ED Decision 2025/007/R
(a) The GH organisation should implement and maintain an SMS that is commensurate with the safety risks of its organisation and activities performed. The SMS should establish processes and procedures covering:
(1) safety policy and objectives:
(i) management commitment;
(ii) accountabilities and responsibilities, including for the accountable manager;
(iii) appointment of key safety roles and assigned personnel;
(iv) SMS documentation;
(2) safety risk management:
(i) hazard identification;
(ii) safety risk assessment and mitigation actions;
(3) safety assurance:
(i) monitoring and measurement of safety performance;
(ii) management of change;
(iii) continuing improvement of the SMS;
(4) safety promotion:
(i) training;
(ii) safety communication.
(b) The capability of a GH organisation to manage safety should be proportional to the safety risks to be managed, which can be at the service level or at the organisational level.
(c) The mitigation measures put in place should reduce the risks to an acceptable level. The effectiveness of mitigation measures should be monitored, as it may change over time.
(d) The GH organisation should establish and apply monitoring activities, measuring tools and indicators to evaluate the organisation’s safety performance. Where the various elements of the GH organisation’s management system are included in separate programmes, procedures or manuals, they should be cross‑referenced.
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