General info about our certification activity

neoEMKI performs certification of quality management systems according to ISO 9001 and ISO 13485 standards and conformity assessment of medical devices / IVD devices.

neoEMKI’s quality policy statement is available here.

neoEMKI follows its overall procedure for certification activity according to the document attached: Client info conformity assessment procedure.

In connection to certifications according to 93/42/EEC directive neoEMKI performs neccessary unannounced visits. neoEMKI follows gudeline 473/2013/EU for unannounced visits (see Amendment III. of the guideline).

For more details on certification visit concerning pages:

• Quality system certification

• Conformity assessment and certification of medical devices

• Conformity assessment and certification of IVD devices

Form used for request for quotation can be found among downloadable documents.

Procedure regarding appeal or complaint against certification decision can be found here: Procedure for complaint handling and appeal.

Special forms for initiating appeal or complaint process also can be found among downloadable documents.

With the first edition of the certificate, clients get informing about application rules of certification symbols. For quality systems and devices, certified by EMKI, procedure how to refer to being certified and usage of certification symbols is available here: Use of certification symbols.