Вы находитесь на странице: 1из 35

CERTIFICATION RULES

RULES FOR THE CERTIFICATION OF


MANUFACTURERS ACCORDING TO
- EWF/IIW SCHEMES (EN ISO 3834, EMS, SMS)
- EN 15085
Document n° CER_QAS 024 R
Document n° CER_QAS 024 R Rev. 06 Page 2/35

CONTENTS
1 SCOPE AND FIELD OF APPLICATION
2 REFERENCES
3 DEFINITIONS
4 SUBMITTING AN APPLICATION
5 REVIEW OF THE APPLICATION
6 QUALIFICATION
7 ISSUE OF THE CERTIFICATION
8 TERM OF VALIDITY OF CERTIFICATION
9 SURVEILLANCE
10 OBLIGATIONS OF COMPANIES WITH CERTIFIED PROCEDURES
11 SUSPENSION AND REVOCATION OF CERTIFICATION
12 DOCUMENTATION
13 CONTRACTUAL CONDITIONS
ANNEXES
A Recording of the assessment of the characteristics of the laboratory

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 3/35

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
1 SCOPE AND FIELD OF APPLICATION
1.1 This rule defines the criteria that IIS CERT applies for activities of certification for manufacturers of welding
products (hereinafter also referred to as Companies) in conformity with:
- series of standards EN ISO 3834 (Parts 2, 3, 4) according to the EWF and IIW schemes;
- EN 15085-2 (with reference to the welding of railway vehicles and components);
- EWF/EMS scheme;
- EWF/SMS scheme.
It discusses how to apply for, obtain, retain and use, as well as the possible suspension and revocation of
the certification.
The Rule is divided in:
- a general section common to the four schemes outlined above;
- four attachments, one for each if the four schemes outlined above.
The Annexes refer, in the numbering of the paragraphs, to the corresponding paragraphs of the Rule for
which additional requirements have been introduced.

1.2 For matters not covered by this document, refer to the general terms and conditions laid down in Rule
CER_QAS 017 R (see § 2) available on the IIS CERT website.

1.3 IIS CERT issues the certification according to standard EN ISO/IEC 17065 to Manufacturers who are found
to conform to all the requirements of the standard or the regulatory document of referral.
IIS CERT can undertake assessments of conformity to the series of standards EN ISO 3834 (according to
EWF/IIW Scheme) together with standard EN ISO 9001. In this case IIS CERT will act under standard EN
ISO/IEC 17021. Such activity is detailed in rule CER_QAS 019 R (see § 2).

1.4 Access to certification is open to all Manufacturers and is not conditioned by their belonging to any
Association or Group.
For its certification activity, IIS CERT applies its own fees and guarantees fairness and uniformity of
application.
IIS CERT can legitimate refuse to accept applications for certification in regards to Manufacturers subject to,
or whose production or activities are subject to, measures of limitation, suspension or proscription by a
Public Authority.

1.5 The certification issued by IIS CERT refers exclusively to individual Manufacturers, where the word
Manufacturer refers to a group, company, corporation, firm, organization or institution or part or combination
thereof, whether incorporated or not, public or private, that has its own functions and administration.
For those companies with more than one operational unit, each unit can be defined as a Manufacturer.

1.6 The prescriptions of the documents issued by ACCREDIA, ANSF and EWF/IIW (where applicable) and
listed in § 2 in relation to certified Companies or those that have applied for accreditation are an integral part
of the document.

1.7 IIS CERT will notify all companies certified by it of any amendment carried out by IIS CERT to the provisions
for obtaining and maintaining accreditation, for example following enactment of new national or international
regulations, or changes to regulations in force. These Companies are obliged to comply with the new
dispositions.
In advising the above said Companies of amendments made to its dispositions, IIS CERT will give them the
opportunity to make possible comments on the matter, setting a time limit within which they must comply
with the new dispositions.

1.8 IIS CERT does not provide consulting services to companies for the implementation of this Rule.

1.9 The Bodies that are guarantors of certification issued by IIS CERT (ACCREDIA, ANSF, EWF, IIW) may
request the presence of their observers to the audits being carried out by IIS CERT in order to ensure that
the methods applied by IIS CERT comply with the rules applicable to it.
The participation of these observers will agreed between IIS CERT and the Company.
The validity of the certificate is suspended if the Company does not give its approval to the above
mentioned participation.

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 4/35

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
2 REFERENCES
CER_QAS 002 R Rules for the use of the IIS CERT marking
CER_QAS 005 P Management of claims, appeals and improper use of the certification.
CER_QAS 017 R Rules for the assessments of systems, personnel, products – General
Contract Conditions
CER_QAS 019 R Rule for certification of management systems
EN ISO 9001 Quality management systems – Requirements
EN ISO 14001 Environmental management systems – Requirements with guidance for use
EN ISO 3834-1 Quality requirements for fusion welding of metallic materials – Part 1:
Criteria for the choice of level appropriate for quality requirements
EN ISO 3834-2 Quality requirements for fusion welding of metallic materials – Part 2:
Comprehensive quality requirements
EN ISO 3834-3 Quality requirements for fusion welding of metallic materials – Part 3:
Standard quality requirements
EN ISO 3834-4 Quality requirements for fusion welding of metallic materials – Part 4: Basic
quality requirements
EN 15085-1 Railway applications - Welding for railway vehicles and the relative
components - Part 1: General information
EN 15085-2 Railway applications - Welding for railway vehicles and the relative
components - Part 2: Quality and certification requirements for the
Manufacturer
EN 15085-3 Railway applications - Welding for railway vehicles and the relative
components - Part 3: Project requirements
EN 15085-4 Railway applications - Welding for railway vehicles and the relative
components - Part 4: Construction requirements
EN 15085-5 Railway applications - Welding for railway vehicles and the relative
components - Part 5: Inspection, testing and documentation
EN ISO 14731 Welding coordinator - tasks and responsibility
EN ISO 19011 Guidelines for auditing management systems
EN ISO/IEC 17065 Conformity assessment – Requirements for bodies certifying products,
processes and services
EWF-636r2-13 EWF Manufacturer Certification System for the Management of Quality,
Environment and Health and Safety in Welding Fabrication – Management
Schemes Interpretation and Implementation
EWF-637r2-12 EWF Manufacturer Certification System for the Management of Quality,
Environment and Health and Safety in Welding Fabrication – Guidance for the
implementation of EN ISO 3834 oriented to welded product standard
EWF-638r3-14 EWF Manufacturer Certification System for the Management of Quality,
Environment and Health and Safety in Welding Fabrication – Rules for
ANBCCs Operating the EWF Manufacturer Certification System
EWF-639r3-14 EWF Manufacturer Certification System for the management of Quality,
Environment and Health and Safety in Welding Fabrication – ANBCC’s
Assessment of Manufacturers of Welded Products Operating the EWF
Manufacturer Certification System
IAB-337r2-13 IIW Manufacturer Certification Scheme for the Management of Quality in
Welding – Interpretation and Implementation of ISO 3834 requirements
IAB-338r2-12 IIW Manufacturer Certification Scheme for the Management of Quality in
Welding – Supplement for the Implementation of ISO 3834 Oriented to
Welded Products

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 5/35

IAB-339r3-14 IIW Manufacturer Certification Scheme for the Management of Quality in


Welding – Rules for ANBCCs Operating the IIW Manufacturer Certification
Scheme
IAB-340r3-14 IIW Manufacturer Certification Scheme for the management of Quality in
Welding – ANBCC’s Assessment of Manufacturers of Welded Products
Operating the IIW Manufacturer Certification Scheme
doc. ANSF Guidelines for the recognition of Bodies of certification of Companies that
operate in the sector of welding railway rolling stock, or parts of them in
conformity with the standards of series EN 15085
IAF-GD5 Guidance on ISO/IEC Guide 65:1996
EA-6/02 Guidelines on the use of EN 45011 and ISOIEC 17021 for certification to
EN ISO 3834
RG-01-03 (doc. ACCREDIA) Regulation for the Accreditation of product Certitication Bodies
The documents of reference cited are applicable in their latest valid and/or revised edition.

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
3 DEFINITIONS
In general, the definitions in the documents of referral listed in § 2 and particularly those in standard ISO
3834-1 and EN 15085-2, integrated with the following, are applicable.

Finding: Matters raised by IIS CERT during audits conducted on manufacturers and formalized in its
audit reports.
For the purposes of this Rule, findings are divided as follows:
- nonconformity;
- observations;
- comments.
Nonconformity: Failure to satisfy a requirement set by the regulatory standards on the part of a Manufacturer
(document of reference, this rule (1), CER_QAS 002 R e CER_QAS 017 R).
The condition of non-fulfillment of a requirement may be due to one or both of the following:
a) failure to take into consideration or insufficient consideration of the actual requirement and/or
failure to define or insufficiently define criteria and methods adopted to comply with the
requirement;
b) failure to implement or insufficient practical implementation of the aforementioned
implementing criteria and methods.
For the purposes of the provisions contained in these Rules, a finding is classified as
nonconformity when the failure to meet the corresponding requirement in the manner specified
above is such that it may compromise the value of the certificates issued by IIS CERT in terms
of the effective and credible assurance of conformity of the object of the certifications.
In particular, the assessments of the EMS and SMS schemes, a nonconformity occurs when
there is a failure to comply with a mandatory requirement.
Observation: The finding formalized by IIS CERT in regards to the manufacturer is classified as an
observation when there is a failure to meet the requirement, although indicative of improper
behavior by the Manufacturer and as such requires correction, but is not such as to immediately
compromise the value of certification issued under the above conditions.
Comment: The finding raised by IIS CERT in regards to a Manufacturer is classified as a comment when it
is not subsequent to the finding of an objective situation of non-fulfillment of a requirement, but it
is intended to prevent this situation from occurring (as it is potentially possible) and/or to provide
guidance for improving the performance of the Manufacturer.
Note: (1) the following are considered as documents of reference:
- the series of ISO 3834 (Parts 2, 3, 4)according to the EWF and IIF plans, or
- standard EN 15085-2,or
- scheme EWF/EMS, or
- scheme EWF/SMS

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 6/35

The following abbreviations also apply:


CS: Coordinator of Welding
CPA: Area of Company Process Certification
GV: Group Audit
RCPA: Person Responsible for the Area of Company Process Certification
RGV: Responsible for the Group Audit

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
4 CERTIFICATION REQUIREMENTS
4.1 In order to obtain certification by IIS CERT, a Manufacturer must first of all satisfy within the time limits all
the requirements of the standards, or the document of reference and those indicated in the following
points, as well as any additional elements provided by Bodies of Accreditation (for example, ACCREDIA
technical Regulations, and EWF and IIW guide lines). In the specific case of assessments of conformity
under EN 15085-2 “technical interpretations of standards” is also considered (see Attachment B).
In fact, during the accreditation activities IIS CERT must follow the determined documents reference
issued by the Bodies of Accreditation.
These documents are available by contacting IIS CERT or directly from the Bodies of Accreditation (for
example, by consulting their websites).

