ISO 15393
In the rapidly evolving world of healthcare and dental services, the need for streamlined communication, standardized data formats, and enhanced patient safety is more crucial than ever. ISO 15393:2018 addresses this need by providing a global framework for the electronic exchange of dental information. At Quality Asia Certification, we provide internationally recognized ISO 15393:2018 certification that ensures your dental organization or software solution aligns with the best practices in dental informatics and interoperability.
Whether you're a software provider, dental clinic, or dental records management company, our certification enhances your global credibility and operational efficiency.
65% Cost Reduction
60% Sustainability
Customer Attraction
Increase Your Competitive Edge
What is ISO 15393?
ISO 15393:2018 – Health informatics — Requirements for a detailed clinical model – is an international standard developed by the International Organization for Standardization (ISO) under the domain of Dental Informatics. It specifically deals with standardizing how dental records and clinical information are digitally formatted and exchanged.
The standard ensures that dental data can be safely and efficiently shared across systems, organizations, and countries without loss of meaning or patient safety. It enables interoperability and improves the quality of electronic dental records.
It is part of a broader framework of health informatics standards that promote uniformity, accuracy, and security in patient data handling.
Why is ISO 15393 important?
Dental service providers, software developers, and healthcare IT companies often face challenges in ensuring their systems can interoperate, comply with data privacy laws, and maintain consistent data quality. ISO 15393:2018 provides a solution by:
- Ensuring interoperability between dental information systems globally.
- Supporting regulatory compliance and data privacy laws like HIPAA and GDPR.
- Reducing errors in dental clinical documentation.
- Promoting international standardization, making your software or services export-ready.
By adopting ISO 15393, you demonstrate your commitment to patient safety, data integrity, and technological excellence.
What are the benefits of ISO 15393?
✅ Standardizes dental information structures for effective data exchange
✅ Reduces risk of clinical errors due to misinterpretation of data
✅ Supports integration of dental software with broader healthcare IT systems
✅ Facilitates smoother implementation of Electronic Dental Records (EDR)
✅ Ensures consistency in documentation across multiple locations or providers
✅ Encourages innovation in digital health technologies within dental practices
What kind of businesses can benefit from ISO 15393?
Implementing and getting certified for ISO 15393:2018 can significantly improve business outcomes, especially in a tech-driven healthcare environment. Here’s how:
- Market Expansion: Certification makes your services/software eligible for global markets that require compliance with international standards.
- Customer Trust: Builds client confidence by showing your commitment to high standards of clinical safety and data handling.
- Operational Efficiency: Helps streamline workflows and reduce redundancies in documentation and data exchange.
- Competitive Advantage: Sets your company apart in tenders, public sector procurement, and international contracts.
- Regulatory Readiness: Aligns your systems with evolving healthcare regulations and international dental data exchange protocols.
- Integration Ready: Prepares your systems to integrate with Electronic Health Record (EHR) and national health databases seamlessly.
- Future-Proofing: Keeps your organization ready for AI-driven and data-centric innovations in dental health informatics.
Top Tips on making ISO 9001 effective for you.
#1
Top management commitment while practicing and accomplishing the standard is the key to success.
#2
Keeping staff informed about the ongoing practices, a well-communicated plan would increase the motivation and zeal of working in them.
#3
Making sure that the various departments of the organization work as a team for the benefit of the organization and customers as well.
#4
Review systems, policies, processes, and procedures for a smooth working of QMS.
#5
Speaking to customers & suppliers while getting feedback & working on improvements.
#6
Training staff carrying out the internal audits with the opportunity for improvement.
#7
Celebrate your achievement and use the QualityAsia Assurance Mark on your literature, promotional material, and website.
#8
Ensure continuous improvement by regularly reviewing and updating your quality management practices.
#9
Promote a culture of quality by encouraging innovation, accountability, and employee involvement at every level of the organization.
Why QualityAsia?
QualityAsia always vanguard in the auditing and governing of internationally acclaimed standards practices. At QualityAsia, we focus on driving the success of our clients through creating excellence with our trained professional auditors. The content of our service provision, comply with international certification rules defined by the accreditation bodies without burning a hole in your pocket. We will take you through the journey of audits with our best kept audit practices, viz.:
Initial Certification – Stage 1 (Preparatory Phase)
- Thorough documented information review.
- Exchange of information with staff through online or onsite presence.
- Identification of key performances, processes & objectives as per the standard requisites.
- Analysis of facilities, infrastructure, systems and processes in regard with the requested certification scope with a resource allocation review.
Initial Certification – Stage 2 (On-site Audit)
- Measurement, reporting & reviewing the performances against key performances objectives.
- Reviewing the suitability of the system meeting the legal, regulatory & contractual requirements.
- Operational control of processes, internal audits & management reviews while understanding the responsibilities for the policies.
- Conclusion based on prescriptive requirements, policy, performance objectives, staff skill, operations, procedures, internal audits, etc.
Surveillance & Certification Renewal
Drawing out the scrutiny on various aspects of the previously done audits on effectiveness while reviewing the various processes and control of the operations in the QMS and finally going for the recertification.
