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  • Is addressing risks and opportunities one time activity?

    IS addressing risk and opportunities a one time process which is to be done only once while establishing the QMS?

  • Defining quality objective

    I need to add one more quality objective. How I should refer to our time response after quality issue has been raised by customer?

  • Risks and opportunities in ISO 9001

    9001:2015, section 6.1, Actions to address risks and opportunities; the risks and opportunities of internal and external issues that affect you to achieve the intended result(s) of the quality management system. Is it about programmatic risk? Not System Safety Risk via Safety Management System (SMS). What is the context of opportunity?

  • Implementing ISO 9001 without any help

    I am a fresh graduate but I am in charge to develop the QMS document and to implement all the procedures and forms in the company. Is it possible to do this alone without any help from others?

  • Is FMEA necessary for ISO 9001:2015

    I don't want to use the FMEA method because that would be another form to have to keep up with. We only manufacture 1 product which is part of a gun but we do buy the rest of the parts to fully assemble the bolt carrier according to what our customers. I know the risk since I have been working on the project for 10 years. I just can't figure the best route to take to address the risk. Any suggestions?

  • Audit findings

    Thank you very much for your unselfish dedication in helping everyone. May I request for your advice in relation to how to find ways so that as an auditor I can respectfully say to the top management that one major concern I found during my audit is that middle management is not so effective or cannot be as productive because the decision making is too much centralized on the top management. That management should give middle management the trust and right to decide on critical issues of the operation. Middle management should not be ceremonial manager who can only decide on personnel vacation leave and training approval. Thank you in advance for your kind support.

  • Internal audit according to ISO 9001:2015

    I Have a query:

  • Understanding clause 9.3.2

    Hello Strahinja,

  • Competitor as an interested party

    Can competitor be an interested party?

  • Análisis DOFA

    En el contexto de la organización, tenemos el DAFO (internos y externos). En una lectura en un foro, alguien indicaba que las debilidades se corregían con Objetivos y las amenazas se controlaban con el análisis de riesgos y la actuación CAME
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