ISO 9000 Where to Start

Randy

Super Moderator
#21
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.
What's the beef, I said that a manual isn't needed and that a manual isn't an absolute. As for me and what I do, I couldn't give a *rap less, have one, don't have one, your business, not mine, meet the basic requirements (standard, customer or whatever), pick up the ball and run for it.
 
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imwilliam

Involved In Discussions
#22
Question of protocol here, should I start new threads when I have questions about this overall project that aren't' strictly about getting started?
Or does it make sense to keep them here?

Let me know.

Thanks for all your help/advice
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
#23
Question of protocol here, should I start new threads when I have questions about this overall project that aren't' strictly about getting started?
Or does it make sense to keep them here?

Let me know.

Thanks for all your help/advice
I'd recommend you start a new thread for when you have specific questions. A friendly reminder, though, to use the search function first - there is a good chance that your question has been asked by someone else. :)
 

Paul Simpson

Trusted Information Resource
#24
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):

It is tempting to mirror the requirements of the standard and write up that mirror image as your quality manual (that isn't required by ISO 9001, BTW).

If you can get your head around it I'd start where @GStough suggested.
  • What is it we do? (Our processes)
  • Who do we do it for? (Our customers and any other interested parties)
  • What are the critical to success factors in how we work?
I'll separately post some more thoughts on process management - they are based on the ISO 9001 requirements in clause 4.4.1 but are hopefully easier to read.
 
#25
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.

Jim, would mind emailing me your gap analysis checklist? I do not have 10 posts yet so I am unable to send you a private message.
 

Funboi

Posts Moderated
#26
There’s nothing magical about gap checklists- they simply phrase the standard as a question: “The organization shall..” becomes “Does the organization…” or very similar.
If you have a copy of the standard you can simply phrase “How do I do this?”

If you don’t understand a requirement pass by and then ask. Sometimes a later requirement sheds light on an earlier one.

A gap checklist is only a fancy form someone typed out on an Excel spreadsheet. It doesn’t explain anything. You might just end up with yes or no answers.

ISO/TS 9002 is worth buying. Its good guidance
 
#27
There’s nothing magical about gap checklists- they simply phrase the standard as a question: “The organization shall..” becomes “Does the organization…” or very similar.
If you have a copy of the standard you can simply phrase “How do I do this?”

If you don’t understand a requirement pass by and then ask. Sometimes a later requirement sheds light on an earlier one.

A gap checklist is only a fancy form someone typed out on an Excel spreadsheet. It doesn’t explain anything. You might just end up with yes or no answers.

ISO/TS 9002 is worth buying. Its good guidance
Used properly a gap checklist can be very helpful. Obviously you and I disagree. In certain circumstances they are extremely useful. In other cases they are nearly useless. I believe he would benefit from one, especially since he is trying to do this on his own while keeping up with the work volume in his shop. The various one I have are in Word format, not Excel, although the format doesn't matter.

I also know some are misleading. The original OER for AS9100 was loaded with misleading information.
 

imwilliam

Involved In Discussions
#28
I'm getting my plan together. I'm reading through the book recommended earlier in this thread and I've bought and am looking through ISO/TS 9002

I think I can safely exclude the design and development section of the standard from my QMS in the scope statement.

Anything else come to mind that a one-person business might potentially be able to exclude? I know you can't say for sure, but anything you'd suggest is a good part of the standard to consider, or sections you've seen other micro businesses successfully exclude.

Thank
 
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