# Quality System **URL:** \ **Category:** In My Humble Opinion\ **Created:** [December 22, 2014, 9:51am UTC](https://boards.straightdope.com/t/quality-system/707899 "2014-12-22T09:51:07Z")\ **Posts on this page:** 20\ **Page:** 1
**Author:** ![Phyllida\_Dickinson](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/phyllida_dickinson/32/7313_2.png) [@Phyllida\_Dickinson](https://boards.straightdope.com/u/Phyllida_Dickinson)\ **Post date:** [December 22, 2014, 9:51am UTC](https://boards.straightdope.com/t/quality-system/707899/1 "2014-12-22T09:51:07Z")
My father recently asked me to check on the system being used by his company. As expected, I have seen some loop holes which disappoints me as well as my father. I am looking to something that might be able to help even if I am not around. Perhaps something that can monitor or track changes made into the system? Or better, if there is something that can automatically tracks what went wrong. I am hoping to be able to find a solution for my dad. ---
**Author:** ![cochrane](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/cochrane/32/10441_2.png) [@cochrane](https://boards.straightdope.com/u/cochrane)\ **Post date:** [December 22, 2014, 9:58am UTC](https://boards.straightdope.com/t/quality-system/707899/2 "2014-12-22T09:58:46Z")
Um, I reported this for a forum change for you. As a new poster, you _really_ don’t want this in the BBQ Pit. ---
**Author:** ![BlankSlate](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/blankslate/32/80_2.png) [@BlankSlate](https://boards.straightdope.com/u/BlankSlate)\ **Post date:** [December 22, 2014, 10:23am UTC](https://boards.straightdope.com/t/quality-system/707899/3 "2014-12-22T10:23:00Z")
Yes, it’s much better suited for What The Hell Are You Talking About. ---
**Author:** ![Smeghead](https://avatars.discourse-cdn.com/v4/letter/s/f1d935/32.png) [@Smeghead](https://boards.straightdope.com/u/Smeghead)\ **Post date:** [December 22, 2014, 12:19pm UTC](https://boards.straightdope.com/t/quality-system/707899/4 "2014-12-22T12:19:50Z")
Neat. ---
**Author:** ![VinylTurnip](https://avatars.discourse-cdn.com/v4/letter/v/b2d939/32.png) [@VinylTurnip](https://boards.straightdope.com/u/VinylTurnip)\ **Post date:** [December 22, 2014, 12:47pm UTC](https://boards.straightdope.com/t/quality-system/707899/5 "2014-12-22T12:47:17Z")
You should probably make an appointment with someone in Systems Engineering or Quality Assurance. ---
**Author:** ![QuickSilver](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/quicksilver/32/7832_2.png) [@QuickSilver](https://boards.straightdope.com/u/QuickSilver)\ **Post date:** [December 22, 2014, 12:50pm UTC](https://boards.straightdope.com/t/quality-system/707899/6 "2014-12-22T12:50:54Z")
> [@VinylTurnip](#): > > You should probably make an appointment with someone in Systems Engineering or Quality Assurance. Hell no. Those guys are definitely in on it. ---
**Author:** ![Bullitt](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/bullitt/32/5725_2.png) [@Bullitt](https://boards.straightdope.com/u/Bullitt)\ **Post date:** [December 22, 2014, 1:21pm UTC](https://boards.straightdope.com/t/quality-system/707899/7 "2014-12-22T13:21:22Z")
> [@Phyllida\_Dickinson](#): > > My father recently asked me to check on the system being used by his company. As expected, I have seen some loop holes which disappoints me as well as my father. I am looking to something that might be able to help even if I am not around. Perhaps something that can monitor or track changes made into the system? Or better, if there is something that can automatically tracks what went wrong. I am hoping to be able to find a solution for my dad. Did they have a compliance analysis or compliance matrix? That would yield a gap analysis, right? Which, in turn, would give them an action plan for re-achieving compliance, and then they could maintain that compliance. As mentioned earlier this shouldn’t be in the Pit. This seems better suited for IMHO. ---
**Author:** ![JKilez](https://avatars.discourse-cdn.com/v4/letter/j/e5b9ba/32.png) [@JKilez](https://boards.straightdope.com/u/JKilez)\ **Post date:** [December 22, 2014, 1:23pm UTC](https://boards.straightdope.com/t/quality-system/707899/8 "2014-12-22T13:23:38Z")
> [@VinylTurnip](#): > > You should probably make an appointment with someone in Systems Engineering or Quality Assurance. No, this is definitely a job for Central Services. ---
**Author:** ![Bullitt](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/bullitt/32/5725_2.png) [@Bullitt](https://boards.straightdope.com/u/Bullitt)\ **Post date:** [December 22, 2014, 1:23pm UTC](https://boards.straightdope.com/t/quality-system/707899/9 "2014-12-22T13:23:38Z")
Also, welcome to the Dope, **Phyllida**. ---
**Author:** ![Leaffan](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/leaffan/32/299_2.png) [@Leaffan](https://boards.straightdope.com/u/Leaffan)\ **Post date:** [December 22, 2014, 1:48pm UTC](https://boards.straightdope.com/t/quality-system/707899/10 "2014-12-22T13:48:04Z")
What you should be doing is consulting someone who is familiar with the ISO9001 standard. There are a few of us on this board who work with the standard and would be happy to answer any specific questions. ---
