ISO 9001 for Small Business

Hi guys,

I have a few customers that have now ceased quoting me simply because we are not ISO accredited. We're a small shop, a little over a dozen employees, doing mostly welded fabrication. We already have loose systems for some things like material certifications, inspection records, maintenance logs, etc... but we have no written quality system. I'd like to start down the path to 9001, but a big fear is of getting a consultant in who is more adept at spending our money than getting us set up with a system that works. As a small shop, I am very much worried that doing it wrong could bury us in unnecessary paperwork and fees in the coming years. I'm interested in any thoughts on approaching this the right way, or perhaps recommendations of reputable consultants in the Northeast who could help us. Thanks!

Talk to your customers and see who they would recommend as a good registrar. Remember that your certification is only as good as the reputation of the registrar who issued it. The registrar you choose can recommend a consultant they work with.

Imin the UK but Id imagine its virtually the same , I used a consultant for the setup as there is so much bs involved someone with a logical brain will be driven mad
I even had to have a procedure for vehicle maintenance

Luckily im out of it now

Dylad said:

Hi guys,

I have a few customers that have now ceased quoting me simply because we are not ISO accredited.

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I don't know how many a "few" customers are but ISO 9001 will cost you and keep on costing. Write procedures yourself on what you do and that you don't mind sharing that information with your customers.

If you don't feel up to it yourself surely you can find a couple of your employees to help out. Why on earth get an outsider to tell you how to run your company?

I was QC manager for over 25 years and ISO 9001 has become a joke - and an expensive one at that.

From experience I wonder how many of your would be customers are themselves ISO 9001 certified?

Think of a "good consultant" and think of a "good politician". Get the connection?

I've considered it as a 1 man show, but it seems a bit overwhelming on time not to mention money. A big brain PhD associate said it woiuld be more expensive, in the long run, to not have it. although i have yet to take the plunge, His words eat away at me 'cause i know he's right.

At any rate, the "system" you put in place needs match what you already do on a daily basis. You can make as simple or complex as you want, but come audit time there needs to be objective evidence/ documentation of those things happening.
-2 cents

one option is to partner with someone who is 9001, Our company is a material handling management company (Pallet Broker) that successfully completed ISO 9001, expensive and time consuming. But worth it if you are targeting specific clients and market share. A lot of our mills or suppliers are not ISO certified, but because we manage the supply, the process is in compliance.

My advice, get new customers. I looked into it very closely and decided the only way I could afford it was to raise my prices. Once i suggested that (raising prices) to the customers who were asking about it, they backed off. We make gauges and tooling for automotive, medical, nuclear, air craft, and defense. They don't require it. Ive been in shops with dirt floors, and 55 gallon drums with pallets on them that serve as work benches that are ISO certified. I do quality work on time with a 10 man shop and haven't needed it. After 37 years in business, I think my reputation has won me lots more work than getting ISO certified would. Maybe in a high production shop with fairly unskilled operators, high turnover, it is justified. In a tool and gauge shop, my experience wouldn't support it. I wrote a quality manual, have procedures in place, can trace material, supply inspection reports, calibrate measuring tools (traceable), and advertise we are ISO "compliant" but not certified. I've never had anyone challenge it.

Good riddance.

ISO 9001 is a dirty corrupt world that is built on paying money to dirty corrupt people for dirty corrupt purposes. Don't become a part of it.

Dylad said:

Hi guys,

I have a few customers that have now ceased quoting me simply because we are not ISO accredited. We're a small shop, a little over a dozen employees, doing mostly welded fabrication. We already have loose systems for some things like material certifications, inspection records, maintenance logs, etc... but we have no written quality system. I'd like to start down the path to 9001, but a big fear is of getting a consultant in who is more adept at spending our money than getting us set up with a system that works. As a small shop, I am very much worried that doing it wrong could bury us in unnecessary paperwork and fees in the coming years. I'm interested in any thoughts on approaching this the right way, or perhaps recommendations of reputable consultants in the Northeast who could help us. Thanks!

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like with any QS, first start with documenting what you do. Get a spreadsheet going and put down all the activities your business performs. In the column next to it put a link to a document that describes how you do it. That will get you started. The document should describe how the thing is done, who does it, who verifies and signs off, and if things do not go as expected what you do. Once you have that mapped out you could hire someone who can shape that into an auditable quality system. It may sound simplistic but the whole idea behind a quality system is not to shackle your company as you make things, but to make everything repeatable and traceable. Technically you should be able to have a quality system that says, i make boomerangs, Joe cuts wood, i carve, Jeff throws it if it comes back it is all good. We ship.....then as you find out that things don't all work out as described in the initial QS, you can refine it.

