INTRODUCTION OF THE NEW STANDARD DSTU EN ISO 13485:2018

According to Paragraph 2 of Part 2 in Article 11 of the Law of Ukraine “On Standardization”, the Order of the Cabinet of Ministers of Ukraine as of November 26, 2014 No. 1163-p “On Determination of the State Enterprise which Performs the Functions of the National Standardization Body”, and for the implementation of the National Standardization Program for 2018, SE “UkrNDNC” issued an Order No. 495 as of December 17, 2018 “On the adoption and abolition of national standards, the adoption of amendments to national standards, the abolition of amendments to the national standard”, which involves the introduction of the new standard DSTU EN ISO 13485:2018 “Medical devices. Quality management system. Requirements for regulatory purposes (EN ISO 13485:2016, IDT; ISO 13485:2016, IDT) by endorsement method and entry into force on January 1, 2019.

This means that the following standard replaces DSTU EN ISO 13485:2015 (EN ISO 13485:2012, IDT; ISO 13485:2003, IDT); DSTU EN ISO 13485:2015/Amendment No. 1:2015 (EN ISO 13485:2012/AC:2012, IDT). It should be noted that for some time in the territory of Ukraine the two following standards will be in effect:

DSTU EN ISO 13485:2018 “Medical devices. Quality Management System. Requirements for regulatory purposes (EN ISO 13485: 2016, IDT; ISO 13485: 2016, IDT)” and DSTU EN ISO 13485:2015 “Medical devices. Quality Management System. Requirements for regulatory purposes (EN ISO 13485:2012, IDT; ISO 13485:2003, IDT)”. According to the Order of the State Enterprise “UkrNDNC” No. 495 as of December 17, 2018 the DSTU EN ISO 13485:2015 standard will be effective until July 1, 2019.

Earlier the Resolution IAF 2015/13 determined a 3-year transition period (since the publication of ISO 13485:2016) and the transition process to the latest edition of ISO 13485:2016. The resolution IAF 2015/13 obliges all the conformity assessment bodies, accredited by the National Accreditation Agency of Ukraine and having the activity of ISO 13485 in the accreditation field, to ensure the transition of its clients from the version of DSTU EN ISO 13485:2015 (EN ISO 13485:2012, IDT; ISO 13485:2003, IDT) to the new version of ISO 13485:2016 until March 1, 2019.

“UNI-CERT” LLC would like to draw your attention to the need of introducing the new ISO 13485:2016 standard in your activity, since all the certificates obtained for the previous version will be invalid from March 1, 2019.

Based on the foregoing, we would like to note that the specialists of “UNI-CERT” LLC have already undergone internal training in the following standards: DSTU EN ISO 9001:2018 “Quality management system. Requirements (EN ISO 9001:2015, IDT; ISO 9001:2015, IDT)” and DSTU EN ISO 13485:2018 “Medical devices. Quality Management System. Requirements for regulatory purposes (EN ISO 13485:2016, IDT; ISO 13485:2016, IDT)”, as well as prepared and submitted documents to expand the scope of accreditation according to the specified standards.

In addition, we plan to conduct training on the above-mentioned amendments in the field of technical regulation. Information about the date of the seminar will be posted in the Education section.

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Respectfully,
Director of “UNI-CERT” LLC R.A. Mykhalko

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