This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

• To assess effects of Lean management in health care on patient, professional, and systems outcomes by addressing the following question.

◦ What are the effects of Lean management interventions in health care on patient outcomes, professional practice, and healthcare systems?

• What are the effects of Lean management interventions in health care on patient outcomes, professional practice, and healthcare systems?

• To answer the following questions in addressing secondary objectives:

◦ What are the effects of Lean management interventions in combination with other management systems (e.g. Six Sigma) on patient outcomes, professional practice, and healthcare systems (utilisation and access, adverse effects, cost)?

◦ Is the effectiveness of Lean interventions influenced by the setting (e.g. Emergency Department, Laboratory, Pharmacy) in which they are implemented?

• What are the effects of Lean management interventions in combination with other management systems (e.g. Six Sigma) on patient outcomes, professional practice, and healthcare systems (utilisation and access, adverse effects, cost)?

• Is the effectiveness of Lean interventions influenced by the setting (e.g. Emergency Department, Laboratory, Pharmacy) in which they are implemented?