April 30, 2024

J Diagn Treat Oral Maxillofac Pathol 2024;8: 33–47.

DOI: 10.23999/j.dtomp.2024.4.1

Under a Creative Commons license

HOW TO CITE THIS ARTICLE

Nagorniak IV. The private dental practice in Kyiv, Ukraine: ISO 9001:2015 certification and recertification procedures in 2022-2024. J Diagn Treat Oral Maxillofac Pathol 2024;8(4):33–47. https://doi.org/10.23999/j.dtomp.2024.4.1

National Repository of Academic Texts

https://nrat.ukrintei.ua/en/searchdoc/2024U000042/ (in English)

ABSTRACT. ABSTRACT IN UKRAINIAN (PDF).

The development and improvement of the reputation of a private dental practice (PDP) is inextricably linked not only with the provision of dental care to the population, but also with compliance with the best international standards. The purpose of this paper is to highlight the procedure for passing certification and recertification ISO 9001:2015 (ISO 9001) by a PDP in Kyiv, Ukraine. ISO 9001 is a globally recognized standard for quality management developed by the International Organization for Standardization (ISO). The passing of these certifications in Ukraine is of particular interest because they took place under the audit of the certification body from the European Union and in the conditions of the highest complexity, namely the large-scale war of the terrorist state (i.e., Russian Federation) against the Ukrainian state. Our PDP was registered in 2016 and has the legal form of an individual entrepreneur. Individual entrepreneur (transliteration from Ukrainian, fizychna osoba-pidpryiemets [FOP]) can also be called as private entrepreneur, sole proprietor, and physical person-entrepreneur. The main economic activity of the presented PDP is stomatological practice (i.e., dental practice). Even though our PDP provides the entire range of dental procedures, its main orientation is oral implantology. The audits and ISO 9001:2015 certifications were conducted in 2022-2024.Detailed data on the completion of two audits is provided and analyzed. The original certificates in two languages, English and Ukrainian, have been added to the article for clarity. The publication also provides step-by-step instructions for checking whether an ISO 9001:2015 certificate is valid on the Internet for both PDP owners and patients. Reflecting after the audits and certifications, I, as the owner of practice, must admit that they significantly improved the practice's organization and allowed it to reach a qualitatively new level. We hope that the details presented in this article will be a guide for other PDP owners in Ukraine and abroad.

KEY WORDS

Private dental practice (PDP); private stomatological practice; the International Organization for Standardization (ISO); ISO 9001:2015 certification; ISO 9001:2015 recertification; certificate for the management system according to ISO 9001:2015.

 

Section Editor, Business: Ivan Nagorniak, Private Dental Practice (Sole Proprietor Nagorniak I.V.), Kyiv, Ukraine. Reviewer: Vitalii Myroshnychenko, Private Dental Practice (Sole Proprietor Myroshnychenko V.O.), Uman, Ukraine.

INTRODUCTION

Doctors and dental practitioners have no legal obligation to put a quality system in place, but there can be no doubt about how important is to have one to improve patient satisfaction and heighten the overall prestige of the dental practice.¹

—Euronda SpA (joint-stock company)

Vicenza, Italy

 

Private dental practice (PDP), which is also known in some countries (Ukraine, etc.) as a private stomatological practice, like other forms of business, is often a lifelong project for the founders.Developing and managing a PDP requires numerous types of licensing, improvements, adherence to certain standards, and investment. Dentists aspire to reach a standard of care that enables them to offer in their practice a service that complies with internationally recognised technological and hygiene requirements.¹ One of the ways to get closer to international standards is to undergo audit and ISO 9001:2015 (ISO 9001) certification. The International Organization for Standardization (ISO) only develops the standards, and certification and recertification are not a requirement.2 Still, service companies require a document to present to their customers as evidence of ISO 9001 implementation.²

 

Many peer-reviewed articles are devoted to various aspects of PDP.^3–14 However, the search for English-language publications showed a lack of described experience of obtaining ISO certification by the PDPs.

 

The purpose of this article is to highlight the procedure for passing certification and recertification ISO 9001:2015 (ISO 9001) by a PDP in Kyiv, Ukraine.

PRACTICE AND ISO CERTIFICATIONS

Our PDP was registered on August 26, 2016, and has the legal form of an individual entrepreneur.¹⁵ Individual entrepreneur (transliteration from Ukrainian, fizychna osoba-pidpryiemets [FOP]) can also be called as private entrepreneur, sole proprietor, and physical person-entrepreneur.^16,17 The main economic activity of our business is stomatological practice (i.e., dental practice).¹⁵ The dental practice class according to 2010 Classification of types of economic activities (CTEA) is 86.23.¹⁸ Despite the fact that our PDP provides the entire range of dental procedures, its main orientation is implant dentistry.

