Quality Management System cheat sheet

The business context

• External issues are factors outside the organisation's control, such as regulation, market competition, technology change and the economy; internal issues are factors within it, such as its culture, resources, knowledge and existing performance.
• External and internal issues are reviewed at planned intervals, or when a significant change occurs, so the quality management system keeps reflecting the environment the organisation actually operates in.
• Interested parties include customers, employees, suppliers, regulators, owners and investors, and the wider community, and the system accounts for each one's requirements, not only the paying customer's.
• Interested parties' requirements change over time, so they are tracked deliberately rather than assumed to stay valid once identified.
• The scope statement defines which products, services, sites and processes the system covers; a clearly bounded scope is what makes the system auditable and its claims credible.