From Lynn Clyde, BRC Consultant
The following is a typical auditing scenario that might be found when auditing an ISO 9001:2008 QMS for clause 8.2.4 Monitoring and Measurement of Product. 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 8.2.4
“The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria shall be maintained.
Records shall indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4).
The release of product and delivery of service to the customer shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.”
Scenario
The auditor asked to see evidence of monitoring and measurement of the product. The quality supervisor showed him the incoming inspections and tests, as well as final inspections and tests. The auditor asked to see evidence of in-process inspections and tests as well, but the supervisor said that they didn’t do any because the process was so simple.
Answer
Conforming.
Explanation
The standard does not specifically state that “in-process” monitoring and measurement must be done. It simply states that monitoring and measurement “shall be carried out at appropriate stages of the product realization process in accordance with planned arrangements”. This allows each organization to determine the appropriate stages that apply to them.
