Question:
Some of the current controls we have are "Customer requirements", PFMEAs, DFMEAs, Six Sigma, etc. Would those count as being part of the COTO?
We also go over these types of changes during management reviews.
Answer:
It goes without saying that, the results analysis during implementation of PFMEAs, DFMEAs, Six Sigma, etc. are part of meeting the requirement «The organization shall monitor and review information about these external and internal issues.» (Cl. 4.1 Understanding the organization and its context, ISO 9001: 2015).
Understanding the organization and its context can be effectively combined with the control of organizational knowledge that is described in the QSP 7.1-03 Control of Organizational Knowledge.
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