Audit Scenario – Product/Service Quality
By Lynn Clyde, BRC Quality Consultant
The following is a typical auditing scenario that might be found when auditing an ISO 9001:2008 quality management system for clause 8.1 General (Measurement, analysis and improvement). Read the scenario to determine if you think it would be conforming or nonconforming, then read the answer and explanation.
Support Information – ISO 9001:2008 Clause 8.1
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed:
a) to demonstrate conformity to product requirements,
b) to ensure conformity of the quality management system, and
c) to continually improve the effectiveness of the quality management system.
This shall include determination of applicable methods, including statistical techniques, and the extent of their use.
Scenario
While visiting the quality control department of a large engineering organization, the auditor discovered there were no statistical techniques being used to confirm product (service) quality. The auditor said they were going to write a non-conformance for this.
Answer
Conforming to Clause 8.1
Explanation
There is no requirement that any organization apply statistical techniques. The standard only requires that the organization determine whether or not they should be applied to their operation. On the other hand, if every other organization in their industry is applying statistical techniques, there should be a good reason for the organization to exclude them and/or be able to show that the operation is running effectively without them.
