ISO 9001 or AS 9000??

[KTD1]

We are in the process of implementing ISO 9001 per customer requirements. The more I get into it, the more I can see both benefits and potential pitfalls.

Anyone else here ISO or AS registered?

Did you write your manual & prceedures or hire it done?

Did you really see an influx of work because of registration?

Any words of wisdom?

Thanks

[CarbideBob]

Implementing ISO9001 because your customer demands it is the worst possible reason. You need to see the system as a way to improve your shop.

I did ISO9001 when it first came out because I had already been through GM's Targets for Excellence and Ford's Q-101 and it was the next logical step for my quality system.

Did you write your manual & prceedures or hire it done?

I wrote my own but you really need to understand the system to do this yourself if you want to pass the audit. I recommend writing your own but hiring a consultant to help you through it if you're not familiar with quality systems. This is not a simple process. Most shops take at least a year before they are ready for the audit.

Did you really see an influx of work because of registration?

No, but there are many companies that just plain won't talk to you if you are not registered. Some will let you do only certain types of work if you are not registered. Having the certification makes things much easier with the big companies. Many will let you slide for a little while if you provide proof that you are working on getting certified.

Any words of wisdom?

Remember KISS (Keep it simple stupid). It's very easy to get carried away and turn your shop into a paperwork factory.
Do you have any friends who will let you look at their manual?
You can buy generic "templates" which you can customize to produce your own system.
Bob

[KTD1]

Thanks for your input Bob. To clarify a little, my current customers have not required registration yet. We must do a few forms and things to satisfy their system and we maintain an “A-Preferred” vendor status. It is those that will not talk to us that I am seeking. I've bought several books on ISO and have spent considerable time reading them.

I admit, I was apprehensive to any QMS before now. I didn’t understand what it truly was. We are a small (2 man) shop and my system is pretty much unlocking the door in the morning, making chips myself, watching and listening to operations, and having a look at his parts before I go home. It works, as long as I’m not away for long. Maybe I’m just getting old but 5:00 am – 6:00+ pm just doesn’t interest me anymore. I haven’t found that widget that would allow one employee working to support my wages and shop overhead. I need to expand if I’m to work less myself.

I had 7 employees at one time and keeping work in front of them and overseeing operations became a challenge. Looking back, ISO would have made things so much easier for me.

I think I understand the ISO system and that is the major reason I fear having someone spend a few days writing how to conduct my operations. I keep hearing “Oh, we’ve done many machine shops!” “We can have your documentation and procedures in just a couple of days!” I start to thinking, yeah and then I’m stuck with your complicated boilerplate only because you know it worked the last time.

I want my shop to run as my shop, and ISO is specifically designed to allow that. Most requirements are things that we currently do anyway and those we don’t we should be.

It sounds you’ve been around QMS for some time. Mind if I bounce a question off you from time to time?

Thanks.

[DavidD]

I haven't been involved in ISO900x work for about 7 years so take the following with a 'grain of salt'.

I have written and developed documentation, and performed internal audits for both a large telecommunications company and a large computer company.

ISO 9001 use to be for a company that was involved in design and could also include manufacture and support.
ISO9002 was only manufacturing if I remember right (no design).

There were about 20 sections to 9001 with lots of the word 'shall' in the simple sentences. Shall = must. No choice about it.

You should find someone that can do a 'gap analysis' of your current operation. That will tell you how much work you have to do to become ready for registration. Gap analysis will tell you where you are deficient according to the standards. You have to either fix or build processes that you are deficient in. It (the gap analysis) could probably be done in a couple of days.

YOU have to become fully involved in this process and STAY involved. You cant' write up the manual(s) and then go back to business as usual.

Bottom line is you document what you do, with enough 'measurements, paperwork trails' to PROVE you actually do it and ALWAYS do it.

As a minimum you need a company 'Quality Manual' (maybe 20-30 pages long, could even be less) This describes, at a high level, how you operate within the ISO guidelines (mandatory guidelines). Usually a couple of paragraphs per piece of the standard. I believe your customers can ask for a copy of it.