4.2 In particular, to obtain certification the Manufacturer must guarantee the continuity of the methods of
production and the quality of the product subject of the certification.
The IIS CERT auditors undertake their assessments with reference to the requirements of the standards
regulating the certification of product/process welding.

4.3 The Company must take all the measures necessary so that the Auditor, the technical experts, observers,
etc, can carry out their visits in total safety. During the audit the Company assumes the same
responsibility towards these subjects as would an employer towards its employees so as to satisfy all the
conditions of the applicable legislation. IIS CERT personal must be constantly accompanied by Company
personnel.

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
5 APPLICATION FOR CERTIFICATION
Manufacturers that wish to obtain certification can supply the essential Company data to IIS CERT and
the relative activities undertaken by sending the specific form, “Information for preparing a contractual
quotation for company certification” (Mod. CSQ 017), duly completed in the applicable sections for the
System chosen, on the basis of which IIS CERT will formulate a quotation as per the fee list in force (in
the form of a contract to be signed).
The sums involved in the certification request for each type of application are listed in the single
Attachments.

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
6 EXAMINATION OF THE DOCUMENTATION
The Responsible for the file will verify the completeness and coherence of the documentation sent by the
Company and will then send the confirmation of acceptance of the application via fax, letter, or email,
together with the name of the RGV and the eventual auditor involved in the activity.
The Company can object to the above nominees within five working days of the notification, justifying the
reasons.
The RGV will then undertake a more detailed analysis of the documentation.
If such documentation is incomplete or does not conform, a request will be made for additional
information, or for it to be amended to complete the application, or to ensure its conformity. In the
meantime the file will remain suspended for a maximum of twelve months after which the whole process

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 7/35

can be repeated after a new quotation has been made, in the case IIS CERT ascertains that there are
circumstances that the contract cannot be respected.
During this stage it is established that the requirements for certification are agreed upon, documented,
understood and that
- the standards for which the certification had been requested are clearly defined in the various
documents issued;
- the product is clearly defined and congruent with what is defined in the various documents;
- IIS CERT has the ability to perform the certification activity with regards to the purpose of the
application and at the offices of the operational activities;
- that there is no conflict with what is shown in the application for certification and the document
supplied by the Company.
The initial audit (assessment) can only take place after documentation has been found to conform and
after all the requirements defined by the standard of reference have been fulfilled
IIS CERT then notifies the Company that the examination of the documentation has been completed.
The company can deliver the proper documentation during the opening meeting of the audit.

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
7 PRELIMINARY AUDIT
Upon formal request from the Manufacturer, a preliminary audit of the application can be carried out
before the assessment audit, based on the implementation of the document of reference.
The RGV will be notify the Company and this will be conducted to examine the requirements of the
document of reference, without carrying out the procedure for the assessment (for example, without
carrying out the opening meeting and checklists are not used).
The Manufacturer will be notified of the result of the audit report (Mod. CSQ 055) that can be delivered at
the end of the audit, or send later

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
8 ASSESSMENT AUDIT
Simultaneously or separately at the close the review of documentation, the RGV will agree the date with
the Company, send notice of the audit, send the audit plan and the name of the auditor appointed to
undertake the activity.
IIS CERT can ask the Company’s authorization of the participation observers and/or trainee auditors in
the audit.
The Company has the right to request the replacement or recuse the individual appointed, in case of
justified conflict of interest, within 5 days of the notification date.

8.1 Opening meeting


Before carrying out the assessment audit, the GV will hold an opening meeting, minuting the audit report
with Company management or its representative, the Coordinator of Welding and the main department
heads.
During the course of the meeting the RGV will:
- present the members of the GV;
- explain and provide any clarifications on the audit plan;
- provides a brief summary of how the audit is conducted;
- request the definition of the official lines of communication between the GV and the Company;
- where necessary, request more personnel to allow the auditors to operate separately;
- reaffirm the commitment to confidentiality of the Auditors and the personnel involved in the certification
practice;
- reaffirm that possible consultants strictly respect the role of observers;

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 8/35

- reaffirm that the audit is based on the sample method;


- state that the audit concerns product as it relates to certification;
- define the date and time of the closing meeting;
- present the ACCREDIA and/or EWF/IIW inspectors, when present.

8.2 Conducting the audit


During the audit the Company is required make available the personnel and give free access to company
premises, information, documentation relative to the standard for which certification is sought, including
the procedures and their equivalent and provide assistance to IIS CERT’s auditors.
The application of the requirements is checked through:
- interviews with personnel involved in the activities (at all levels);
- examination of the documents, procedures, instructions, Minutes of meetings, reports, etc to assess
the conformity to the documents of reference;
- assessment of the operation of the welding process;
- where applicable, verify the presence of documents of the qualification of the processes and the
welders/operators for each process for which the Manufacturer seeksr certification in accordance with
the product object of the certificate;
- verification of possible exclusions;
- correct definition of the scope of the certification.
The verification is carried out with the use of the applicable questionnaires on which the observations and
shortfalls found can be noted.
Note ,If during the course of the audits, taking into account the sample nature of the audit, should IIS CERT accidentally
find failures of legal requirements regarding aspects not directly related to the system being audted or of the product
inspected, but related to other matters of activities carried out by the Company (for example, in the case of ISO 3834,
environmental matters, or matters of health and safety) such anomalies will be duly recorded by the auditors in a
manner separate from the audit report and promptly advise the management of the Company under audit so it may
apply the applicable treatments and corrective actions. The recording of the matter will then be sent to IIS CERT’s
management for appropriate evaluation.

8.3 Meeting of the Audit Group


At the end of the audit and before the closing meeting the AG will meet to;
- verify that is has considered all the requirements applicable to the standard object of the certification;
- describe nonconformities in the appropriate report form (Mod. CSQ 020);
- elaborate the Audit report which will report eventual obervations and/or comments;
- solely for ISO 3834, record information relating to the product, the regulations/standards used for the
manufacture of the product, the basic materials group, the welding process and the like, the standards
(if different from those of EN) used per for qualification of the welding processes and the name(s) of
the Coordinator(s) of Welding;
- solely for EN 15085 verify the presence of documents of qualification of the welding processes and of
the welders/operators for each process for which the Manufacturer seeks certification, consistent with
the product object of the certificate.

8.4 Closing Meeting


The assessment audit ends with a closing meeting in which the RGV illustrates to the representatives of
the Company and to the CS:
- any reports of nonconformity;
- the possible observations and/or comments (described in the Audit Report);
- the “Audit Report” document.
The documents listed above are handed over to the Company representative who, if in agreement, will
sign them for acceptance and will keep a copy. If not in agreement he will express the reservations in the
space provided in the audit report.

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 9/35

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
9 MANAGEMENT OF THE FINDINGS
9.1 The nonconformities formalized by IIS CERT must be the object of the necessary treatment and
corrective actions on the part of the Organizations. Within thirty solar days from issue of the
nonconformity they must advise IIS CERT of these actions for eventual approval.
IIS CERT has the right within 15 solar days to request variations of the contents of the audit report and to
any nonconformities formulated by the Auditors.
In the presence of nonconformity the certificate and its extension will not be issued until confirmation of
the due application of the necessary treatments and the finalization of the corresponding corrective
actions and the assessment of their effectiveness by IIS CERT.
When the nonconformities are found during surveillance, or renewal activities they will notified to the
Deliberating Organ, together with a proposed treatment, corrective actions and time frame for their
assessment.

9.2 The observations formalized by IIS CERT must be the object of the necessary treatments and corrective
actions by the Organizations and submitted to IIS CERT whenever requested for eventual approval.

9.3 The comments do not require immediate and formal action. However, the degree of implementation of
the indications made by IIS CERT will be assessed on the occasion of the first useful audit.
If the aforementioned instructions are not adequately considered, the comment may be turned into an
observation. In that case the aforementioned conditions apply.

9.4 In the case of nonconformity the certification will not be issued until confirmation of completion of the
necessary treatment, closure of the corresponding corrective actions and the assessment of their
effectiveness by IIS CERT.

9.5 Dispensation of the proposed actions by the Company is not allowed, except for concessions by IIS
CERT for justified reasons.

9.6 IIS CERT reserves the right to assess the implementation of the actions proposed to the Company even
with the use of unplanned audits. If the treatment, the identification of the causes and possible corrective
actions/preventive actions are not considered assessable, the assessment will be made with only
documentary evidence.
In this case it is IIS CERT’s duty to give the Company adequate warning in order to prepare the visit.

