ISO 9000 Certification

We have recently had a flurry of customers request that we become ISO 9000 certified. It has happened in the past, and we passed up a fair amount of work for lack of being certified, but this time, one of our biggest customers is "requesting" that we do the deed. They are requesting it for manufacturing and design as well.
My question is, has anyone done this, what is involved, is it expensive, how do we go about finding a company to provide what is needed, and any other helpful info. I did a search here and surprisingly found very little. A google search provided a bit of info, but I need the inside view if possible.

The last place I worked did it, fortunately as I was leaving 12 years ago. The biggest thing I remember is writing procedures for everything. Each task had to be done in the exact order every time. This included setting up machines. You must always change chuck jaws or headstock collets at step 3 no exceptions. Also each part needed a router that could not be deviated from. If you 1st op'ed a part on a CNC Screw machine, that is where it got 1st op'ed forever. Each machine had a maintenance log book and a tooling replacement log book,
anything other than loading blanks or bars was written down. The inspection room was sealed off from the rest of the shop and climate controlled (humidity and temp). All instruments and gauges were on calibration schedules, material never went anywhere with out a tag, it was under lock and key with only one person allowed access per shift. I think it cost $50,000 to implement and that was just for all the outside hand holding and audits. I am sure a lot of companies do ISO certifications, seems like a big racket. Back then it was lots of paperwork, everything was tagged and or labeled, some of it was good for organization, most of it overkill. I would say it took the average worker an extra hour a day to be in compliance you would have to work 9hrs to get 8hrs production. Disclaimer, that is my personal experience your's will probably vary.

Ask you costomers why , Is my work unsadisfactory . Ask them how will it help you if i spend 50 grand and get ISO certified. I know what they would like to say , We went throught all the bullsh-t and paid out alot of money and its only fair you do the same. Its a racket .Its doesn't make you put out a better product.This is just another step to make it harder to do work in the US.

If you are the OEM how needs it
If you are sub it helps getting bad jobs

Dave

sometimes iso compliant is good enough.... certified is expensive to get and even maintain,,, compliant is good enough for dod work.

SmithSolar said:

If you are the OEM how needs it
If you are sub it helps getting bad jobs

Dave

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Ox please run through your decoder.

Mad Machinist said:

Ox please run through your decoder.

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OEM is the manufacturer and does not do subcontracting
Sub is a subcontractor
Be for 911 I was the OEM and use subcontractor for some of my work.

Dave

Mad Machinist said:

Ox please run through your decoder.

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If you are the OEM how needs it
If you are sub it helps getting bad jobs

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If you make your own products for resale, it really don't make no never-mind.
However - if you are hoping to git werk from some other entity, the Cert DOES help you to land that work. However - they don't expect to hafta pay more for their parts b/c of it. All too often they actually ask for a reduction in price after the fact. (you ARE more efficient now - aren't you?)


At least that's what I read. YMMV?

If you 1st op'ed a part on a CNC Screw machine, that is where it got 1st op'ed forever.

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So much for that other buzz phrase "Continuous Improvement" eh?



Dual - Most enyone that I know of getting ISO in recent yrs has learned how to make it worded as basic as possible. The ISO guys are not exactly in fovor of this as it reduces the need for them largely, but none of the small shops that are looking to stay in business would go for the big sh-bang. So they have had to git much more realistic in recent yrs.


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Think Snow Eh!
Ox

The big thing about ISO 9000 certified is sub can check the parts for OEM needs.
Bad news you still need to check the parts if you are the OEM so why ISO 9000 certified???
Just a add for the sub

Dave

WILLEO6709 said:

sometimes iso compliant is good enough.... certified is expensive to get and even maintain,,, compliant is good enough for dod work.

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Please excuse my ignorance, but what is dod work?

We have a job shop that is also a support shop for the parent company. It's the parent company's customers that want the ISO certification.

Sometimes you have ISO companies that like to deal with ISO certified vendors in order to skip their own inspection / costs involved, paper says its good and they did it all before it left the shop right?

As to getting it done, quality manual, calibration schedule and sheets for the tools, track materials certs/label it, you can have an area for each material/job package and all, make it as fancy as you want before bothering to put $ to have someone waste your time with it.
I know only a few shops who did it and wow what a drag to get through that.

