HomepageBusiness customersIndustriesHealthcare and Medical TechnologyHealthcare Institutions and Practices

Healthcare Institutions and Practices

Independent certification for quality, safety and trust in healthcare

Healthcare organizations work towards one central goal every day: providing high-quality and safe care for patients and clients. At the same time, the environment in which they operate is becoming increasingly complex. Quality requirements, information security, privacy, staff shortages, digitalization and changing laws and regulations place considerable demands on the way healthcare processes are organized and managed.

In the Netherlands, DEKRA supports healthcare institutions, healthcare practices and welfare organizations with independent audits and certification. Our auditors assess management systems and processes in areas such as quality, patient safety and information security. We look not only at whether procedures and documentation meet the applicable requirements, but also at how processes function in day-to-day practice.
Certification by an independent third party enables healthcare organizations to demonstrate that they manage relevant risks, work systematically on continuous improvement and meet requirements set by standards, clients, insurers and other stakeholders.
How DEKRA supports healthcare organizations
Demonstrating quality

High-quality care requires effective processes, not just documented procedures. DEKRA assesses quality management systems against healthcare-specific and general standards. This gives organizations independent insight into their performance and enables them to demonstrate that quality is systematically embedded in their operations.

Patient and client safety

Safety is essential in healthcare. Our auditors assess how risks are identified, managed and followed up, and how organizations learn from incidents and nonconformities.

Information security in healthcare

Healthcare organizations process sensitive patient information. DEKRA provides certification to NEN 7510, the Dutch standard for information security in healthcare, under accreditation by the Dutch Accreditation Council (RvA).

An independent view of processes

An audit goes beyond assessing compliance with a standard. Our auditors examine how processes work in practice, with particular attention to the human factor. We refer to this approach as People Based Auditing.

Relevant certifications for healthcare institutions and practices

  • HKZ Certification
    HKZ certification helps organizations in the healthcare and social services sectors demonstrate the quality of their services and continuously improve their performance. HKZ Healthcare and Social Services provides a broad quality standard based on ISO 9001 and tailored to the specific themes within healthcare and social services. HKZ Small Organizations has been developed for smaller organizations, enabling them to have their quality and improvement processes assessed independently in a way that suits their size, without having to implement a management system that is disproportionate to their organization. In addition, HKZ sector-specific standards are available for areas including mental healthcare, community pharmacies, probation services, and nursing, residential care and home care organizations. These standards reflect the unique processes, risks and legislation applicable to each sector and can be combined effectively with ISO 9001.
    DEKRA is accredited by the Dutch Accreditation Council (RvA) for HKZ Healthcare and Social Services, HKZ Small Organizations and the HKZ sector-specific standards.
  • NEN 7510
    NEN 7510 specifically addresses information security within the Dutch healthcare sector. The standard helps organizations systematically manage risks related to personal health information and implement appropriate organizational and technical measures.
    Certification provides independent evidence that information security is managed systematically. At DEKRA, NEN 7510 can also be combined with ISO 27001, allowing audits against both standards to be organized efficiently. DEKRA is accredited by the Dutch Accreditation Council (RvA) for certification according to NEN 7510.
  • NEN-EN 15224
    NEN-EN 15224 is an international quality management standard specifically tailored to healthcare and welfare. It combines a systematic approach to quality management with healthcare-specific attention to areas such as patient safety, risk management and clinical processes. DEKRA is accredited in the Netherlands to provide certification according to NEN-EN 15224.
  • NEN 8009
    For organizations providing hospital care, patient safety is an essential part of the management system. NEN 8009 is the Dutch standard for safety management in hospital care and specifically focuses on managing risks and preventing avoidable patient harm. DEKRA performs independent assessments against this standard. Accreditation by the RvA is not available for this standard.
HKZ certification

HKZ certification

In the rapidly changing healthcare sector, you want to show that your organization puts quality first. A HKZ certification demonstrates the quality level of your healthcare services.
Details
Certification information security

Information security

Certification of your information security demonstrates that you are dealing with (digital) data exchange and storage carefully, and guarantees the quality of your IT processes.
Details
ISO 9001 certification

ISO 9001 certification

Benefit from international competitive advantages with a certification of your quality management system.
Details
Stethoscope on a keyboard

NEN 7510 certification

NEN 7510 certification provides guidelines for secure information management within healthcare institutions. As of December 16, 2024, NEN 7510-1:2024 has been amended.
Details
NEN 8009 certification

NEN 8009

The NEN 8009 certification proves that your system has been independently tested. DEKRA hereby provides an independent judgment, for the safety of your patients.
Details
NEN-EN 15224 certification

NEN-EN 15224

The NEN-EN 15224 certificate will demonstrate that your healthcare services meet the quality requirements of insurers and clients.
Details
/>

Our approach

A management system only adds value when it genuinely contributes to the quality and safety of healthcare. That is why DEKRA audits go beyond procedures and documentation.

Audits focused on day-to-day practice

Our auditors assess how processes actually function, how employees work with them and to what extent the management system contributes to the organization's objectives. The focus is not only on obtaining a certificate, but above all on the effectiveness of the processes being assessed.
By working with auditors who understand the healthcare sector, assessments can be placed within the context in which healthcare professionals and organizations operate every day. DEKRA has been conducting audits within the Dutch healthcare sector since the 1990s.

Frequently Asked Questions

This depends on the type and size of your organization, its activities and the requirements applicable to your services. HKZ, for example, has been specifically developed for healthcare and welfare, while ISO 9001 provides a broader international framework for quality management. For information security, NEN 7510 is specifically aimed at the Dutch healthcare sector. Hospitals may also need to consider NEN 8009. DEKRA can help determine which certification best matches your organization's situation.
ISO 9001 is an internationally applicable quality management standard for organizations across a wide range of sectors. HKZ has been developed specifically for healthcare and welfare organizations and therefore aligns more directly with the processes and quality challenges within this sector. HKZ Healthcare and Welfare is based on the principles of ISO 9001 but translates them into the context of healthcare practice.
Healthcare organizations process sensitive personal health information. NEN 7510 provides a specific framework for systematically organizing and managing the security of this information. The standard aligns with ISO 27001 but contains additional measures specifically developed for the healthcare sector.
Yes. DEKRA can audit NEN 7510 and ISO 27001 in combination. Because the standards are closely aligned, combining the audits can improve efficiency and reduce duplication of work.
HKZ Small Organizations has been specifically developed for smaller organizations in healthcare and welfare. For larger organizations or organizations with a broader range of services, HKZ Healthcare and Welfare may be more appropriate.
During the certification process, DEKRA assesses whether the management system and relevant processes meet the requirements of the selected standard. Following a positive certification decision, a certificate is issued. Periodic surveillance audits are then carried out to assess whether the management system continues to operate effectively and remains compliant with the applicable requirements.
No. During audits, DEKRA also assesses the functionality, effectiveness and performance of processes. This includes examining how the management system is actually applied within the organization and how it contributes to achieving the organization's objectives.
DEKRA's services are relevant to a wide range of healthcare and welfare organizations, including healthcare institutions, home care providers, mental healthcare organizations, welfare organizations and smaller healthcare practices. The most appropriate standard and certification depend on the organization's size, services and specific requirements.