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
10 RESULTS OF THE CERTIFICATION PROCESS
Only the files of the Companies for which the RGA has expressed a positive judgment and satisfy the
following conditions are presented to the Deliberating Organ:
a) the non conformities have been resolved, after having supplied evidence of the treatment and the
implementation of corrective actions within the agreed time;
b) the observations were treated presenting to the RGV an adequate plan to define the treatments
(where applicable), the causes, the corrective actions and the relative times of implementation.
In the case the RGV decides not to request the plan above, he will record the motivations in the
document of deliberation.
The Deliberating Body analyzes at least the following requirements and documentation:
- document review;
- purpose of the certification;
- the audit report;
- reports of nonconformity;
- observations;
- proposals for corrective actions;
- documentation regarding disputes that may have arisen.

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 10/35

If the Deliberating Organ deems the file incomplete, including the RGV’s report, or finds the plan defined
by the company inadequate, it will reject the resolution recording the reasons in the specific document.
The RGV will advise the Company of the motivations and will act to resolve the issues and then propose
another resolution for further consideration.
The positive outcome of the Deliberating Organ will be communicated to the Company together with
possible limitations (for example, a request for additional visits) and determines the release of a certificate
of conformity with a three or five year period of validity (see § 14.1) for the file in question. The certificate
will be made available to the Organization in electronic format in the restricted area of the IIS CERT
website (for the certificates issued according to the EWF/IIW plans, see also § A.10).
In any case the outcome will be presented at the first useful meeting of IIS CERT’s Committee for
Safeguarding Impartiality.
The validity of the certificate is defined in § 14 and in any case is subject to the results of the successive
surveillance audits.

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
11 SURVEILLANCE AUDIT
During the period of validity of the certificate the Company is obliged to maintain conformity of its systems
according to the standards of reference.
IIS CERT implements periodic audits ( annually ) of Constructions in order to :
- assess the maintenance of conformity to the requirements of the Standard of reference;
- verify the correct use of the certification and the IIS CERT marking;
- assess the correct implementation of the corrective actions (if applicable) in regards to the
nonconformities found in the course of the previous visit.

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
12 EXTRAORDINARY OR ADDITIONAL SURVEILLANCE AUDIT
The Deliberating Body reserves the right to require additional surveillance audits at the Company (or
based on documentation at the IIS CERT office) in the following cases:
- complaints or reports received by IIS CERT that are considered particularly significant in regards to
the nonconformity by the Manufacturer to the requirements of the standards of reference and this rule;
- processing of nonconformities or observations found during an audit or corrective actions which
cannot be evaluated just through review of the documentation;
- nonconformities found during an audit that do not give sufficient assurance of correct and/or
continuous application of the system introduced.
- unsatisfactory results during a surveillance audit, where applicable, at IIS CERT’s premises.
The aforementioned decision is notified to the Company together with the relative reason and the
deadlines by when it must be conducted.
It is preferable that the audit be conducted by one of the Auditors who participated in the preceding audit.
The requirements of the standard being reviewed are at least those considered noncompliant and/or
indicating a weakness in the system, found during the preceding audit.
The methods of conduct are the same as those defined for the surveillance audits.
The cost of the supplemental audit will be borne by the Company.
In case of refusal, without valid reasons, by the Company, IIS CERT can start the suspension process of
the certification.
The additional audit does not affect the frequency of the surveillance audits.

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 11/35

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
13 AUDITS WITHOUT NOTICE
It may be necessary for IIS CERT to implement audits without notice on certified Companies to
investigate complaints, or subsequent to modifications, or as follow up actions after the suspension of
certification.
The cost for the implementation of these audits must be considered contractually like those of additional
surveillance audits and therefore must be borne by the Company.
These audits:
- are implemented without warning;
- can be undertaken by the auditors nominated for the previous audit, unless as a result of it, the
Company has not disputed or made a formal complaint of said auditor. In this case, IIS CERT will
need to appoint other auditors in their place and will advise the client of them at the time of the
substitution.
The Company cannot raise objections with the members of the audit group.
In case of refusal, without valid reasons, by the Company, IIS CERT can start the suspension process of
the certification.
The audit without notice does not affect the frequency of the surveillance audits.

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
14 VALIDITY AND RENEWAL OF THE CERTIFICATION
14.1 The period of validity of certification is:
- in the case of ISO 3834, three or five years, according to the path chosen by the Company;
- in the case of EN 15085, three years
- in the case of the schemes EWF EMS, three years;
- in the case of schemes EWF EMS, five years (in alternative, three years of the Company asks to tiethe
certification and the others in effect to the three year period of validity).

14.2 A renewal audit will be implemented at the expiry of certification


The renewal is subject to a new order before a new quotation prepared with the assistance of the
information in IIS CERT’s possession.
The Company must send IIS CERT, should changes have occurred since the last visit, the following
documentation:
- application for certification and everything listed therein,
- the procedures(s) if modified in respect to the previous documentation sent to IIS CERT.
In the case of changes, IIS CERT formalizes the acceptance of the application and appoints the RGV for
the contractual period defined.
If there are no changes, the RGV is appointed directly for the contractual period defined.
The RGV will undertake the examination of the documentation only in the case of variations, notifying the
client of the audit plan and the appointment of any other auditors.
The renewal audit will be conducted by examining:
- the documentation of the audits of the precious period;
- all the quality requirements for the welding standard object of the assessment;
- the continued validity of the qualifications of the welders/operators relating to the processes/materials
object of the certification (where applicable), or risk the revocation of their certificate.
In any case, the renewal audit will follow the method of conduct of the audit, management of the findings
and the resolution are as §§ 8, 9, 10.

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 12/35

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
15 AMENDMENT OR EXTENSION OF THE CERTIFICATION
During the period of validity of the certification the Company must promptly advise IIS CERT of any
significant changes regarding its organization or activities.
The specific cases and the relative decisions made by IIS CERT are dealt in details within the single
Attachments.

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
16 OBLIGATIONS OF THE CERTIFIED COMPANIES
The certified Company is obliged to comply with the following conditions:
- not to use the IIS CERT, EWF, IIW, ACCREDIA marking in such a way as it can be interpreted as
product certification (e.g. marking on the product, etc.);
- not to use the certification is such a way as it can be considered held valid for activities other than
those for which it was issued, or in any case, in such a way as to mislead, or bring disrepute to IIS
CERT;
- immediately advise IIS CERT of any changes of Coordinators(s) of Welding;
- promptly notify IIS CERT of any changes to the Company or changes in ownership, or other changes
which could affect its ability to satisfy the certification requirements;
- accept, at its own expense, even unscheduled audits which may become necessary to keep the
certification valid following changes in ownership, organizational modifications or other situations
considered significant by IIS CERT;
- allow access to its premises by IIS CERT’s auditors, or its authorized representatives (including
possible observers), supplying them the assistance necessary during the audits;
- implement the corrections for a correct management of the quality requirements for the welding
following deviations detected;
- not use the certification when it has been suspended, revoked, or has expired;
- keep a record of all complaints relating to their activities, as well as actions taken as a result;
- manage the copies of the certificate that are no longer valid as an obsolete document;
- keep the documentation sent by IIS CERT updated.
Nota In addition, the company should also take into account the following requirements taken from the EN ISO/IEC 17065:
- always meet the certification requirements, including implementation of necessary modifications notified by IIS
CERT;
- take all necessary measures for the conduct of audits, including the provision of the necessary documentation
and records and access to equipment, staff and subcontractors;
- under suspension, revocation or expiration of the certification discontinue use of all advertising material that
contains any reference to it;
- in the case of delivery of certificates to others, to reproduce them in their entirety.

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
17 WAIVER BY THE COMPANY
If the certified Company intends to waive the certification, it must give formal notice to waive the contract
at least 6 months before the date (month / day) of expiry of the certificate.
The Company may also waive certification in the case of changes to these rules and variations of the
reference standard certification.
The withdrawal by the Company involves the simultaneous and automatic revocation of certification. This
situation shall be communicated to the Bodies of accreditation/recognition, which will provide the
appropriate measures (such as, by way of example, the obligation to proceed to the next surveillance
audit in a time equal to that established in the quotation for similar activities).
Following the waiver, the Company must:
- return the certificate to IIS CERT;
- not use the certification;

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 13/35

- remove every reference to and symbol of IIS CERT certification from its letterheads, technical
documentation and advertising.
IIS CERT will delete the Company from the list of certified Companies and make public the waiver using
the means by which the certification had been advertised.
Furthermore, the certificate already issued to the Company will be removed from the restricted area of the
IIS CERT website after prior and formal notification.
The company, which after waiver wishes to be re-certified must submit a new application repeating the
whole process.

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
18 SUSPENSION AND REVOCATION OF THE CERTIFICATION
18.1 The certification may be suspended in the following cases:
- nonconformity and/or observation, for which no treatment has been completed nor corrective actions
implemented within the specified time;
- nonconformity and/or observations for which IIS CERT had not defined, nor accepted,within the terms
of the contract, the treatment, the corrective actions and the times of implementation;
- repeated delays in the processing of the nonconformities and/or observations and in the
implementation of the resulting corrective actions;
- changes to the organization of the Company that had not been accepted by IIS CERT;
- in the case of major restructuring of the Company which were not communicated to IIS CERT;
- refusal or obstruction of monitoring visits;
- improper use of certification and/or the IIS CERT marking;
- delinquency in the payments of the IIS CERT services;
- verified claims received for IIS CERT that the Company had not properly managed;
- any other circumstance that IIS CERT, in its opinion, believes have a negative influence on the
certification granted.
The suspension procedure is preceded by a written warning setting out the terms which, if not met, would
trigger a suspension.
The Company may also request of IIS CERT, justifying the reason, the suspension of the certification.
The suspension is decided by the Deliberating Body and cannot last more than six months (after that, the
revocation becomes effective).
Suspension shall begin from the date of the resolution and is given in writing by registered mail to the
Company, stating the conditions for re-instating the certification and the date by which they must be
implemented. Such notice is submitted to IIS CERT’s Committee for Safeguarding Impartiality.
As a result of the suspension, the Company must inform its customers of the situation.
The suspension of the certificate’s validity may be made public by IIS CERT.
The restoration of the certification is subject to certification of the elimination of the deficiencies which
caused the suspension. It is notified in writing by registered letter to the company and made public by IIS
CERT if the news of the suspension had been made public at the time.

