An interested party can be a stakeholder, person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity. Relevant interested parties are those that provide significant risk to organizational sustainability if their needs and expectations are not met (ISO 9000:2015 2.2.4). Examples of interested parties can include:
- Regulatory bodies
- Opposing pressure groups
You are only required to take into consideration those interested parties that are relevant to your quality management system. Once you have identified who those interested parties are you will need to determine what their requirements are and have a system to monitor or review those requirements.
You do not need a documented process for this or records capturing your interested parties and their requirements but, it will help you provide to your auditor objective evidence that you are meeting this requirement if you have documentation to support your process.