The Future Structure of ISO Management System Standards - from HLS to HS (Harmonized Structure) September 2023
- Thread starter Sidney Vianna
- Start date
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I'm betting the acronym WTF was first created for just such a situation - someone saw something like this and it was born.
lanley liao
Lingli Liao
Hi,Sidly, Thanks for your sharing.
No longer HLS- for High Level Structure, but HS for Harmonized Structure.
Withholding much of the comments I can give, i find it hilarious that the given reason for the medical device quality management remaining at its ISO 9001:2008 branch-off is that it is a heavily regulated sector. Gosh, how unlike automative, aerospace and nuclear which are (supposedly) tapping in.
Not that i'm necessarily happy with where 13485 is at or sad for the direction 9001 is going. I just think that while the concept of little 'plug-in' management system aspects can have its value, its execution is anything but that. Any single of the plug-in standards does not truly provide any value to its true customers other than that they can technically claim they expect something of their suppliers (just not in much of a specific way, depth or level). Any sane company wasn't splitting its generic processes anyway, unless they were trying to hide stuff from 'the man'. Something like the INCO terms does better at providing useful resolution on what to expect than the multitude of management system standards with their on/off nature and variable scope statements and exclusions/non-applicabilities.
Not that i'm necessarily happy with where 13485 is at or sad for the direction 9001 is going. I just think that while the concept of little 'plug-in' management system aspects can have its value, its execution is anything but that. Any single of the plug-in standards does not truly provide any value to its true customers other than that they can technically claim they expect something of their suppliers (just not in much of a specific way, depth or level). Any sane company wasn't splitting its generic processes anyway, unless they were trying to hide stuff from 'the man'. Something like the INCO terms does better at providing useful resolution on what to expect than the multitude of management system standards with their on/off nature and variable scope statements and exclusions/non-applicabilities.
If people only knew how politically-driven some of the technical committees decisions are. But, it is hypocritical how ISO attempts to circumvent its own standards (directives). Case in point: It was recently announced that ISO 9001:2015 has been confirmed AS-IS. So, according to the ISO Directives, the next review cycle should be balloted in 2025, at the earliest. But, publicly, they are already paving the way for an "early start" of the ISO 9001 revision. Why? Why can't they respect their own rules? Monetization is the answer why not.
