process planning,
process control and testing, inspection, corrective action, verification, dispatch and the
associated records. „
Guidance
Process control should be designed to prevent non-conformities arising. This
cannot be achieved by testing only. To ensure that cement complies with the
relevant product specification standard, planning of the production process is
required and should address the following:
- A process flow description/diagram to illustrate the important production
elements and show how each stage is interrelated. This should include all
stages covered by
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.