Every practice in statutory care must introduce internal quality management and develop it further, under § 135a SGB V and the G-BA's QM-Richtlinie, with every listed method in place and reviewed within three years of Zulassung. Risk management, error management with a reporting system, and OP checklists where they apply are minimum standards no practice may waive.
Who the QM-Richtlinie binds
§ 135a Absatz 2 of the SGB V obliges doctors, MVZ and hospitals in statutory care to introduce internal quality management and keep developing it.2 The G-BA sets the basic requirements in its Qualitätsmanagement-Richtlinie, last amended on 18 June 2026 and in force in that version since 20 August 2026.3 Teil B says every provider in vertragsärztliche Versorgung must run it, and that in a group practice or an MVZ the reference point is the Einrichtung as a whole, never the single doctor.1
The Richtlinie names six Grundelemente, from patient orientation including patient safety to responsibility and leadership, with information security and data protection among them.1 Quality management is a leadership task, run on the PDCA cycle, and a practice may design its own system or use an existing model.1 The KBV's own model for practices is QEP, and the KBV says certification is optional.4
The methods and instruments, one by one
| Method or area | What the QM-RL asks |
|---|---|
| Messen und Bewerten von Qualitätszielen | Goals for care or organisation, their achievement measured and reviewed |
| Erhebung des Ist-Zustandes und Selbstbewertung | Regular reviews of where the practice stands |
| Regelung von Verantwortlichkeiten und Zuständigkeiten | Organisation and responsibilities in writing, for example as an organigram |
| Prozess- bzw. Ablaufbeschreibungen | Key processes described, available to staff, reviewed at set intervals |
| Teambesprechungen, Fortbildung | Structured meetings and training tied to each person's work |
| Patientenbefragungen, Beschwerdemanagement | Regular surveys, and complaints handled with feedback to the patient |
| Risikomanagement, Fehlermanagement und Fehlermeldesysteme | A risk strategy, and anonymous reporting without sanction |
| Notfall, Hygiene, Arzneimitteltherapiesicherheit | Application areas the practice regulates |
| Schmerz, Stürze, Missbrauch und Gewalt | Further areas, with a Schutzkonzept where children are treated |
A practice may leave out a method only where its staffing, equipment or local situation plainly rules it out. That exception never covers the minimum standards of risk management, error management and error reporting, or OP checklists for procedures with two or more doctors or under sedation.1 The practice reviews its QM regularly as a self-assessment and documents the result for internal use.1
- Name the owner. A practice with several doctors names one doctor responsible for QM, and the QM-RL recommends a staff member to coordinate it.
- Set three quality goals. One for patient care, one for organisation, one for safety, each with a measure.
- Write down responsibilities. An organigram or table, with an owner for every safety-relevant process.
- Describe the key processes. Booking, consultation, results, prescriptions, emergencies and hygiene, in tables or flow charts.
- Set up the minimum standards. A risk strategy, an anonymous error reporting route and OP checklists where they apply.
- Review and document. A self-assessment at least once a year, its result filed with the date.
- Practice ______ Zulassung since ______ Three-year date ______
- QM lead doctor ______ QM coordinator ______
- Goal 1 ______ Measure ______ Reviewed on ______
- Goal 2 ______ Measure ______ Reviewed on ______
- Error reporting route ______ Last review of reports ______
- OP checklist needed ______ In use since ______
- Self-assessment on ______ Filed by ______
The Berufsordnung sits beside it
The model Berufsordnung obliges every doctor to take part in the quality measures the Ärztekammer introduces and to give the Kammer the information needed for them.5 It binds a doctor once their Landesärztekammer adopts it as a Satzung.5
Questions
How long does a new practice have to set up QM?
Three years from Zulassung or Ermächtigung to put every method and instrument in place and review it, then it develops the system continuously.
Do we have to follow a set order?
No. The QM-RL lets a practice introduce the instruments step by step, in any order it chooses.
Is QEP compulsory?
No. QEP is the model the KBV and the KVs developed for practices, and a practice may also build its own system or use another model.
Does the QM-RL apply to an MVZ doctor by doctor?
No. In a Berufsausübungsgemeinschaft or an MVZ the requirements apply to the Einrichtung as a whole.
Sources
- 1Gemeinsamer Bundesausschuss, 2026Richtlinie über grundsätzliche Anforderungen an ein einrichtungsinternes Qualitätsmanagement (QM-RL), Volltext, BAnz AT 19.08.2026 B4Read source
- 2Bundesministerium der Justiz, Gesetze im Internet, 2026§ 135a SGB V, Verpflichtung der Leistungserbringer zur QualitätssicherungRead source
- 3Gemeinsamer Bundesausschuss, 2026Qualitätsmanagement-Richtlinie (QM-RL), zuletzt geändert am 18. Juni 2026, in Kraft seit 20. August 2026Read source
- 4Kassenärztliche Bundesvereinigung, 2026QEP, Qualität und Entwicklung in PraxenRead source
- 5Bundesärztekammer, 2026(Muster-)Berufsordnung für die in Deutschland tätigen Ärztinnen und Ärzte, MBO-Ä 1997, in der Fassung des 130. Deutschen Ärztetages vom 13. Mai 2026Read source
Written by the wai team from Gemeinsamer Bundesausschuss, the Kassenärztliche Vereinigungen and the Länder guidance, checked on 16 October 2026. This is guidance, not legal advice. Neither the G-BA, any KV nor any Land authority endorses wai or any software.