18.2 Failure to meet the requirements of the point above and/or in due time will lead to revocation of the
certificate.
The revocation of the certificate may be decided in the following cases:
- suspension that continues longer than six months;
- misuse of the certificate and/or IIS CERT marking;
- failure by the Company to adopt the new rules expressed by IIS CERT following changes to the
Regulation;
- persistent delinquency in the payments of the IIS CERT services;

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 14/35

- Company’s failure to implement the measures requested by IIS CERT following incorrect use of the
logo and the certification;
- termination of the activity certified;
- proof that the scheme certified does not ensure compliance with the binding laws and regulations
applicable to the characteristics of the product supplied;
- Company’s failure to accept the new financial conditions established by IIS CERT for the possible
change in the contract;
- for any other justified reason, in the opinion of IIS CERT.
The revocation is decided by the Deliberating Body.
Withdrawal of the certificate shall be notified in writing by registered letter to the Company.
IIS CERT notifies the Accreditation Bodies the name of the organizations whose certifications have been
revoked, specifying the reasons.
The Company which has had the certification revoked must:
- return the original of the certificate;
- not use copies or reproductions;
- remove every reference to and symbol of IIS CERT certification from the letterheads, documentation
technical and advertising;
IIS CERT will delete the company from the list of certified Companies and make public the revocation
using the means by which the certification had been advertised.
Furthermore, the certificate previously issued to the Company will be removed from the restricted area of
the IIS CERT website, following prior and formal notification.
The Company, which after revocation wishes to be re-certified must submit a new application repeating
the whole process.

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
19 PUBLICATION BY IIS CERT
IIS CERT will make publicly available the information relating to certifications issued, suspended, or
revoked.
IIS CERT will publicize certification gained by a Company by inserting it in the list of certified Companies
in its website(www.iis.it),where the following information is shown:
- number of the certificate;
- The Company name;
- the addresses of the site object of the certification;
- the products supplied under the System;
- the qualified materials;
- the processes used for their production;
- the principle Coordinator of Welding;
- The standard of reference adopted;
- the expiry date of the certificate.
The data above will be provided by IIS CERT to the Bodies of accreditation, in relation to the state and
the type of accreditation.

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
20 USE OF THE CERTIFICATE AND THE MARKING
The Company can also use the IIS CERT marking relative to the certification obtained- eventually
together with those of ACCREDIA, ANSF, EWF and IIW (each where applicable)- on technical
documentation, goods and instrumental means used for the realization of the processes (such as
commercial vehicles, buildings, as well as shirts and overalls and similar) and advertising as long as:

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 15/35

- correct reference is always made to the field and limits of the certification obtained and in any case in
such a way as not to mislead;
- that the requirements for the use of the marking are always met, with the obligation to respect the
conditions provided for in Rule CER_QAS 002 R (see § 2).
In particular the company is forbidden from using the certificate and logo when :
- certification has not yet been granted, it has been suspended or revoked or the licensee has waived
the certification;
- new requirements that result from amendments to this Rule or the certification scheme in question
have not been applied;
- situations have been found which may adversely affect the certification scheme chosen.
In addition, the Company is forbidden from:
- altering the certificates, or copies of it;
- using the IIS CERT marking in such a way that it can be interpreted as product certification (e.g.,
marking on the product, on primary packaging, etc);
- implement solutions differing from those in rule CER_QAS 002 R, without prior authorization.
Once ascertained the improper use of the certification, IIS CERT will put into effect the measures
necessary to protect its image and to preclude such use.

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
21 STANDARDIZATION OF THE VISIT DATES FOR VARIOUS CERTIFICATIONS
If a Company has been certified in differing times and according to differing plans and/or standards, it
may formally request to standardize the dates for the successive audits. IIS CERT can consent subject to
examination of the request and recording of the considerations/motivations that led to the decisions and
reissue the certificates, in any case without implementing the audits in periods longer that 12 months.
If the surveillance audits should be combined with audits of other schemes of management systems both
the planning of the audits and the report will indicate clearly the aspects relative each system.

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
22 AMENDMENTS OF SCHEME EWF FOR CERTIFICATION
In the case of amendments to scheme EWF for Company certification, IIS CERTwill immediately officially
advise the interested Companies and make available the updated applicable documentation, as well as
the time frame within which the Companies must meet the new requirements.
The starting date for the amendments will be agreed between IIS CERT and Company (which has the
possibility to make observations) with the aim to allow the Company the time necessary to implement the
amendments.
The Company interested in the amendments must, in any case, provide proof of taking charge of the
matter by written notice to IIS CERT of having accepted (at the agreed date) the amendments. IIS CERT
will assess the conformity of the new requirements at a later date, during the first surveillance or renewal
audit of the certification (following the date agreed for implementing the amendments).
Companies that do not intend to accept these amendments can surrender the certification.

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
23 REGISTRATION DOCUMENTS
The records of activities undertaken must be kept in electronic format.
In general the following registration documents must be kept (each one where applicable)
- quotation request,
- quotation/order;
- application for certification,
- acceptance of the application,

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 16/35

- registration in the CCIIA,


- procedures,
- appointment of the RGV and/or Auditor (if required);
- comments in the quality and the procedural manuals (if any),
- preliminary audit report (if any);
- closing of the document review,
- notification of the audits,
- audit plan,
- questionnaires used during the visits,
- reports of nonconformity and/or observations (if any),
- audit report,
- evidence of corrective actions (if any),
- copies of the certificates issued by IIS CERT,
- correspondence to and from the Company.
Company records with certifications that are no longer valid must be kept for 6 years from the date of the
last audit undertaken.

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
24 CONTRACTUAL CONDITIONS

For the contractual conditions, the provisions contained in the " Rules for the assessments of systems,
personnel, products – General Contract Conditions " (see § 2) are applicable in the latest revised edition.

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 17/35

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
ANNEX A Special features for the certification of Manufacturers according to EN 3834 (EWF/IIW
Scheme)
A.1 Scope and Field of Application
A.1.1 This Attachment defines supplementary, non replaceable rules applied by IIS CERT for the certification of
Manufacturers according to EN 3834 (EWF/IIW Scheme) in respect to the definitions contained in the
preceding general section.
Only the points of the General section for which supplementary rules are applicable and the relative
numeration of the sections correspond.

A.5 Application for certification


A.5.1 Upon request by the Company, IIS CERT can undertake assessments of conformity of the quality
requirements for:
- supplements to the product relating to the manufacture of structures in steel or aluminum;
- supplements to the product relating to the manufacture of pressure vessels;
- supplements to the product relating to the manufacture of railway components and vehicles.

A.5.2 The applicant Manufacturer must give IIS CERT at least the following information:
- the standard subject of the certification;
- the manufactured product for which certification is requested;
- the number of persons interested in the certification and involved in the Company;
- the number of shifts,
The RCPA will verify IIS CERT’s capacity to carry out the request and, if all is found to be clear, prepare a
suitable quotation, justifying any differences from the prices listed.
In the case the quotation is accepted, the Company will formalize the request for certification by sending
IIS CERT the contract duly signed.
The contract can be amended subject to the agreement of both parties when, in the course of the contract
beginning with the examination of the documentation, there should be changes in the conditions on which
IIS CERT’s initial offer was prepared (e.g., amendments to the regulations of the Bodies of accreditation,
the site, the Company, processes, number of persons, type of products fabricated).
The documents needed by the Company to put the practice of certification in effect are available on the
website http://www.iis.it :
a) this rule;
b) rule for the use of the IIS CERT Marking (CER_QAS 002 R);
c) Application for certification form (Mod. CSQ 009);
d) the questionnaire for the quality requirements for welding EN ISO 3834-2 accroding to EWF/IIW Scheme
(CSQ 012 A);
e) the questionnaire for the quality requirements for welding EN ISO 3834-3 according to EWF/IIW scheme
(CSQ 019 A);
f) the questionnaire for the quality requirements for welding EN ISO 3834-4 according to EWF/IIW scheme
(CSQ 009 A);
g) the instructions for Companies requesting EN ISO 3834 certification in conformity with EWF/IIW scheme.
If the Company is unable to visit the Web address of the IIS CERT, it may request the necessary
documentation.
The Company must send the following documentation together with the order, or subsequently to it:
- Application for certification form (mod. CSQ 009), duly completed in the parts within its competency
(including what is requested within it);
- the procedures(s) defined as per instruction CSQ 020 I;
- documents of the appointment of the Coordinator(s) of Welding.

A.8 Assessment audit

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 18/35

A.8.1 Minimum requirements


In order to undertake the assessment audit, the Company must have implemented and maintained in
operation the contents defined in CSQ 020 I ("Instructions for Companies requesting EN ISO 3834-2, 3
and 4 certification in conformity with scheme EWF e IIW”).

A.8.2 Assessment of the Coordinator of Welding


Companies which also request certification in conformity with standard EN ISO 3834 must appoint the
CS.
In the absence of binding requirements, the following describes the level necessary and the minimum
knowledge required in relation to the products fabricated:
1) Comprehensive level: For the execution, supervision and testing of manufacture of welded articles
highly critical for safety and regarding a wide range of welding processes and
base materials, the minimum level of knowledge requested is the E/IWT
diploma or its equivalent assessed by written questionnaire;
2) Specific level: For the execution, supervision and testin of the fabrication of welded articles
of an average level for criticality for safety and regarding a limited range of
welding processes and base materials, the minimum knowledge required is an
E/IWS diploma or its equivalent assessed by written questionnaire;
3) Basic level: For the execution, supervision and control of the manufacture of welded
articles not critical for safety, characterized by a particularly simple method of
fabrication (e.eg. a single material and process), the minimum level of
knowledge required is an E/IWP dilpoma,or its equivalent assessed by written
questionnaire;
The assessment of experience is made by analysing the curriculum vitae of the CS that had been
archived with the results of the audit and on the basis of evidence gathered in audits undertaken of
products, the standards applied, processes, materials and the CND used.
If a Company requests a level for which the candidate possesses a qualification/certification considered
insufficient in respect to the minimum requirements described, the candidate will be assessed on the
basis of a written questionnaire and an interview.
The levels defined above will be assigned to the CS.
IIS CERT must be immediately advised on any change in relation to the CS.

