S
SteveK
“When the organization chooses to outsource any process that affects product conformity to requirements, it shall monitor and ensure control over such processes.”
Now I can see that sending an item to be e.g. anodized by an external company is an example of outsourcing a process. However, in this context does “process” also mean using an external company to supply moulded parts, machined components, PCBs etc .to your design for assembly into the final device at your production site? By answering my own question – I assume it does. It is just that now the requirement of this clause is to obtain written supplier agreements. In our case we have enough problems getting supplier quality questionnaires returned as part of our vendor approval process (no problems with major ones) – noting that we have hundreds of suppliers! Can anyone confirm my assumption?
Steve
Now I can see that sending an item to be e.g. anodized by an external company is an example of outsourcing a process. However, in this context does “process” also mean using an external company to supply moulded parts, machined components, PCBs etc .to your design for assembly into the final device at your production site? By answering my own question – I assume it does. It is just that now the requirement of this clause is to obtain written supplier agreements. In our case we have enough problems getting supplier quality questionnaires returned as part of our vendor approval process (no problems with major ones) – noting that we have hundreds of suppliers! Can anyone confirm my assumption?
Steve