New to ISO 9001? What frustrates you about the standard?

Good prompt @Andy Nichols ;
My answer may be somewhat of a disappointment...
During the past 26 years that I have dealt with the "ISO gods", I have actually been very pleased with their generally pragmatic approach. As we know, in many of the standards they have actually reduced mandates and specificity for HOW things are to be done, and instead, have increased their focus on RESULTS . This allows organizations to tailor what method(s) work best for them, while still holding them accountable to provide evidence of achieving the intended results.

(Now, if you want to get me "started", ask the same question about IATF 16949 )

Be well.

 

Wow, this questions was what I was trying to post in other forum elsewhere, but as a newbie I do not have sufficient rights yet.

The most frustrating work I had ever encountered working in the QA Department is to see all the ISO standards using the word quality. The word "quality" somehow push all the responsibilities to the Quality Department. Take for example : Quality Policy, Quality Objectives and Targets, Quality Records, Quality Manual etc

Why cant Quality Manual be named Operations Manual ? Automotive Manual, Environmental Manual, Medical Manual , Reliability Manual ? I understand "quality" refers to quality of work from each department but somehow others would tend to shove it down to the Quality Department.

And the Quality Head tends to be the MR which makes things worse. Some inexperienced Quality Heads even posted only Quality Dept goals and targets as Quality Targets and Objectives instead of focusing it company wide.

All those clauses like "top management shall be responsible.. ". How much of it can really be executed? Its still back to lower management being truly responsible isnt it?

 

Possibly controversial...but you asked...

My biggest frustration with implementing ISO9001 was knowing that there wasn't going to be much value in the work I was doing.
Basis for that belief:
- We already had a solid and functional QMS...just not ISO.
- All we had to do was write things in "ISO-ese"
- ...and pay for audits and take the time for audits.

In the beginning, it seemed like a great thing...one Registrar audit to replace the many customer audits since customers could see that we were already "certified" and trust that.
Except that not a single customer backed off of their own audits...so the net result was more audits, not less.
If ISO had never existed, we would have been the exact same company doing things the exact same way but would have had less interruptions by auditors and would have saved ~$5K a year.

Since ISO did exist, and customers mandated that we have it...it simply became one of the costs of doing business. My frustration came from the recognition that it was a completely avoidable cost.

 

Respect always assumed, no need to be careful here...we've known each other long enough.
You asked about requirements...being audited by a CB is one of the requirements of ISO, no? What does ISO require outside of certification (pass) to itself?

ISO does not require that things be written a certain way...but CB auditors do...pay a $15/hr temp for 10hrs to write stuff how CB auditors want it, or pay a $150/hr professional for 6hrs/yr to defend why you didn't write it the way the CB auditor wanted...math is easy. Cheapest way to accomplish audit pass on a functional and robust QMS is to have a sight challenged subterranean mammal...remember that malarkey?

I can honestly say that I have never, not even once,

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I've used said functional and robust QMS every single day.

I've used a functional and robust QMS most of my working life. ISO just didn't add a darned thing except audit time and expense...thus my answer the way it was.

...told you it may be controversial... I am not intending to make a stand here, just answering what you asked...hoping it helps with whatever you asked the question for...if I'm derailing your point, just tell me to shut up.

Added in afterthought: My disappointment is not with ISO...it is with the application thereof. So perhaps my 'beef' as it were is with the required application of the standard rather than the standard itself...

 

I understand that I come across negative...and to a degree I mean to...but I'm really not any more negative about it than I am about a 25mph speed limit on a wide road with no cross streets...it is simply an unjustified burden, not a horrible situation.

So I can be ISO Certified without needing any CB audits? I think not.
I think you're saying I can just "use ISO" without CB audits.

To me, "Using ISO" is like a single person having a second car...the first one gets me everywhere I need to go, the second one doesn't really have a point, it's just redunant.
I'd only get the second one if there were a solid reason to do so.
Customers requiring the cert in order to buy from you...that's a solid point to do so, but they look for the cert, not "using ISO". They will then audit you themselves regardless of "using" or Cert.
What am I missing here, or are we agreeing but missing on the words?

 

Good day @Midori and welcome to the site;
Your observation is very astute. As a matter of fact, when I am speaking to/training clients, I often point out exactly what you observed. One of the greatest "errors" (my opinion) is indeed calling it a QUALITY management system for exactly the reasons you point out.

Regardless of the intent, it DOES indeed cause responses and inferences exactly as you mention. We're going to get along just fine

Hope this helps.
Be well.

 

Good day @Eric Twiname ;
The key here is that a vibrant and sustainable management system should not be developed with the current staff in mind. t should instead be developed when considering future the future "generation" of workers, who will not posses and depend upon the current tribal knoweledge.
The key is sustainability, which is the greatest gap that I find when reviewing organization's existing management systems. Often the QMS is developed with the current staffing in mind (in reality, it is often "developed" by and for a single individual!). This does nothing to support the organization if/when those individuals leave the company. And even if it is a well developed functioning robust QMS, there is need for oversight/accountability if/when the existing staff leave the organization. For that reason the accountability of having a 3rd party periodically review and organization's QMS is the benefit that an ISO registrar can add.

Agreed. This was a pipe dream that never had a chance of coming to fruition.

Hope this helps.
Be well.

 

"...when Moby Dick was a minnow " ??!

This is why we love you @Andy Nichols

 

SO back around to Andy's OP:

My main frustration with ISO is that the goal for which it was intended has not been reached, and yet we still "have" to do it anyway with no forward progress to that goal.

("Have" in quotes since it isn't strictly true...any "Have to" in there is applied by customers, and even then not always.)

 

I am saying that there was no value in ISO9001:2015 that we had not already realized prior to "using ISO"...
internal audit, yes...we just didn't call it that, we called it "process review".
Management review, yes...we called it "Monday morning Directors meeting".
The only thing we didn't have was some of the ISO-required documentation...the stuff was done, just not documented (training for example). Folks were trained, we just didn't have formal records of it, we had daily competency reviews (management by walking around).

There is value in the ISO requirements...in my case there simply wasn't ADDITIONAL value.

No, there is no specific requirement of "using ISO" that annoys. If we didn't already have it in place, having the reference would have had value in the form of "what did we miss?".

I think ISO is a good metric to measure your organization against, and a responsible leadership should have 90+% of the requirements met already without having read the standard.
100% of my gripes are the add-ons beyond using said reference as a general guide.

 

Hi everyone. When the company I work for now started implementing QMS, they were all frustrated because they didn’t know much about the standard and where to start. Then they hired a QMS manager (me) and we immediately started with plans to implement QMS. I definitely think that the most difficult thing for beginners is How to start, because they do not know the standard, and they are still not aware of how important QMS is for the company. In the initial phase, they always think that it is a necessary evil and they are not very interested in carrying it out.

 

Welcome to the site @ValeriaGar ;
Yes...well said! Sadly, "top management" often delegates this "QMS thing" to an individual (i.e. you) and maintains a QMS separate from the day to day operations instead of as the foundational benefit to day to day operations.

The authors of the current :2015 version of the standard attempted to help in this area by adding emphasis to the responsibility of "top management" (24 "shalls" specific to top management) but without the commitment of those leaders and due diligence of the CB auditors, sadly, the situation continues to be somewhat as you describe (in many, but not all, organizations).

Best of luck. There is a wealth of resource available to you on this site.

Be well.