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ISO 9001 and Sharing machines and space with another shop

Joined
Oct 26, 2017
Location
Long Island, NY
Hello all!

I have been fortunate enough to start my own business as a manufacturing consultant and have had good success in finding clients who need my help, lots of startups and engineers.

One of my long term clients has agreed to let me partner with them and have allotted to my company up to 30 hours per week of time on their equipment for my own prototype and production activities.

Their shop is ISO 9001 and 60601 Certified, and I have been involved with making sure their paperwork is compliant at all times.

My big question is, if I want my company to be ISO 9001 how would the sharing be treated? My business address is not theirs, though I may be able to discuss changing that if it were absolutely required but I would rather not. As for tooling and paperwork I will have my own seperate cabinets and server.

If anyone has an idea of how I would present such a situation to an auditor I would appreciate it.

- Chris
 
Easiest way is to simply treat them as a supplier. The precise nature of the contract is immaterial.

That way your ISO 9001 paperwork simply needs to say that you source from ISO 9001 compliant suppliers. Potential issue there is if your business requires components to be sourced from non-ISO 9001 suppliers too. However there are ways round that, I had to amen such arrangements when DERA went ISO.

Clive
 
Clive,

I think that is a great solution! I have always dealt with the ISO paperwork from a shop actually running parts, do you what what is different going for just “ISO Certified Suppliers” certification? Do I require QC paperwork from the supplier?
 
Think twice before you go ISO. Ask yourself, "will my customer require it?" If not then don't do it. Ask me how I know.

BTW, it would be easier to implement when you are just starting. I did it after operating a few years, it was much more difficult. Also, I would never do it again unless there were some really high paying, long term work associated with it. JMHO YMMV
 
Think twice before you go ISO. Ask yourself, "will my customer require it?" If not then don't do it. Ask me how I know.

BTW, it would be easier to implement when you are just starting. I did it after operating a few years, it was much more difficult. Also, I would never do it again unless there were some really high paying, long term work associated with it. JMHO YMMV

It’s actually a two fold positive for my business.

Right now I am a one man show, so implementing it right now will be easy enough since I can write my own procedures. When I start hiring my staff I can institute the right habits from the beginning. It will be a learning experience as well since I’ve never done ISO from the ground up, I’ve always just been a piece of the puzzle so to speak. As a consultant I will be able to be answer questions for clients in the future regarding ISO from a different point of view which will be valuable.

I would love to have a good contract come along which I won’t have to say “no” to. When I get a purchasing department going they won’t have to worry about turning down work either.
 
You are overthinking this. You have your own ISO 9001 certified system for all the work you directly do. But you don't make parts. Your partner firm makes the parts and has their own ISO 9001 certified system so the ISO just rolls through seamlessly for parts they make for you to supply. So in the appropriate section of your ISO process you could simply put "specially manufactured parts will be sourced from ISO 9001 compliant vendors". Job done.

I wouldn't do things that way personally. The art with ISO is to keep things as general as possible whilst adopting work practices that let you deliver appropriate quality products at appropriate cost. Get too specific and it can tie you up so badly that nothing can get done to the book. Thats what happened at DERA. Monster book and well over half the work was done via clever ways to get round what it said. Folk who started the ISO 9000 series thing had never heard of "working to rule". A very common tactic with British Trade Unions dealing with management side.

ISO 9001 is a warm security blanket for folk ordering from suppliers they don't know and don't have the time / resources / capability to properly verify.

Clive
 
ISO 9001:2015 Is a walk in the park to obtain. There isn't much to it really, but it part of pay to play with larger organizations for reasons already described. I know of a stain glass window company with 2 full time and 2 part time employees that are certified. You can make the system simple or as difficult as you want.

Your organization and the partner are two separate legal entities. You will never be able to certify your business using the other entity certificate unless it is listed as a second site/entity on their certificate, which still requires full audit of the entire system of your business. The only way to truly dodge this is to work under their business and sell your services using their name and establish a plan of how to properly account for it.

Being a consultant you should already know this, but interwining yourself with a company to this degree with a company you have no control of will be your achilles heel. Picture yourself finding work and using their equipment for these very few hours you are getting in barter. As soon as the company with all the assets gets a bug up their ass and cuts you off for whatever reason that will happen, how are you going to explain to your customers they are not getting their parts?

Additionally, best to discuss these issues with the gift horse. Look at the iso cert for the accreditor and call them to discuss.
 
You are overthinking this. You have your own ISO 9001 certified system for all the work you directly do. But you don't make parts. Your partner firm makes the parts and has their own ISO 9001 certified system so the ISO just rolls through seamlessly for parts they make for you to supply. So in the appropriate section of your ISO process you could simply put "specially manufactured parts will be sourced from ISO 9001 compliant vendors". Job done.

I wouldn't do things that way personally. The art with ISO is to keep things as general as possible whilst adopting work practices that let you deliver appropriate quality products at appropriate cost. Get too specific and it can tie you up so badly that nothing can get done to the book. Thats what happened at DERA. Monster book and well over half the work was done via clever ways to get round what it said. Folk who started the ISO 9000 series thing had never heard of "working to rule". A very common tactic with British Trade Unions dealing with management side.

