ISO 9001 certification
Healthcare Audits
Compliance through healthcare audits
The healthcare sector is constantly evolving, with an increasing focus on prevention: promoting health instead of treating conditions. Multidisciplinary collaboration and technological innovations play an essential role in this. However, this approach also brings new challenges, such as changes in legislation and regulations and extra attention to the safety of clients and patients. Book your healthcare audits with DEKRA to ensure safety and compliance for your organization.
DEKRA specializes in healthcare audits and assesses whether your management systems comply with various standards. Our auditors have in-depth expertise in the healthcare sector and also offer customized solutions that go beyond simply complying with the standard. In this way, DEKRA supports you in safeguarding and continuously improving the safety of your patients and clients.
Certification of your quality management systems according to ISO 9001 is a prerequisite for the introduction of an optimal quality standard.
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NEN 7510 certification
NEN 7510 certification provides guidelines for secure information management within healthcare institutions. NEN 7510-1:2024 was amended on December 16, 2024.
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HKZ certification
In a fast changing healthcare sector, you want to show that your organization puts quality first. A HKZ certification shows the quality of your healthcare services.
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HKZ Care and Welfare
For care and welfare organizations of 10 FTE or more: demonstrate that your services meet the highest quality standards with the HKZ Care and Welfare certification.
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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.
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NEN-EN 15224
The NEN-EN 15224 certificate will demonstrate that your healthcare services meet the quality requirements of insurers and clients.
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HKZ Small Organizations
For smaller healthcare and welfare organizations of up to 10 FTE: discover how HKZ helps you demonstrate quality with the HKZ Small Organizations certification.
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Safety standard Domestic abuse organizations for Women
The quality mark has the aim of improving the functioning of the national victim support network.
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Compare healthcare standards and systems
Healthcare audits:
ISO 9001
In healthcare, the ISO 9001 standard contributes to increasing the quality of processes and services. This internationally recognized standard increases patient safety by ensuring consistent and reliable processes, reducing errors and stimulating a culture of continuous improvement. ISO 9001 provides a clear structure to streamline business processes, use resources more efficiently and improve overall effectiveness. In addition, the standard supports healthcare institutions in complying with laws and regulations, limiting risks and providing accountability.
| ISO 9001 certification | |
| Certification type | Quality management system |
| Accreditation body | Raad van Accreditatie (RvA) Dutch Accreditation Council |
| Orientation | International |
| For which sectors? | All |
| Certificate validity | 3 years |
| Audit frequency | Annually or semi-annually |
| Auditors | Subject matter expert in the sector (generic healthcare and welfare) |
| Details | Generic standard that includes all the basic requirements of a quality management system. |
Healthcare audits:
NEN-EN 15224
NEN-EN 15224 is a healthcare certification focused on patient safety, risk management and clinical outcomes. It addresses the specific needs of healthcare institutions and ensures consistent and reliable processes that meet both clinical and regulatory requirements. By implementing NEN-EN 15224, organizations can reduce errors, work more efficiently and demonstrate their commitment to safe and high-quality care.
| NEN-EN 15224 certification | |
| Certification type | Quality management system |
| Accreditation body | Raad van Accreditatie (RvA) Dutch Accreditation Council |
| Orientation | European |
| For which sectors? | Healthcare and Welfare |
| Certificate validity | 3 years |
| Audit frequency | Annually or semi-annually |
| Auditors | Subject matter expert in the relevant indusry |
| Details | Includes 11 quality aspects for which requirements are set and which have been translated and operationalized within the organization |
Healthcare audits:
HKZ Small Organizations
HKZ Small Organizations (HKZ Kleine Organizaties) is an important certification that helps small healthcare institutions to manage quality efficiently. The certification is tailored to the scale and available resources of these organizations and makes it easier to meet set standards, while at the same time complying with legal requirements.
| HKZ Small Organizations certification | |
| Certification type | Quality management system |
| Accreditation body | Raad van Accreditatie (RvA) Dutch Accreditation Council |
| Orientation | Dutch, specifically for practices and organizations up to 10 FTEs |
| For which sectors? | Healthcare and Welfare |
| Certificate validity | 3 years |
| Audit frequency | Annually |
| Auditors | Subject matter expert in the relevant indusry |
| Details | Primarily suitable for start-up or small organizations or practices |
Healthcare audits:
HKZ Industry specific
The HKZ (Harmonization of Quality Assessment in the Healthcare Sector) provides the necessary structure to maintain the focus on quality within your organization in times of change.
