We are not ISO 9001 but still want to bid. We need a Quality System.

With a shop that usually does consulting engineering and prototypes, we have never considered ISO compliance. But we recently have been requested to quote on a complex project and the documentation does not require ISO, and if not, states the following...

"Potential suppliers having neither an ISO 9001 certified nor compliant Quality System will be required to create a
quality document addressing the main points of ISO 9001 with respect to the work. Only potential suppliers lacking certification shall submit a copy of their Quality System along with the bid package for consideration."

Looking for ideas and solutions.

Thanks for helping.

Layout each step on a spreadsheet with a brief description of the operation (CNC Lathe, 1st Turn Operation), as well as any inspection features required or you feel needs included. Next to each measurement category give a method of measure, like "Calipers", "Micrometer", "Height Gauge", "Optical Comparator." Next to each method, put a frequency of measure. Some features may be non critical, like stock diameters, so a 1st part buy off is sufficient, and also put a place on the inspection report for the heat # of the material. The part number obviously needs to be on there, and probably good to place the PO # for traceability on it as well.

Basically they want all of the quality assurance that an ISO9001 company offers, which means documentation.

I'd try to get a broader overview of this from somewhere.
It is not about inspection and documenting it. Such is more the floor view as that is what they see and have to deal with.
Do not mistake a quality policy with an inspection or part checking policy.
Bob

Having worked at a couple of large employers who were heavily invested in ISO 9000 certification, there are ways to game the system. But really, it's all about process. Documented, repeatable process. It doesn't even have to be good process. But it has to be written down (digital documents are fine, so long as it's always clear what the master document is), so you can train people on it, discuss it with vendors and customers in detail (including your bad processes), and double-check that people are following it.

Part lot/material/metrology traceability would be in addition to repeatable process. There's probably some other ISO standards that focus on the per-part paper trail. When I did ISO 9001 it was in the context of software companies, with digital replication of SKUs, so we didn't have to deal with traceability as such.

might be worth talking to an ISO consultant and see what it would take to be "ISO compliant"

When you become ISO certified or compliant it's upto you how complicated you make it.

A couple of companies ago I worked for a company that was ISO certified thru our sister company in TN. they designed the forms and were overly complicated. Each line item req'd a signature and date.
Lines on the form were something like

1) was the Purchase order examined and found to be in accordance with the SOW and Proposal?
2) was the material placed in a secure location and tagged?
3) were mat'l certs examined and found to conform to requirements of RFQ?
4) was mat'l cut and identified for cnc?
5) was there a first article inspection?
6) were any out of tolerance dimensions tagged and bought to customers attention?
7) was there a positive customer disposition for out of tolerance conditions?
8) were any parts remade?
9) was there any plating req'd?
10) was plating carried out in accordance to the PO?
11) was remaining mat'l returned to secure location?
12) was customer mat'l returned to customer?
13) has inspection signed off on parts and verified they conform to customers PO?
14) have parts been packed in accordance to customers PO?

This was a fraction of what we had to fill out on a project. The same ISO paperwork was required for a $10k and $900k project. It can be very extensive if you let it get out of hand.

What the customer is looking for is much more than whether you can make acceptable parts. They want to know that your capable of keeping track of a job, they'll get what they've ordered, the correct material/processes were used etc etc.

Be carefull what you wish for though, getting ISO compliant is not free, it's easy to ignore the system you have to create, and I've seen it were companies have become ISO certified or compliant, expecting it would open access to markets that didn't materialise.

The other thing to know is if you become ISO compliant, a customer who requires this is assuming your applying the ISO compliant system for everything that comes thru the shop, not just their job. If they audit the shop, if your working on a $200 bracket for Joe Schmoe, their going to expect to see the ISO compliant paperwork next to the part(s). If they don't see that then you'll likely be disqualified. That's whey I will never be ISO anything.

Sounds like your customer basically wants an ISO equivalent system. I'm assuming that this project you intend to quote involves actually manufacturing something. If you have no system now and no one familiar with Quality Systems you should hire someone who is. Once you have a system there will need to be someone to manage it. If you are manufacturing something there will be procedures needing development, inspections to be done, equipment to be inspected and calibrated and documents to be managed. Also customers like to see that there is someone whose main focus is quality control.
When I had to develop our first system I found a friend at a shop in our industry who would let me look at their manual an I basically copied what they were doing. It was an easy way to take the first step.

laminar-flow said:

With a shop that usually does consulting engineering and prototypes, we have never considered ISO compliance. But we recently have been requested to quote on a complex project and the documentation does not require ISO, and if not, states the following...

