TECHNICAL SUPERVISION AND CERTIFICATION OF THE MANUFACTURER'S QUALITY ASSURANCE SYSTEM
These technical instructions provide basic information for obtaining a certificate, in accordance with the Regulations on equipment and protection systems intended for use in potentially explosive atmospheres, “Official Gazette” Republic of Croatia no. 34/10, or per the requirements of the IECEx System
The purpose of these instructions is to clarify the procedure of certifying the quality assurance system of a manufacturer who produces equipment, components and systems intended for use in areas at risk of explosive atmospheres (gases, vapors, mist and dust). This procedure applies to the certification of the quality assurance system, based on Annexes IV and VII of the Regulations for equipment and protection systems intended for use in potentially explosive atmospheres, (OG no. 34/10), and the corresponding unified standards for quality assurance. The procedure of quality assurance assessment is specified in the IECEx System, based on publications IECEx 02, IECEx OD 005-1, IECEx OD 009, IECEx OD 025 and other appropriate documents (www.iecex.com).
The Regulations of equipment are identical to European Directive 94/9/EC (ATEX 95). In order to assess compliance with requirements of the Regulations of equipment, integrated Croatian standards (identical to European standards) are used (e.g. HRN EN 13980 for quality assurance systems of Ex-equipment manufacturers).
These instructions do not contain the procedure of equipment certification (per Annex III of the Regulations of equipment) – this procedure is described in the instructions on Equipment Certification (TU-CERT).
2. INITIAL CERTIFICATION, SURVEILLANCE AND RECERTIFICATION
The quality assurance certification by Ex-Agencija consists of: inspection of documentation (with regard to conformity and preparation for assessment), on-site assessment of the quality assurance system and elimination of any nonconformities ascertained. Once these nonconformities have been successfully eliminated within the given deadlines, a Quality Assurance notification is issued with an expiration date of 3 years, with mandatory surveillance inspections to be performed regularly. Recertification is performed right before the expiration date.
Ex-Agencija prepares audit program for independent on-site assessment of the quality assurance system. This program and the time necessary to implement it are determined according to the complexity and type of quality assurance system and the production plant, the number of type certificates and class of protection applied, as well as any other relevant information (e.g. 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 wishes a revision or supplement to the area or scope of the certificate 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, any necessary activities and deadlines for completion of work.
Surveillance inspections are performed according to the following schedule:
- annually, no more than 12 months apart, for quality assurance systems that are not certified or covered by standard ISO 9001 or
- no more than 18 months apart for quality assurance systems that are also certified by ISO 9001.
Surveillance inspection and assessment involve 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 issued with an expiration date of 3 years.
Periodically surveillance and recertification inspections implement the same procedure as initial inspections, along with the results and remarks from previous inspections which are now taken into consideration.
3.SUBMITTING A REQUEST
To initiate the certification process, manufacturers or their authorized representatives in Croatia (for foreign manufacturers) must submit form C-3-1 (available on Ex-Agencija web page), which must bear the signature of a person authorized by the manufacturer or representative. The request is then assessed and if the inquiry is clear, the client is sent an offer and an Agreement. 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 Regulations of equipment. Ex-Agencija confirms receipt of the order and initiates work.
The same form is used to submit a request for a supplemental certificate; that is, to expand the coverage of the certificate.
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 Regulations of equipment, and standard HRN EN 13980. If the results are satisfactory at the end of the procedure, Ex-Agencija issues the client a Quality Assurance notification marked HREx Q gg.xxx. This certificate is issued with an expiration date of 3 years, under the condition that surveillance inspections are performed regularly.
Assessment of the quality assurance documentation
Ex-Agencija evaluates compliance (according to basic requirements, or with the use of integrated standards) of the quality assurance documentation with the Regulations of equipment. 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 examination the documents yield any anomalies (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 program of on-site assessment of the client/manufacturer. The assessment program, 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 wishes to produce, in accordance with the Regulations of equipment and protection systems.
The client may request exclusion of any member of the assessment team or seek changes to the schedule. If the client does not provide any objections to the program in writing, Ex-Agencija presumes the client has accepted the assessment program and members of the assessment team.
During the assessment Ex-Agencija observes implementation of the quality assurance system, and its compliance with the Regulations of equipment and protection systems, HRN EN 13980 and other integrated 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,
- 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.
At the end of the on-site assessment, an Assessment Report is prepared based on the data gathered and a meeting held with the client in which all findings, observations and conclusions are reviewed. The Assessment Report on the quality assurance system contains (minimally) the following:
- date and place(s) of independent assessment,
- names of assessment team members and persons present who represent the manufacturer and/or client,
- the coverage for which the quality assurance assessment has been performed, including type of protection and type certificate,
- notes on the compliance of quality assurance with the requirements of Regulations and applied standards, with clear emphasis of any nonconformities and their detailed descriptions.
The 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, of the supplier considered to be relevant to the explosion protection of
Ex-equipment that the client wishes to produce, is made an additional Assessment Report is prepared.
Evaluating the results of system compliance and issuing the certificate
Once all nonconformities have been eliminated, Ex-Agencija evaluates compliance with the requirements. Based on the information gathered during the certification process and the repair activities 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 quality assurance notification are issued for the manufacture of equipment, components and systems intended for hazardous areas of gases, vapors, mist and dust.
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 certificate.
The conditions for use of Ex-Agencija symbol are specified in technical instructions TU-LOGO-TN_Aktivnosti, which can be found on Ex-Agencija web page.
Foreign manufacturers who wish to supply their products to the Croatian market (but do not want to be under the technical supervision of Ex-Agencija), can use a combination of Annexes III and V (Product Verification). They can implement the type certification procedure and then request
Ex-Agencija to check their products when shipped to Croatia.
5. SUSPENSION, WITHDRAWAL AND COVERAGE REDUCTION OF THE QUALITY ASSURANCE NOTIFICATION
There are four main reasons for suspending a quality assurance notification:
- 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 legal 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 certificate is temporarily invalid during suspension. If the certificate has been suspended, per the Agreement the client is obligated to cease using the Ex-Agencija logo and discontinue all references to Ex-Agencija certificate in any advertising media. The suspension of the certificate will be clearly indicated in the registry on Ex-Agencija web site.
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 certificate or reduce its coverage. Certificates that have been withdrawn are deleted from the certificate registry on
Ex-Agencija web site.
In case the user or client does not return the original certificate to Ex-Agencija, and the certificate was issued for equipment that compromises the safety of the plant and the people in it, Ex-Agencija will inform the appropriate authority.
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 effecting the rest of the quality assurance system, Ex-Agencija can reduce the coverage of the certificate to incorporate only those parts of the system that comply with regulations and standards.
6. APPEALS AND COMPLAINTS
Any appeals/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 appeals/objections according to procedure B-15, which can be provided on request, before a decision is made. The complainant is notified of the results in writing. Records are kept on all complaints and measures implemented. If the grievance/complaint has not been resolved in a positive manner, the client may submit a complaint to the appropriate authority.
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 process the complaints and, if proven adequate, undertake appropriate actions. 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.