DIN EN 15224

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Logo of the German Institute for Standardization DIN EN 15224
Area Healthcare
title Healthcare services - Quality management systems - Requirements according to EN ISO 9001: 2008
Latest edition 2017-05
ISO -

The DIN EN 15224 is the first sector-specific standards for quality management in medicine based on the ISO 9001 . It wants to counter the doubts that have been expressed so far against the application of ISO 9001 in health care . The initiative for such a standard was started in 2001 by CEN . The document was accepted by DIN in June 2012 and published as DIN standard DIN EN 15224 in December 2012 . After the revision of ISO 9001: 2015, the standard was revised and published as DIN EN 15224: 2017-05. It now follows the basic structure of the quality management standards (High Level Structure), adopts all changes to ISO 9001 and updates its area-specific requirements.

DIN EN 15224

The DIN EN 15224 is an explanation of the quality management system according to ISO 9001 for organizations of health care . It is an independent and sector-specific standard. It can be used by all organizations that provide clinical services as defined in the standard, including the associated research and training. "Clinical" is understood here to mean the context "in which patients and health care personnel collaborate on a health problem". The scope is the definition of requirements for a QM system, "if a health care organization must a) demonstrate its ability to consistently provide health care products and services that meet customer requirements and the applicable legal and regulatory requirements and b) seeks to increase customer satisfaction through effective use of the system ... ". It is applicable "to all health care organizations irrespective of the structure, organization, owner, size or type of health care services provided". It thus includes all clinical services - medical work, care, physiotherapy, laboratory, X-ray, prevention, etc. EN 15224 can be used to certify health care organizations within the framework of the European conformity assessment procedure. The certificates are to be recognized throughout Europe.

Differences between ISO 9001 and DIN EN 15224

DIN EN 15224 follows the text of ISO 9001 word for word. The requirements of ISO 9001 are explained for health care, some statements are reinforced and the text of ISO 9001 is supplemented by some statements. The additions and comments are highlighted in italics and blue letters. Deletions from the text of ISO 9001 are generally not permitted. The following points are clearly emphasized or completely new:

  • responsibility for outsourced processes (service providers),
  • the integration of risk management into the QM system,
  • Knowledge management in the section on resources,
  • Internal communication, document control,
  • Confidentiality (confidentiality and data protection) and the
  • Maintenance of the infrastructure after operational disruptions

EN 15224 unequivocally sees clinical treatment as the "product" of the hospital (or other organizations) - which means that all requirements from Chapter 8 also apply to health care services.

Quality features

In contrast to all other comparable standards, DIN EN 15224 identifies eleven fundamental quality aspects that should be based on experience with health care organizations that have been rated as "good". The eleven quality aspects should be observed, checked and proven for all services. If an aspect does not apply, it can be deleted with justification. Further aspects can be added. The eleven characteristics are considered "prerequisite characteristics" and do not need to be specified by the patient. However, they do not replace the "Determination of the requirements relating to the product" as required in Section 8.2. The eleven quality aspects (also called quality requirements or characteristics) are explained in Appendix D:

a) adequate, correct care

The patient is examined and treated according to his / her needs as assessed by health care professionals. The assessment of the needs of examinations and treatments should be based on careful history, physical examination and observations with an acceptable risk of adverse events, complications or side effects. Activities carried out (examinations and treatments) should not exceed the stated requirements;

b) availability;

Health care services within the reach of the patient who needs this type of service.

c) continuity of supply;

There is a seamless and streamlined chain of patient health care services from referral to examinations, treatment and rehabilitation to evaluation / follow-up care;

d) effectiveness;

Health care activities carried out increase the chance of an expected positive result (have a positive effect on the health status of the person to be cared for) compared to examinations or treatments that are not carried out or other examinations or treatments. Positive results can be shown by improving the observed condition.

e) efficiency;

The best possible relationship between the results achieved and the resources used (space, equipment, material and working time) must be preferred. Economic efficiency is considered as a quality feature in the health care system, as it enables the organization to help several patients and thereby increases customer satisfaction.

f) equality;

All patients with similar and equally severe needs receive the same type of care - regardless of gender and sexual, cultural, ethnic, social, linguistic or other circumstances. Non-discrimination and no preference that is not based on health needs is seen as a quality feature in the health care system.