A.8.3 Specific activities: Companies that undertake activities outside the headquarters/operative units
Companies that undertake activities of installation and/or assemblage fall under this section.
Companies that request that this type of activities undertaken by them also be checked must also, once
the contractual aspects have been settled, supply the list of the work sites open during the period in which
the assessments are planned.
The audit will then proceed in the following way :
- at least one work site must be assessed for each type of visit (assessment/surveillance/renewal) and
in any case all the products, processes and materials to be included in the certificate must be
assessed;
- the presence of at least one qualified welder/operator per type of product, process, base material
requested must be verified;
- at least one Coordinator of Welding for each single work site must be appointed and present on site.
The certificate will show the Coordinator(s) of Welding of the factories (not the work sites) and, according
to how the product made, with one of the following written statements:
a) L. only erection on site / L.
b) L. erection on site included / L.

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 19/35

A.8.4 Specific activities: Companies that do not weld, but entrust the welding activities to subcontractors
The organizations that are responsible towards their clients also for the process of welding, but do not
undertake welding themselves and transfer the execution of said process to subcontractors come within
this section.
The organizations that request that this type of activity also be checked must, once the contractual
aspects have been settled, supply a list of the subsuppliers to whom they have entrusted the fabrication
of the products object of the certification.
If the above subcontractors are certified dy Accreditation Bodies according to standard EN ISO/IEC
17065,will be considered qualified subcontractors
If said subcontractors are not certified by Accreditation Bodies according to standard EN ISO/IEC 17065,
IIS CERT reserves the right to plan part of the audits (assessment, surveillance and
renewal) with said subcontractors to assess the correct application of the quality
requirement for welding.
The certificate will show the Coordinator(s) of Welding and after the products the following will be written:
-) L. welding activities subcontracted
The certificate will show the welding processes and materials as non applicable.

A.10 Results of the process of certification


The certificate will show the following information:
- The certification scheme (ISO 3834, EN 15085, EWF/EMS, or EWF/SMS);
- the unit, the name of the certified Company;
- located in: the addresses of the production sites assessed and therefore covered by the certification;
- company: the Corporate name and structure;
- the product subject of the certification;
- the number of the certificate and revision;
- issue date: date of the first release (beginning of the period of validity) that coincides with the date of
the resolution of the certification;
- renewal date, not to be filled in on the first release:
- expiry date of the certificate (three or five years, respectively according to whether or not it is tied to
another standard- in respect to the date of closure of the assessment audit);
- the standards for the product;
- the processes and base materials covered by the qualification;
- the name(s) of the Coordinator(s) of Welding.
The certificate will also be sent to the Company in paper.

A.11 Surveillance audit


With the exception of those Companies that undertake activities only on site, the 2nd, 3rd and 4th
surveillance audits can be undertaken through the use of a questionnaire and at IIS CERT’s offices,
instead of the Company’s manufacturing sites, provided that the Company, since the last surveillance
audit maintained strict conformity with the items shown on the schedule of the certificate and had shown
objective evidence of the proper implementation of the certification plan. In which case the Company
must send, within the time stated in the surveillance audit, the questionnaire regarding the relative
standard, fully completed as self-evaluation at least one activity carried out and one in the process of
fabrication.
The periodic visits must be carried out by the date (date and month) of the expiry date of the certificate
and no more than three months before the end of validity.
Any changes to the date (day and month) due to justified motives, must be agreed in advance with IIS
CERT and in any case cannot exceed three months.
The company is subjected to assessment according to a program set out in such a way that:

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 20/35

- the compulsory requirements shown on the audit plan are verified in the course of the assessment,
including the continued validity of the qualifications of the welders/operators in relation to the
processes/materials object of the certification, otherwise the certificate will be modified;
- the verification of all the other (non compulsory) requirements is carried out at least once (during the
surveillance undertaken at production sites;
- the competence of the Coordinator(s) of Welding already defined during the assessment phase will be
assessed.
The validity of the certificate is confirmed following the positive outcome of the surveillance activity.
The dates of the surveillance audits will be agreed with the Company in due time and officially confirmed
before each visit.
Details of notification and conduct of visits are the same as set forth for the assessment audit, while the
management of the comments is defined in § 9.
The Deliberating Organ will analyze the file and will highlight any problems, recording ita intervention.
The principal documents analyzed for monitoring the efficiency of the single audits are listed below:
- the audit report;
- any reports of nonconformity;
- documentation regarding disputes that may have arisen;
- information raised in the “Activity of certification by standard”;
- CV of the Coordinator of Welding if not professionally qualified and in course of validation.
The Deliberating Organ may request clarifications, additions and/or amendments.

A.14 Validity and renewal of the certification


The renewal audit must take place within three months before the expiry date shown on the certificate in
force.
If the audit takes place shortly before the expiry date of the certificate, the RGV will activate an
emergency procedure aimed at allowing the Deliberating Organ to verify the file and to allow release of
the new certificate before the expiry of the previous certificate.
The methods of conduct of the renewal audit, the management of findings and the resolution of
certification are those indicated in §§ 8, 9, 10.
The certificate will be amended as follows:
- increase the revision number;
- Renewal date to coincide with the date of resolution of the renewal of the certification;
- Date of expiry of the certificate (which will correspond with previous certificate, day and month, plus 3
or 5 years), except for agreements made before hand between the organizations concerned.

A.15 Amendment or extension of the certification


A.15.1 During the period of validity of the certification the Company must immediately notify IIS CERT of any
significant changes concerning:
- company organization;
- change in company name and/or change in the address of the registered office and/or of the production
units;
- production sites;
- procedures;
- products;
- company personnel;
- change of CS.
In relation to the type of changes made, IIS CERT reserves the right to:
a) make an unscheduled inspection visit to evaluate the effects of variations on the quality requirements
for welding;
b) review the contract terms for subsequent visits.

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 21/35

Below please find some cases.

A.15.2 In cases of changes on the juridical entity named ad the holder of the certificate, or within the certified
Company, IIS CERT will gather all the information necessary to understand the entity and nature of the
changes in the policies, in the activities and in the Company. In those cases in which there is, or there
could be a change on the policies and/or the activities and/or the Organization IIS CERT will assess the
possibility of activating a new process of certification with an initial visit properly sized and planned to
ensure the execution of all the assessments necessary. The scope and all the other information
contained in the certified will be suitably adjusted to the new situation.
The certificate will be reissued changing:
- the number of the certificate;
- the name of the Company;
- the first issue date;
- current issue date.

A.15.3 In the case where the changes to the legal entity have no significant effect on the organization (e.g. does
not change the aims of the constitution, does not change the structure of ownership, and/or Board of
Management, and/or C.E.O., etc) IIS CERT will verify the conditions and can examine the hypothesis of
maintaining the number of emission and eventually the scope of the certificate.

A.15.4 In the cases where the Company asks for modifications or extensions of the certification (e.g. addition of
products, materials, sites other than those certified) the modifications are to be considered as extensions
of the filed of application of the certification.

A.15.5 IIS CERT reserves the right to examine the requests on a case by case basis and to decide the methods
of assessment, including variations to the contract, executing unprogrammed (additional) audits with the
aim of issuing new certification, or the extension of the current valid certification.
The decision made in this regard are recorded.
Refusal by the Company is the equivalent of waiver of the contract.
The management process of these files will be recorded.
The following are examples of some documents useful for the purpose:
- application for a variation;
- Minutes of the decisions and / or delivery of the quotation;
- receipt of the order;
- receipt of the revised procedures;
- opening of the examination of documentation;
- appointment of the RGV and/or assessor and/or technical expert, if those previously appointed do not
have the competecies required;
- comments on the documentation received;
- closing of the document review;
- notification of the visit of extension of the variation requested, even if it is implemented together with a
surveillance audit.
If it becomes necessary to change the certificate in the 1st and/or 2nd page, the following procedure will
follow;
- the entire certificate will be reissued;
- the number of review will be increased;
- The “Place, date” on the 2nd page will be reissued.
The file will be presented to the Deliberating Organ that will analyze at least the following requirements
and documentation:
- the application by the Company;
- the standard;
- document review;
- purpose of the certification;

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 22/35

the outcome of the documental analysis will be recorded and if favourable, the certification will be issued
and sent to the Company together with eventual relevant condition (e.g. requests for additional audits) or
observations.
The drafting amendments to the certificate will be implemented without the resolution by the Deliberating
Organ.
If the Company suspends production of a produce subject of certification for a period of time superior to
one year IIS CERT reserves the right to verify the maintenance of the competencies and to eventually
modify the certificate.

A.16 Duties of certified Companies


If during an assessment, surveillance or renewal audit differences are found in the number of employees
concerned with the quality requirements for welding declared by the Company and present at the time of
the assessment, the RGV will issue a nonconformity that the Company must act upon.
Certification of conformity with the quality requirements for welding granted the Company is limited to
production units mentioned in the certificate and is not transferable
Furthermore, this does not absolve the company from legal obligations arising from the products and
services provided and the contractual obligations to its customers.
When the Company revises the documentation relating to the quality requirements for welding it must
advise IIS CERT which reserves the right to request a delay.
The results of the documental analysis will be communicated officially.
On the occasion of the first programmed visit, the Company will deliver to IIS CERT a copy of said
revised documentation and at the same time make available copies of the previous editions of
documentation or under revision beginning with the last edition examined up to the first programmed visit.

