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ISO9001

09/21/2011 1:27 PM

The following quote comes from Wikipedia.

"ISO 9001 is not in any way an indication that products produced using its certified systems are any good. A company can intend to produce a poor quality product and providing it does so consistently and with the proper documentation can put an ISO 9001 stamp on it.[citation needed] According to Seddon, ISO 9001 promotes specification, control, and procedures rather than understanding and improvement.[28][29] Wade argues that ISO 9000 is effective as a guideline, but that promoting it as a standard "helps to mislead companies into thinking that certification means better quality, ... [undermining] the need for an organization to set its own quality standards." [30] Paraphrased, Wade's argument is that reliance on the specifications of ISO 9001 does not guarantee a successful quality system."

We see a lot of products for sale from China that bear the ISO9001 label. According to the quote from Wikipedia, quality is no guarantee. I see machine tools coming from China some with and some without the ISO label. The ones with the ISO label cost much more than ones without. As consumers, how are we to determine quality? The danger is people will buy under the assumption that if it has the ISO9001 stamp, it has to be good. I personally have been under this assumption.

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#1

Re: ISO9001

09/21/2011 1:59 PM

I am in TOTAL agreement that ISO9001 is complete and utter bullsh!t. Unfortunately our customers demand it because they have drank the Kool-Aid.

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#12
In reply to #1

Re: ISO9001

09/22/2011 7:40 AM

Agreed, I believe ISO9001 is a system to ensure the quality selected by the manufacturer is achieved. That quality could be anywhere from abysmal to excellent, it doesn't mean (high) quality as normally understood.

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#2

Re: ISO9001

09/21/2011 2:11 PM

Interesting.

The Wikipedia quote is incorrect I think. Here is some actual info on ISO 9001.

It looks to me that it is indeed intended to be a measure of quality. That said, it appears that an ISO certified company, Chinese or otherwise can easily lie about the quality of their product. Or possibly just put a stamp on their products without being certified at all.

To answer your question, I guess the next step would be to check and see if a particular company is actually certified. And if a product is found to be inferior, follow these steps.

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#3
In reply to #2

Re: ISO9001

09/21/2011 2:22 PM

That may indeed be their intended purpose, the problem is that the ISO regulations do not ensure that. if you make crap and do so consistently and have documented how to consistently make crap and follow your documentation to the letter you STILL make crap, but you can be ISO9001 certified to make crap.

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#6
In reply to #3

Re: ISO9001

09/21/2011 5:21 PM

Ironically, if your process documents how to make c*** consistently and some young buck on the assembly line decides he is going to put in a bit more effort and actually make a quality product on his own hook, you could conceivably get dinged for non-compliance!

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#7
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Re: ISO9001

09/21/2011 5:26 PM

True. It is mostly to do with documentation of, and compliance with, procedures. It has little to do with the quality of the procedures or the product.

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#11
In reply to #3

Re: ISO9001

09/22/2011 6:26 AM

I posted too much and locked myself out yesterday.

It sounds to me like the entire program is an expensive fraud.

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#13
In reply to #11

Re: ISO9001

09/22/2011 8:57 AM

That is my feeling on it.

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#14
In reply to #11

Re: ISO9001

09/22/2011 9:17 AM

Calling ISO 9001 an expensive fraud is to much of a harsh comment. Many manufacturers foolishly obtain ISO 9001 certification when their products don't need this certification and thus their overhead costs are much higher than their competitors. However, there are products that really should have ISO 9001 certification and that this certification can save money in the long haul. One example is raw material refinement for chemical reagent use or other scientific purpose. By knowing exactly the refinement process used and the uncertainty in the quality of the refined product a new chemical assay is not required for chemicals from an ISO 9001 provider. Now many users of various chemicals and other products don't require this level of source fabrication certainty, but there are users that do need this tight of a control in fabrication.

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#15
In reply to #14

Re: ISO9001

09/22/2011 9:24 AM

I disagree that it is too harsh, if anything it isn't harsh enough. taking one very narrow application and using it as proof that the system is a good fit for many/most organizations is a HUGE stretch. And of course the "credentials" "proving" that a company has been certified can be easily forged and most companies don't second guess the claim of certification.

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#16
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Re: ISO9001

09/22/2011 9:52 AM

I did not say that ISO 9001 is or should be a good fit for many or most organizations. DO NOT PUT YOUR LIES IN MY MOUTH!

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#17
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Re: ISO9001

09/22/2011 10:34 AM

This is from my link above:

Without satisfied customers, an organization is in peril! To keep customers satisfied, the organization needs to meet their requirements. The ISO 9001:2008 standard provides a tried and tested framework for taking a systematic approach to managing the organization's processes so that they consistently turn out product that satisfies customers' expectations.

I think the concept is great. But if no one is insuring the quality, if companies are doing their own bogus audits with no oversite, and if it's OK for shoddy products to be produced, as long as they are being produced consistently.................it's worthless in my opinion. The companies that are cheating are destroying the validity of the certification for everyone.

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#18
In reply to #16

Re: ISO9001

09/22/2011 11:03 AM

Fred, I'm sorry if you took it that I was putting words in your mouth, that was my interpretation of what you were saying. But my contention still remains that that one narrow application does not a justification for insanity make.

