CERTIFICATION OF THE MANUFACTURER'S QUALITY
ASSURANCE SYSTEM
(EXPLOSIVE FOR CIVIL USES AND PYROTECHNICAL ARTICLES)
Technical instruction
CERTIFICATION OF THE MANUFACTURER'S QUALITY
ASSURANCE SYSTEM
(EXPLOSIVE FOR CIVIL USES AND PYROTECHNICAL ARTICLES)
These technical instructions provide basic information for obtaining a certificate, in
accordance with the
Directive 2014/28/EU on the harmonisation of the laws of the Member States relating to the
making available on the market and supervision of explosives for civil uses
and
Directive 2013/29/EU on the harmonisation of the laws of the Member States relating to the
making available on the market of pyrotechnic articles
Agencija za prostore ugrožene eksplozivnom atmosferom – Ex-AGENCIJA
Industrijska 25, HR-10431 Sveta Nedelja
Tel/Phone.: ++ 385 1 36 67 260 Fax.: ++ 385 1 36 67 262
www.ex-agencija.hr
[email protected]
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CERTIFICATION OF THE MANUFACTURER'S QUALITY
ASSURANCE SYSTEM
(EXPLOSIVE FOR CIVIL USES AND PYROTECHNICAL ARTICLES)
1. INTRODUCTION
The purpose of these instructions is to clarify the procedure of certifying the quality assurance
system of a manufacturer who produces explosive for civil uses or pyrotechnical articles. This
procedure applies to the certification of the quality assurance system, based on Modules C2, D or E
of Directive 2014/28/EU and Modules C2, D or E of Directive 2013/29/EU (in further text The
Directive).
These instructions do not contain the procedure of type certification (per Module B of the Directives
which is described in the instructions on Certification od explosive for civil uses and pyrotechnical
articles (TU-CERT-ekspl).
2. INITIAL AND RE-ASSESSMENT (SURVEILLANCE)
The quality assurance certification by Ex-Agencija consists of: examination of the documentation
(with regard to conformity and preparation for assessment), on-site assessment of the quality
assurance system and elimination of any nonconformity ascertained. Once these nonconformities
have been successfully eliminated within the given deadlines, a Quality Assurance notification is
issued with an expiration date of 1 years (Modules D and E. The quality assurance certification
procedure is repeated before the notification expires.
For Module C2 it is carried out batch tests for every production batch of explosives for civil
uses/pyrotechnical articles according the relevant parts of the harmonized standards and/or
equivalent tests set out in other relevant technical specifications in order to verify the quality of the
internal production control measures and conformity to type. When the results of testing the test
samples and conformity assessment with the requirements of satisfactory Certificate of conformity to
type is issued for that batch of explosives for civil uses/pyrotechnical articles..
Ex-Agencija prepares an audit plan for independent on-site assessment of the quality assurance
system. This plan and the time necessary to implement it are determined according to the
complexity of quality assurance system and the production plant, the number of type certificates, as
well as any other relevant information (e.g. the existence of other certificates for the quality
assurance system, or number of locations if production is carried out at various facilities). If there
are several manufacturing locations, the assessment of the quality assurance system is
implemented at those locations deemed necessary. For Module C2 Ex-Agencija reviews
documentation for products that will be tested and certified and defines number of test samples for
batch testing.
If the client wishes a revision or supplement to the scope of the notifiction already issued, the client
must submit a request in writing. Ex-Agencija will evaluate the request and notify the client within 14
days regarding approval/denial of the request, and specify the activities and deadlines necessary for
completion of work.
The re-assessment (surveillance)for Modules D and E is performed according to the following
schedule:
- before the expiration date of the Quality Assurance notification,
- immidiately, if quality system has been changed and the change has influence to
conformity with the Directive.
The re-assessment (surveillance)involves evaluation of any changes in quality assurance
documents and a on-site assessment in the production plant. The purpose is to check the function of
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CERTIFICATION OF THE MANUFACTURER'S QUALITY
ASSURANCE SYSTEM
(EXPLOSIVE FOR CIVIL USES AND PYROTECHNICAL ARTICLES)
the system and its further compliance with the requirements of the quality assurance notification
issued.
Periodic re-assessment (surveillance) is performed according to the same procedure as the initial
assessment, along with the results and remarks from previous assessments which are now taken
into consideration.
