any small machine shops ISO 9001? steps? cost?

I am a one-man side business shop making widgets. A couple of my potential clients want to know if i am ISO 9001. I see this being something that is going to occurr more and more, so I am considering it.

However, I am a one-man operation and don't have deep pockets. How much does it cost? What steps are involved? Does anyone have any samples of the documentation that is expected?

Thanks
Caspian

Check your local or state economic develpement programs, they might have resources and/or funding available for you.

You have to document every step of everything you do, then convince them that you are following the steps. Major PITA. They should have a website that tells you all you need to know. I was on a steering committee for ISO9000 for a small manufacturer, and I was the naysayer, and successfully got the program canceled. Maybe diffe3rent for a small shop, and you should look into it, but we never lost any biz not being iso (different industry though).

ISO 9001 is all about traceability.

Fundamental ideas are:-
1) that when the brown stuff hits the rotating blades you can step back through things and find out what went wrong
2) when you get asked "where did that come from" or "is that what we ordered" you can step back though things and say here's the proof. Important with certified materials.
3) when you get asked "how do you know that measurement is right" you can say I used this micrometer which was calibrated on ....
4) when you get asked "which tool did you use to get that finish / did you use the same tooling as on the prototype which we accepted" you can say yes I did or I used this alternative which is recommended by .....(reputable authority) for production.
5) when you get asked "are you qualified to do that" (eg welding) here are my qualifications/certificates.
6) when you get asked "how do we know the job is right" you can say here are the inspection reports done in the approved manner which you accepted on the contract.
7) when you get asked "how do we know you aren't using tatty, worn out machines" you can say here is the service schedule and the regular accuracy check results.
8) clear demarcations of responsibility for getting things done and records of them having been done. This is probably the hardest thing to sort in a one man shop where usual practice is just to get on and do it.

If you are reasonably organised you should already have most of that under control and it will just be a matter of formalising things and keeping simple records. Best thing you can do is to come up with some simple paper forms on which you keep track of what's going on for each job. Do it on paper not the computer 'cos its easy to see when things are getting silly. If it starts looking like a tax return it is silly. Once you have everything as simple as can be pull someone in to get it all formalised and official. Don't get a consultant in to start with or grab a pre-pack solution (unless its from someone in a similar situation with practical experience of what works for them) likely to be either be silly complex, not the way you work or both. 10 A4 size forms or thereabouts should do it. Much as any normal person hates forms a good one encapsulates a complicated procedure and multiple steps in a process. Think job / part progress tickets.

Awful warning:- MoD research department where I used to work decided to go ISO 9001 by the consultant route. Our department ('bout 50 people) ended up with over 8 linear feet of procedures and paperwork in A4 binders, allegedly the stores and financial departments got 16 feet each and the overall management side got 10 feet. Taken as a whole gobbledygook although most individual sections made a sort of sense in a vastly over explained way. Gawd knows what it cost, took me over a month to bring my lab into alignment with les books (at £55 per hour charge out) plus about a fortnights training on the system making not a jot of difference in practice except for everything done by the book taking 3 times as long.

Clive

I wouldn't attempt it unless you want to spend half your day keeping records. ISO certification takes lots of time and if you're the whole show, when are you going to find time? I am not saying it's no good, just time consuming.

hdrider63 said:

I wouldn't attempt it unless you want to spend half your day keeping records. ISO certification takes lots of time and if you're the whole show, when are you going to find time? I am not saying it's no good, just time consuming.

Click to expand...

Its only time consuming and bloated if you make it that way, unfortunately, thats usually how it ends up. Some pencil pushing, tie wearing douche bag decides they need to "justify" their job, and they do that by continually adding to the pile of crap.

Caspian, as a one band, becoming compliant should be easy. Being "certified" means you just puked up a bunch of money to have a stuffed shirt tell you that you are compliant, and you get a certificate and a # (Yippee!!!).

Basically, you write your own procedures, they can be really simple with little to no paper work, or they can be a huge monstrous cluster fuck with piles of useless crap(<-- this is what happens when you hire a crappy consultant or hire an ISO manager).

All you really need is a quality manual, which will reference some procedures and a few forms. Its mostly stuff you should actually already be doing and recording anyways.

Most of the companies I've dealt with either want an ISO #, or fill out a questionnaire and send them your quality manual. For a one man band, a quality manual of a few pages should cover everything.

On your procedures, you are saying what you are going to do, then DO IT, if you're not going to do it, don't put it in there.

Quality systems that are simple work, bloated crap doesn't. Remember the KISS principle.

Yep, documentation hell. And nobody expects you to pass it along in your costs either. Royal screwing dreamed up by big business to squash the little guy.

I can't really see it working in a one man shop. We've got full time regulatory specialists that make sure we stay in compliance with ISO and FDA. The auditors don't play around and they'll ding you for anything they find. If you screw up bad enough, they'll take away your certification.

Maybe you could pull it off? I will say that it's easy to bitch and moan about, but if follow it you'll probably make a better product. We make a very complex device and no bad product makes it out the door.

