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  • External processes

    Is it necessary for a person handling the external service processes have their own job description?

  • Procedures and requirements

    Implementing the ISO 9001:2015 - what are really the procedures and the requirements?

  • ISO 9001 / 8.3. Design and development of products and services

    "COO appoints persons responsible for planning, realization, and management of product design and development and project management according to the Procedure for Design and Development.

    References "Procedure for Design and Development" ...

    Should this be an external document?

    If yes, should we include this document with our final ISO 9001 submission or should it simply be available for someone upon request?"

  • ISO 9001 / Interested parties

    "what is meant by interested parties? is it "stakeholders", or is it something else?"

  • Sign-offs on procedure

    For ISO 9001:2015,  when we write a procedure, do we have to get sign-offs by departments to show it is accurate?

  • Analyzing implemented standards

    The company that I am working in has 2 ISO standards implemented already (ISO 9001:2015 and ISO 1400:2015) and they asked me if these ISOs are right and correct or not. How can I analyze and confirm them?

  • ISO 9001 / Quality roles for iso requirements


    I need to know if a supervisor can do the work for iso requirements or it has to be a manager

  • ISO 9001 / Procedure vs processes

    Hi! I am looking at the documentation toolkit and there are many usel procure documents. But let say, procedure for design & development. The design & development could be based on one main process or many processes with dependencies to each other. But these processes don´t have to be documented - right? (I will document the processes anyway!) . The procedure in your list seems to be at the top. The procedure document contains process flows, planning, requirement settings, controls and so on. Is the procedure manadatory and the processes up to the organization to document? Just want to have a clarification on that...

  • Scope of service provider

    I am a service provider and calibration should not be in my scope. So, how do I justify its non-applicability inline with ISO 9001: 2015?

  • ISO 9001 / QS Registered


    Hello, my organization has labels that say "ISO 9001:2015 QS Registered"... is the "QS Registered" part obsolete and out of date? What are the implications, if any, of having that on the label?
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