Thanks to its new emphasis on addressing risk, the 2015 International Organization for Standardization (ISO) quality management standard is better suited to ensure high-quality teleradiology services than previous versions of the standard, according to researchers from Austria and Germany.
After comparing ISO 9001:2015 with the 2008 and 2000 versions of the standard and assessing its value in teleradiology, the researchers determined the new standard goes much further toward preventing quality problems in teleradiology services.
"With the new mandatory risk-orientated requirements of the ISO 9001:2015 standard, there is a much higher potential to avoid failures and risks in teleradiology services," said Dr. Peter Sögner of the Institute for Diagnostic and Interventional Radiology at Feldkirch State Hospital in Feldkirch, Austria. He shared the findings during a session at the recent ECR 2016 in Vienna.
Quality management standard
ISO 9001 is the most commonly used quality management standard in the world and is utilized in many industries. More than one million organizations -- including healthcare institutions -- have received ISO 9001 certification for their quality management systems, according to Sögner.
"There is no other quality management standard that has had the success of the ISO 9001," he said.
Sögner and co-author Dr. Torsten Möller of Reif and Möller Diagnostic Network in Germany have 15 years of experience at ISO 9001-certified institutions that have performed more than 600,000 emergency teleradiology cases. They wanted to compare the value of the 2015 version of ISO 9001 with the previous 2000 and 2008 standards. Specifically, they wanted to assess the standard's value for preventing or reducing undesired effects to teleradiology services for patients, doctors, and healthcare institutions, according to Sogner.
First, they analyzed how the existing ISO 9001-certified quality management systems at their institutions conformed with the 2015 standard. They also evaluated the 2015 standard as applied to two different teleradiology strategies: a centralized approach as used in Austria for public hospitals and medical universities, and a decentralized model employed in Germany for radiologists throughout the country.
They found the 2008 standard provides for a quality management system that focuses on customer requirements and satisfaction with products. However, the ISO 9001: 2015 model not only takes into account customer requirements, but also the organization and its context, the needs and expectations of relevant partners, the results of the quality management system, and products and services, Sogner said.
"So there are much more views on the situation and [many] results you have to compare," he said.
Applying the principle of looking at "the organization in context" to Austria, Sögner noted there are currently approximately 600 radiologists in Austria who serve 270 public hospitals. However, there's a need for approximately 1,620 radiologists to provide 24-hour, seven-days a week radiology service. That's a minimum of six radiologists per hospital, he said.
Focus on risk
The 2008 version of the standard focused on process-based thinking; risk management was officially excluded in chapter 0.4, and "preventive" actions are only required in Chapter 8.5.3, Sögner said. In contrast, the 2015 standard emphasizes a risk-based approach in chapters 0.4, 4.4.1.f, 5.1.1.d, 5.1.2.b, 6ff, 9.1.3.e, and 9.3.2.e.
Sögner shared an example of the risk-based model in an excerpt from ISO 9001:2015:
6.1 Actions to address risks and opportunities
6.1.1 When planning for the quality management system, the organization shall consider the issues ... determine the risks and opportunities that need to be addressed to:a) give assurance that the quality management system can achieve its intended result(s)
b) enhance desirable effects
c) prevent or reduce undesired effects
d) achieve improvement
"You go through the existing workflows and look if [some risk] exists between the institutions," Sögner said.
There is a checklist of 40 risk-related requirements that need to be completed for 100% compliance with ISO 9001:2015, according to Sögner. After comparing the teleradiology quality management systems in place at their institutions, the researchers found systems did not have a high level of compliance with new risk-related requirements under the 2015 standard:
- German teleradiology quality management system: 26/40 risk-related requirements: 65%
- Austrian teleradiology quality management system: 6/40 risk-related requirements: 15%
The new risk-based requirements offer much higher potential for avoiding failures and risks in teleradiology services for all customers and interested parties, including patients, physicians, and healthcare institutions, Sögner said.
