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ISO 9001 - Expert Advice Community

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  • Defining scope of QMS

    I am looking to improve my scope, i have been advised that 'boundaries of the qms are not clearly identified (in respect to personnel and legal structure of the group.
  • Clause 1 Scope vs clause 4.3 Scope of QMS

    I want to understand the difference between clause 1 Scope and clause 4.3 Scope of QMS of ISO 9001: 2015.
  • Implementing ISO 9001 in a library

    I'm doing course in ignou ie Master degree in library science so my topic is Implementation of ISO 9001:2008 of state central library panaji goa so please explain me what I need to add in project. I will be very much thankful if u look in my matter.
  • Documenting clause 5

    Concerning the new paragraph in the 2015 version (leadership clause 5) is that one is obliged to have documented information (a procedure)?
  • Requirements for documented procedures in ISO 9001:2015

    Within ISO 9001:2015 is there a requirement for the preparation of documented procedures for all quality critical activities? and what would be the relevant clause to review this?
  • Design validation, verification and review

    I have one doubt about Design Review, Verification and Validation with one instance.
  • Clause 5 and ISO 9001 Documentation Toolkit

    I am having trouble understanding how the Documentation Toolkit correlates to the Standard. For instance, there is no reference to Clause 5-leadership nor does any exist in policies and procedures... how should I be interpreting this?
  • Structuring work instructions

    I would like to know if work instructions have to be structured the same across the board or if there can be different levels written.
  • Evaluation of outsource partners

    Would like to know if we need to perform evaluations of all outsourced process providers similar to a customer survey/feedback or supplier survey?