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 23/35

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
ANNEX Features specific to the certification of Manufacturers according to EN 15085-2
B.1 Purpose and Field of Application
B.1.1 The present Attachment defines the supplementary, non substitutive, rules applied by IIS CERT for the
certification of Manufacturers according to EN 15085-2 in respect to what was previously defined in the
general section.
Only the points of the General section for which supplementary rules are applicable and the relative
numeration of the sections correspond.
Furthermore, a specific point (B.27) is inserted regarding the technical interpretation of EN 15085-2 which
does not correspond to a point in the general Section.

B.5 Application for certification


The applicant Manufacturer must send the following information to IIS CERT:
- the address of the production sites to be subjected to certification;
- the level of certification (CL) in reference to § 4 of EN 15085-2 ( the definition of CL is the exclusive
burden and responsibility of the Company ) ;
- construction of new products, conversion or repair;
- field of certification (welding processes, base materials, thicknesses, etc);
- name, surname, date of birth and qualification of the Coordinator of Welding;
- notes and extension of the application (work undertaken in other production sites different from the
principle sites);
- number of persons interested in the certification and engaged in the Company;
- the number of work shifts.
According to data provided IIS CERT will prepare a quotation in accordance with the fee list in force.
In the case of acceptance of the quotation, the Companies involved will formalize the application for
certification by sending IIS CERT an order of acquisition.
The contract can be amended, subject to agreement between the parts if, over the period of the contract,
beginning with the examination of the documentation, there should be changes of the base conditions by
which IIS CERT’s initial offer was prepared (e.g. amendments to the regulations of the accrediting Body
site, Company, processes, number of persons, type of product made).
All the documents necessary for a Company to begin the process of certification are availabe on the
website http://www.iis.it;
a) this rule;
b) the rule for the use of the IIS CERT marking (CER_QAS 002 R);
c) application for certification (CSQ 079 A).
If the Company is unable to visit the IIS CERT website, it can request the documents by post.
Together with the application for certification, or subsequently, the Company must submit to IIS CERT :
- the application for certification(CSQ 079 A), including the attachments requested therein;
- the procedures requested for certification in accordance with standard EN ISO 3834;
- the documents of appointment and the curriculum vitae of the Coordinator(s) of Welding.

B.8 Assessment audit


B.8.2 Assessment of the Coordinator of Welding
For the assessment of the CS, refer to details in § B.27.3.
Any changes in relation of the CS must be immeditaely communicated to IIS CERT.

B.10 Results of the process of certification


The certificate will show:
- The name of the certified Company (name and legal form);

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 24/35

- addresses of production sites audited and therefore covered by the certification;


- the level of qualification;
- the product subject of the certification;
- the processes (EN ISO 4063);
- the groups of the base materials (CR ISO 15608) covered by qualification and for which at least 2
qualified welders/operators are available;
- the type of joint
- the thicknesses of the base materials covered by the qualification;
- any thicknesses of joints valid by themselves;
- the name of the person responsible for the coordinators of welding;
- the name of the Deputy person responsible for the coordinators of welding;
- the names of any other coordinators of welding;
- any notes/prescriptions;
- date of " first issue " ( beginning of the validity of certification), which coincides with the date of the
resolution of the certification;
- date "current issue", which coincides with the date of subsequent resolutions ( e.g. variations in the
certificate, renewal, etc.);
- "expiry date" of the certificate (three years after the closing date of the successful assessment audit).
The certificates issued in recognition of the National Agency for the Safety of Railways bearing the
reference to the Guidelines, with the phrase: “Certification has been granted in accordance with the
"Guide lines for recognition of Certification Bodies of the companies that operate in the sector of welding
of railway vehicles or parts thereof in accordance with the standards of series EN 15085-2 ed. 2008“.

B.11 Surveillance audit


During the period of validity of the certificate, the Company is obliged to maintain conformity of the
requirements of the standard of reference.
IIS CERT will implement periodic audits (annual basis) in order to:
- assess the maintenance of conformity to the requirements of the Standard of reference;
- verify the correct use of the certification and the IIS CERT marking;
- assess the proper implementation of any applicable corrective actions relative to nonconformity and to
the observations found during the previous visit;
- assess the analysis and eventual handling of the comments.
The periodic visits must be undertaken within 12 months of the day in which the meeting of the closure of
the first audit is held (the date, day and month, the expiry of the certificate).
The audits undertaken at the Company premises can be carried out up to three months in advance.
Any changes to the date (day and month) due to justified motives, must be agreed in advance with IIS
CERT and in any case cannot exceed three months.
The company is subjected to assessment according to a program set out in such a way that:
- mandatory requirements highlighted in the audit plan will be checked during each assessment,
including the continued validity of the qualification of welders/operators in regard to
processes/materials object of the certification, otherwise the certificate will be modified.
- the assessment of all the remaining non mandatory requirements will be implemented at least once
(during the assessments undertaken at the production sites);
- the competence of the Coordinator(s) of Welding already defined during the assessment phase will be
assessed.
The validity of the certificate is confirmed following the positive outcome of the surveillance activity.
The results of surveillance visits shall be recorded, including any findings (nonconformity, observations,
comments, etc.). A finding of nonconformity will result in the request for an additional visit.
The dates of the surveillance audits will be agreed with the Company in due time and officially confirmed
before each visit.

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 25/35

The methods for the notification and conduct of the visits are the same as for the assessment audit.
Any nonconformity found during the surveillance activity will be presented to the Deliberating Body
together with a proposed treatment, corrective action and time frame for its assessment. The Body
reserves the right, to accept the proposal, or to request additions or variations within fifteen calendar
days.
The RGV can request that the Company forward a plan for the treatment and the corrective actions of all
matters found. For these matters, the RGV reserves the right to also request evidence of the closure of
the treatment and the corrective actions within the time limits set by the Company.
The principal documents analyzed for monitoring the efficiency of the single audits are listed below:
- the audit report;
- any reports of nonconformity;
- documentation regarding disputes that may have arisen;
- information raised in the “Activity of certification by standard”;
- CV of the Coordinator of Welding if not professionally qualified and in course of validation.
The Deliberating Body will analyze the above, choosing samples from the Company subject of the
surveillance and will record the intervention.
The Deliberating Body can request explanations, additions and/or variations.

B.14 Validity and renewal of certification


The renewal is subject to the release of a new order following a quotation prepared with the assistance of
the information in IIS CERT’s possession, or the application (CSQ 079 A), compiled in case the variations
in respect to the certification in place.
The Company must send IIS CERT the procedures, if modified in respect to those previously sent.
The Responsible for the scheme will appoint an RGV and any auditors for the following three years.
The methods of notification are the same as those established for the Assessment audit.
The renewal audit:
- can take place only after the documentation is considered in conformity, taking into account the
outcome of the previous visits;
- follows the same methods as the assessment audit;
- is conducted by re-examining all the requirements, including the verification of the validity of the
qualifications of the welders/operators in regards to the processes/materials subject of the certification,
confirming or reducing the scope of the certification;
- must be implemented within the three months before the expiry date shown on the certificate in force,
except by agreements made in advance between the interested organizations
The outcome of the assessment will be recorded.
Any nonconformity found will be presented to the Deliberating Body together with a proposal treatment,
corrective action and time frame for its assessment. The Body reserves the right to accept the proposal,
or to request additions or variations within fifteen calendar days.
If the audit takes place close to the expiry date of the certificate, the RGV can activate an emergency
procedure in order to allow the Deliberating Body to verify the file and allow release of the new certificate
before the expiry of the previous certificate.
The treatment of the nonconformity must be completed before the expiry of the certification.
The RGV can request that the Company forward to IIS CERT its plan for the treatment and the corrective
actions for all the other findings
The RGV also reserves the right to ask for proof of the closure of the treatment and the corrective actions
defined by the Company.
IIS CERT may request further clarifications and additions by the Company.
Waivers from the actions proposed by the company are not allowed unless conceded by IIS CERT for
justified reasons.
Subsequently, the file will be examined by the Deliberating Body which will examine it, record the
outcome and if favorable, release the certification that will be sent to the Company.

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 26/35

In any case, the outcome will be presented to the Committee for Safeguarding Impartiality during the first
effective meeting.
The certificate will be amended as follows:
- the date of "current issue" which will coincide with the date of the resolution;
- the new expiry date (corresponding to that of the previous certificate, day and months, plus three
years), unless previously agreed with the organizations concerned.

B.15 Amendment or extension of the certification


During the period of validity of the certification the Company must immediately advise IIS CERT of any
significant changes concerning:
- the Corporate name;
- the addresses of the production sites shown on the certificate;
- products;
- procedures;
- the base materials;
- the CS (also regarding the level, e.g. Responsible, the substitute, etc);
- any notes or explanations.
In relation to the type of changes made, IIS CERT reserves the right to:
a) make an unscheduled inspection visit to evaluate the effects of variations on the quality requirements
for welding;
b) review the contract terms for subsequent visits.
In the case of refusal by the Company, IIS CERT reserves the right to cancel the contract, by revoking the
certificate.
In the case of change of name, the company must advise IIS CERT changes made by sending a copy of
the new certificate of incorporation or equivalent document and IIS CERT, after investigation, will issue a
new certificate.
The company in possession of certification may request changes or extensions of the certification, such
as taking on requirements previously not provided, such as processes, products, sites other than those
certified. These changes are to be considered as an extension of the field of application of the certification
IIS CERT reserves the right to consider the requests on a case -by-case basis and to decide the
assessment methods, including contractual changes, in order to issue a new certificate or the extension
of the certification in force.
The management process of these files will be recorded.
The following are examples of some documents useful for the purpose:
- application for a variation;
- Minutes of the decisions and / or delivery of the quotation;
- receipt of the order;
- receipt of the revised procedures;
- opening of the examination of documentation;
- apointment of the RGV and/or auditor and/or technical expert if those previously appointed do not
possess the necessary competencies;
- comments on the documentation received;
- closing of the document review;
- notification of the visit of extension of the variation requested, even if it is implemented together with a
surveillance audit.
If it becomes necessary, the certificate has amended with :
- the date of "current issue" which coincides with the date of the resolution.