3. SUBMITTING AN APPLICATION
To initiate the certification process, manufacturers or their representatives must fill out and submit
form C-3-5 (available on Ex-Agencija’s website). The application is then assessed and if the inquiry
is clear, the client is sent an offer and Agreement. If the offer is acceptable the client submits an
order and the Agreement signed by manufacturer, and sends documentation on the quality
assurance system, as specified in Modules of the Directives. Ex-Agencija confirms receipt of the
order and initiates work.
The same form is used to submit a request for a supplemental notification; that is, to expand the
scope of the notification.
4. ASSESSMENT OF THE QUALITY ASSURANCE SYSTEM (Modules D, E i
H)
The assessment of the quality assurance system is carried out in accordance with Modules D and E
of Directive 2014/28/EU and Modules D, E and H of Directive 2013/29/EU. If the results are
satisfactory at the end of the procedure, Ex-Agencija issues the client a Quality Assurance
Notification. This notification is issued with an expiration date of 1 year. At the end of 1 year period
re-assessment (surveillance)should be performed.
Assessment of the quality assurance documentation
Ex-Agencija evaluates compliance (according to EHS requirements or with the use of harmonized
standards) of the quality assurance documentation with the Directive. The quality assurance
documentation should be written in either English or Croatian. The use of a third language can also
be agreed upon if this is acceptable to both parties.
If during the examination the documents find any deficiency (which are, or may become
nonconformities), the user is then notified of those findings, which should be clarified and/or
eliminated before the on-site assessment.
On-site assessment of the quality assurance system of the client/manufacturer
After the documentation has been assessed, in agreement with the client Ex-Agencija prepares a
plan of on-site assessment at the manufacturer. The assessment plan, as needed, can also include
an on-site assessment of the supplier, who may be considered relevant to the characteristic of
explosive for civil uses or pyrotechnical articles that the client intend to produce, in accordance with
the Directive 2014/28/EU or Directive 2013/29/EU.
The client may request exclusion of any member of the assessment team or ask changes to the
schedule. If the client does not provide any objections to the plan in writing, Ex-Agencija presumes
the client has accepted the assessment plan and members of the assessment team.
During the assessment Ex-Agencija observes implementation of the quality assurance system, and
its compliance with the Directive Modules D or E and other harmonized standards applied. The
on-site assessment includes the following mandatory procedures:
- checking compliance with all requirements of regulations and standards applied,
- assessing the implementation of the quality assurance system, with regard to anticipated
effects in accordance with the requirements of regulations and standards applied,
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CERTIFICATION OF THE MANUFACTURER'S QUALITY
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assessing the quality assurance system with regard to legal requirements (e.g. the
company's registration with the court),
monitoring processes within the company,
executing internal audits and management reviews,
management's responsibility for the policy and objectives of quality assurance,
any other legal, technical and standard requirements (for applicable types of protection)
relevant to validating compliance of the existing quality assurance system.
The assessment results are presented during the final meeting at which all the findings,
observations and conclusions are presented to the client and a brief report is prepared.
After the on-site assessment, an Quality Assessment Report is prepared based on the data
gathered regarding implemented quality assurance system.
The Quality Assessment Report on the quality assurance system contains (minimally) the following:
a) date and place(s) of independent assessment,
b) names of assessment team members and persons present who represent the
manufacturer and/or client,
c) the coverage for which the quality assurance assessment has been performed and type
certificate,
d) notes on the compliance of quality assurance with the requirements of the Directive and
applied standards, with clear emphasis of any nonconformities and their detailed
descriptions.
The Quality Assessment Report is presented during the final meeting and signed by all parties
present. Based on this report the client will, as needed, analyze causes and initiate corrective
actions for any nonconformities determined, and inform Ex-Agencija accordingly.
If an additional assessment is conducted of the supplier considered to be relevant to the explosion
protection of Ex-equipment that the client wishes to produce, an additional Quality Assessment
Report is prepared.
Evaluating the results of system compliance and issuing the Notification
Once all nonconformities have been eliminated, Ex-Agencija evaluates compliance with the
requirements. Based on the information gathered during the certification process and the corrective
actions performed, a decision is made regarding certification of the client's quality assurance
system. If the corrective actions are satisfactory, the decision is positive and a quality assurance
notification is issued.
