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Certification Process

Application

The certification of a product for the use in the food sector is a separate order assigned to our expert, Dr. Derra. Within the framework of our accreditation, the certification order has to be placed in written form according to our application for certification form. The order has to clearly define the scope of the certification and the separation of analysis order and the certification has to be pointed out explicitly.


Certification agreements

With his signature on the application for certification, the client pledges to uphold the terms agreed upon and to observe the certification conditions. This forms the prerequisite for beginning the certification process.


Product designation

The applicant has to put down in writing how the product is formulated, in which form the product is intended to be used or which defined requirements it is to comply with. Based on this information, the examination scope encompassing the necessary parameters will be planned.


Confidentiality

ISEGA undertakes to keep all knowledge gained during the processing of an order secret, to protect it against third parties and not disclose it without prior approval of the client. Exempted from this are supervising authorities within the framework of accreditations/notifications as well as public authorities.

For our testing and certification process, information from the suppliers of the clients are required. However, there exists no direct contractual relationship with the suppliers and an appropriately worded secrecy agreement is concluded.


Evaluation of the application

The certification body evaluates the information received by the client to ensure that said information on the client and the product are sufficient to carry out the certification process.


Certification programs

There are specifically designed certification programs targeted towards the individual material types, intended applications as well as test requirements which take into consideration the current legal provisions, regulations and recommendations. The scope applied for is reflected in the examination scope. The interpretation of the legal provisions and the compliance with the respective standards by the certification body forms the basis for this process. If the certification should have to be denied, the client is given the opportunity to rework the product.


Certification

The certification body evaluates products on the basis of food legislation or a range of standards which are reflected in the certification programs

  • European Framework Regulation (EC) No. 1935/2004
  • US-American CFR of the FDA, Title 21: Food and Drugs

The conformity evaluation for the following points are handled under the same conditions:

  • Antimicrobial activity according to JIS Z 2801:2010, ASTM E 2149-10, ASTM E 2180-07, AATCC Methode 100 (2004), or ISO 22196-2011
  • Packaging of medical devices according to ISO 11607-1, 2009-09

The client may also apply for or agree to certifications issued in the name of distributors. Other derivative usage is prohibited.

The accreditation according to DIN EN ISO/IEC 17065:2013 requires a monitoring of certificates. This is why they are issued with a validity of 2 years. A prolongation is possible provided that an application is submitted in good time. For such a prolongation, the product has to be evaluated after the client's order according to our files and the current certification requirements. Should partial analyses be necessary, the client has to be informed accordingly.

The certification scope can be modified if additional corresponding analysis results are available, however, the validity of the certification will not be extended thereby. Should the certification requirements have changed in the meantime, for example due to revisions in the legal foundations which possibly also affect the basis of the ongoing certification, the client has to be informed accordingly and the certificate has to be modified or withdrawn.


Rules related to the handling of the certification

The use of the certification encompasses

  • Remarks in written, pictorial or oral form on the fact of the certification,
  • Use of original certificates, copies or other representations of the certificates,
  • Use of the certification signet with the ISEGA logo.

The rules of use are as follows:

  • During use, only the actual basis of the certification and wording of the certificate will be referenced.
  • The certificate owner will not use the certification in a form likely to oppose ISEGA’s goals or discredit ISEGA.
  • The certificate owner will not make any statements on the certification which ISEGA may regard as not authorised.
  • In cases when the certificate owner is unclear about particularities of the present rules on the use of the certification, the certificate owners commit themselves to contact the certification body as a precaution to seek agreement for the intended form of use.
  • All usage rights of the certification (including certificates and signets) shall lapse upon expiration of the validity of the certificate of compliance or a premature declaration of invalidity (e.g. for reasons of suspension or withdrawal of the certification).
  • After withdrawal or expiration of the validity of the certification, it must not be used for promotional purposes and a misleading impression of an ongoing certification is not permitted.
  • Upon request, the certificate owner can be granted the use of the certification signet with the certificate number for promotional purposes.
  • The certification, a certificate of compliance or the certification signet must not be conferred by ISEGA onto third parties or legal successors without permission neither can it be the object of an assignment agreement, disposal or other forced legal measure.

The use of the certificate by presentation of the original documents, copies or other visual representation is admissible. It has to be ensured that all certificate components are legible or, in case of a scaled-down, not completely legible presentation, the non-legible parts are explained separately in their entirety.

When handing over the certificate, the owner is not obliged to enclose accompanying documents. That has to be clarified with the respective business partner. The certification body is not obliged to hand over enclosures to third parties.

Certificates which are in possession by the certificate owner remain property of ISEGA and, unless they have duly expired after the set validity date, have to be returned to ISEGA after a declaration of withdrawal or the destruction of the documents has to be confirmed in writing.


Restriction of Certification

If a non-compliance with the certification requirements is found, there is the possibility that the product could be certified for only a certain part of the scope requested. The client is given the possibility to rework the product or to remove non-compliant product variants.


Withdrawal of the Certification

If information or circumstances become known to the certification body which result in the statements in a certificate of compliance being invalid, the client has to be informed immediately. As required, the suspension or, in case of an active breach of the certification terms, the withdrawal of the certification has to be considered.

SPRACHE NICHT INSTALLIERT"