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Keep it Clear: Word wizardry in quality management systems.

  • Forfatters billede: Frederik Hjort
    Frederik Hjort
  • 4. feb. 2022
  • 2 min læsning


Words don't come easy, although some come more easy than they probably should...

One such word is "shall". We have all seen it littered throughout many a quality management system, I'd wager...


"Why this sudden aggression towards this particular term" you might wonder?

Well, since English is not my first langauge I sometimes wonder how to write in a clear and concise way, and some years back I looked into the matter of how to best express myself when drafting SOP's. What I learned shook me, I have always thought it cool to write "shall" in my work to imply requirements, but it seems not everyone thinks so...


Apparently the use of the word "shall" is being discouraged for several reasons.

  • Lawyers have misused it to an extent where it holds no firm meaning.

  • Probably related to the above point, "Words and Phrases" (a legal reference) has 76 pages dealing with interpreting "shall".

  • I have never come upon someone using it in their daily speech.

For the above reasons, and probably more, the use of "shall" to imply obligations is now being abandoned and several legislative bodies around the globe are turning towards "must".


Instead of using "shall", use:

  • "must" for an obligation

  • "must not" for a prohibition

  • "may" for a discretionary action

  • "should" for a recommendation

If you are authoring documents for your company's quality management system choose your words carefully.

If you do wish to continue the use of "shall" in your QMS documents you might consider an approach like ISO13485:2016. The standard firmly defines the meaning of a few key terms ("shall", "Should", "may" and "can") in section 0.2 "Clarification of concepts". As a start, getting these straight might get you a long way.


If you are interested you can find some more information at:


As a closing comment, if ever I find myself fleeing a Balrog in the mines of Moria and you stand a chance of getting it off my tail, feel free to let it know that it "shall not pass".

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