Management System Professionals Support | CBG Inc.

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 . Free downloads:  PFMEA and DFMEA templates  Preview of Control of Organizational knowledge quality system procedure

ISO 9001:2015 requires the identification of external and internal issues.  The standard gives several examples of external issues, however is very "light" on internal issue examples.  Could you provide some?  Absolutely true, ISO 9001:2015 is scarce on the internal issues description. Internal issues include: the organization's management system excellence (compliance with international management system standards ISO 9001, ISO 14001, ISO 45001, ISO 27001, ISO 11462, SA 8000, ISO 31000, ISO 10002, ISO 10006, etc.).  dynamics of organization indicators (production, profit, performance, various expenses, efficiency, etc.); organizational knowledge (employed and emerging technologies, know-how, completed projects, enterprise standards, etc.) the level of personnel competence ; the balance of stakeholders interests; social responsibility indicators (motivational system excellence, including the level of pay and career planning; social benefits, includ...