This is a good overview http://www.iso.org/iso/pub100080.pdf

dee
;-D

Damn this is a dirty road. I'm 100% convinced that it's 75% to the consultant's benefit for a company to implement ISO. And 99% of the remaining 25% is the big companies benefiting from the "high cost of entry" to the little guy (think of a regressive tax and you're pretty spot-in). There should be a "free and open source" QMS system that is self-certified as the self certification would be inherently evident (you're either doing it or not) and wouldn't need a bunch of audits.

Dylad said:

Hi guys,

I have a few customers that have now ceased quoting me simply because we are not ISO accredited. We're a small shop, a little over a dozen employees, doing mostly welded fabrication. We already have loose systems for some things like material certifications, inspection records, maintenance logs, etc... but we have no written quality system. I'd like to start down the path to 9001, but a big fear is of getting a consultant in who is more adept at spending our money than getting us set up with a system that works. As a small shop, I am very much worried that doing it wrong could bury us in unnecessary paperwork and fees in the coming years. I'm interested in any thoughts on approaching this the right way, or perhaps recommendations of reputable consultants in the Northeast who could help us. Thanks!

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Your concerns are extremely well founded.
To begin with, at the first glance nothing about ISO makes any sense at all.

It takes awful amount of time and extraordinarily good consultant to explain it and then all of sudden it clicks and thereafter you don't want to operate without it.

Even the paperwork becomes very simple.

In my case State of Alabama received federal money to pay all ISO consulting expenses for few selected small companies which is typically about $20,000.

Somehow, we qualified and had to pay only the certification fees and consultant's travel expenses.

That amounted to about $7,000 and we have enough grant left to get ASA100 certified.

Since that money came from federal source it is possible your state has same monies available.

I would recommend you to contact your local state representative and ask him if he can swing some of that money to pay ISO consultants.

If he succeeds your next problem will be to fill out grant application. That is tricky you need help. Again ask your state reprehensive if there is an ISO consulting firm in your state that is already processing ISO grants. Contact them and let them fill out your grant application. With some luck and a year later you may get ISO certified only for about $7,000.

Looking back, that money was well spent because we have the same problem without ISO certification it is hard to get on any bidders list.

But if I had been quoted and had to pay the full amount about $20,000 consulting fees plus $7000 more for estimated travel expenses I would have turned it down, and today we would be high and dry.

Now, I can only praise the Lord for the luck of being in State of Alabama.

One of the most business friendly states in Union, that voted almost 100% for Trump.

I hope that you will succeed and get some of the federal grant money to pay most of your ISO expenses.

Good Luck

[email protected]

The Dude said:

Damn this is a dirty road. I'm 100% convinced that it's 75% to the consultant's benefit for a company to implement ISO. And 99% of the remaining 25% is the big companies benefiting from the "high cost of entry" to the little guy (think of a regressive tax and you're pretty spot-in). There should be a "free and open source" QMS system that is self-certified as the self certification would be inherently evident (you're either doing it or not) and wouldn't need a bunch of audits.

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Nice thought, but that's kinda like having your machinist sign off on the inspection. And a major leap of faith that it would consistently be carried out 100%. If in-house inspectors weren't necessary, they wouldn't exist.
Quality manuals are not THAT hard to come by and tailor to your shop which is the compliance part of ISO.

mkd said:

Quality manuals are not THAT hard to come by and tailor to your shop which is the compliance part of ISO.

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Have you practical experience or is that just your opinion?

What you are suggesting is a major reason for ISO 9001 being useless.

We had a bad experience with a consultant recommend by the registrar, we had a passing system in place but had alot of holes that were found during the audit, she was suppose to stick around and help make the necessary fixes but ended up leaving us high and dry. We ended up redoing everything ourselves. In hindsight not such a bad thing as we learned a lot doing it on our own, but very time consuming. If any of your local universities have a manufacturing extension partnership (MEP) i would check with them as they may be able to get you someone lined up to help. Also you can check out Oxebridge Totally Free ISO 91:215 QMS Documentation Template Kit | Oxebridge Quality Resources. Its enough to get you going and see what will be required.

dvance85 said:

We had a bad experience with a consultant recommend by the registrar, we had a passing system in place but had alot of holes that were found during the audit, she was suppose to stick around and help make the necessary fixes but ended up leaving us high and dry. We ended up redoing everything ourselves. In hindsight not such a bad thing as we learned a lot doing it on our own, but very time consuming. If any of your local universities have a manufacturing extension partnership (MEP) i would check with them as they may be able to get you someone lined up to help. Also you can check out Oxebridge Totally Free ISO 91:215 QMS Documentation Template Kit | Oxebridge Quality Resources. Its enough to get you going and see what will be required.

