Technical Instruction
CERTIFICATION OF THE MANUFACTURER'S
QUALITY ASSURANCE SYSTEM
These technical instructions provide basic information forconformity assessment of manfacturer’s quality assurance system of production of Ex-productin accordance with theDirective 2014/34/EU or per the requirements of the IECEx System
Agencija za prostore ugrožene eksplozivnom atmosferom – Ex-AGENCIJAIndustrijska 25, HR-10431 Sveta Nedelja
Tel/Phone.: ++ 385 1 36 67 260 Fax.: ++ 385 1 36 67 262
/ PQC-TU-PRe/9
/ CERTIFICATION OF THE MANUFACTURER'S QUALITY ASSURANCE SYSTEM
1.INTRODUCTION
The purpose of these instructions is to clarify the procedure of certifying the quality assurance system of a manufacturer who produces Ex-products. This procedure applies to the certification of the quality assurance system, based on Annexes IV and VII of the Directive 2014/34/EU (in further tex The Directive)), and the corresponding harmonized standards for quality assurance. The procedure of quality assurance assessment is specified in the IECEx Scheme, based on publications IECEx 02, IECEx OD 009, IECEx OD 025 and other appropriate documents (
In order to assess compliance with requirements of the Directive, European and international standard EN ISO/IEC 80079-34 is used.
These instructions do not contain the procedure of type certification (per Annex III of the Directive with respect to the Regulations of the IECEx Scheme (IECEx 02)which is described in the instructions on Equipment Certification (TU-CERT).
2.INITIAL, Surveillance AND RE-ASSESSMENT OF THE QUALITY SYSTEM
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/IECEx QAR is issued with an expiration date of 3 years, with mandatory surveillance assessments to be performed regularly. The quality assurance certification procedure (recertification)is repeated before the certificate expires.
Ex-Agencijaprepares an auditplanfor independent on-site assessment of the quality assurance system. This planand 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 and protection type applied, 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.
If the client aska revision or supplement to the scope of the notifiction/IECEx QARalready 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 surveillance assessmentis performed according to the following schedule:
-annually, no more than 12 months from the previous assessment, for quality assurance systems that are not certified or covered by standard ISO 9001 (or other management system certificate of equal validation) or
-no more than 18 months apart two audits for quality assurance systems that are also certified by ISO 9001 (or other management system certificate of equal validation).
The surveillance and assessment involvesthe evaluation of any changes in quality assurance documents and a control rating in the production plant. The purpose is to check the function of the system and its further compliance with the requirements of the Quality Assurance Notification/IECEx QAR issued with an expiration date of 3 years.
Periodicsurveillance and re-assessmentare performedaccording to the same procedure as the initial assessment, along with the results and remarks from previous inspections which are now taken into consideration. Also, greater emphasis is placed on the efficiency of the quality assurance system, the aim towards continuous improvement, realization of one’s own goals and expected results, as well as monitoring and adapting internal and external changes (e.g. legal or standardrelated), for the purpose of maintaining compliance of the certified scope of the quality system with the requirements of the corresponding standards and regulations.
3.SUBMITTING AN APPLICATION
To initiate the certification process, manufacturers or their representatives submit request and relevant information about its quality system and scope of assessment. The applicant can use form C-3-1 (available on Ex-Agencija’s website). The application is then assessed and if the inquiry is clear, the client is sent an offer and anAgreement (C-10-8). If the offer is acceptable the client submits an order and a signed copy of the Agreement, and sends documentation on the quality assurance system, as specified in Annexes IV and VII of the Directive or IECEx Scheme. Ex-Agencija confirms receipt of the order and initiates work.
The client also accepts (as needed) the presence of a third-party observer during the assessment of the quality assurance system; e.g. assessors from the Croatian Accreditation Agency.
4.ASSESSMENT OF THE QUALITY ASSURANCE SYSTEM
The assessment of the quality assurance system is carried out in accordance with Annexes IV and VII of the Directive and standardEN ISO/IEC 80079-34. If the results are satisfactory at the end of the procedure, Ex-Agencija issues the client a Quality Assurance Notificationmarked EXA gg ATEX Qxxxor IECEx QAR. This notification/IECEx QARis issued with an expiration date of 3 years, under the condition that surveillance assessments are performed regularly.
