O1

Responsibility and legal identity

Responsibility plan, real legal entity and location allocation, documented assumption of responsibility.

O2

Roles and economic interests

Remuneration structures, intermediary relationships, bias and disclosure.

O3

Information and communication

Understandable information on services, risks, costs and responsibilities.

O4

Decision making process

Advice, questions, justified decisions not to treat and referral.

O5

Handovers and documentation

Mandatory interfaces and completeness checks.

O6

Aftercare and escalation

Availability, cover arrangements, escalation routes and responsibilities.

O7

Qualification and competence management

Checking actual permissions and assigning tasks.

O8

Data protection and confidentiality

Data flows, access controls and data minimisation.

O9

Complaints and safety learning

Protected, traceable processing and documented improvement.

O10

Internal verification

Effectiveness control, deviation management and implemented changes.

O11

External partners and continuity

Limits of responsibility for platforms, partners and cross-border processes.

O12

Transparent evaluation of results

Understandable definitions and open handling of uncertainty.

Requirements with verifiable evidence

Each criterion specifies its purpose, mandatory requirement, applicability, acceptable evidence, sampling approach and assessment instructions. Findings, severity and deadlines are documented transparently.

No offsetting of critical deficiencies

A positive certificate requires compliance with all applicable mandatory requirements. “Not applicable” requires justification and independent clearance.

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