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 27/35

If the Company suspends the production of a product or the provision of a service to be certified for a
period, generally less than one year, IIS CERT reserves the right to verify the maintenance of
competencies and possibly revise the certificate.

B.16 Obligations of the certified Companies


If during an assessment, surveillance and renewal audit there are found to be differences in the number
of employees involved in the requirements for the quality of welding, declared by the Company and which
iss present at the time of assessment, the RGV after having heard the RCPA will define the changes of
the contractual terms (eg. visit times, economic changes)
The above variations will be minuted in the audit report.
Failure to accept the new contractual condition will be the subject of a nonconformity
The certification of the quality requirements for welding is granted to the Company is limited to production
units mentioned in the certificate and is not transferable.
Furthermore, this does not absolve the company from legal obligations arising from the products and
services provided and the contractual obligations to its customers.
When the Company reviews its documentation it must advise IIS CERT, which reserves the right to
request submission. The results of the examination of the documentation will be notified officially.
On the occasion of the first programmed visit, the Company will deliver to IIS CERT a copy of said
revised documentation and at the same time make available copies of the previous editions of
documentation or under revision beginning with the last edition examined up to the first programmed visit.
Furthermore, in cases of irregularities found by the control Authorities, suspensions or revocation of
permits or concessions regarding aspects related to the object of the certification and legal proceedings in
progress or final judgment concerning the scope of certification (cases treated in § 11.2 of Rule
CER_QAS 017 R) IIS CERT will promptly inform the Bodies of accreditation/authorization in respect of
the matters raised.

B.17 Waiver by the Company


If the certified company waives its certification before the recertification audit, IIS CERT will advise ANSF,
which will advisee the appropriate measures to be taken.

B.27 Technical interpretation of EN 15085-2


The criteria of interpretation referred to in this paragraph must be applied in the course of assessments of
conformity at the Company premises and are therefore an integral part of the certification scheme.
For each requirement of EN 15085-2 this paragraph states what is deemed necessary for the proper
application of the requirement.
In any case, the information in this section assumes full compliance with all the requirements of standard
EN 15085 in all its parts.

B.27.1 Minimum requirements


A separate certificate for each productive site of a Company must be issued.
To obtain certification in accordance with standard EN 15085-2, beyond what is specifically detailed in
said standard, the Company must:
- respect the provisions defined in document CSQ 079 A(Application for certification);
- implement the information in this document;
- have in production at the time of the assessment audit, welded components belonging to the field of
application of the standard.
Should the Company while it produces the types of products for which it seeks certification find itself in
one of the following conditions :
a) the Company is producing the product without the specific requirements relating to the EN 15085 or
b) the Company has no products in the class requested.
the RGV may propose the release of the certificate subject to request for a supplementary visit when the
company starts production in the terms defined in the application for certification.

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 28/35

The Company must:


- communicate to IIS CERT the start of production as defined above, or risk suspension of certification;
- apply all the requirements of EN ISO 3834, for the applicable part as indicated by EN 15085 Part 2,
Attachment C.
If the company is already in possession of valid certificate according to EN ISO 3834, issued by an
accredited certification body, IIS CERT can consider this requirement satisfied by standard EN 15085-2,
provided a copy of the report audit of the last visit with the relative findings of the latest visit is made
available and the measures stated have been taken.

B.27.2 Welders and welding operators (ref. EN 15085-2, paragraph 5.1.1)


In addition to the requirements of EN 15085-2, the Company must :
- have at least two welders certified according to the applicable EN standards, for each welding
process, each type of coupling (BW/ FW) and each group of basic material for which it seeks
certification;
- schedule the execution of pre-production testing as required by EN 15085-4 paragraph 4.2.4. The
samples must be kept at least one year from the date of execution and Minutes of the execution of the
same shall be issued.

B.27.3 Coordinators of Welding (ref. EN 15085-2, paragraph 5.1.2)


In addition to the requirements of EN 15085-2, the company that wants to operate in accordance with its
terms and is interested in obtaining certification must :
a) have Coordinators of welding whose level of qualification meets the requirements of EN 15085-2
section 5.1.2 and Attachment C, for each production site. In particular, the welding coordinators must:
- be qualified/certified to EWF/IIW Scheme (levels E/IWE, E/IWT, E/IWS, E/IWP ), or equivalent
schemes (eg. other schemes of International/National qualification/certification) at the planned level
and have at least three years experience in the railway sector
or
- in the absence of qualifications/certifications, possess schooling consistent with the levels of
qualification referred to the EN 15085-2, paragraph 5.1.2, three years of experience in the railway
industry and technical knowledge appropriate to the required level highlighted in the curriculum
vitae that must be kept up to date.
b) have Coordinators, preferably Company employees.
If the coordinators are not qualified/certified to EWF/IIW Scheme, an assessment will be carried out
during the audit, also with the assistance of the specific questionnaire, in order to assess their knowledge
of the welding processes adopted, the standard of reference, etc.
The positive outcome of this assessment will help to assign the level (A or B or C) corresponding to the
Coordinator.
The Coordinator who fails the examination may take the assessment again after adequate training.
In the case of CL1 certification of large Companies with multiple production lines, the Coordinator of
Welding responsible for level A must possess a qualification equivalent to the level of engineer, while the
position of delegate must possess A level qualifications at the level of technologist.
The change of one or more Coordinators of welding must be promptly reported to IIS CERT which must
undertake an supplementary visit to evaluate the competence of the new staff. Failure to communicate is
considered a comment.

B.27.4 External Coordinators of Welding (ref. EN 15085-2, paragraph 5.1.3)


In addition to the requirements of EN 15085-2, Companies that wish to operate in accordance with its
terms and are interested in obtaining certification and decide to entrust the coordination of welding
activities to external personnel in respect of the provisions of EN 15085- 2, paragraph 5.1.3, must
provide evidence of the presence and activities carried out by the coordinators at each visit.
Furthermore, each outside Coordinator can assume this role strictly limited to a maximum of two
Companies.

B.27.5 Inspection and testing Personnel (ref. EN 15085-2, paragraph 5.1.4)

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 29/35

In addition to the requirements of EN 15085-2, the company that wishes to operate in accordance with its
terms and is interested in obtaining the certification must ensure that the personnel involved in non-
destructive testing has certification in accordance with EN 473 ( or ISO 9712) at level 1 or 2 according to
the assigned tasks issued by a Body of certification to the accredited staff as per EN ISO / IEC 17024.

B.27.6 Specifics of welding procedure (ref. EN 15085-2, paragraph 5.4)


In addition to the requirements of EN 15085-2, the Company that wishes to operate in accordance with its
terms and is interested in obtaining the certification must work in production based on WPS qualification
as per EN ISO 15613, EN ISO 15614, EN ISO 14555.
Qualifications issued in accordance to superseded EN standards are acceptable.
In the case of production of joints made with fillet welds, the qualification of the process must be carried
out on welding heels with fillets.
The qualification of the WPS can be carried out by a Body of certification of a third party or the
coordinator responsible of the Company.
The Company must also establish appropriate criteria for the execution of pre-production testing as
required by EN 15085-4, section 4.2.5 ( these tests should be retained for at least one year and must be
traceable also to the practitioner).

B.27.7 Destructive and non-destructive testing


Destructive and non-destructive testing concerning the qualification of the process and of the
welders/operators must be performed by a testing laboratory that operates as per EN ISO / IEC 17025.
Some cases are detailed as follows:
a) laboratories accredited by ACCREDIA;
b) laboratories approved by IIS CERT as per rule CER_QAS 018 R;
c) in the case of laboratories that do not fall within the previous points: the Company applying for
certification shall provide proof on the qualification of the laboratory and staff, workplace and
environmental conditions, testing methods, equipment, calibration, manipulation of objects to be
tested, assurance of the test results and presentation of the results

B.27.8 Fields of validity


Only EN standards are to be considered.
Fields of validity to be shown on the certificate are only those resulting from the intersection of the fields
of validity of QP and QS (subject to the conditions of § B.27.2 ).
Qualifications issued in accordance to superseded EN standards are acceptable. The field of validity to
be shown on the certificate is that resulting from these qualifications. Should the company transform the
qualifications in accordance with current standards and forwards it to IIS evidence the certificate will be
re-issued. This situation will be minuted.
Joints qualified according to the EN ISO 15613 are generally not taken into account. However, where a
qualification was issued to support the products mentioned in the subject of the certification, they can be
taken into account with the validity range defined in WPQR (process, joint type, thickness ).

B.27.9 Extension of the fields of certification


The Company may request additions to the certificate in subsequent audits relating to :
a) fields of validity (thicknesses and/or diameter);
b) products, processes, materials, etc.
In the first case, all necessary documentation to provide adequate proof (including test reports) must be
sent. The RGV will assess the documents and propose the revision of the certificate with the appropriate
fees.
In the second case, an additional surveillance audit must be made.

B.27.10 Assessment of a Company in CL 4


To assess a Company requesting CL 4 (Company that does not weld, but subcontracts products to be
welded ):

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 30/35

- Conformity to EN 3834 standards (eg. assessing suppliers, purchase orders, checks in acceptance,
expertise of CW, the presence of the mockup, the validity of QS and QP suppliers, etc) must be
verified;
- The RGV must record the processes applied by the Organization: planning and/or acquisition and
assemblage and/or marketing.

B.27.11 Products certified according to EU directives


Certification to EN 15085-2 is not requested of Companies which provide products to be inserted in
railway products falling in specific European directives for which they already hold certification (e.g.
simple container under pressure according to UNI 286 ).

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 31/35

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
ANNEX C Special features for certification of Manufacturers according to EWF EMS Scheme
C.1 Purpose and field of application
C.1.1 This Attachment defines additional, non substitutive rules applied by IIS CERT for the Certification of
Manufacturers according to EWF EMS Scheme in regards to what was previously defined in the General
section.
Only the points of the General section for which supplementary rules are applicable and the relative
numeration of the sections correspond.

