What is ISO 9001?
ISO 9001: 2008 «Quality management systems – Requirements» is an international standard that regulates the creation and implementation of a quality management system in enterprises of any profile and form of ownership. This standard is today recognized in 190 countries of the world and is the base for building other management systems. The Ukrainian analogue of the ISO 9001:2015 standard is DSTU ISO 9001:2018 “Quality management systems. Requirements”. Asking the question: what standard does it make sense to certify their enterprise ?, its owners should keep in mind that although both standards are essentially identical, the ISO 9001:2015 Certificate of Conformity (international standard) is recognized in Ukraine, and the DSTU ISO 9001:2018 Certificate of Conformity (Ukrainian sample) has no legal force in other countries. Therefore, it makes sense to choose certification according to DSTU ISO 9001:2018 only if the company operates exclusively in the domestic market.
Benefits of implementing ISO 9001
The quality management system according to ISO 9001 has long become the world standard for doing business, and the presence of the ISO 9001 Certificate of Conformity is an indispensable attribute of a steadily growing successful company.
What does a company get out of this quality management system? First, the optimization of existing business processes in the company and, as a result, reaching a higher level of efficiency. The implementation of ISO 9001 allows the company not only to optimize work based on available resources but also to develop the most effective development strategy by improving the quality of managerial decision-making.
No less important is the fact that the implemented ISO 9001 quality management system allows the company to guarantee the stability of the quality of products and services. Which, in turn, not only increases the competitiveness of the company but also helps it in the successful expansion of market sales. After all, the presence of the ISO 9001 Certificate of Conformity not only opens the door to foreign markets but increases the effectiveness of participation in various tenders.
How to implement ISO 9001?
Any changes in the company – if they are not implemented as an empty formality – require time and coordinated efforts of the entire enterprise team. The integration of the quality management system is one of the global changes in the work of the company, so the implementation of the principles and requirements of the ISO 9001 standard can take a long time. Indeed, to build a functioning quality management system, it is necessary to go through the following steps:
- Analysis of the company’s work and its compliance with the requirements of the standard. Determination of the scope of the quality management system;
- Description of actions and development of procedures provided by the standard. Preparation of documentation;
- Implementation of a quality management system;
- Conducting an internal audit and, if necessary, developing a package of corrective and preventive measures to eliminate identified or possible non-compliances.
As practice shows, the period for implementing a quality management system can range from several months (for a small enterprise or the implementation of a QMS for individual processes) to several years (for the full implementation of a quality management system for a large company).
How to pass the ISO 9001 certification procedure
IMPROVE MEDICAL is an accredited conformity certification body in accordance with DSTU ISO 9001:2018 “Quality management systems. Requirements” and ISO 9001:2015 “Quality management systems – Requirements”. Our competence and qualifications of our employees are confirmed by certificates valid both in Ukraine and abroad. In our work, we strictly adhere to the principles and requirements set forth in the DSTU EN ISO/IEC 17021-1:2017 (ISO/IEC 17021-1:2015).
If your company is interested in obtaining a Certificate of Conformity to the Quality System according to DSTU ISO 9001:2018 and/or ISO 9001:2015, you can always contact us and sign an agreement both for conducting a preliminary audit and for passing the certification procedure.