In which schemes is DEKRA active?
DEKRA is accredited for the following schemes:
- HKZ Mental Health Care (2015)
- HKZ Maternity Care (2015)
- HKZ Public Pharmacies (2022)
- HKZ Probation (2019)
- HKZ Nursing homes, care homes, and home care institutions (2015)
- HKZ Welfare and Social Services (2025)
| HKZ branche specific certification | |
| Certification type | Quality management system |
| Accreditation body | Raad van Accreditatie (RvA) Dutch Accreditation Council |
| Orientation | Dutch |
| For which sectors? | Sector-specific schemes in Healthcare and Welfare |
| Certificate validity | 3 years |
| Audit frequency | Annually or semi-annually |
| Auditors | Subject matter expert in the relevant industry |
| Details | Generic standard that includes all basic requirements of a quality management system |
Healthcare audits:
HKZ Healthcare and Welfare
An HKZ certification shows that your healthcare organization is well-organized within the dynamic landscape of healthcare and welfare. It emphasizes that you put the client first and are continuously working on improving the quality of your healthcare and service provision.
| HKZ for Healthcare and Welfare | |
| Certification type | Quality management system |
| Accreditation body | Raad van Accreditatie (RvA) Dutch Accreditation Council |
| Orientation | Sector-specific schemes in Healthcare and Welfare |
| For which sectors? | Healthcare and Welfare |
| Certificate validity | 3 years |
| Audit frequency | Annually or semi-annually |
| Auditors | Subject matter expert in the related industries |
| Details | Primary requirements from the governance code. Safety culture is a common thread throughout the standard. |
Healthcare audits:
NEN 8009
NEN 8009 plays a crucial role in healthcare by focusing on risk management and patient safety. It provides a clear framework for recognizing and controlling risks, optimizing processes and ensuring a safe environment. By implementing this standard, you improve the quality of care, comply with regulations and demonstrate commitment to safety and responsibility.
| NEN 8009 certification | |
| Certification type | Safety management system |
| Accreditation body | Not applicable |
| Orientation | Hospital care |
| For which sectors? | Healthcare and Welfare |
| Certificate validity | Not applicable |
| Audit frequency | Not applicable |
| Auditors | Trained in client and patient safety |
| Details |
Healthcare audits:
NEN 7510
NEN 7510 is all about information security and protecting patient data. The standard provides a clear framework to protect sensitive information against risks such as data leaks and unauthorized access. By implementing NEN 7510, healthcare institutions not only safeguard the privacy of patients, but also comply with privacy legislation such as the GDPR.
| NEN 7510 certification | |
| Certification type | Information security system |
| Accreditation body | Raad van Accreditatie (RvA) Dutch Accreditation Council |
| Orientation | European |
| For which sectors? | Healthcare and Welfare |
| Certificate validity | 3 years |
| Audit frequency | Annually |
| Auditors | Subject matter expert in the sector (generic healthcare and welfare) |
| Details | Based on ISO 27001 and expanded with management measures specifically for Healthcare and welfare |
DEKRA's approach to healthcare audits
You can become certified when an accredited external certification body, such as DEKRA, has audited your organization's processes. A certification process at DEKRA consists of fixed steps. We test your processes against the established standard, a series of rules that must be met. In healthcare, an external audit is important to enable certification, but the actual functionality and performance of your management system are paramount.
Personal approach
During the external audit, our auditors penetrate to the core of your processes and thereby reveal the real bottlenecks. Our team of experienced professionals offers a personal approach during the certification process, also known as People Based Auditing.
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