Then you may have another manual for each of the 20 (used to be that many) sections of ISO9001. You state how you follow the section and how you measure and document how it is done so you can PROVE to an auditor that you do it that way.

Typically you have to do periodic internal (self) audits, document what you found, document how you fixed those problems and then update all your documentation covering the new/updated process so hopefully you don't have problems in that area again.

As a minimum (if you haven't already) get a copy of the particular ISO standard you want to apply for (9001, 9002). They aren't very long (10-14 pages?). I think you have to buy them from the ISO standards folks.

Audits typically start at the top (you, the owner in this case) You get asked a bunch of questions for about 30-60 minutes on how you do things. Auditor asks a few leading wquestions to see if you understand your processes and documentation and then (based on your quality manual that they got in advance) start drilling down into your company. Obviously for a small, several person company, its easy to 'drill down' quickly.

Internal audits typically are harder than external audits. One of the processes you document is your audit process.

The auditor audits you to how your documentation says you run the business. Its how YOU run YOUR business.

Some of the processes you have to document (at least 7 years ago anyway) are:

Internal audit process
Documentation (how do you write/update/approve)
How do you (owner, secretary, Joe on the floor, etc) handle (and document) customer complaints
Employee education
Test/inspection process
manufacturing process(es)
Test instrument calibration (ie: how do you know Joe's micrometer measures accurately?)

Here is a 'white paper' giving you some basic info on the latest proposed 2008 standard.

There is lots of info floating around out there and it can be overwhelming.
http://www.praxiom.com/iso-9001.htm

One time I applied for a position to build all the ISO documentation for a small manufacturing company of about 50 people. They had almost no documented processes and I was told I couldn't interrupt people and ask them how they did their job. I could only watch and figure it out on my own.

I didn't take that job.It was doomed to failure because NO ONE at the company was 'bought in' to the ISO idea. At the time they made small sub assemblies for the big 3 Detroit auto makers.

[CarbideBob]

It sounds you’ve been around QMS for some time. Mind if I bounce a question off you from time to time?
Thanks.

Well I'm glad to hear that you are looking at 9001 as a way to improve your business. I've seen way too many people that have "bought" their certification without understanding the system. These people typically complain that ISO 9001 is a waste of time and paperwork.

I'd be more than happy to share my limited knowledge if you have some questions.
Bob

[harryn]

I have worked for two companies that went through the iso 900x process. The part that was good, is it forced them to think about their work flows more formally.

The part that was not so good, is that some managers used it as a way to build little kingdoms and have more excuses to say "no", we cannot do that. In once case, the service dept ended up with procedures that had to be ignored / signed off almost every time they did something.

My brother works for a company where he was in charge of building up quick turn prototypes / customer samples of their product. This was one of the hardest parts to pull into ISO, as most of his work was manual and he used many different hand tools and metrology to do the work. Bottom line, thier ISO procedures meant each tool / meter had to be certified per ISO procedures. The engineer in charge of the ISO process determined that it would cost too much to keep his tools certified, so they eliminated his job, and went to a CAD / CNC approach by an engineer.

I suppose this is the right direction overall, but his perspective is not so positive (as you might expect)

[cs_sas]