"Potential suppliers having neither an ISO 9001 certified nor compliant Quality System will be required to create a
quality document addressing the main points of ISO 9001 with respect to the work. Only potential suppliers lacking certification shall submit a copy of their Quality System along with the bid package for consideration."

Looking for ideas and solutions.

Thanks for helping.

Click to expand...

I've been in your situation more than once and it can be done by writing a few pages on how your shop does what it does. Do it yourself or it'll end up as costly rubbish. The secret is to write as little as possible and keep it vague without it appearing vague. Chances are that all they want is something that can be regarded as "documentation" for their archives.

Have you an employee with the gift of the gab on paper?

P.S. I'm just about willing to bet that your potential customer doesn't themselves have any documented quality system. Don't ask them that!

Thanks, all this is some very good information. Doing this on a spreadsheet sounds very doable. We do use spreadsheets already for similar tracking of parts and costs, but not individual operations or feature measurement tracking.

I'll look around for some examples.

Any more ideas are welcome.!

Early 2000’s I did self audit type docs for several companies when I went independent contractor once a year. It required my part routing sequence (plan & documentation), equipment and methods for inspection and all WPS’s, quallys and reports if any welding or heat treating was done.

I did a very narrow range of work similar to a jobbing shop. Anyway after 4-5 years they all stopped sending me the audits but kept sending the work???

Good luck,
Matt

laminar-flow said:

Thanks, all this is some very good information. Doing this on a spreadsheet sounds very doable. We do use spreadsheets already for similar tracking of parts and costs, but not individual operations or feature measurement tracking.

I'll look around for some examples.

Any more ideas are welcome.!

Click to expand...

Skip the misinformation here and go right to the source: About us

In 2006 we went through the paranoia from our CEO on down. Until the leadership team got their arms around ISO and understood ISO and what it means and brings to the table we were at a stalemate. Once understood we started the process of implementation and follow through. We got ISO Certified in 2008.

Mid January 2019 we just got our second ISO 2015 Certification without any minor or major non-conformities...as noted by our auditor this never happens and for us it is twice in a row...

If you keep the process focused, say what you do and do what you say ISO will only enhance your business. It takes commitment from the very top on down. Those who don't want to play need to move on as they will be the ones holding you back.

And for those things that do not comply to the ISO System (pretty rare) you just write up a process for Prototypes which is the exclusion to following all the processes. But do not use this as your silver bullet not to follow the ISO System on everything.

"I've been in your situation more than once and it can be done by writing a few pages on how your shop does what it does. Do it yourself or it'll end up as costly rubbish." Correct! If your not careful, ISO can be a money-making scheme for consultants. From the OP, I understand you just need a working quality system in place, not the actual ISO certification (stay away from that if you can $$$). Quality can be controlled from the "top down" but also from the "bottom up", i.e. your people know what to do, and do it consistently.

Here is all you need to know, with proper documentation as simple as possible that your company ACTUALLY follows to the letter:

"DO WHAT YOU SAY, SAY WHAT YOU DO"

Coming from a process heavy business, I can only recommend that you do the minimal you can to get the job.
I don't buy into the ISO needs to be supported from the top down. To me if it works then it sells itself and people get onboard. The top down mantra seems to be a marketing ploy by ISO and consultants to force it on the employees because no one is going to question the boss. There a few good points in it but any business worth a shit is already doing something anyway without a fancy title associated with it.

DJ2 said:

"I've been in your situation more than once and it can be done by writing a few pages on how your shop does what it does. Do it yourself or it'll end up as costly rubbish." Correct! If your not careful, ISO can be a money-making scheme for consultants. From the OP, I understand you just need a working quality system in place, not the actual ISO certification (stay away from that if you can $$$). Quality can be controlled from the "top down" but also from the "bottom up", i.e. your people know what to do, and do it consistently.

Here is all you need to know, with proper documentation as simple as possible that your company ACTUALLY follows to the letter:

"DO WHAT YOU SAY, SAY WHAT YOU DO"

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We did our ISO System without any consultants. We also have an awesome Director of Quality. Made an investment into the best Quality guy we could find and it is paying off. Internally we are at 98.8% on NCPR's. About 70% of our NCPR's are from outside suppliers.

IWUP said:

Coming from a process heavy business, I can only recommend that you do the minimal you can to get the job.
I don't buy into the ISO needs to be supported from the top down. To me if it works then it sells itself and people get onboard. The top down mantra seems to be a marketing ploy by ISO and consultants to force it on the employees because no one is going to question the boss. There a few good points in it but any business worth a shit is already doing something anyway without a fancy title associated with it.

Click to expand...

Any directive in a company needs to be supported from the top down with alignment from top to bottom. You pick a direction as a leader and want to head that way it is near impossible with mutiny happening at every turn if the top does not believe in the concept and the mutiny is accepted. You are destine for failure.