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speaking of MEP i think this is a perfect engagement for a good grad student as an internship to wrk with your management to do the documenting. look for an engineering discipline that is high on manufacturing processes like an ME or Chemical or Process engineer. Using an existing template library is a good start. Most of the work is tedious documentation of how you do the tasks that are every day activities. To set expectations let everybody know that ISO is not going to be a tool to solve the Chinese fire drills, those are the incidents that cause you to revise the QS. I have not set up ISO but have been part of teams and directed teams setting up FDA (21 CFR part 820) QS, that is largely harmonized with ISO 9001, with the addition of complaint handling and incident reporting. I can tell you it is a pain, but a well organized and streamlined QS is not an undo burden, as a side benefit it makes training new employees a breeze.

The other thing i know from doing it about 3 or 4 times for different organizations is that you cannot hire a consultant put them in a corner and have the QS materialize, you need to dedicate resources to the engineering of the QS to suit the way you work and the needs that you have.

dee
;-D

RJT said:

Ive been in shops with dirt floors, and 55 gallon drums with pallets on them that serve as work benches that are ISO certified.

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Isn't that because ISO 9001 certification is simply about consistency and paperwork.

That is why so many chinese firms are 9001 certified according to the packaging their goods come in. They might make shit, but damn that shit is consistently shitty.

suggest you look to japanese quality control methods, not to European quality control paperwork there is a big big difference.

if you invest in the japanese methodology you actually get something beneficial and worth the money.

Only reason i think they may be pulling jobs is they don't like your quality or quality control attitude, anyone who has been in ISO knows what its about and its faults, the more they promote it the more i dislike it.

Ultimately its up to you what you do its your business and you suffer the consequences of your decisions both good and bad.

A shop warranty should be as good as it gets.

RJT said:

My advice, get new customers. I looked into it very closely and decided the only way I could afford it was to raise my prices. Once i suggested that (raising prices) to the customers who were asking about it, they backed off. We make gauges and tooling for automotive, medical, nuclear, air craft, and defense. They don't require it. Ive been in shops with dirt floors, and 55 gallon drums with pallets on them that serve as work benches that are ISO certified. I do quality work on time with a 10 man shop and haven't needed it. After 37 years in business, I think my reputation has won me lots more work than getting ISO certified would. Maybe in a high production shop with fairly unskilled operators, high turnover, it is justified. In a tool and gauge shop, my experience wouldn't support it. I wrote a quality manual, have procedures in place, can trace material, supply inspection reports, calibrate measuring tools (traceable), and advertise we are ISO "compliant" but not certified. I've never had anyone challenge it.

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My old customers that demanded iso9000 were the worst 120 day payers
So good riddance

mkd said:

Nice thought, but that's kinda like having your machinist sign off on the inspection. And a major leap of faith that it would consistently be carried out 100%. If in-house inspectors weren't necessary, they wouldn't exist.
Quality manuals are not THAT hard to come by and tailor to your shop which is the compliance part of ISO.

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And what the HELL is WRONG with someone saying, "I made it and it's good."? First of all, ISO has very little to do with assuring actual part quality. It's more about how you monitor your customer satisfaction and react to when things do go wrong. Second, inspection is viewed by many companies as "non value added" (it doesn't actually change the part) and anything you can do to eliminate or reduce it should be kudos to the supplier.

The system we have now, I can assure you, is simply very broken.

The Dude

The Dude said:

And what the HELL is WRONG with someone saying, "I made it and it's good."? First of all, ISO has very little to do with assuring actual part quality. It's more about how you monitor your customer satisfaction and react to when things do go wrong. Second, inspection is viewed by many companies as "non value added" (it doesn't actually change the part) and anything you can do to eliminate or reduce it should be kudos to the supplier.

The system we have now, I can assure you, is simply very broken.

The Dude

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I hope most can agree with the fact that Japanese quality is usually excellent. They live by "You can't inspect quality into a product, it's got to be designed in". Too few designers think about or live by that.

IMO the most important chapter (OK "message") in ISO 9001 is Corrective Action. IOW when a mistake happens, and it is inevitable, then figure out how to avoid making the same mistake again. Too many just fix and forget.

Learn from mistakes but never make mistakes in the hope of learning more

To the OP: the day you get ISO 9001 common sense goes out the window. You'll spend a good bit of time trying to figure out how not to do what you've written you do When audit time comes find someone that can lie convincingly to the auditor.