ISO 9000 Where to Start

Sidney Vianna

Post Responsibly
Leader
Admin
You think an auditor would buy that or am I setting myself up for a brawl with the auditor? I mean it is all in my head, other than inspection records, calibration records and job notes.
If I were in your situation, I would most definitely take the minimalist approach to documenting the system. If the auditor feels "uncomfortable" about auditing a scarcely documented system, too bad for him/her. You mentioned being aware of the ISO APG papers. There used to be one there for auditing with minimum documentation. That APG paper has been withdrawn but I attach it here.

ISO 9000 Where to Start

For you, make sure you are familiar with the Guidance Document available below.

ISO 9000 Where to Start
 

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Funboi

On Holiday
You think an auditor would buy that or am I setting myself up for a brawl with the auditor
It‘s impossible to tell. However, one way is to forget traditional thinking about documents, procedures etc. Why not develop a bunch of checklists which start with the review of inputs and step through the process (typically about 9 steps or so) to an output. You might find that actually useful, like a list when you visit the hardware store…
 

Big Jim

Admin
You think an auditor would buy that or am I setting myself up for a brawl with the auditor? I mean it is all in my head, other than inspection records, calibration records and job notes.

Hopefully it should never become a brawl, but you should be able to stand up for yourself and demonstrate that you know the requirement and can explain how you have met it. Most auditors would respect that.
 

Big Jim

Admin
I could list quite a few things that are in ISO9001 that our people know, but not in any relation to ISO - just our internal processes.

I'm sure that many of the things that apply to your internal processes are based on an ISO 9001 requirement. For example, could you have an effective internal process for control of nonconforming outputs if you are not applying element 8.7? I'm also sure that you could march through the standard and find many more pertinent examples.
 

imwilliam

Involved In Discussions
I'm sure that many of the things that apply to your internal processes are based on an ISO 9001 requirement. For example, could you have an effective internal process for control of nonconforming outputs if you are not applying element 8.7? I'm also sure that you could march through the standard and find many more pertinent examples.


Yes, of course you could. ISO9001 is neither necessary or in itself sufficient to produce quality "outputs". People have been keeping what works and tossing out what doesn't forever. ISO9000 didn't invent these concepts.

Correct me if I'm wrong, I might be misunderstanding you, but sometimes it seems like you don't think quality can be accomplished outside of these standards/systems or that it existed before them.

ISO9001 is a tool at best not a theophany. I don't get the religious like zeal for the chapter and verse of it.
 

Sidney Vianna

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Leader
Admin
For example, could you have an effective internal process for control of nonconforming outputs if you are not applying element 8.7?
It is the other way around. People were controlling nonconforming products way before ISO 9001, BS5750, Mil-I’s and Mil-Q’s, etc. ISO 9001 is nothing more than the collection and packaging of semi-universal industry practices. The only “novel concepts” brought about (and to an extent still misapplied) were internal audits and management reviews.
 

imwilliam

Involved In Discussions
It is the other way around. People were controlling nonconforming products way before ISO 9001, BS5750, Mil-I’s and Mil-Q’s, etc. ISO 9001 is nothing more than the collection and packaging of semi-universal industry practices. The only “novel concepts” brought about (and to an extent still misapplied) were internal audits and management reviews.

Genghis Khan was doing internal audits and management reviews.
 

Paul Simpson

Trusted Information Resource
It is the other way around. People were controlling nonconforming products way before ISO 9001, BS5750, Mil-I’s and Mil-Q’s, etc. ISO 9001 is nothing more than the collection and packaging of semi-universal industry practices. The only “novel concepts” brought about (and to an extent still misapplied) were internal audits and management reviews.
Exactly so, Sidney. Nothing written in standards is new! All that happens is the standards writers pick up with users' practice. MIL standards were developed based on lessons learned from the Second World War in managing supply chains.

My particular quality control example is taken from Juran's 'A History of ...' and is reproduced on LinkedIn here. I have copied the relevant text here:

'One early example of quality control is from the excavation of a mine for producing flints in Denmark (believed to date from around 3500 BC) – used in the production of Viking boats. The excavation work uncovered discarded parts- finished tools rejected at the mine (internal failure costs) and before they were sold to the travelling merchants. The reason for rejection was to prevent unsuitable flints from being transported to Sweden, only to be rejected at the point of use (external failure costs). An early example, perhaps, of a move to reduce the cost of non-quality by finding rejects in-house.'
 

Big Jim

Admin
Yes, of course you could. ISO9001 is neither necessary or in itself sufficient to produce quality "outputs". People have been keeping what works and tossing out what doesn't forever. ISO9000 didn't invent these concepts.

Correct me if I'm wrong, I might be misunderstanding you, but sometimes it seems like you don't think quality can be accomplished outside of these standards/systems or that it existed before them.

ISO9001 is a tool at best not a theophany. I don't get the religious like zeal for the chapter and verse of it.

I don't know where you got that misconception. The standard can be a big help, but you are right, some have figured out how to do it without an ISO 9001 based quality management system. I do believe though that embracing what ISO 9001 provides can be a big help.
 
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