- 1- Вы задавались вопросами:
- 21. «Можно ли, внести изменения в РУ 2006 г.?»
- 22. «Требуется ли, переоформление РУ при смене организационной формы?»
- 23. «Как присвоить вид медицинского изделия в соответствии с Приказом № 4н от 06.06.2012 г.?
Necessity and compulsoriness of transition to EEU standards is no news but still not much time is left to perform thorough and qualitative transition.
One of mandatory conditions which can't be avoided during this transition is introduction of the quality management system (QMS) in production process. That's why sooner or later all manufacturers of medical products will have to introduce QMS in their own universal management systems and comply with ISO 13485.
Under current conditions forming the state of the market, everyone understands that the quality management system is the basic premise of successful operation of the enterprise. Nowadays, everybody is sure it's necessary to introduce it. As the sands are running out, world quality and safety standards of all products including medical products improve every day.
In current state of market development, there are different models allowing to develop, introduce, improve and enhance the quality management system of production process. These models have periodic nature and eventually one model is substituted by another which is more perfect than the previous one.
The most popular quality management systems are those developed on the basis of the 9000 series international standards. Although such systems are still not widely spread in Russia, they have good prospects of development in the domestic market as their popularity keeps growing.
Necessity of introduction of quality management systems based on international standards is also dictated by Russia's WTO accession. That's why it's so important to reform own activity in full compliance with international requirements and standards which are mandatory at this stage.
Therefore, although the procedure of introduction of QMS in the production process requires performance of a large scope of very complex and time-consuming works, utilization of such system grants a lot of advantages for limitless development of every production enterprise.