I was a part time quality auditor for an ISO9000 organisation. From memory there are only TWO documents that an ISO9000 Co. needs. #1 Customer complaints book. #2 Quality manual. The quality manual is where you write down what you do. It could be we buy the cheapest fittings and try to foist them on to the customers. Not high quality, but its what the Co. works on and if people are caught exchanging fittings they are actually working against the Co's ethos and should be disciplined.
In reality most Co.s do insist that the level of rejects etc. are below a certain level and that the manufacturing processes are commensurate with this. i.e you don't use CNC manufacture for mouse traps or a jig-saw for jet turbines.
If the processes are complex it could be beneficial to detail them, or you could just write "Fred cut outs the blanks to a template"(mouse traps not jet engines).
Frank

First disclaimer, I'm a little biased towards quality standards.

Interesting range of opinions.

ISO 9001 is not about traceability. If this is the way you see it, your system is , well lacking to say the least.

I'm with Bobw here. Most importantly if this does not help increase productivity and profits something is wrong.
Bob

CarbideBob said:

First disclaimer, I'm a little biased towards quality standards...Bob

Click to expand...

I thought ISO 9001 was about quality control not standards. Meeting 9001 requirements simply means you turn out consistent quality; but the quality that you make consistently can be top notch or utter crap.

For a one person operation i think it is bordering on pointless.

I'd you are making concrete lifejackets by the book, you are good to go.
ISO means doing it the way you were surposed to be doing it anyway.....:-)

Isn't it logical to use ISO procedures to ensure that those who work for you are making the product as you, the expert, would make them?
So it barely makes any sense to have a quality control manual when you're the only guy making the parts. You'd be better off with a system where a second party inspects your parts before they go to the customer.

That second party can give you back a report with the number of rejects in it. This you could use to graph "shop passed parts" versus "second party passed parts" to get a rejection percentage going. This graph can then be passed on to the customer as a real measure of how your quality is.

But vouching for your own parts is akin to having the fox guard the henhouse.

You can have a basic quality control/calibration schedule, that's probably the 1 important thing and easy enough to do as a 1 man shop.

I, personally, have a bad taste in my mouth for ISO certification. When the company I worked for was going through this process, we were given a list of questions that the certifiers could ask us and the answers we were supposed to give! When someone raised their hand and said, "But we don't do this. Some of these answers are wrong", the terse response was "these are the questions and these are your answers!" In the end, nothing changed once certified from the previous 22 years I worked there!

friend of mine was a machinist/die mangler at an ISO certified plastic injection molding company. every time they scheduled an inspection the door to the tool room was hidden with a big cabinet and he got the day off

If anyone has a Quality Manual and samples of forms that they can e-mail me, i would REALLY appreciate it. I am starting out cold and would like a template to at least get an idea of what is expected.
caspian45 (at) sbcglobal.net

Thanks,
Caspian

Last I was in ISO900x activity was about 8 years ago. Back then.....

If you did design work you went after ISO9001.
No design work then ISO9002 (looks like the 7.3 section of the 2008 standard you could ignore)
Just service was 9003

If you are supplying the automotive industry they have their own flavor of 900x (QS9000?)

Here is a link I found to get you headed down the road of confusion (describes the standard at a decent level).

http://www.praxiom.com/iso-9001.htm

The only way to ignore a section of the standard is if it flat doesn't apply to your business. You can't selectively ignore it just because you want to.

I know an auditor that runs around doing audits of smaller businesses. He says he has to find some problems to satisfy the registering organization but can't look too hard and make the client mad. I see no ISO900x quality 'add' for what he does or the organizations he audits. Seems all political to me.

For a small shop I would wonder how you would prove everyone is trained on what they do and how you prove your equipment and measurement instruments are within the tolerance you require.

A good auditor will ask generic type questions that will let them 'drill' into your organization and allow specific questions without knowing a pre canned set of questions to answer. Remember each answer needs to be backed up by some kind of controlled documentation. otherwise the auditor isn't doing their job.

You also have to do audits on yourself. How do you know the auditor knows how to do them? Documented training records. That implies taking an auditing course.

How do you know your measurement instruments are accurate? Do you have them run through calibration once a year by a recognized calibration company?

For a big company they have all kinds of overhead to cover this stuff. The challenge is how do you do it for the 1 man or small shop. I have no experience in the small company area.

Every bit of ISO is a cash cow for someone. You pay through the nose for ISO know how to get you educated and pass the real audit.

For the several big computer companies I was associated with it was a real
'circle jerk' when they learned 'the auditors are coming'.

iso

As suggested, I would establish a basic qc manual, have it double checked to be parallel to iso requirements, then contact the customer and to explain you are iso 'compliant'. This says you are doing the necessary steps, but without the official blessing of the iso people.

From there you could expect a visit from their qc dept. Traceability is what it's about. They need to be reasonably assured the end product will not fail because of an oversight on your part.

A person dies in the operating room because of equipment failure establishes all kinds of legal problems. However, at the end of the day, if all practices, procedures and protocals were followed in accordance to FDA requirements and regulations, the equipment manufacturer is held harmless.

How many 1964 Chevys (or Fords) do you pass every day? Yet, most of our B52's are that vintage. This is where an iso system shines in there were no 'escapes' of bad parts out the door.

I think your customer wants has a 'climate of concern' that they will be receiving acceptable parts and 'close nuff and good nuff' isn't your shop armosphere.

You are 90% there now...else they would not even be talking to you.

If you play smart you can probably do this, and maybe even do it for not too much $$. IMHO it will help your image when doing sales. That said, every company I've ever dealt with who went ISO900x continued to produce exactly the same level of quality, or lack of, that they did before. The only evidence of ISO from a customer standpoint was that prices went up and the company became much harder to deal with, especially if specials of any type were needed. Yes, it's a scam.