C
Charles Osenbaugh
Thank you, Sidney. That lack of understanding the integration makes our job very difficult. It sends a message that the QMS is stand-alone and solely owned by the Quality Dept.Amen. It is utterly frustrating that the ISO TC's have been failing to make this point clearer after so much confusion over the years. The "QMS processes" are the components of the organization's business/operational processes that deal with product conformity and/or customer satisfaction. It should be THAT simple.
Every ISO Standard should make ABUNDANTLY clear that their respective disciplines relate to the organization's BUSINESS PROCESSES. The HLS requirement in 5.1.1.c) needs to be CENTRAL to the implementation of any discipline specific standard. Until all people understand that, we will be sub-optimizing subsets of the organization's systems.