The terms "process" and "procedure" are closely related, often making it challenging to distinguish between them. However, in a Quality Management System (QMS), this distinction is crucial, and confusing the two can create significant issues when implementing ISO 9001:2015, as both terms permeate throughout the standard.
ISO 9000:2005 provides the foundational definitions for quality management terminology used in ISO 9001. Its definition of a "process" states: "a set of interrelated or interacting activities that use inputs to deliver an intended result (output)." A procedure, conversely, is defined as "a specified way to carry out an activity or process."
Any organizational QMS contains numerous processes, as nearly all organizational activities can be classified as processes. Whenever inputs are transformed into outputs through defined activities, a process exists.
However, not all processes require documented procedures. This determination depends on whether specific execution steps are essential. Procedures become necessary when processes require strict execution methods and aren't automated, while knowledge-based processes relying on operator expertise may not.
The process approach constitutes one of ISO 9001's seven quality management principles. Understanding process interactions is critical for effective QMS implementation and improvement. Through process analysis, organizations can identify:
- Processes requiring strict execution protocols (necessitating procedures)
- Documentation needs for consistent results
- Interdependencies between operational processes
To clarify the fundamental distinction: processes answer "What?" by defining input-output transformations, while procedures answer "How?" by specifying execution methods.
Practical analogy: Cooking pasta represents a process, while the recipe constitutes the procedure. A process exists as action-based rather than documentation-dependent, while procedures are explicitly documented through various media (text, flowcharts, videos, etc.) providing:
- Step-by-step execution guidance
- Role clarifications ("who does what")
- Competency requirements for personnel
Effective procedures must be comprehensible to their intended users while maintaining technical precision.