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The certification body for the dental field |
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Nordic Dental Certification |
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Label for certified products: |
BackgroundThis certification program is applicable to all dental products for which an international standard exits specifying requirements for the product. The program specifies a procedure for certification of dental products which are based upon the relevant basic, group and product related standards developed by ISO. For products where no such applicable standards are available, other standards may be considered used. The required documentation of product properties and criteria for approval is established by test reports from independent laboratories. Certification according to this program is valid for 5 years provided an annual surveillance confirms continued fulfillment of quality requirements. This certification program is accredited according to EN 45011 / ISO/IEC Guide 65. Principles for certificationThe certification is voluntary. Certification is an approval of the quality of specified product(s) (see Definitions). The requirements of international standards for the products are used as basis for the certification. Certification is valid for 5 years provided annual surveillance confirms continued fulfillment of requirements. Certification is not longer valid if any of the following conditions occurs: Criteria and procedure for assessment and approval (certification)Certification is based on evaluation of properties of a specified product established by accredited testing. Criteria for certification Formal requirements in basic, group and product standards are fulfilled. Physical, chemical and possible other requirements in relevant product or group standards are fulfilled. Initial certification procedure 1 The manufacturer applies for certification of a specified dental product. 2 The manufacturer's signed application form and all other documents (see Required information and documentation) are registered at Nordic Dental Certification. The reception of documents is confirmed. An invoice for the certification fee is sent to the manufacturer. 3 After receipt of the certification fee, an initial assessment of the documentation is performed. If incomplete, manufacturer is notified. When documentation is regarded complete, it is distributed to the relevant certification personnel for assessment of general and formal data and of the specified requirement for the product. 4 Certification personnel inform Nordic Dental Certification about the results of the assessment in a written, signed report. 4.1 If no further information is regarded necessary, the case is due for final assessment. 4.2 If further testing or documentation is regarded necessary, the manufacturer is notified of the decision and its rationale. 5 Final decision regarding certification of the product, based on an assessment whether all documentation is sufficient and all specified requirements are met is taken by the Head of Nordic Dental Certification. 6 When certification of a product is granted, a certificate is issued valid for 5 years provided the annual surveillance confirms continued fulfillment of quality requirements. Certification gives the manufacturer the right to mark the product with text and/or mark(s) to inform about the certification status of the product.
Annual surveillanceGeneral Surveillance methods The surveillance of product certification by Nordic Dental Certification is performed using one of two methods. The method for the first surveillance is freely chosen by Nordic Dental Certification. The method is chosen on the basis of the client's quality system and a compilation of the production during the period since initial certification. The surveillance method is thereafter alternated each year, if appropriate. One surveillance method is to take appropriate sample(s) of the product for testing. The other surveillance method is to inspect the production line/quality assurance system and the production records for the product at the site of production. Surveillance by testing The client informs Nordic Dental Certification about planned and/or produced batches of the product. Nordic Dental Certification will select representative samples for testing according to the relevant product standard. Surveillance by production inspection Nordic Dental Certification appoints the auditor(s)/inspector(s) who will make the necessary arrangements/agreements to visit and inspect the client's production line/quality assurance system and production records for the product. Surveillance costs There is an annual fee for surveillance. Costs for testing and/or audits (production inspection) shall be negotiated each year, on the basis of Nordic Dental Certification's current price list. Travel, lodging and per diem costs are covered by the client.
Common elements Some elements are common for both surveillance methods: The surveillance shall be performed annually for four years subsequent to the initial certification. A contract/agreement must be reached/signed with respect to the extent and nature of the surveillance procedure. Nordic Dental Certification will each year issue an invoice for the surveillance fee. Submission of a summary of the complaint file, concerning specified certified products or quality systems, is part of the annual surveillance requirements of Nordic Dental Certification. The complaint system shall incorporate registration, investigation, interpretation, and corrective actions related to complaints from in-house quality control or customers in accordance with defined procedures by a designated person (for guidance, see EN 724). The product/production system is assessed in accordance with the agreement/contract. If the product/production system is found to be satisfactory, Nordic Dental Certification will issue a continuation letter to the manufacturer. If the product/production system is not found to be satisfactory, the certification will be suspended, and the product/production procedures must be more thoroughly assessed to evaluate the reason for the non-compliance. After sufficient corrective and preventive actions have been implemented and documented, the suspension can be lifted and the certification continued.
Surveillance by product testing From the compilation of the production of the certified product(s) from the time the product(s) was (were) certified, Nordic Dental Certification will request samples of one or two batches (lots). Nordic Dental Certification will arrange testing of the samples according to the requirements of the relevant product standard. The extent of the testing will normally be planned and performed in such a way that during the four years surveillance period the testing according to the product standard will be repeated at least once. The test report forms the basis for the decision about continued certification.
Surveillance by production system inspection Nordic Dental Certification will appoint an auditor/inspector. The auditor will make the necessary arrangements/agreements to visit and inspect the production line/system and product records. The report from the auditor forms part of the basis for the decision about continued certification.
Application for certification An application form signed by the manufacturer for each specified product. Composition, where appropriate Specification of the chemical composition/formulation. Formal documentation Copies of packaging, instructions for use and other promotional literature. Physical/chemical data Test report(s), relevant to the product under assessment, from accredited laboratories based on testing according to relevant group or product standard(s) where appropriate. Other data, where appropriate Documentation of relevant data, preferably by test report(s), relevant to the product under assessment, from accredited laboratories.
Nordic Dental Certification will issue a list of fees for the various parts of the certification program. Special deals ("package prices") may be negotiated for series of products or for products with several variants, e.g. shades.
Usually, testing is not included in the certification fee. Production inspection is normally performed on the basis of remuneration of expenses for time, travel and accommodation.
Note Products certified under the previous ("First Edition") program, and for which there is no applicable standard, may continue its certification under requirements of the "First Edition" program. However, if an applicable ISO standard is issued, the product must be transferred to the present program, i.e. tested for compliance to the requirements of the standard.
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Phone: +47 67 581530 |
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Contact information: |
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Dental product certification |
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Postal address: P.O. Box 70 |
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Visiting address: Kirkeveien 71 B |