![Examples of ultrasound findings and techniques. (A) Images in a 39-year-old male patient with a mass in the left thigh. The mass is heterogeneous on the B-mode US image (compared with the patient in D) and showed increased microvascularity (superb microvascular imaging [SMI]) and shear-wave elastography (SWE) values. Undifferentiated pleomorphic sarcoma was diagnosed at biopsy (with pleomorphic rhabdomyosarcoma in surgical specimen). (B) Images in an 18-year-old male patient with a mass in the left leg. The mass is hypoechoic on the B-mode image, with no other findings suggestive of malignancy. The lesion is in contact with the cortex of the tibia, which is slightly irregular. CT revealed a doubtful anteromedial tibial erosion. The microvascular study demonstrated high vascularization, suggestive of malignancy. Periosteal Ewing sarcoma was diagnosed with both histologic and immunohistochemical confirmation. (C) Images in a 69-year-old female patient with a lump growing on the outside of the left leg. Multiple SWE examinations were performed (please note the high values obtained in the measurements, whereas the color map highlights the stiffness relative to adjacent tissues). SMI showed areas of increased vascularization to target for sampling. Undifferentiated spindle cell sarcoma was diagnosed at biopsy, with residual leiomyosarcoma in the surgical specimen after neoadjuvant therapy. (D) Images in a 56-year-old female patient with a mass in the right thigh. The mass is heterogeneous at both B-mode ultrasound (similar to patient A) and MRI (coronal T2-weighted spectral attenuated inversion recovery [SPAIR]; T1-weighted pre-contrast and postcontrast imaging), which even shows uptake after the administration of paramagnetic contrast material, which is traditionally suggestive of malignancy. Low values at SMI and elastography are suggestive of benignity. Spindle cell lipoma was diagnosed at biopsy, with atypical spindle cell lipomatous tumor in the surgical specimen.](https://img.auntminnieeurope.com/mindful/smg/workspaces/default/uploads/2026/08/images-radiol250278fig2.APCFLSvX6p.jpg?auto=format%2Ccompress&fit=crop&h=100&q=70&w=100)
![Examples of ultrasound findings and techniques. (A) Images in a 39-year-old male patient with a mass in the left thigh. The mass is heterogeneous on the B-mode US image (compared with the patient in D) and showed increased microvascularity (superb microvascular imaging [SMI]) and shear-wave elastography (SWE) values. Undifferentiated pleomorphic sarcoma was diagnosed at biopsy (with pleomorphic rhabdomyosarcoma in surgical specimen). (B) Images in an 18-year-old male patient with a mass in the left leg. The mass is hypoechoic on the B-mode image, with no other findings suggestive of malignancy. The lesion is in contact with the cortex of the tibia, which is slightly irregular. CT revealed a doubtful anteromedial tibial erosion. The microvascular study demonstrated high vascularization, suggestive of malignancy. Periosteal Ewing sarcoma was diagnosed with both histologic and immunohistochemical confirmation. (C) Images in a 69-year-old female patient with a lump growing on the outside of the left leg. Multiple SWE examinations were performed (please note the high values obtained in the measurements, whereas the color map highlights the stiffness relative to adjacent tissues). SMI showed areas of increased vascularization to target for sampling. Undifferentiated spindle cell sarcoma was diagnosed at biopsy, with residual leiomyosarcoma in the surgical specimen after neoadjuvant therapy. (D) Images in a 56-year-old female patient with a mass in the right thigh. The mass is heterogeneous at both B-mode ultrasound (similar to patient A) and MRI (coronal T2-weighted spectral attenuated inversion recovery [SPAIR]; T1-weighted pre-contrast and postcontrast imaging), which even shows uptake after the administration of paramagnetic contrast material, which is traditionally suggestive of malignancy. Low values at SMI and elastography are suggestive of benignity. Spindle cell lipoma was diagnosed at biopsy, with atypical spindle cell lipomatous tumor in the surgical specimen.](https://img.auntminnieeurope.com/mindful/smg/workspaces/default/uploads/2026/08/images-radiol250278fig2.APCFLSvX6p.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