If the results of the assessment do not comply with requirements, Ex-Agencija will notify the client
accordingly, citing the reasons for denying issue of the notification.
5. ASSESSMENT OF CONFORMITY TO TYPE (Module C2)
For Module C2 it is carried out batch tests for every production batch of explosives for civil
uses/pyrotechnical articles according the relevant parts of the harmonized standards and/or
equivalent tests set out in other relevant technical specifications in order to verify the quality of the
internal production control measures and conformity to type. When the results of testing the test
samples and conformity assessment with the requirements of satisfactory Certificate of conformity to
type is issued for that batch of explosives for civil uses/pyrotechnical articles.
6. SUSPENSION, WITHDRAWAL AND COVERAGE REDUCTION OF THE
QUALITY ASSURANCE NOTIFICATION
There are four main reasons for suspending a quality assurance notification:
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CERTIFICATION OF THE MANUFACTURER'S QUALITY
ASSURANCE SYSTEM
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if Ex-Agencija determines that the manufacturer is not adhering to conditions stipulated in
the agreement,
if the quality assurance system does not continuously fulfill the requirements of
regulations and applicable standards,
if the client does not permit the performance of a surveillance assessment or does not
wish another reassessment,
if the client requests a suspension of the certificate.
A notification is temporarily invalid during suspension. If the notification has been suspended, per
the Agreement the client is obligated to cease using the Ex-Agencija Number and discontinue all
references to the Ex-Agencija notification in any advertising media. Ex-Agencija will on its web site
clearly declare that the notification is suspended.
Ex-Agencija will request an explanation from the manufacturer and try to resolve any problems
within a reasonable time-frame, but no longer than 6 months. In case an agreement cannot be
reached, Ex-Agencija will, in accordance with the Agreement, withdraw the notification or reduce its
scope.
If the user’s quality assurance system is only partially non-compliant with the requirements of
regulations and standards, and the part in question can be excluded from coverage without
significantly affecting the rest of the quality assurance system, Ex-Agencija can reduce the scope of
the notification to incorporate only those parts of the system that comply with regulations and
standards.
7. OBJECTIONS AND COMPLAINTS
Any objections/complaints the client may have concerning the quality assurance notification issued,
or any other unfavorable decision made by Ex-Agencija throughout the certification process, must
be submitted to Ex-Agencija in writing. If the complaint is not in writing, Ex-Agencija will proceed in
the manner it deems appropriate. Unfavorable decisions include:
- denial of applications,
- refusal to continue an assessment,
- requests for repair work,
- changes to the coverage of the quality assurance notification,
- denial, suspension or withdrawal of the quality assurance notification
- any other activities that prevent the client from acquiring and/or maintaining the quality
assurance notification.
Ex-Agencija will process the objections/complaints according to procedure B-15, which can be
provided on request. The complainant will be notified of Ex-Agencija’s position on the matter in
writing. Ex-Agencija will attempt to resolve the issues by agreement within a reasonable time-frame,
but no longer than 30 days. If the objection/complaint has not been resolved in a positive manner,
the client may submit an appeal to the appropriate authority.
Before a decision is reached, the information in the complaint is reviewed and analyzed, and the
client is informed of the results in writing. Records are kept on all complaints and actions
implemented.
Any person or organization can express dissatisfaction to Ex-Agencija (where a response is
expected) regarding its activities or the activities of the manufacturer whose quality assurance
system has been certified by Ex-Agencija.
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CERTIFICATION OF THE MANUFACTURER'S QUALITY
ASSURANCE SYSTEM
(EXPLOSIVE FOR CIVIL USES AND PYROTECHNICAL ARTICLES)
Ex-Agencija will assess the significance of the complaint and, if the complaint is justified, undertake
the appropriate actions needed. The procedure of handling complaints is considered to be strictly
privileged information, for the protection of both the complainant and Ex-Agencija clients.
If the complaint is not in writing, or is received from an unidentified source, Ex-Agencija will proceed
in the manner it deems appropriate. If such need is indicated, Ex-Agencija will (with the permission
of the complainant and the client) stipulate the conditions under which the content and resolution of
the complaint may become public information. Ex-Agencija will attempt to resolve the issues by
agreement within a reasonable time-frame, but no longer than 30 days.
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