g) evidence-based / knowledge-based care;

Health care services (examinations, treatments including prevention, care, etc.) must be based on scientific evidence and / or empirical knowledge // best practices. Quality for health care depends on the systematic application of medical knowledge.

h) patient-centered care, including physical, psychological and social integrity (ICF);

Healthcare services must be provided taking into account the patient's values, preferences and personal situation, and performed with the patient's informed consent and with a view to maintaining his / her physical and psychological integrity. These aspects are often referred to as “personalized care”. When health needs are identified, the health components of the WHO International Classification for Functioning, Disability and Health (ICF) should be used to categorize and specify quality requirements. Health needs based on ICF can be determined by the patient and / or by health professionals who work with the patient in clinical processes.

i) patient involvement;

The patient is informed, advised and, whenever possible, actively involved in all decisions and health care activities that affect him / her. Patient involvement is seen as synonymous with patient involvement.

j) patient safety;

The risks associated with health care services must be identified, monitored and any avoidable harm to the patient prevented. The implementation of clinical processes that do not lead to harm or unnecessary health care activities (with additional risks and time expenditure for patients) is regarded as a quality characteristic of clinical processes.

k) Timeliness / Accessibility

Health care services must be provided in a timely manner. The sequence of activities in the provision of services must be based on the optimized efficacy, the identified needs of the patient, the acute condition and the severity of the illness, regardless of the patient's social status, etc.

The concept of quality features is sometimes criticized as inconsistent: Feature i) is not an adjective in terms of language. The feature j) security is a feature of the patient. What is meant is the risk of treatment, i.e. the dangerousness of the service. e) and g) are not quality features, and f) is not a feature of treatment, but of allocation in the health care system.

Further requirements

DIN EN 15224: 2017-05 supplements requirements in particular for the following topics:

Certification

EN 15224 can be used for certification within the framework of the European conformity assessment procedure. For certification according to ISO 9001, the auditors will take into account the explanations in EN 15224. The national accreditation bodies will still have to create the necessary basis (requirements for bodies that want to certify QM systems according to EN 15224). The legislature has not yet declared the standard to be the state of the art for QM systems in health care. The basis for quality management in accordance with Section 135a SGB V has so far been the G-BA's quality assurance guidelines. A QM system according to ISO 9001 can also include all the requirements of the directive or DIN EN 15224: 2017-05. The introduction of a QM system is often equated with certification. However, you can set up a complete QM system without having its effectiveness confirmed by a notified body. For certification within the framework of the European conformity assessment procedure, the implementation of the requirements is checked in an audit by a notified body. Completeness and effectiveness are confirmed in the certificate.

TÜV Nord describes the path to certification using the following stations:

  1. Briefing
  2. Determination of certification eligibility
  3. Certification audit
  4. Corrective Actions (if necessary)
  5. Issuing of certificates

advantages

  • Explanation of ISO 9001 for health care organizations
  • Supplement to newer aspects of quality management
  • recognized basis for conformity assessment programs
  • Overcoming the confusing quality seals and certificates
  • Clarification on the product in health care

disadvantage

  • Less known than ISO 9001: 2015. Only a few certificates so far
  • The concept of quality characteristics and requirements is inconsistent.

Individual evidence

  1. DIN EN 15224: 2017-05 p. 17
  2. DIN EN 15224: 2017-05 p. 17
  3. Ulrich Paschen: Quality management in health care according to DIN EN 15224 and DIN EN ISO 9001 standard text, explanations, additions, sample forms, Beuth Verlag; 2016. ISBN 978-3-410-25097-5 . from p. 34.
  4. Ulrich Paschen: Quality management in health care according to DIN EN 15224 and DIN EN ISO 9001 standard text, explanations, additions, sample forms, Beuth Verlag; 2016. ISBN 978-3-410-25097-5 . from p. 22.
  5. Social Code (SGB) fifth book (V) - Statutory health insurance - (Article 1 of the law of December 20, 1988, Federal Law Gazette I p. 2477) § 135a Obligation of service providers to ensure quality
  6. Quality management guideline Guideline on the basic requirements for an institution's internal quality management for contract doctors, contract psychotherapists, medical care centers, contract dentists and approved hospitals - QM-RL
  7. DIN EN ISO 9001 Documented performance by TÜV Nord