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QM Level in ISO 26262

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Vincent Hsu, May 22, 2020.

  1. Vincent Hsu

    Vincent Hsu New Member

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    From ASIL perspective, we can say QM is no ASIL on functional safety, but still keep Quality Management Level.
    So, can we say if the product development and process comply with ISO 9001 and IATF 16949, it is QM Level? Or is QM level mandatory to be compliance with A-SPICE or equivalent Design Quality standards?
    in ISO 26262 Part 1, it defined "QM" as coordinated activities to direct and control an organization with regard to quality.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Hi Vincent. Can you give us what you mean by these abbreviations, so there's no confusion? ISO 26262 isn't widely known, neither is A-SPICE nor ASIL.
     
  3. Juergen Schmied

    Juergen Schmied New Member

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    Hi Vincent, I just was coming over your question with regard to QM level in ISO26262 and ASPICE. Although your question might be obsolete in the meantime, here comes my interpretation:

    QM level in ISO 26262: Determined by HARA (Hazard Analysis and Risk Assessment).
    Meaning: The function is not safety-relevant → no ISO 26262 safety measures necessary.
    Has nothing to do with the process maturity of the organization.
    An organization with an excellent development process can still have many QM functions in the product (e.g., infotainment).

    Automotive SPICE Level 1: Meaning: The process is defined and implemented, but not yet systematically controlled or improved (this would lead to higher ASPICE Capability Levels)
    All base practices (e.g., requirements analysis, design, implementation, testing) are formally fulfilled, but not yet measurable or improved (this would come at Level 2+).
    It says nothing about the safety relevance of functions.

    If you want to learn more about Automotive SPICE (which is nowadays considered state of the art in developing software for automotive industry): you should check out as well spice4cars.com which summarizes several SPICE models and gives hints as well about interpreting and implementing those standards.
     
  4. Juergen Schmied

    Juergen Schmied New Member

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    sorry, missing link :) spice4cars.com