Before I had my own Business, I was in Quality for 25 years. Worked my way from floor inspector to being Quality Manager for a few large companies. That said I have been through a lot of Quality systems. From GM to ford to QS9000 to ISO 9001, 9002, and now 9000/2000. I have brought 14 companies to ISO Registration. As many above mentioned you eather commit! or don't bother going after it. I know companies that feel that as long as they have a piece of paper hanging on the wall they are good to go. Believe me when I tell you that that system will always fail. Eventually you will get cornered and not been able to answer questions about your system. I am also like yourself a small company with 5 employees and that includes myself working in the shop floor. With that in mind I did all of the paperwork needed for ISO9002/2000 and consider myself ISO Compliant not certified. If you have a good quality system in place and follow what you preach most companes will consider Auditing your system and if you pass their audit you will be in their system as a new vendor on probation. How do I know this? well I was just Audited by Manitowoc Crane Company a well known name in the crane industry and about a month later they started to send me RFQ's. Certification is not for everyone, expecialy for a small business that can't afford to pay the $2,600 per year for external Audits. Now here is how I developed my Quality system. Of course it was easy for me since I have done it many times before but the process is simple. Start with your QA Manual. This should be as small as possible mine is 18 pages. the more you put in the manual that you will due, chances of falure are high. Base your QM on the ISO Standard, go right down the stadard and fill in what will work for your business. Any element that does not apply to your business mark it as NA. you can get a lot of info including a sample ISO Standard from BSI.com that is the British Standard Institute, they are one of the largest and most recognized register firm in the country. The standard has six or seven elements that must be in your QM, like Corrective and Preventive action, calibration system, Quality policy, etc. Once your QM has been Written, you need to make sure that every one in your company knows the standars, applies the standards to everyday tasks and understand why they are doing this. Develop forms as you go such as correcive action forms, audit forms, process control manuals etc. once that is in place and working you can go to tier 2 SOP's (Standard Operating Procedures) and than tier 3 ( Work instructions) tier 3 will help a lot on the shop floor so every one operates in the same manner by following the procedure. I can go on for a long time but I think that if you have any other questions you can e-mail me at cs_sas@peoplepc.com and I will try to help as much as I can. This goes for any members that may want to get into ISO.

Good Luck
Claude

[JulieEastern]

I believe ISO 9001 2008 is just an upgrade of ISO 9001 2000 without any additional requirements.

[billystein]

Hey carbidebob,
can you give an estimated cost for implementing you q.a. system?
did you have to pay for your certificate?
is there a recurring cost for staying certified?

thank you
billy

[KTD1]

I purchased the ISOXpress Software and have been working on the manual and procedures for the past few months. I have a only few more work instructions to complete and some fine tuning to do.

We will be very close to a paperless system. Paper documents are used only in the job travelers and are destroyed after use. (Records are scanned and stored as pdf files.)

[PinMan]

Im proud to say we just got our preliminary ISO 9001 and AS9100 certifications the beginning of this year. We have another audit in June for the real deal.

We did all our work ourselves, didnt hire out the job. Fortunately, I have had a bit of experience with ISO from previous jobs so it wasn't too difficult to implement it here.

We are a small company with a lot of 'set in their ways' people (including the owner... shhh. lol) The transistion has been tougher for some. It took awhile to get people out of the habit of saying, 'we've always done it this way'.

Im currently trying to get a Kaizen or 5S system going here...

[ImanCarrot]

Yep, you have to buy into the system for it to work. If you're doing it just as a paperwork exercise it will cost your business money instead of actualy making you more profitable. But at the end of the day some companies won't even talk to you unless you got it.

I've been involved with ISO90001 since it was BS5750 (showing my age now). I'm a founder member of the Chartered Quality Institute and a Lead Auditor.

I've written my own Quality Manual, Procedures, Works Instructions etc etc and it did take a lot of time, but that was for a big defence company so it had to be right and it did work. In my current job we sub- conned the certification to a third party and, ok, we got the certification but it didn't really add much to the company profits since it was purely a paperwork exercise.

Basicaly, in it's simiplest form, you ask everyone what they do then write it down and tell them that's how they should do their job. The biggest hassle is internal audits but even that becomes not too bad when folk realise you're not "out to get them", but to improve the company. One very useful hint: if they're not working to procedure then change the procedure instead of getting them to change how they do whatever it is they're doing.

Continual improvement: If, on your first audit you are 100% perfect then there's no room for improvement, better to be a wee bit bad on the first audit so that next year you can say "look! we're improving a lot".

Training: An easy way round this is internal CD courses, can be anything from "anger management" to "finance for non financial managers", I've found that people actualy enjoy the change from their normal work routine. They get a nice certificate and you have documented proof that you're implementing a structured training regime.

As an aside; I left that big defence company a few years back when I was required to implement ISO14000, the environmental procedure. We made missiles and I couldn't figure out how to make them environmentaly friendly- they're designed to blow things up, including the environment.

Environmentaly friendly missiles *shakes head* an obvious oxymoron if ever I heard one