The elimination of registration to ISO 9001-2008 2

[Histogram]

I would like to present a topic for discussion. The elimination of registration to ISO 9001-2008 Quality Management Systems. If a company followed the ISO 9001-2008 as a guideline for their QMS and used this system to its fullest with the discipline required to gain the most out of it but without employing a registering body what would the ramifications be? In my opinion as a quality professional I know that having an ISO 9001-2008 registered company indicates nothing about the quality of products or efficiency of operations. It only indicates this company basically purchased the registration. Any thoughts on this postulation?

 

[MikeClay]

The ramification is that you would be shipping a product with few nonconformences. You may even have the best and cheapest left handed smoke shifter on the market. As a user, I'd lament that I would like to use your product, but you are missing that one specification on my RFQ.

The ISO-9000 process is just a set of quidelines necessary for a quality program. If a company is ceritfied, there is an outside body that states that the program meets minimal guidelines. You are right, if you plan to make a poor product, you can tailor an ISO-9000 program that will still allow you to make poor products.

The companies that I've worked for have had their own QMS programs in effect. In most cases they were making a fine product. Howerver new customers were always an issue. If they would talk to us, a detailed customer review of the QMS would be required. It was easier in the long run to make the modifications in our QMS and get and maintain the ISO-9000 certification. After certification, most of these vists stopped.

--Mike--

 

[safetydan]

Basically you are putting together a QMS that is built around the ISO structure of contuniuous improvement, but you would not have the marketing ability of a 9001 system. Unless you have a customer requirement, or a future customer requirement, there is little use in attaining an ISO 9001 certification other than paying a registar to audit your system for compliance to a standard you say you ahering but are not taking credit for.

Bottom line, if your company or customers want the 9001 certification, then get it. If you want it for laughs and busy work, forget it.

 

[Histogram]

Thanks for the replies. I posed this question for discussion only, probing to see if any quality professionals have the same concerns as me. I am not a newbie, I have set-up ISO 9001, AS9100, NADCAP, TS16949 QMS systems for companies over the last 15 years working as an employee and sometimes a consultant.

Thanks again,
Histogram

 

[jweber72]

I agree that many company can simply purchase a registration, however, in most cases doesn't having the actually paper indicate a higher quality product. As I said, "In most cases"!!



John

http://www.iso9001compliance.com/ISO-9001-2008

 

[KENAT]

The ISO 9001 thing is all smoke and mirrors. Having been involved in audits etc. I have very little faith in it.

That said, as long as customers ask for it, if you're going to go to the effort of having policies and procedures etc. you may as well get the cert.

KENAT,

Have you reminded yourself of faq731-376 recently, or taken a look at posting policies:

http://eng-tips.com/market.cfm?

What is Engineering anyway: faq1088-1484

 

[metalonis]

I agree with Kenat. Other than marketing, the whole ISO 9001 thing has little value. However, the marketing value is formidable.

 

[MadMango]

If a company followed the ISO 9001-2008 as a guideline for their QMS and used this system to its fullest with the discipline required to gain the most out of it but without employing a registering body what would the ramifications be?

I've worked for a company that held cert/registration for a couple of years, then dropped it. They still made reference to ISO-9001 in all their literature, but were careful not to say they were certified or registered, but they "complied with". It seemed there were no hindrances to losing the certification, everything continued to run as though they were still going to have a registrar visit one day. The internal auditors took the lead to not let the QMS fail. So I guess the short, non-quantified answer would be "none".

"Art without engineering is dreaming; Engineering without art is calculating."

Have you read faq731-376 to make the best use of these Forums?

 

[emmgonzalez]

The ISO quality system is something that could be used for marketing purposes especially that a lot of people don't know the details about it. Yes, it may have a small value for us quality professionals, but we should take this as a challenge to help us and our companies improve not only our quality processes but also the products or services we are providing. Yes, we are free to draft our own quality processes, but it doesn't stop there. We need to update and upgrade our system from time-to-time, making our own quality standard and ensuring that the perceived quality we are providing meeting the real quality we need to provide. For me, the ISO quality system is just there to remind us that we have things to improve. This is just the lighter side of my opinion. =)

 

[stanweld]

An effective, well implemented QMS is a management/business tool to sustain profitability over the long term. ISO certification is primarily a sales tool.

 

[fcsuper]

Even saying "complied with" is false advertising without some external auditor that will back up that statement (and you'll not likely get one to do that). That said, 9001 is easily passed. The whole idea of auditing for quality is nonsensical. Even the FDA is often fooled in their audits when dealing with companies that are good at playing the shell game.

Matt Lorono
Lorono's SolidWorks Resources & SolidWorks Legion

 

[DHambley]

I'm 3 months behind on this thread but I do have my own 2-cents to say.
The word "quality" as defined by ISO is not the same word as most people think. Most people think quality means that a product works a long time without breaking, it exceeds specifications, and it has a high MTBF, etc.

NOT!

"Quality" per ISO is making the same product exactly the same each time with a controlled process. Even if the product is a piece of junk which doesn't work, you can say that it has "quality". This is an incredible blockade to American innovation and market dominance.

I've designed products for aerospace for decades and it is ALWAYS certification expense which prevents good corrections from being introduced into products, so the same junk keeps getting manufactured. Gee whiz, once again, just 2 weeks ago, we had an issue with one of our products failing. The engineering team found that they could add a simple 10-cent part and have it meet all specs, but WE AREN'T ALLOWED TO! It wouldn't be manufactured the same as the certified product therefore, it wouldn't have "quality". Re-certification would cost us like, $30,000, so even the customer OK'd the inferior product to keep getting produced.

Can't offend that God of "Quality", can we.

 

[micalbrch]

hgldr: ISO 9001:2008 does not bar the manufacturer from improving the quality (reliability) of a product. Your example sounds a little bit as if.

I think ISO defines quality not in a different way. It is just the purpose of the 9001 standard which covers more (or other) stuff than just the material quality. You mentioned it: It covers the whole process within a company incl. sales, purchase, manufacturing, procurement etc. These controlled processes should increase the quality level of the products, too. But it is not specifically related only to the product.

My experience is that people know in the meantime what ISO 9001:2008 means. It is good, but not automatically a certificate for 1st class product quality.

 

[crjones]

My impression is that for the ISO standards you produce your product in a consistent and defined fashion. It assumes that it will cause you to recognize areas of improvement, but it does not mandate that you make a quality product, just do you document what you do.

 

[DHambley]

micalbrch, you are correct, ISO 9001:2008 does not bar the manufacturer from improving the quality (reliability) of a product.

I 'm not in the QA department so I can only see the results of their policies, not the details of how or why. All I know is that, from my engineering department, we are prevented many, many times from improving a project. The story from QA starts to sound the same in every company I've consulted with. "can't do", "re-cert too expensive", paper work too time consuming" along with quoting some paragraph from ISO or the FCC or other requlatory agencies.

What I do know is that, quite a few times I've seen faulty projects get shipped, sometimes unsafe and sometimes for aircarft which will carry human beings. But, the good news; All of those products had paperwork with the word "Quality" stamped on the front page.