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  • Fady Khalla started the topic Quality Management System Documentation Hierarchy in the forum Device Documentation 8 years, 7 months ago

    Hi everyone,

    As we have learned from this week’s simulation, The company’s quality management system documentation hierarchy was as follows : Quality Manual, Quality System Procedure, Work Instructions (a.k.a. SOP). I have worked in multiple organizations that have defined their Quality Management System in different ways. One of the small organizations I worked for defined their QMS as follows:
    – Quality Manual
    – Quality Procedures
    – Records

    While other organizations that I worked for defined their QMS as follows:
    – Quality Manual
    – Quality Policy
    – Quality System Procedures
    – Work Instructions
    – Quality Records

    From your experience, what is the advantages and disadvantages of each QMS? which is the best setup for a QMS and why?