Question

Using the diagram below, fill in the box with the needed data on how you were going to explain the process. In what hierarchy of the ISO 9001 does diagram belong?

Process procedure

Measurements-

Methods-

Tools-

Responsibilities-

Purpose-
​

Answer 1

Answer:

ISO 9001 Processes, Procedures and Work Instructions

ISO 9001:2015 has relaxed the strict requirement for quality management documentation. However, in order to satisfy the remaining documentation requirements and to properly implement the Quality Management System (QMS), ISO 9001 Processes, Procedures and Work Instructions are typically still employed.

Section 4.4 of the standard, titled Quality Management System and its Processes covers the general requirements for work processes. Unfortunately, within the QMS planning and documentation realm, the terms are often confused. Below you’ll find definitions of each of these terms with examples and links to resources to help you improve creation of your ISO 9001:2015 documentation.