**Author:** ![Bullitt](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/bullitt/32/5725_2.png) [@Bullitt](https://boards.straightdope.com/u/Bullitt)\ **Post date:** [December 22, 2014, 1:51pm UTC](https://boards.straightdope.com/t/quality-system/707899/11 "2014-12-22T13:51:22Z")
> [@Leaffan](#): > > What you should be doing is consulting someone who is familiar with the ISO9001 standard. > > There are a few of us on this board who work with the standard and would be happy to answer any specific questions. It might not be this standard, it might also be ISO13485. And yes we’d be happy to answer specific questions. ---
**Author:** ![BubbaDog](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/bubbadog/32/333_2.png) [@BubbaDog](https://boards.straightdope.com/u/BubbaDog)\ **Post date:** [December 22, 2014, 1:55pm UTC](https://boards.straightdope.com/t/quality-system/707899/12 "2014-12-22T13:55:06Z")
Actually the first thing you should do in this scenario is determine if that man is really your dad. ---
**Author:** ![Bullitt](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/bullitt/32/5725_2.png) [@Bullitt](https://boards.straightdope.com/u/Bullitt)\ **Post date:** [December 22, 2014, 2:06pm UTC](https://boards.straightdope.com/t/quality-system/707899/13 "2014-12-22T14:06:59Z")
A good resource to check is the Elsmar Cove site: [Elsmar Cove Quality and Business Standards Discussions](http://elsmar.com/Forums/). Many sub-forums, including one specific to ISO 9000 / 9001 / 9004: [ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards](http://elsmar.com/Forums/forumdisplay.php?f=208) Also, the ISO13485-specific forum: > **[ISO 13485:2016 - Medical Device Quality Management Systems](https://elsmar.com/elsmarqualityforum/forums/iso-13485-2016-medical-device-quality-management-systems.44/)** > > ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016). Take a look at their sub-forums. Some of us here on the Dope have experience and can help. Many more here have opinions and you’ve seen some already. The Elsmar Cove forum will be much more focused. I’ve been a member there since 2007. ---
**Author:** ![friedo](https://avatars.discourse-cdn.com/v4/letter/f/8edcca/32.png) [@friedo](https://boards.straightdope.com/u/friedo)\ **Post date:** [December 22, 2014, 5:31pm UTC](https://boards.straightdope.com/t/quality-system/707899/14 "2014-12-22T17:31:31Z")
Sounds like somebody forgot about the new cover sheets for their TPS reports. ---
**Author:** ![andros](https://avatars.discourse-cdn.com/v4/letter/a/e480ec/32.png) [@andros](https://boards.straightdope.com/u/andros)\ **Post date:** [December 22, 2014, 6:28pm UTC](https://boards.straightdope.com/t/quality-system/707899/15 "2014-12-22T18:28:03Z")
Hmmm. Did she get the memo? ---
**Author:** ![TroutMan](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/troutman/32/6721_2.png) [@TroutMan](https://boards.straightdope.com/u/TroutMan)\ **Post date:** [December 22, 2014, 6:28pm UTC](https://boards.straightdope.com/t/quality-system/707899/16 "2014-12-22T18:28:55Z")
> [@Bullitt](#): > > It might not be this standard, it might also be ISO13485. ISO13485, are you crazy?? She’s trying to track changes made into the system. You’re out of order! The whole freaking system is out of order! ---
**Author:** ![Bryan\_Ekers](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/bryan_ekers/32/183_2.png) [@Bryan\_Ekers](https://boards.straightdope.com/u/Bryan_Ekers)\ **Post date:** [December 22, 2014, 6:30pm UTC](https://boards.straightdope.com/t/quality-system/707899/17 "2014-12-22T18:30:49Z")
> [@BubbaDog](#): > > Actually the first thing you should do in this scenario is determine if that man is really your dad. What’s the acceptable tolerance? ---
**Author:** ![Bullitt](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/bullitt/32/5725_2.png) [@Bullitt](https://boards.straightdope.com/u/Bullitt)\ **Post date:** [December 22, 2014, 6:39pm UTC](https://boards.straightdope.com/t/quality-system/707899/18 "2014-12-22T18:39:39Z")
> [@TroutMan](#): > > ISO13485, are you crazy?? She’s trying to track changes made into the system. You’re out of order! The whole freaking system is out of order! I object! I object! Wait a minute, I need My Cousin Vinnie! > [@Bryan\_Ekers](#): > > What’s the acceptable tolerance? None, dammit! I object! Didn’t you hear me? ---
**Author:** ![Hampshire](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/hampshire/32/4887_2.png) [@Hampshire](https://boards.straightdope.com/u/Hampshire)\ **Post date:** [December 22, 2014, 7:31pm UTC](https://boards.straightdope.com/t/quality-system/707899/19 "2014-12-22T19:31:24Z")
Um, can you repeat the part of the stuff where you said all about the…things? ---
**Author:** ![TroutMan](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/troutman/32/6721_2.png) [@TroutMan](https://boards.straightdope.com/u/TroutMan)\ **Post date:** [December 22, 2014, 7:38pm UTC](https://boards.straightdope.com/t/quality-system/707899/20 "2014-12-22T19:38:59Z")
> [@Hampshire](#): > > Um, can you repeat the part of the stuff where you said all about the…things? It’s an old story. The man had a system, the system done did him wrong, and a lady is there to pick up the pieces. What more do you need to know? [Next page](https://boards.straightdope.com/t/quality-system/707899.md?page=2)