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4.4 Quality Management system and its processes

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by David Oakley, Sep 22, 2020.

  1. David Oakley

    David Oakley New Member

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    Hi all,

    Working on section 4.4 of ISO 9001:2015 and I'm confused. I have many written procedures in place from sales through design, goods in through to goods out but do I have to map all the required processes out or is having written procedures enough to fulfil this section?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    How have you complied with the requirement to determine the sequence and interaction? You can have a "system of documentation", but completely missed that the standard requires (in effect) a "documented system"
     
  3. David Oakley

    David Oakley New Member

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    Thank you Andy. I have missed the sequence and interaction requirement and if I'm honest I'm not sure how to start with this. I have found a matrix template online which I find confusing but may be able to modify it in some way to fit our organisation.
     
  4. Parag Kumar

    Parag Kumar Member

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    Sequence can be depicted in a flow chart showing the flow of work through different processes of the system.

    For interactions I use a matrix with processes written in the first row and first column, and the intersecting items/boxes can show whether the corresponding processes interact or not. To be more descriptive, the intersections may also show the interactions between the corresponding processes.
     
    Andy Nichols and David Oakley like this.
  5. tony s

    tony s Well-Known Member

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    ISO/TS 9002:2016 (Guidelines for the Application of ISO 9001:2015) provided this statement for your reference:

    4.4.1b)
    "when determining the sequence and interaction of these processes, the links with the inputs and outputs of the previous and subsequent processes should be considered; the methods for providing details of the sequence and interaction of the processes depends on the nature of the organization; different methods can be used, such as retaining or maintaining documented information (e.g. process maps or flow diagrams), or a more simple approach, such as a verbal explanation of the sequence and interaction of the processes"
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    David:

    It's pretty simple: 30,000ft, what do the processes look like? Does the organization do design? Is it innovative, market leading design, which is then sold? Or does the organization do design in response to a sales processes request from clients? It's really "big block" core process and support process sequence and interactions the standard is looking for. TBH, many organizations have never had to think about it. It's also key to determining where the QMS doesn't work so well when you discover the true nature inputs/outputs from/to each interacting process...
     
    Last edited: Sep 27, 2020
    John C. Abnet likes this.

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