ISO 9001:2008 “Quality management systems – Requirements” is the international standard, which regulates the creation and implementation of the quality management systems in the enterprises of any profile and form of ownership. That standard has been acknowledged today in 190 countries of the world and is the basic standard for the creation of other management systems.

The Ukrainian analogous standard for the ISO 9001:2008 is DSTU ISO 9001:2009 “Quality management systems – Requirements”

If you want to find out which standard to choose in order to certify specific enterprise its owner has to know that although both standards are in fact completely identical, the Certificate of compliance ISO 9001:2008 (international certificate) is acknowledged in Ukraine and the Certificate of compliance DSTU ISO 9001:2009 (Ukrainian certificate) has no legal force in other countries. Therefore, it makes sense to choose the DSTU ISO 9001:2009 certification only if the company works exclusively in the domestic market.

Quality management system according to ISO 9001 is the world standard of business conduct for a long time, possession of the Certificate of compliance ISO 9001 has become indispensable attribute of the smooth-running and successful company.

What gets the enterprise due to the implementation of that quality management system? In the first line it gets the optimizing of the existing business-processes and, as the consequence, achievement of higher level of effectiveness. Implementation of ISO 9001 allows the company not only to optimize its work on the basis of available resources, but also to work out the most effective development strategy due to the improvement of quality of taking managerial decisions.

  No less important is that the introduced quality management system ISO 9001 allows the company to ensure consistency of performance of products and/or the services. Which in turn not only improves the competitiveness of the company, but also helps it to successfully expand the sales market. The possession of the Certificate of compliance ISO 9001 not only opens doors to the external markets, but also improves the result of participation in different tenders.

Any changes in the company – if they are not introduced as a mere formality – requires time and well-coordinated endeavors of the entire team of the enterprise. Integration of the quality management system is one of the global changes in the work of the company, therefore the implementation of the principles and requirements of the standard ISO 9001 may take much time. In order to build the effective quality management system, it is necessary to pass the following stages:

• Analysis of the operation of the company and its compliance with requirements of the standard. Definition of the field of implementation of the quality management system;
• Description of processes and working out of procedures, envisaged by the standard. Preparation of the documentation;
• Implementation of the quality management system;
• Performance of the internal audit and, if necessary, working out of the package of corrective and proactive measures for the elimination found out or eventual discrepancies.
• As practice shows, the period of implementation of the quality management system may take several months (for small enterprise or implementation of the quality management system for individual processes) to several years (for complete implementation of the quality management system for the big company).
• Only after the company has implemented the quality management system and convinced that that system works properly, one may proceed with obtaining of the Certificate of compliance ISO 9001. In order to perform this, it is necessary to apply to the accredited certification authority.

The certification procedure according to ISO 9001 takes much less time. It consists of the following stages:

• Consultation with certifying authority and conclusion of the certification services agreement;
• Analysis of the documentation and audit of the quality management system of the company subject to the certification;
• Analysis of the audit results and issuance of the сcertificate (in case of the positive result).

IMPROVE MEDICAL is the accredited authority to certify the conformity according to the DSTU ISO 9001:2009 «Quality management systems. Requirements» and ISO 9001:2008 «Quality management systems – Requirements»». Our competence and qualification of our employees is confirmed by the certificates, which are valid both inside and outside the territory of Ukraine. Executing our work, we strictly adhere to the principles and the requirements set forth in the Standard ISO/IEC 17021:2011.

If your company is interested in obtaining the Certificate of compliance with the quality system DSTU ISO 9001:2009 and/or ISO 9001:2008 you may apply to us to conclude agreements of performance of the preliminary audit or to undergo the certification procedure.