ISO 9001 is a warm security blanket for folk ordering from suppliers they don't know and don't have the time / resources / capability to properly verify.

Clive

I agree. Additionally, just because the parts are manufactured sourced from ISO compliant/registered vendors doesn't remove all risk.

ISO 9001:2015 has major risk based focus and even if the parts are made at an iso compliant/registered vendor does not remove the major risks of a value stream that is not iso certified on the administration side. No or late delivery is just as damaging as nonconforming parts.

A non certifed administration marketing selling parts made at ISO compliant vendors is a huge red flag for me. I look at it being a clear attempt at cutting corners that have no reason of being cut seeing how simple it is to get ISO certification. You can damn near find them in a cracker jack box.

Best bet is to go stand alone which Quality consultants have turn key packages on the cheap and registrar costs are weighted to a degree based on company size. I know of a local company of 10 people in size got a turn key iso system for $1500 from a quality consultant and the certification cost for three years is $6500 from a registrar. A year later they are iso certified.
 
Thanks everyone for all the input, it’s all very valid especially the risk assessment.

I am lucky to be in a very good relationship with the owner of the partner business. His business would not be what it would be without my help, and this partnership is a “return the favor” type of deal specifically so he can help me expand my own business. He is someone who does not have to worry about money or competition as this facility produces and manufactures their own products from the ground up, built on his investments alone.

The answer I was looking for seems to be that either I go ISO or I don’t. If I do the actual logistics of how parts ultimately end up in the hands of customers is clear.
 
Thanks everyone for all the input, it’s all very valid especially the risk assessment.

I am lucky to be in a very good relationship with the owner of the partner business. His business would not be what it would be without my help, and this partnership is a “return the favor” type of deal specifically so he can help me expand my own business. He is someone who does not have to worry about money or competition as this facility produces and manufactures their own products from the ground up, built on his investments alone.

The answer I was looking for seems to be that either I go ISO or I don’t. If I do the actual logistics of how parts ultimately end up in the hands of customers is clear.

Right on.

We read about a lot of partnerships on here and how they work out. Most go one specific direction. Maybe you won the lottery.

Good luck with everything. I'd suggest calling a registar and asking their thoughts on your specific situation and the investment you would have to make for it to work at your current level. They are all super helpful becuase they want your money.
 
It’s actually a two fold positive for my business.

Right now I am a one man show, so implementing it right now will be easy enough since I can write my own procedures. When I start hiring my staff I can institute the right habits from the beginning. It will be a learning experience as well since I’ve never done ISO from the ground up, I’ve always just been a piece of the puzzle so to speak. As a consultant I will be able to be answer questions for clients in the future regarding ISO from a different point of view which will be valuable.

I would love to have a good contract come along which I won’t have to say “no” to. When I get a purchasing department going they won’t have to worry about turning down work either.

Write your own procedures by all means. In fact that is a good idea. I think you may be surprised at how often you'll want to change what you have written as time goes by and experiences mount up.

Never forget that being ISO certified is NOT a once only expense.

From personal experience I've never known an ISO certified company that was more trustworthy or made better quality products than a non certified one. Either a company makes good products or it doesn't.
 
+1 as Gordon C. said.
ISO does NOT make You quality.

It is theoretically supposed to make traceable paperwork, which in practice it does not do.
A 1-man iso 9000 is "nice" on paper -- but if it is actually implemented, followed/audited/paid for will eat more than your margin and time.
If it is not later implemented/followed/paid for your certs/sales will not be covered -- and in case of major disaster YOU will be left responsible- by the insurance company and lawyers.

ISO will make sense if You are making something like nuclear reactor parts, space equipment mirrors/brackets, etc.
Something where 100$ in material transforms into 100.000 $ in product.

It is sometimes relatively easy to get some "iso" cert via a consultant for not much money.
This is worthless - unless You get major $$$ sales from it, and then spend, later, major bucks to actually do real ISO.
ISO demands in truth checking and updating and delivery of docs and products/services.

If You sell ISO stuff for lots of money, and something fails, and You did not have the checkups.. You will be liable in the real world.
The ISO stuff is a great, good, idea at base.
The real implementation has nothing to do with that idea.

ISO is a way for the cert. organisation to collect fat fees, while doing nothing, and impose ridiculous constraints in paperwork with high cost on excellent businesses - almost all being unnecessary and unhelpful and usually extremely negative for the business itself.
It is of note that almost all major businesses that failed in the past 10 years, had iso certs and auditors etc.. and none of them helped in any way to avoid the failures.
Enron, worldcom, sune, etc. come to mind - 100B plus.

It is of note that in all the major failures of aircraft companies, airlines, railways, the iso/auditors etc. standards helped nothing.

By all means- if You can make profits via ISO go for it.

Most ISO and IT consultants are the same garbage.
They wont tell You what You need, how much of, and what it costs, and how long it takes, up-front.
Because if they did, no sane person would go for it.
 
If You sell ISO stuff for lots of money, and something fails, and You did not have the checkups.. You will be liable in the real world.
The ISO stuff is a great, good, idea at base.
The real implementation has nothing to do with that idea.

Bit like communism. Great in theory, useless in the real world.
 








 
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