"but what is dod work?"

I believe this is D.O.D.

Department of Defense

Listen to Gordon, he's right on. (can you come work here )

People act like ISO is a huge deal, but it's really not that hard to do. Here is the key, write procedures and follow your procedures.

You can set up a system that will actually help your company be better. It doesn't have to be a bunch of stupid useless paper work.

If you want to go insane try being FDA compliant.

ISO - News - New edition of ISO 9001 for Small Businesses

I havn't done it, but my company does and I work closely with those involved in the process. Basically it's just a matter of documenting your processes and procedures. The processes don't have to be overly detailed, just documented. Maybe the book in the link lays it out. Our processes are a rough draft of what we do, such as "isolate failure", "order parts", etc. I believe there's also a requirement for training levels of workers. In our case we're covered by having one person that has expertise available to those who don't. Don't know if that helps. We're also A2LA certified. It may be costly, but it brings in more business and allows you to charge more because of your certification.

David

The easy mans way to ISO 9000 is to write down what you do, and how often you do it, for everything that needs records kept. One sheet of paper should cover each section of what your business does e.g. taking and recording progress of orders from enquiry down to document storage and invoice issuing. I chose that example 'cos its the most obvious paper trail. More than one sheet either you are getting too detailed or the breakdown is bad. Prolly manage it in twenty not too dense sheets.

As Gordon said don't try to write detailed instruction manuals for anything. What ever anyone may try to tell you different ISO 9000 is purely about record keeping so that you can show by paper or electronic trail that you have done what you said you were going to do and know the process by which you do it. For example the inspection department shows you have made stuff to size, the calibration contractors make sure the measurement kit is up to snuff, ISO 9000 simply covers the record keeping process verifying that the parts have been inspected and the equipment used has been calibrated. For most physical work a job card or electronic equivalent annotated as the component goes through the shops can be made to cover the bulk of non-admin ISO9000.

As an example of Gordons "writing diarrhoea" the place I wage slaved at created approximately 8 linear feet of A4 loose leaf binders covering local ISO 9000 procedures for each section. These were issued at one for everyone to access set kept in the "registry" and one set per manager at 2 grades + over me. For a 60 person section that came out at 5 sets! Allegedly there was a further 8 linear feet of stuff for site level admin for section heads and deputy heads etc and around 16 feet for head office stuff. Each lab was also supposed to produce procedures and local instruction manuals for all the kit in there. All written at sub-11-plus level. Had I complied there would probably have been about 10 feet of books in my lab. Right down to procedures for using a tape measure!! Plus fat safety and component traceability manuals. A bit of serious arm twisting got my lab ISO 9000 down to 9 A4 size posters. Which seriously upset everyone who tried to do what the consultants and bosses said. Not the first time that being the departmental security officer in a defence research establishment added to a carefully cultivated reputation for being absolutely the wrong guy to upset paid off in spades. It did help that I knew the rules better than the consultants! Officially something like £1 million was spent over the whole organisation on that fiasco and I know the books were heavily fiddled. Tea break calculations settled on around 2 miles of shelf space all told.

Clive

Gordon B. Clarke said:

I've worked as Quality Manager at several companies and also as Quality Assurance Engineer (where the boot is on the other foot).

The companies I've worked at (over 25 years) vary from oil regulators, high pressure cleaners, F-16 heat exchangers, centrifugal pumps, and a couple more. I've had more than a couple of them certified.

The problem isn't so much ISO 9001 as the person or persons writing the handbook, procedures and instructions that seem to get carried away with what I describe as "writing diarrhoea" where too much is written in too great detail. Also known as BS.

The biggest mistake most make is writing to impress the outside world as to how good they are rather than writing what is necessary and essential to the company itself.

If I had to invent rules then they'd be along the lines of:

1) Never write more than is necessary to achieve official company policy and goals. A Quality Manual is written for the company and not for the customer, for which it's only information.

2) Operations or procedures that can cost injury or money if not followed are the most important to describe.

3) Apply common sense and allow for the fact there is often more than one way to do things.

4) Get all in the company involved somehow. It's a joint effort.

It's always much easier to add something on (tighten up) than it is to try and remove something, especially with a "theoretical" auditor looking over your shoulder.

