ISO 9000 Where to Start

Sidney Vianna

Post Responsibly
Leader
Admin
I have a longtime customer that's requiring it,
I hope, for your sake, this is not one of those cases where a customer puts a challenge ahead of you to see if you go away, as a supplier. ISO 9001 certification for a 1-man band is simply dumb. Either your performance has demonstrated you to be a reliable supplier or it hasn’t. Going for certification will make you generate silly bureaucracy for the sake of an audit, and add costs to your operation, while changing absolutely NOTHING in the way you do business.

Good luck.
 

GStough

Leader
Super Moderator
Adding to what Sidney said, sometimes a claim of "compliant to" is acceptable to customers who need to know that their suppliers have the proper processes documented and maintained, which adds to their confidence level that you will be able to continue providing quality products. Of course, you will need to be able to demonstrate that your company is compliant to ISO 9001 and not just make the claim.

Do you already have a quality agreement in place with this customer? This may be an acceptable alternate option.
 

imwilliam

Involved In Discussions
Adding to what Sidney said, sometimes a claim of "compliant to" is acceptable to customers who need to know that their suppliers have the proper processes documented and maintained, which adds to their confidence level that you will be able to continue providing quality products. Of course, you will need to be able to demonstrate that your company is compliant to ISO 9001 and not just make the claim.

Do you already have a quality agreement in place with this customer? This may be an acceptable alternate option.

Sometime ago I came here to the Cove and asked/discussed whether this was an external requirement, as my customer was claiming, or not. What other options I might have to meet their requirement and the like. Sidney contributed to that discussion. And I'd hoped to be able to go back to my customer and make the case for something short of full certification.

No dice. At the end of the day, whether they're correct or not, it's a demand they're insisting on if I want to continue to do business with them.

So, my choice is either get the certification or break ties with them.

Sidney, you're right.

And I have thought about whether this is just an excuse to cut ties. But that doesn't make sense to me, why not just stop sending work? They're not sending anything here they can do in house, so we're sort of a safety net for them, a stop gap even, until they can do everything in house.

Would be a lot easier if I could convince myself they just didn't want to work with my company anymore, or if I thought they could actually do everything themselves in the short term, or ever for that matter. But I haven't been able to do so.

I'm going to try to maintain a good attitude and make every effort to make as many real-world improvements as I can here over the course of this project and minimize the wasted time, but it's not unclear to me that I could realize much greater improvements if I spent my time in other ways.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
imwilliam, you have received lots of good advice so far. :agree: I can offer only that the current version of ISO 9001 (2015) is asking for controls more relevant to a business plan as opposed to the previous version, when there were 20 "shalls" to conform to. So whatever you end up with, I hope it is a business-friendly system that focuses on customer satisfaction and does not include a lot of nonsense.

Now, to be clear: customer satisfaction is not always a linear transaction. It can depend on a lot of things going right, for example contract review, process preparedness to deliver the desired product/service (that's process realization for us wonks), control of purchased raw materials and services, calibration, traceability, managing nonconforming material etc. So the system is made to include all these things. We here cannot reliably provide you with checklists for all of that. You will need to develop them, if they aren't already existing in your organization.

Then there's Internal Audits and Management Review, which are done on a frequency you decide (the standard does not dictate) and don't need to include every clause every year. Again, let your business needs decide: What has been stressing the business? What requirements and/or interested party needs are new? How have previous actions resulted?

These are not just ISO requirements, they are business needs that so happen to also be included in ISO. I am hoping this helps to decode the relevance of ISO 9001 to small business.
 
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Randy

Super Moderator
I hired a consultant a couple of years ago, just before Covid took off. They did a gap analysis of sorts and some work on a Quality Manual. We were at 5,000 dollars at that point, they were looking for another 10,000, and I just didn't think I was getting much for the money, I thought the quality of what I was seeing was poor, so I stopped working with them.
$5,000 and looking at another $10,000? For what, gold plated, Ermine lined, diamond encrusted "quality gibberish stuff"?

You're basically a 1 man shop?
From my perspective, if it's true, your customer is being a horses patootie mandating a certified QMS. You need to do a really quick, down and dirty CBA (cost-benefit-analysis) .... Are they really worth the effort? YES or NO

For a 1-5 man shop a rough estimate for your certificate (3rd party worth a flip) could be around $3,000-$4,000 +/- give or take expenses, quoted day rate, whatever admin costs and all that other fancy stuff. (based on IAF MD5 @ 1-5 empl = 1.5 days initial)

You were getting something for your money all right and you were getting it with your pants on. Other than some mundane ISO 9001 "stuff" you've probably got, in one way or another, 75-90% of what you need already......You just don't know it...........And one thing you absolutely don't need is a MANUAL........... Nice, but not an absolute and most are nothing more than a regurgitation of the standard saying you're going to do stuff, but not how.