C.5 Application for certification


When a manufacturer of welded products – already operating under the EWF ISO 3834 – contacts IIS
CERT for certification as per EWF EMS Scheme, IIS CERT’s Environmental Scheme Manager will
send/request the following documents of the Manufacturer:
- The document CSQ 041, "Guideline for EWF EMS certification for manufacturers of welded products”,
which describes how the manufacturer must interpret and apply EN ISO 14001 to the welding
activities and connected processes within the Company;
- the informative questionnaire that the manufacturer shall complete and return to IIS CERT which must
contain at least the following information:
- the welding processes applied and the processes connected to them,
- materials used, directly and indirectly;
- environmental processes used to keep pollution under control;
- the internal rules, the laws and regulations applicable to the environment.
- The "Questionnaire for the EWF EMS certification for manufacturers of welded products” (CSQ
document 042 A) which can be compiled by the manufacturer and returned to IIS CERT.
In addition to the above documents, the Manufacturer must submit the latest revision of the environmental
analysis report( EAR ).
Upon receipt of the above documents duly completed the Scheme Environmental Manager will appoint
the EWF EMS assessment group that will define and record at least the following information/documents:
- the polluting agents that come from the welding process and the processes connected to it;
- the internal rules showing the limits of environmental pollution;
- the laws and regulations applicable to the acceptable pollution levels provided for each pollutant
agent.
The IIS CERT Assessment Group will then compile a "table of pollutants" (referred to the Manufacturer).
Before the end of this phase, the Manufacturer may request and obtain from IIS CERT a preliminary visit (
which will be done by the above EWF EMS group) after which the Manufacturer will be formally briefed on
the points of EWF EMS Scheme that have not yet been completely satisfied.

C.8 Assessment audit


C.8.1 Assessment of a Manufacturer that has already applied for the EWF ISO 3834 plan
The actual situation of the application of EWF EMS Scheme applied by the Manufacturer is formally
assessed at the site of the manufacturer’s premises by the Assessment Group through interviews,
examination and analysis of documents and direct observation of activities in the areas of production of
welded products.
In particular, the Assessment Group must consider whether:
- the environmental analysis report includes all aspects and the related environmental impacts due to
the welding process and the connected processes;
- all the pollutants defined and reported in the "Table of pollutants" were used as a basis for the release
of the environmental analysis report;
- the negative environmental impacts mentioned in this report have given rise to plans for reducing
pollution within the prescribed limits required;
- the Environmental Coordinator of Welding possesses all the requirements imposed by §§ 2 and 3 of
document CSQ 041;

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 32/35

- the Manufacturer applies (and how) standard EN ISO 9001;


- the Manufacturer uses all the points of standard EN ISO 14001, not only in the area of welding but
also in all the other production areas.
The questionnaire ( CSQ 042 A) can be used by the evaluation team as a guideline to be followed during
the assessments.
Any nonconformity found must be recorded in a nonconformity report which must include at least:
- type ofnonconformity (essential, important, marginal);
- the area where the nonconformity has been found;
- description of the nonconformity;
- reference to the environmental rules/laws that were not met;
- corrective actions and dates of resolution/completion proposed by the Manufacturer.
Before closing the nonconformity report, IIS CERT must verify that corrective actions planned have been
properly and fully applied.

C.8.1 Assessment of a manufacturer that does not apply scheme EWF ISO 3834
Guideline CSQ 041 I allows a Manufacturer which does not apply scheme EWF to request and obtain
ISO 3834 certification EWF EMS provided that said Manufacturer demonstrates an equivalent
management system for the control and optimization of the entire welding process.
IIS CERT fully applies the following to assess the above equivalent system.
The actual situation of the application of EWF EMS Scheme applied by the Manufacturer is formally
assessed at the premises of the manufacturer by the Assessment Group through interviews, examination
and analysis of documents and direct observation of activities in the areas of production of welded
products.
In particular, the Assessment Group verify if:
- the Environmental Analysis Report includes all the aspects and the related environmental impacts due
to the welding process and connected processes;
- all pollutants defined and listed in the "Table of pollutants" have been used as the basis for the
release of the Environmental Analysis Report;
- the negative environmental impacts indicated in said Report have given rise to plans for reducing
pollution to meet the prescribed limits requested;
- the Environmental Coordinator of Welding possesses all the requirements imposed by paragraphs 2
and 3 of the Guideline ( CSQ 041 I);
- if (and how) the Manufacturer applies standard EN ISO 9001;
- The Manufacturer applies all the points of standard EN ISO 14001, not only in welding, but also in all
the other production areas.
The questionnaire (CSQ 042 A) can be used by the Assessment Group as a guideline to be followed
during the assessment.

C.10 Results of the process of certification


At the end of the audit the leader of the Assessment Group will issue a final assessment report.
This report is then delivered to the IIS CERT Environmental Scheme Manager for approval.
Any reports of nonconformity must be highlighted in the final assessment report.
The report must indicate whether the result of the audit assessment is considered "Satisfactory" or
"Unsatisfactory".
Only the Manufacturers for which the result of the assessment audit was " Satisfactory " may be proposed
by the Environmental Scheme Manager to the Certification Commission.
The certificate is issued after the positive ruling by the Certification Commission.
When the Environmental Scheme Manager proposes certification of the Manufacturer under scheme
EMS, the Manufacturer must not have any nonconformities still open.
A large number of observations not preclude the possibility of the proposal of certification by the
Environmental Scheme Manager to the Deliberating Body, provided that these observations are corrected
within a reasonable period of time agreed between Manufacturer and IIS CERT.

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 33/35

The Environmental Scheme Manager will record the Deliberative Body’s decision and inform the
manufacturer of its results. In the case of a positive result, the Environmental Scheme Manager
Environmental will issue the relative EWF EM certificateS and send it to the manufacturer.
If the Manufacturer does not apply scheme EWF ISO 3834, the Deliberating Body must also approve the
Table (Mod. CSQ 024 ) compiled by the Environmental Scheme Manager and attach it to the certificate.
Any change relating to the welding process or processes connected to it which results changes in the
information entered in the schedule attached to the certificate must lead to the formulation of a new Table
This revision must be submitted to the Deliberative Body for due approval.

C.11 Surveillance audit


The surveillance of EWF EMS Scheme applied by the manufacturer is made to verify the correct
implementation and proper maintenance of the scheme as certified.
Audits usually take place once a year with the same procedure described for the initial assessment and
with the addition (when applicable) of assessing the closure of nonconformity and the effectiveness of the
corrective actions implemented.

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 34/35

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
ANNEX D Specific features for the certification of Manufacturers according to EWF SMS Scheme
D.1 Scope and field of application
D.1.1 This Schedule defines additional, non substitutive rules applied by IIS CERT for the Certification of
Manufacturers according to EWF SMS Scheme as previously defined in the General section.
Only the points of the General section for which supplementary rules are applicable and the relative
numeration of the sections correspond.

D.5 Application for certification


When a Manufacturer of welded products already operating under scheme EWF for the application of
standard EN ISO 3834 contacts IIS CERT for certification according to the EWF SMS Scheme it must
submit the following documents:
- the application for certification (CSQ 009 A) duly completed as per the request made;
- the procedure that describes how the Manufacturer applies the system.
Upon receipt of the above documents duly completed the Environmental Scheme Manager appoints the
Assessment Group.
Before the end of this phase, the Manufacturer may request and obtain from IIS CERT a preliminary visit
(which will be done by the Assessment Group) after which the Manufacturer will be formally briefed on the
points of EWF SMS Scheme not yet completely satisfied.

D.8 Assessment audit


The effective application of EWF SMS Scheme applied by the manufacturer is formally assessed at the
site of the manufacturer by the same Assessment Group through interviews, examination and analysis of
documents and direct observation of activities in the areas of production of welded products.
In particular, the evaluation group for scheme SMS assesses whether:
- the procedure implemented is adequate;
- the system implemented is properly applied.

D.10 Results of the process of certification


Only Companies for which the AG give a favorable or otherwise beneficial judgment, as a result of the
assessment audit and for which the following conditions are met :
- any issues of nonconformity have been resolved and proof provided of the implementation of
corrective actions (within the agreed time) and
- for the observations that the treatment, the corrective action and timing are defined.
They are retained by the Proponent Function which analyzes the results of the audit and reserves the
right to propose additions or changes within 10 working days.
The process continues with the analysis of the documentation recorded on form Mod. CSQ 063.
The file will be presented to the Deliberating Body that will analyze it, recording the outcome on form
Mod. CSQ 063 and if favorable the certification will be issued and sent to the Company.
The result will still be presented to the IS CERT Committee for Safeguarding Impartiality during the first
useful meeting.
Should the certification not be issued, the Manufacturer will be advised of all the causes for which it was
not granted and the times within which they must be eliminated.
The above time limits can be modified in special cases at the request of the Company and in the
judgment of IIS CERT.
If the times are not met, the certification process is concluded and the Company must submit a new
application for certification.
The Company is obliged to accept the decisions made by IIS CERT and in such a case the Company
must return the certificate. If it considers the motivation injustified and does not accept the decision, the
Company can activate the appeal procedure.
The certificate is valid for three years but is subject to the results of the subsequent surveillance audits. In
addition to the information about the certification as per ISO 3834, the certificate will also show:

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA
Document n° CER_QAS 024 R Rev. 06 Page 35/35

- the certification scheme (SMS);


- the name of the CSS.

D.11 Surveillance audit


Surveillance of EWF SMS Scheme is applied by the Manufacturer to verify the correct implementation
and proper maintenance of the Scheme as certified.
The audits usually take place once a year with the same procedure described for the initial assessment
and with the addition (when applicable) of verifying the closure of nonconformity and the effectiveness of
corrective action taken.

IIS CERT srl


Lungobisagno Istria, 29 r. - 16141 GENOVA

Вам также может понравиться