ISO 9000 Where to Start

[imwilliam]

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.

 

[blackholequasar]

I may have a few checklists, but I do highly recommend a consultant - even if they come in and survey and give you a game plan that you can go off it would be invaluable. Is it just you in your company? What sort of products do you make? I'll look through my files!

 

[GStough]

It would be helpful if you could identify the existing processes in your company, make notes or process flowcharts on them, and then do a gap analysis to get a clear picture of where you are and how far you have to go to become compliant. To do the gap analysis, take the standard (you mentioned ISO 9000, but I'm thinking maybe you meant ISO 9001) and look at the processes you've identified and see if they meet each of the requirements in that standard. Once you've done this, you will have a better idea of which areas need more attention.

Hope this helps.

 

[ScottK]

I recommend starting here:
https://www.amazon.com/ISO-9001-2015-Plain-English/dp/1932828729/ref=sr_1_1?crid=1BPBWYESQ1977&keywords=iso+9001+2015+in+plain+english&qid=1659709639&sprefix=ISO9001:2015+i,aps,65&sr=8-1

it's a good book for beginners and it's readable. I bought one each for my ISO implementation team at my current job.

 

[imwilliam]

I may have a few checklists, but I do highly recommend a consultant - even if they come in and survey and give you a game plan that you can go off it would be invaluable. Is it just you in your company? What sort of products do you make? I'll look through my files!

Morning Blackholequasar,

It's a small machine shop, just me here. I do small orders for the most part.

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.

It seems to me that since so much of this stuff is in my head, I'm going to have to do most of the writing myself. And given my previous experience I'm reluctant to hire another consultant. I do imagine myself hiring someone to do a gap analysis, but only after I've made my best effort to put something in place, because right now there's so little in the way formal documented processes in place.

 

[ScottK]

Why are you looking to get registered?
Have you lost business because of lack of registration?
Just curious as to the motivation of a one-man shop.

 

[yodon]

A template can give you a higher jumping off point, but be aware that template packages, by definition, have to be a one-size-fits-all deal. You may see something and think "oh, if it's in the template, then I need to do things that way" and that may not be the best for your company. (And then folks get frustrated with system and abandon it.)

I wouldn't start with corrective actions. That has the potential to lead into a lot more confusion and unnecessary overhead.

9001 introduced some things that many companies have struggled with; e.g., context of the organization, so as @blackholequasar suggested, a consultant can help you navigate these things.

 

[imwilliam]

Why are you looking to get registered?
Have you lost business because of lack of registration?
Just curious as to the motivation of a one-man shop.

I have a longtime customer that's requiring it, otherwise I wouldn't work towards registration, maybe compliance with certain parts of the standard that make sense to me and I think would improve things here, but not full compliance or registration.

Will this open up other opportunities? Easy to say of course it will, but I honestly don't know and am a bit skeptical.

 

[imwilliam]

I recommend starting here:
https://www.amazon.com/ISO-9001-2015-Plain-English/dp/1932828729/ref=sr_1_1?crid=1BPBWYESQ1977&keywords=iso+9001+2015+in+plain+english&qid=1659709639&sprefix=ISO9001:2015+i,aps,65&sr=8-1

it's a good book for beginners and it's readable. I bought one each for my ISO implementation team at my current job.

I've ordered it, thanks Scott.

 

[Tagin]

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?

Because its a one-man shop, I'd start by:

• Creating an outline doc, with the sections being clause 4, clause 5, etc.
• Sketch in a few sentences or thoughts for each. Don't try to be exhaustive at first.
• Then start breaking down each section into subsections (4.1, 4.2, etc.) and see what you have for each subsection. And then go to the next sub-level...

Eventually, I think, this one doc may become most of your QMS process documentation. There is no requirement for a separate quality manual, nor is it required to document in detail all your procedures (although you may have blueprints, etc. you follow that would be part of your QMS):

4.4.2 To the extent necessary, the organization shall:​

a) maintain documented information to support the operation of its processes;​

b) retain documented information [i.e., "records"] to have confidence that the processes are being carried out as planned​

​