I audit a couple small machine shops, have done so for years (certification audits), and I don't think any of them spent near $15,000 in consulting fees and one that I know of for sure didn't spend a stinking dime (the "Q" guy got everything he need from "here" for free).

There is a pea pot full of free stuff on the internet and in our files here and all you have to do is "look".
 

imwilliam

Involved In Discussions
$5,000 and looking at another $10,000? For what, gold plated, Ermine lined, diamond encrusted "quality gibberish stuff"?

You're basically a 1 man shop?
From my perspective, if it's true, your customer is being a horses patootie mandating a certified QMS. You need to do a really quick, down and dirty CBA (cost-benefit-analysis) .... Are they really worth the effort? YES or NO

For a 1-5 man shop a rough estimate for your certificate (3rd party worth a flip) could be around $3,000-$4,000 +/- give or take expenses, quoted day rate, whatever admin costs and all that other fancy stuff. (based on IAF MD5 @ 1-5 empl = 1.5 days initial)

You were getting something for your money all right and you were getting it with your pants on. Other than some mundane ISO 9001 "stuff" you've probably got, in one way or another, 75-90% of what you need already......You just don't know it...........And one thing you absolutely don't need is a MANUAL........... Nice, but not an absolute and most are nothing more than a regurgitation of the standard saying you're going to do stuff, but not how.

I audit a couple small machine shops, have done so for years (certification audits), and I don't think any of them spent near $15,000 in consulting fees and one that I know of for sure didn't spend a stinking dime (the "Q" guy got everything he need from "here" for free).

There is a pea pot full of free stuff on the internet and in our files here and all you have to do is "look".

I get it Randy. But any way you work the numbers, any CBA, taken by itself, would dictate that I comply with this demand. I don't think this is a very good use of my time and there would be greater benefits to my shop and my customer if I spent the time and money this is going to use up elsewhere. But I'm facing a mountain of work and I'm trying to keep a reasonably positive attitude.

I wouldn't be opposed to paying someone to do this, but I don't think anyone could since so much is in my head. As you've said there is a lot of information available, especially here on Elsmar. I'm hoping with a few books and some help here I can pull this off.

EDIT: Just to add, I do think a gap analysis would be helpful after I've got my system to a point where I think it's compliant or at least close to compliant
 

Big Jim

Admin
I have worked with a few one man companies, both as an auditor and as a consultant.

A comment I often hear from clients is that they could have done it by themselves, but it was much faster working with a consultant.

Finding a consultant that wants to work in our interest, particularly for a small company, may be hard to do, but the good ones are out there. I suggest you don't rule this out. Pin the consultant down about what he will do and what the costs are. Most important, ask for references.

If you wish to continue to work through this yourself the next recommendation I would make would be to obtain a copy of ISO 9002:2016. It is a guidance document meant to aid setting up a quality management system loaded with examples.

Next, I would suggest doing a gap analysis yourself. I have a checklist I use for that if you want to PM me.

Early in I would suggest you pin down your scope statement and then determine what your core processes are. For example, Management, Sales, Purchasing, & Production. Figure out what they actually are and use the names that you use.

Get back to us when you have done that.
 

qualprod

Trusted Information Resource
Morning,

I'm trying to come up with a game plan for moving my company into compliance with ISO 9000 so I can get certified in the same.

I'm a one- man shop and frankly it's more than a little over whelming and I haven't had a lot of success moving this project along to date.

Does it make sense to start with some sort of a template and work from there? A company called REDACTED has one that can be downloaded from their site, there's another at School for Champions by Ron Kurtus - online lessons for those seeking success that I've looked over, and I sort of like. Any thoughts on these or other's you recommend? Or is starting from a template not the best of ideas?

What about which part of the standard might it be best to start with. Does it make sense to develop a corrective action procedure first and then "corrective action" yourself to compliance or something like that?

Are there checklists you would recommend?

I bought the standard and I've read through it a few times, but large portions are just a wall of text to me.

Since it's just me here, I do have to set this aside sometimes, without an overall game plan it's hard pickup the project in a productive way when I'm able to return to it.

Appreciate any help/advice you can offer.
If it is possible to spend money to hire a consultant, do it, and spend your valuable time on thinks you have competency.
If is not your case, there are out there lot of material to start an implementation, of course, will take more time, and your are
running a risk of not being successful.
My two cents.
 

Funboi

On Holiday
And one thing you absolutely don't need is a MANUAL........... Nice, but not an absolute and most are nothing more than a regurgitation of the standard saying you're going to do stuff, but not how.

surely this is up to the OP to decide. If a customer needs or expects him to be certified, they might equally need/expect a manual too. There are great examples of good manuals out there. No-one should dismiss the notion simply based on what is (apparently) stated or not.
 
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