 

It is worth noting that the first ISO certification in the history of our PDP was passed on November 30, 2022 (Fig 1), when Ukraine was repelling the large-scale aggression of the occupying state (i.e., the Russian Federation). The ISO recertification was approved on March 8, 2024 (Fig 2). A comparison of data from the two audits is presented in Table 1.

In the received сertificates, it is indicated in two languages, in Ukrainian and in English: 

 

1. The proof of the conforming application with the regulation was furnished and in accordance with the certification procedure it is certified for the company Private Entrepreneur Nagorniak I.V.

2. This certification was conducted in accordance with the TÜV international certification (TIC) auditing and certification procedures and is subject to regular surveillance audits.

Specialists emphasize that, when the audit is over, the PDP will receive its quality certification, which is valid for three years but subject to surveillance audits.¹

 

Part of the certification process is the issuance of an audit report, which can be published in two languages, in German language and in Russian language, and nine to ten pages.

 

According to the PDP audit report, the certificate is used as follows:

 

• The certificate is posted on the organization's information stand.

• A copy of the certificate is supplied to the consumer upon request.

• The certificate is applied in accordance with the requirements established in the certification contract.

Our PDP used the services of TÜV Thüringen Ukraine, which is the only branch of the international company TÜV Thüringen on the territory of Ukraine. The official website of the TÜV Thüringen Ukraine is https://tuv-thuringen.com.ua/.¹⁹ TÜV Thüringen e.V. (Jena, Germany) is an accreditation body for systems and personnel. The official website of the company is https://tuev-thueringen.de.²⁰

 

The audit report includes such sections as:

 

1. Summary assessment.

2. Potential for improvement of the organization's management system.

3. Corrective actions for nonconformities from the previous audit.

4. Nonconformities.

5. Positive aspects.

6. Information about organization.

   6.1. Description of the conditions of the organization's location: (1) brief historical background, (2) description of the organization type, (3) regions in which the organization operates or is represented, (4) products (services), and (5) consumers. 6.2. Description of the resources used. 6.3. Changes in the management system since the last audit.

7. Scope of management system.

8. Complaints about the organization's management system.

9. Use of TIC trademark/certificate.

DISCUSSION

In London, in 1946, 65 delegates from 25 countries meet to discuss the future of international standartization. In 1947, the International Organization for Standardization (ISO) officially comes into existance with 67 technical committees (groups of experts focusing on a specific subject).²¹

—History of ISO,

an independent, non-governmental international organization

 

ISO 9001 is a globally recognized standard for quality management.22 Passing an audit and obtaining ISO 9001:2015 certification by a private practice is a completely voluntary procedure. But it can significantly raise the status of your practice and attract the attention of new clients. So, if the PDPowner has already decided to go this route, there are three steps necessary to obtain a quality system certification¹:

 

1. Choosing a consulting agency and drawing up a project plan identifying the objectives to be achieved.

2. Quality improvement in terms of structure, organisation, equipment and technological systems, materials, know-how, and skills.

3. Identifying an accreditation body to audit quality levels and issue the certification. 

Among the advantages of obtaining such a certification is that embassies of countries such as Germany, Austria, and Switzerland can be guided when referring patients within Ukraine to clinics that have ISO 9001 certificates issued by certification bodies located in German-speaking states.

 

The experts note, getting ISO 9001 certification is a long process; it may take a minimum of three to four months to complete the certification process.2 Anyway, the North American ISO consulting firms emphasize, that ISO 9001 certification is the best and most trusted quality system certification for dentists office.²

 

Figures 3–6 demonstrate how the validity of the PDP certificate can be checked on the German-language website of TÜV Thüringen e.V. (https://tuev-thueringen.de).

CONCLUSIONS

Reflecting after the audits and certifications performed in 2022-2024, I, as the owner of small PDP, must admit that they significantly improved the practice's organization and allowed it to reach a qualitatively new level. We hope that the details presented in this article will be a guide for other PDP owners in Ukraine and abroad.

