Standards

• Does 9001:2015 clause 4.4.1 require every process within an organization to have objectives that demonstrate ongoing continual improvement?
  
  • 6.2.1 answers that by stating "at relevant functions, levels and processes..." You only need to make objectives and goals "Relevant" to your QMS. You can be as selective, or as inclusive as the company deems necessary to function.
  
  


• Is it "acceptable" to have a process meet a level of satisfaction for an organization such that the organization does not see the need to improve that process?
  
  • What we did for our Goals and Objectives was set an acceptable margin of error. If a goal needs to be at 95% complete, then we would set a margin of error at 90%. But another thing we did was color code our goals. If someone achieved the goal it would show up as green. If they were within the margin it would show up yellow, and if the goal was not met, then it would show up red (where the goal owner would give a small statement of how they were working to get back on track). We do assess our goals to ensure that they are still SMART (Specific, measurable, achievable, realistic, timely). If we are over achieving the goals then it would make sense to change it. On the flip side, if we are having issues achieving them, we can talk about how to get the number up- or maybe even consider dropping it down.
  
  


• Lastly, we recently had an auditor suggest that our Quality Objectives could be the targeted outcomes of things like CapEx projects.  While I agree these can be critical components of maintaining and/or improving a QMS, I've never thought of this type of project as a top tier Quality Objective and would like some input from other Quality Professionals.
  
  •  (I am sorry that I do not know how to really answer this last question).
  
  

 

I have three questions that I would like to receive some input on:

• Does 9001:2015 clause 4.4.1 require every process within an organization to have objectives that demonstrate ongoing continual improvement?


• Is it "acceptable" to have a process meet a level of satisfaction for an organization such that the organization does not see the need to improve that process?


• Lastly, we recently had an auditor suggest that our Quality Objectives could be the targeted outcomes of things like CapEx projects.  While I agree these can be critical components of maintaining and/or improving a QMS, I've never thought of this type of project as a top tier Quality Objective and would like some input from other Quality Professionals.

 

Hello Laura,

I'd be remiss not to point out that the US TAG to ISO TC 176 has an interpretations process that's designed to address your first two questions.  They are excellent candidates for the interpretations process because they can be answered with a simple "yes or no."  Email standards@asq.org and you will receive the application by return email.


Your third question was: "Lastly, we recently had an auditor suggest that our Quality Objectives could be the targeted outcomes of things like CapEx projects."  I'd offer that your auditor was correct in that such projects certainly could be subject to one or more objectives.  CapEx projects are no different from other projects in that meeting milestones and measurements are a basic requirement, the least of which in this case is ROI.  I've seen others manage these projects as objectives, but it's certainly your choice to do so.  Finally, I'd add that CapEx projects are also worthy of mention at management review as these projects often have multiple impacts to the effectiveness of the QMS such as new training needs or the risk of disrupting existing schedules or deliveries.


Great Questions!

Thank you!