Shop around and find a company that can give authorization and that you feel you can work with. Is it expensive? Depends not only how big your company is but also on how much you've written. The more you write the more that has to be checked.

Don't be one of those companies that, the day after certification, start to figure out how to circumvent what they've written.

If anyone wants me to go into more detail on this subject just let me know - I'm free

An after thought. If you are a sub contractor, then it may reduce your insurance and liability costs if you are ISO 9001 certified. From some major contractors it is a must to minimize their risk and liability. Windturbines for example.

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Gordon, I've got a question for you. Let's say we were to start down the ISO road today, and came up with an adequate quality manual, organized and labeled the shop/materials/etc, cleaned out any random parts and material lying around the shop, finish all pending work, and got all ready for an audit.

At that point, I take start and complete ONE new job, and follow all of documented processes according to the book. Can I have an auditor come in at that point to approve the registration? Or does there need to be a history of compliance prior to certification?

I get the feeling many companies doing the creditation would still charge a high price even if you did 99% of the work, just cause they feel they should have been involved and " lost money ".

I plan to remain a 1 man shop

Yes sireee....

Joe788 said:

Gordon, I've got a question for you. Let's say we were to start down the ISO road today, and came up with an adequate quality manual, organized and labeled the shop/materials/etc, cleaned out any random parts and material lying around the shop, finish all pending work, and got all ready for an audit.

At that point, I take start and complete ONE new job, and follow all of documented processes according to the book. Can I have an auditor come in at that point to approve the registration? Or does there need to be a history of compliance prior to certification?

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I suggest you buy the ISO book mentioned before… write and tidy up the manuals add what you can figure out in the books stuff… and in the shop put all the guards back on, get new or have the fire extinguisher charged… QC documents, receiving, billing… procedures…procedures…procedures…OK…OK… !!!The procedures are not that bad, just identify the areas and services you provide and write a page of instructions (i.e. procedures) for each one and detail as simply as possible how you want things done. That’s what it is all about. And, yes there are a few other things like LOTO, HAZ waste, MSDS’s, job descriptions…

Then contact an ISO inspecting agency for your area, state, country, planet...whatever… Hire their services to first come in and do a pre-audit and later the audit. They send a guy out to do the pre-audit and he acts as a counselor telling you what you are missing and what needs to be worked on more. Then you work your ass off trying to first understand just what he said to fix …and fixing it. Then that same guy comes back after you've fixed all the stuff because he already knows what you needed to fix, and if you’ve done a reasonable job fixing it... he will give some minor noncompliance’s to fix (There that Dam# word again "fix")down the road before the next audit (in two years I think, I don’t recall now) and a few major noncompliance’s even …to fix... while he’s there… or in 90 days or so… and if you fix the majors to his liking (well, these are sort of real majors) and they were not MAJOR MAJORs (i.e. a real majors) he gives you your cert…that is kind of how I remember it goes. You just work 24/7 right?
And… Oh yea…. They get something like 7.5K of your money from coming in and spending a total of about a week at your place …2 plus days the pre-audit… and 2 plus for the final audit…just one guy…nice gig… if you can get.
Oh...and you think that is a great gig... it gets even better...every few years ... he comes back for a renewal Audit (3K more ..thank very much!)
Steve
See... its not too bad...

When the auditors come through don't let them talk to anyone but those that can talk on their feet. Make sure those people are prepped with the pat answers. "Hell if I know, let's go ask the boss" is not one of the answers.

Go as bare bones as possible on documentation. Part of ISO 9000 or 9001 certification means every document used on the job has to be identified as the most current, and you should take control of all the documents to make sure the old versions are not in use. Sounds good in theory, impossible in practice, so make sure everyone using data current or not keeps it behind a door or in a drawer.

ISO paperwork never made a single piece or part.

Our company documents our work processes by flowchart, and of course all our policies are documented. The flowcharts we have look very complicated, but our actual workflow is 10 times as complicated. The flowchart can be very basic. In our audits most of the time is spent on whether or not our customer-facing documents match what we say we did, such as serial numbers for equipment used match the documents. They'll ask workers about processes, and they only need to know where to find them to give the correct answer, they don't have to memorize them.