 

Private dental practices play a crucial role in maintaining the oral and general health of the nation.⁸

—Catherine Rutland

Denplan, part of Simplyhealth, Andover, UK

CONFLICT OF INTEREST

The author declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

REFERENCES (22)

1. Euronda: improved management in the dental surgery [document on the internet]; Nov 13, 2016 [cited 2024 Apr 16]. Available from: https://www.euronda.com/news/quality-management-system-in-a-dental-practice/

2. Limited Management Group Ltd: ISO 9001 certification [document on the internet]; Apr 13, 2024 [cited 2024 Apr 13]. Available from: https://www.iso-certification.us/iso-9001-certification/service/dentist.html

3. Garcia RI; Santa Fe Group. The restructuring of dental practice: dentists as employees or owners. J Am Dent Assoc2014;145(10):1008–10. https://doi.org/10.1016/s0002-8177(14)60160-4

4. Holden ACL, Adam L, Thomson WM. Dentists' perspectives on commercial practices in private dentistry. JDR Clin Trans Res 2022;7(1):29–40. https://doi.org/10.1177/2380084420975700

5. Williams RE. Dental practice structure. J Am Dent Assoc 2015;146(5):286–7. https://doi.org/10.1016/j.adaj.2015.03.002

6. White JG. Interacting forces influencing private dental practice in South Africa: implications for dental education. SADJ 2008;63(2):080–5.

7. Holden ACL, Adam L, Thomson M. Private practice dentists' views of oral health injustice. Community Dent Health 2021;38(4):268–74. https://doi.org/10.1922/cdh_00009holden07

8. Rutland C. The future of private dentistry. BDJ In Pract 2021;34:20–21. https://doi.org/10.1038/s41404-021-0834-0

9. Holden ACL, Adam L, Thomson WM. Rationalisation and 'McDonaldisation' in dental care: private dentists' experiences working in corporate dentistry. Br Dent J 2021 Jun 25. https://doi.org/10.1038/s41415-021-3071-3

10. Nagorniak IV. Managing private practice in a war zone. J Diagn Treat Oral Maxillofac Pathol 2022;6(3):35–6. https://doi.org/10.23999/j.dtomp.2022.3.1

11. Koba NM, Nagorniak IV. One million dollar private practice. J Diagn Treat Oral Maxillofac Pathol 2022;6(2):30–1. https://doi.org/10.23999/j.dtomp.2022.2.2

12. Gillette J, Matthews JD, Frantsve-Hawley J, Weyant RJ. The benefits of evidence-based dentistry for the private dental office. Dent Clin North Am 2009;53(1):33–45, viii. https://doi.org/10.1016/j.cden.2008.09.002

13. Hare K, Yadev N, Campbell C. Initiating research in a private dental practice. Br Dent J 2018;224(7):487–9. https://doi.org/10.1038/sj.bdj.2018.228

14. Tuominen R, Palmujoki J. Perceived  competition  in  private  dental  practice  in  Finland. Acta Odontol Scand2000;58:213–216. https://doi.org/10.1080/000163500750051764

15. Sole proprietor Nagorniak I.V. [document on the internet]; Apr 16, 2024 [cited 2024 Apr 16]. Available from: https://youcontrol.com.ua/en/catalog/fop_details/65540991/

16. Koba NM, Nagorniak IV. Ukraine: legal forms for private practice in oral surgery and dentistry. J Diagn Treat Oral Maxillofac Pathol 2021;5(9):97–8. https://doi.org/10.23999/j.dtomp.2021.9.1

17. Sole proprietor Kosteichuk O.M. [document on the internet]; Apr 12, 2024 [cited 2024 Apr 12]. Available from: https://youcontrol.com.ua/en/catalog/fop_details/33902666/  

18. CTEA-2010: class 86.23 (in Ukrainian) [document on the internet]; Apr 10, 2024 [cited 2024 Apr 10]. Available from: https://kved.ukrstat.gov.ua/KVED2010/86/KVED10_86_23.html

19. TÜV Thüringen Ukraine [document on the internet]; Apr 14, 2024 [cited 2024 Apr 14]. Available from: https://tuv-thuringen.com.ua/uk/

20. TÜV Thüringen e.V. [document on the internet]; Apr 14, 2024 [cited 2024 Apr 14]. Available from: https://tuev-thueringen.de

21. About ISO [document on the internet]; Apr 5, 2024 [cited 2024 Apr 5]. Available from: https://www.iso.org/about-us.html

22. ISO 9001:2015: quality management systems: requirements [document on the internet]; Apr 5, 2024 [cited 2024 Apr 5]. Available from: https://www.iso.org/standard/62085.html