Assessment of the quality assurance documentation
Ex-Agencija evaluates compliance (according to EHSrequirements or with the use of harmonizedstandards) of the quality assurance documentation with the Directive and IEC standard. 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 findany deficiency (which are, or may become nonconformities), the user is then notified of these 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 planof on-site assessment at the client/manufacturer. The assessment plan, as needed, can also include an on-site assessment of the supplier, who may be considered relevant to the explosion protection of Ex-equipment that the client intendto produce, in accordance with the Directive.
The client may request exclusion of any member of the assessment team or askfor changes to the schedule. If the client does not provide any objections to the planin writing, Ex-Agencija presumes the client has accepted the assessment planand members of the assessment team.
During the assessment Ex-Agencija observes implementation of the quality assurance system, and its compliance with the Directive, EN ISO/IEC 80079-34 and other harmonizedstandards 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,
-assessing the quality assurance system and its ability to meet the contractual, legal, normative and technical requirements (e.g. the company's registration withthe court, requirements of the applied protection type, etc.), which are essential in verifying the compliance of the existing quality system,
-monitoring processes within the company,
-executing internal audits and management reviews,
-management's responsibility for the policy and objectives of quality assurance.
The results of the assessment are presented at the final meeting, led by the lead auditor. All significant findings and conclusions of the assessment team are presented at the final meeting, including any eventual non-conformities, remarks and/or opportunities for improvements, and brief meeting minutes are compiled. Non-conformities are presented in a manner that is clear to the client, and that reasonable deadlinesto eliminate the non-conformities are mutually arranged.
The final meeting as a rule also includes:
a)familiarizing the client wth the fact that an element of uncertainty always exists in the information and evidence gathered during the audit through methods of information sampling,
b)method and deadlines for the preparation of the assessment report,
c)further procedure and obligations of the client for eliminating non-conformities and deadlines for their elimination, as well as consequences in the event the non-conformities have not been eliminated,
d)deadlines in which the client must provide a proposal of corrective actions for non-conformities,
e)further procedure for Ex-Agencija,
f)information on the procedure of processing complaints and appeals.
A concise version of Minutes is presented during the final meeting, and if deemed acceptable, the document is signed by all parties. If an additional assessment is performed at the site of the supplier (considered essential for the explosion protection of Ex-products the client wishes to manufacture), those results are also recorded in the Minutes. Based on the results of the on-site assessment the client (if necessary) examines the cause of any non-conformity found and initiates corrective action. The client then notifies Ex-Agencija of these activities.
Evaluation of results of the conformity assessment and issue of Notification/QAR
Based on the data gathered once the on-site assessment is finished, the assessment team prepares an assessment report that contains all relevant information on the established quality system. Once the non-conformities have been eliminated Ex-Agencija examines the results of the quality system assessment to ensure they comply with the requirements. Based on the information gathered during the certification procedure, as well as the corrective actions performed, the decision to certify the client’s quality assurance system is brought forward for consideration. If the corrective actionsare satisfactory, the decision is positive and a Quality Assurance Notification isissued for the manufacture of Ex-products.
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 IECEx QAR.
5.SUSPENSION, WITHDRAWAL AND COVERAGE REDUCTION OF THE QUALITY ASSURANCE NOTIFICATION/QAR
There are four main reasons for suspending a Quality Assurance Notification/QAR:
-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, and/or the corresponding documents in the IECEx Scheme,
-if the client does not permit the performance of a surveillanceassessment or does not wantanother reassessment,
-if the client requests a suspension of the certificate/IECEx QAR.
A notification/IECEx QARis temporarily invalid during suspension. If the notification/IECEx QARhas been suspended, per the Agreement the client is obligated to cease using the Ex-AgencijaNumberand discontinue all references to the Ex-Agencijanotification/IECEx QARin any advertising media.
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. If the issue is resolved, the suspended notification/IECEx QAR will be returned to “valid” status. In case an agreement cannot be reached, Ex-Agencija will, in accordance with the Agreement, withdraw the notification/IECEx QAR or reduce its coverage.
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 coverage of the notification/IECEx QAR to incorporate only those parts of the system that comply with regulations and standards.
6.OBJECTIONS AND COMPLAINTS
Any objections/complaints the client may have concerning the Quality Assurance Notification/QAR 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/IECEx QAR,
-denial, suspension or withdrawal of the Quality Assurance Notification/IECEx QAR
-any other activities that prevent the client from acquiring and/or maintaining the Quality Assurance Notification/IECEx QAR.
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 or IECEx Secretariat.
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.
Ex-Agencija will assess the significance of the complaintand, 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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