Quality meets health

DIN EN 15224 defines a Europe-wide standard for quality management in the healthcare sector. The standard is based on the requirements of ISO 9001 and transfers these to the specific quality requirements for healthcare. It also contains additional requirements, specifications and interpretations as well as aspects for the management of clinical risks.

Sustainable increase of patient safety in your facility

Integrated quality and clinical risk management

Continuous improvement of your processes and quality of care

Specific encouragement of your error and safety culture

Beschreibung Standard/Regelwerk

Why EN 15224? Information on the regulation

As an industry-specific standard for the healthcare sector, EN 15224 offers users numerous design options, examples and assistance. The focus of the standard is on "clinical processes" and "clinical risk management". In this way, EN 15224 offers the integration of risk and quality management with only one set of rules.

The standard, which is recognized throughout Europe, defines a total of eleven quality characteristics for healthcare and focuses on the integration of clinical risk management in all planning, execution and steering processes. Patient safety is emphasized as the most important quality criterion.

By limiting the need for regulation to the clinical processes necessary or actually performed, the standard is designed to be user-friendly. Thanks to its integrative approach to quality and risk management, redundancies and duplicate structures are avoided.

With the revision of ISO 9001 in September 2015 (ISO 9001:2015), EN 15224 also had to undergo a revision. The current, revised version EN 15224:2017-05 now also follows the common basic structure of modern ISO management system standards, the so-called High Level Structure (HLS). The new standard replaces the previous version EN 15224:2012 and can be obtained from the ISO website.

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Risk management and patient safety

EN 15224 requires comprehensive clinical risk management and thus much more than risk-based thinking. Clinical risk management is a key component within the quality management system. The risk requirements are based on the high level of ISO 31000 - an ideal combination for more patient safety.

The term "clinical" refers to all types of interactions between patients and healthcare personnel (medical and nursing staff). A "clinical risk" is defined as any risk that could have a negative impact on outcomes relevant to a quality requirement associated with the eleven basic healthcare quality criteria.

Here, the risk factors may be non-clinical, such as a power outage. This risk is also a clinical risk if it has a negative impact on one of the QM requirements, in this example the risk to patient safety in the event of a power failure.

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The eleven quality characteristics of the EN 15224 standard

As a sector-specific standard, EN 15224 identifies eleven fundamental quality aspects that are known to be relevant based on clinical experience and must be fulfilled by healthcare providers in every case. This makes quality measurable and verifiable. The quality characteristics are:

  • Appropriate, correct care
  • Availability
  • Continuity of care
  • Effectiveness
  • Efficiency
  • Equity
  • Evidence-based/knowledge-based care
  • Patient-centered care, including physical, psychological, and social integrity
  • Patient involvement
  • Patient safety
  • Timeliness/accessibility
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Who is EN 15224 suitable for?

The user group of the quality standard developed for the healthcare sector is broad. It ranges from outpatient and inpatient health care, including psychiatric care, to nursing and care facilities, to rehabilitation. Practices, pharmacies, dentists, physiotherapists, hospices and nursing homes are also included.

All healthcare facilities are eligible for certification. Any facility whose customer can be titled a "patient" is eligible for the scope and can benefit from the numerous advantages of the healthcare standard, which is recognized throughout Europe.

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What are the benefits of EN 15224 certification?

The central aspect in healthcare is the quality of care - and thus also the management of clinical risks. Your EN 15224-certified facility proves that it can do both with just one set of rules.

Certification still brings these advantages:

  • By focusing on clinical processes, the focus is on patient safety.
  • EN 15224 is based on the requirements of the proven QM standard ISO 9001 and thus offers the benefits that come with a well-structured and effective quality management system.
  • Measurable clinical quality through demonstrable compliance with the eleven quality aspects.
  • Mandatory addressing of clinical risks reduces liability risk.
  • Valid for all healthcare organizations.
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How does EN 15224 certification work?

In the first step, you discuss your company, your management system and the goals of DIN EN 15224 certification with us. On this basis, you will promptly receive a detailed and transparent offer, tailored to your individual needs.

Especially for larger certification projects, a planning meeting is a valuable opportunity to develop an individual audit program for all involved departments and locations. For an initial assessment, we recommend a pre-audit. It will determine what you have already implemented in your facility with regard to the requirements and what still needs to be done. An existing QM system in accordance with ISO 9001 will make implementation easier for you.

The certification audit starts with a system analysis (audit stage 1) and the evaluation of your documentation, objectives, the results of your management review and internal audits. In the subsequent system audit (audit stage 2), your DQS auditor assesses the conformity of your management system with the requirements of EN 15224 on the basis of a process-oriented on-site inspection and interviews.

After the certification audit, the results are evaluated by the independent certification board of DQS. You will receive an audit report documenting the audit results. If all standard requirements are met, you will receive the EN 15224 certificate.

With a view to continuous improvement and the ongoing effectiveness of your quality management system, on-site audits of key components of your system are carried out at least once a year, during which potential for improvement is again identified.

The EN 15224 certificate is valid for a maximum of three years. Recertification is carried out in good time before expiry to ensure continued compliance with the applicable standard requirements. Upon fulfillment, a new certificate is issued.


What does EN 15224 certification cost?

The cost of EN 15224 certification depends on various factors. For example, it plays an important role whether a certified management system, for example according to EN ISO 9001, is already in place. In addition, the size of your organization and the complexity of the quality management system have an influence on the duration of the audit and the price.

For these reasons, the cost of certification cannot be given as a lump sum. We will be happy to make you an individual offer.

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What you can expect from us

  • More than 35 years of experience in the certification of management systems and processes
  • Auditors with clinical experience and experts from the field
  • Value-adding insights into the risk orientation of your facility
  • Accredited certificates with international acceptance
  • Personal, smooth support from our specialists - regionally, nationally and internationally
  • Individual offers with flexible contract terms and no hidden costs
  • Meaningful audit reports including recommendations for action
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Request a quote

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We would be happy to provide you with an individual quote for EN 15224 certification.