In a well run organization positional authority means nothing (the Bosses opinion carries the same weight as general labor). Anyone in the company should be able to say their piece and back it up with facts and data no matter who is in the room no matter their position. As an owner I start every meeting with this premise. I want to be challenged and told when I am off my rocker...but it had better be done with facts and data and check the emotions at the door. This makes everything around here productive and keeps us in check, competitive and growing.

In any business you want to do the minimum while meeting your customers specifications or expectations. And eliminate any non-value add BS along the way. My motto I live by "We subtract before we add."

A couple things to note about process:

A VP of manufacturing at a large company who I really respect had a chat with me about process. The main point was that the appropriate amount of process varies depending on what you do, and even within that, how experienced your employees are. More process can help beginners get their feet wet and ensure that they produce consistent results. Less process lets the old hands take care of business, and doesn't hold them back from productive tasks to "check boxes" so to speak. Make sure to take a look at your workforce and see what kind of cross-section of experience you have. Tailor your documentation and process requirements to that level, and make sure to follow through with what you write down.

The other thing, especially if you are considering certification down the road, is to use "all" in your process. Exceptions and special rules are an easy way to make things needlessly complex and harder to follow (look no further than the 86,000+ page US tax code for an example of what not to do). More importantly, it makes it harder for an auditor to be able to tell if you follow the process. If your process applies to all of something, it's easy to see right away if it's being done or not. With special rules and exceptions everywhere, you would have to consult your handbook in every case to know for sure. Not required, but auditors tend to like it, and if they're happy with you, it'll be easier to get them to side with you on borderline issues and sign the certification rather than challenge everything.

4 FN 27 said:

We did our ISO System without any consultants. We also have an awesome Director of Quality. Made an investment into the best Quality guy we could find and it is paying off. Internally we are at 98.8% on NCPR's. About 70% of our NCPR's are from outside suppliers.



Any directive in a company needs to be supported from the top down with alignment from top to bottom. You pick a direction as a leader and want to head that way it is near impossible with mutiny happening at every turn if the top does not believe in the concept and the mutiny is accepted. You are destine for failure.

In a well run organization positional authority means nothing (the Bosses opinion carries the same weight as general labor). Anyone in the company should be able to say their piece and back it up with facts and data no matter who is in the room no matter their position. As an owner I start every meeting with this premise. I want to be challenged and told when I am off my rocker...but it had better be done with facts and data and check the emotions at the door. This makes everything around here productive and keeps us in check, competitive and growing.

In any business you want to do the minimum while meeting your customers specifications or expectations. And eliminate any non-value add BS along the way. My motto I live by "We subtract before we add."

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How many employees do you have?

Just me and another two... and not many more years left. I'm looking forward to the pile of home projects and hiking.

laminar-flow said:

Just me and another two... and not many more years left. I'm looking forward to the pile of home projects and hiking.

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In that case "model Gordon" is probably best. Minimally intrusive, defined in loose terms, no other benefit other than you have "quality" system to show.
Fully implementing it would need time, money and commitment so probably best to accept that this is going to be "smoke and mirrors"

IWUP said:

How many employees do you have?

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102. Looking to fill about 12-15 open positions too...automation is our best friend right now...

laminar-flow said:

With a shop that usually does consulting engineering and prototypes, we have never considered ISO compliance. But we recently have been requested to quote on a complex project and the documentation does not require ISO, and if not, states the following...

"Potential suppliers having neither an ISO 9001 certified nor compliant Quality System will be required to create a
quality document addressing the main points of ISO 9001 with respect to the work. Only potential suppliers lacking certification shall submit a copy of their Quality System along with the bid package for consideration."

Looking for ideas and solutions.

Thanks for helping.

Click to expand...

What CarbideBob said.

I go through this every two years for FAA compliance. I am not ISO or AS9100, so I do an audit that documents the applicable standards are met. There's a lot of crap that is not really relevant but you have to include it. Like housekeeping- clean work spaces, well lit work areas, MSDS's are available.

The organizational information- who are the responsible persons, their roles, and their contact info.

Then there's some actual stuff- calibration logs for measuring and test instruments, NIST traceability, drawing and documentation control, production and inspection control, non-compliance process, record retention.

Have you ever done an ISO audit? You can just follow that format and you should be fine.

4 FN 27 said:

102. Looking to fill about 12-15 open positions too...automation is our best friend right now...

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Good on you for being involved that much with that size business.
I think our motto at work lately is we add then multiply. Just to give you an idea:
We are 300 people
We have:
84 SOPs
68 forms
57 templates
46 policies/directives

Commercial business