The first steps in implementing ISO 9001:2015 in a small to medium enterprise include:

- Ensuring top management involvement to secure necessary resources.
- Performing a Gap analysis to determine compliance with ISO 9001:2015 requirements and identify areas needing improvement.
- Setting up a project team, including a project sponsor and project manager.
- Developing a project plan with defined activities, responsibilities, and deadlines.
- Providing basic training on ISO 9001 for project team members.
- Defining the scope of the quality management system (QMS).
- Mapping processes and determining internal and external context.
- Identifying interested parties and defining quality policy, objectives, and plans.
- Determining risks and opportunities and creating action plans.
- Documenting processes and starting performance measurement.
- Conducting internal audits and management reviews to assess readiness for certification.