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ISO 9001 - Expert Advice Community

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  • Excluding engineering process from ISO 9001 scope

    The company I work for is a 3rd party manufacturing company. We currently don't have Engineering, Service dept.....all we currently have is procurement, production line and a CFO. For sections of ISO that talk about Engineering how will we fulfill those during an audit.

  • PPAP and occurrence, severity and detection

    How severity, occurrence and detection number should be given in PPAP ?

  • Process capability and Process Capability Index

    Process capability is the ability of a process to produce output within specification limits. In process improvement efforts, the process capability index or process capability ratio is a statistical measure of process capability. The concept of process capability only holds meaning for processes that are in a state of statistical control. Process capability indices measure how much "natural variation" a process experiences relative to its specification limits and allows different processes to be compared with respect to how well an organization controls them.

  • Documenting the context and risks and opportunities

    I want from you to send me in details if that possible from you the details of the processes,procedures of the following

  • Leadership requirements

    5. Leadership

  • Conducting internal audit for the first time

    I am tasked to perform an internal audit on our Key Process: Data Analysis, but do not know where to start.

  • Integrating ISO 9001, ISO 14001 and OHSAS 18001

    I want to know how to integrate all three 9001, 14001 & 18001 standards in one system with new clauses applicable in ISO 2015 particularly in Product Realization or Operation which will be in line with business requirement and should not lengthy.

  • SMETA Certificate

    I want to know information about SMETA Certificate.

  • Justification in a Statement of Applicability

    One of the columns on your Statement of Applicability is “Justification for Selection/Non-Selection”. I understand that generally that column would tie back to a specific item on the risk assessment results, but some of the controls are common sense/normal operating procedure for most companies. As a result, we already had some of these controls in place prior to this project, so they didn’t appear on the risk assessment/risk treatment table, as we’d already eliminated those associated threats. In this instance, how should we “justify” the inclusion of that control. Is it enough to say “already implemented”, or should we try to justify why we implemented them originally?

  • List of internal documents

    For the list of internal documents, should scope of QMS and quality policy and objectives be listed as well?
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