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#4

Re: ISO9001

09/21/2011 2:32 PM

IMHO ISO 9001 is a compliance mark on how well your organization's documentation tracks the quality of your product not where that quality level is placed.

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#5

Re: ISO9001

09/21/2011 4:50 PM

Perfect for LynDoor™ Industries: the quality is very uniform...as extensively documented on CR4.

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#8

Re: ISO9001

09/21/2011 6:16 PM

The ISO certified products cost more because lavish amounts of labour are required to complete the paperwork.

Hard to comment on China where labour is so cheap, but a heavily bureaucratized process is hard on the bottom line. So a materially better product could, in principle, be made and marketed at a lower price point.

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#9

Re: ISO9001

09/21/2011 6:59 PM

Yes,

ISO compliance just says that you have all your manufacturing processes documented and that you have followed them, to the letter.

I worked for Motorola's aerospace division in the 60'-90's. Being compliant only meant that it would surly cost more.

Our products had a reputation for excellent quality, as they did pre-ISO.

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#27
In reply to #9

Re: ISO9001

10/01/2011 12:13 AM

They had a bit of a problem on the communications side in the late '80's. Very high failure rates out of the box. Sigma Six did seem to help them out. By early '90's they were back on track.

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#10

Re: ISO9001

09/22/2011 1:15 AM

Scott Adams did a great Dilbert riff on this a few years ago. Basically, every machine, computer, and pencil sharpener was meticulously labeled with a 5-digit code. Whoop-de-doo.

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#22
In reply to #10

Re: ISO9001

09/22/2011 5:05 PM

At work, we are ISO-compliant. We use plastic rulers for measuring samples, etc.; not anything for product consistency, mind you. But, because we COULD use them in that way, they all have to have calibration stickers on them and the calibration checked every year.

What would we do if they were out of calibration? Ridiculous crap.

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#23
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Re: ISO9001

09/22/2011 5:32 PM

at what temp and humidity do you use them and calibrate them at? plastic expands and contracts a LOT with temp and humidity....

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#24
In reply to #22

Re: ISO9001

09/22/2011 7:28 PM

As I said, most manufacturers do not need to be ISO-compliant. It is a waste of money. There are a few manufacturers that ISO-compliance allows them to sell their product to a narrow market that does properly require ISO-certification of their suppliers. Frankly I would be surprised if 1/4 of the ISO-compliant suppliers make money from being compliant.

None the less, there is a niche market that requires ISO certification of their critical suppliers.

But getting back to the initial point of this thread, ISO certification is not a quality control standard. ISO certification is a quality tracking certification.

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#25
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Re: ISO9001

09/22/2011 7:49 PM

It might be different in the US, but in the UK (& Europe) it has been necessary to be compliant ever since BS5750 (the precursor to ISO9001). It's just like paying tax - you have to do it whether you like it or not.

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#26
In reply to #24

Re: ISO9001

09/23/2011 8:29 PM

For us, it isn't a waste of money. The only reason we do ISO is because our customers do and it's expected. I think most of them believe that it IS a measure of product quality. However, if we didn't do it, we wouldn't have the business. The medical device industry is its own weird little world.

We have customers constantly ask us for MSDSs for our products (we do have datasheets available for all of our products), when they they are not even close to being hazardous materials (e.g. a (roll of) nonwoven fabric coated with a (dry) adhesive on a release liner paper). The "Article" card works most of the time, but we have had to capitulate a few times and write one. How many times can you say N/A in an MSDS before it becomes absurd?

The real reason we have quality products is that (in order of importance):

  1. We treat our operators with respect and pay them well.
  2. We meticulously document everything.
  3. We respond to customer issues and complaints quickly and helpfully.
  4. Continuously strive to improve our understanding of the markets we are in and improve our own infrastructure.

ISO is useful for understanding the importance of traceability. But, if you want to have product quality, and credibility with your customers, wouldn't you want to have that anyway?

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#19

Re: ISO9001

09/22/2011 11:56 AM

The big problem is: The consumer will rely on the ISO stamp of approval as much as the UL stamp. Again we see products with the UL and CSA stamp that fail. Almost everything I see has the UL stamp on it; even those from China. I've seen TV programs that show how UL tests products for safety, but with the millions of products out there, can they possibly test each and everyone of them? I'm not so sure.

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#20
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Re: ISO9001

09/22/2011 12:38 PM

UL does not test every item produced with their stamp. To my knowledge UL does do a destructive series of tests for safety (not quality) of every design that has their stamp. This safety test verifies that an undamaged device will not harm a user and that known failure modes of the device will not cause an unsafe incident like poisonous gas release, fire, shrapnel, etc. Now a UL approved design maybe repeated in many different products by a company and still be granted UL approval. UL has removed approval of a design when a variation in the design exceeds their level or a unexpected safety incident occurs on any of the designs.

In contrast, a CSA label just means that the manufacturer uses CSA tested components. CSA does not test the whole assembled design.

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#21
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Re: ISO9001

09/22/2011 1:00 PM

Agreed. Neither of these marks actually insure performance, or reliability.

I've had noise cancelling electronic equipment tested by UL and certified by them. They did not render an opinion of either of these desirable qualities.

That's a different set of tests.

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