No quality system exists in small company! – implementing ISO 9001

I find myself in the situation that I am working for a small company and then have nothing in place at all. They do not even have a system that conforms in any way to ISO 9000 so basically, I am starting from zero. I have 2 years’ experience as a quality engineer 10 years ago doing supplier audits and supporting production and resolving supplier quality issues and 20 years’ experience as an engineering.

I need recommendation of books or resources I can refer to that will assist me on how to approach implementing ISO 9001 in this small company from scratch! I will have to have to do everything from looking at the company structure, working out the processes, writing the quality manual and writing all procedures etc. Any advice would be greatly appreciated!

 

I received this today thanks to a tip-off from another member: https://www.amazon.co.uk/ISO-9001-2...8&qid=1505935393&sr=1-6&keywords=iso9001+2015

So far it's really good.

 

Actually you are in a really great position. I think it is much easier to start from scratch than try to modify the framework of an existing system, provided you do it correctly from the start! You are already on the right track and your SQA experience will go a long way as the basics have not really changed that much. Take your time and do it right, there is lots of help here.

 

Thanks for the reply. That will be a good text to refer to for ISO 9001:2015 and I have been working with previous version of the standard so that is not so new to me.

The bit I am finding tricky is:

• Defining the processes that exist in the organisation
• Translating that into procedures (i.e. how to write procedures)
• Writing the Quality Manual (Need guidelines on how to structure the Quality Manual)

I have no experience of writing procedures or indeed putting a quality system in place in an organisation, but it appears to a major part of my job now...

Yes agree that actually having nothing in place is an advantage. Having written a patent and lifetime of technical reports what i need is the methodology to follow so some good references are the key...

Any suggested texts to refer to or online resources greatly appreciated!

 

Actually I'll bet they have 80% of it. You just have to know where to look. A lot may be informal and your challenge will be to formalize it without mucking things up. Start with a copy of the standard and reading as much as you can about it. There is another quality website you can search for. Good luck.

 

I agree with Andy, keep it minimalist. Flowchart what is actually happening for your reference. Decide what to document and what to ignore (for now), decide what records you will need. Get everyone involved, now is the time to create some buy-in. If you do all the work, you will own it, and that never works out well.

 

Good day "Lost-Sock" and welcome to the forum.

May I ask the following questions?...
a) What type of organization is this? (do they manufacture goods ?, provide services?, etc...)...[(what is the scope?) ]
b) How long has the company been doing "a" ?

It is important to ask these questions for the following reason...
Let's assume that your organization...
i. has been in business for 5 years,
ii. is manufacturing widgets,
iii. is delivering widgets to your customers,
iv. is making a modest profit.

If there is any parallel between this example and your organization, then I would assume it is unlikely that your organization has "nothing in place at all", and is not in any way "do not...conforms to...to ISO 9000" (it is important to note here that ISO 9000 is not an auditable standard. I assume you are intending to state
ISO 9001 [this is an important delineation] ).

It is likely that your organization does indeed set goals, respond to nonconformances, review performance, record customer complaints, etc..etc...In other-words, it is likely that you are more "conforming" than you may realize. I would recommend instead starting from scratch and creating documents, processes, etc..., based on the stated ISO 9001 requirements, that you first find all the existing documents and processes that you have in place and/or utilize. Then you can see where that existing activity "fits" within the ISO 9001 requirement structure. Once that is complete, then you only need to do a gap analysis to see what may still be missing.
Take care not to throw out the proverbial "...baby with the bathwater".

Hope this helps.

 

Right guys absolute nothing to do with manufacturing widgets.

We tender for contracts and if we win them we pass them onto a third party to execute.

Let us consider as an example, a gas installation or chemical facility. Let us put a project value of the order of 50 million. So, I can already hear the screams that it would not be possible to win contracts in those sectors without having ISO 9001. Please bear with me…

We are in such a position with a large contract and no quality system in place!

Our one and only sub-contractor who undertakes the work will be ISO 9001 accredited, so that is our saving grace…

Been routing around and some parts of the business do have things written down but it is the exception rather than the rule. These guys have undergone fairly exponential expansion and many of the processes that are being followed are almost happening for the first time, which in fact is leading to some conflict as process is not clearly defined nor who Joe has finished doing his part and he throws it over the fence to Tom who starts doing his part…

hogheavenfarm

Yes, I am in a good position as I am starting from zero…


Golfman25

Tomorrow I hope to spend some time with someone who will let me know what exactly they have (or hove not) written down. So hopefully that will become clear quite soon…


Andy Nichols

Great post. You extracted the essence and quoted it at the start….

Doing it alone – point taken and to be avoided.

As to what is practised daily – I can only describe it as complete mayhem!!!

Flow charts are the way to go clearly. I have down one procedure but it is descriptive but it is not issued yet.

Quite happy to avoid not doing a Quality Manual. All I want is the bare Skelton of a quality system that meets the requirements of ISO 9001, with no bells or whistles! My attitude is keep it as simple as possible as you have stated also hogheavenfarm.


John C. Abnet

With regard to the nature of the business I have answered that above.
They have been operating for above 7 years but suddenly expanded very rapidly and that is going to continue. They rare multiple contract tenders in the pipeline and we quite possible may have to manage multiple contracts. Incidentally, they do not have the staff at this moment to even manage the business they have already won!! Got the picture….

HR have their house in order but nobody else. It is all fairly chaotic.

“It is likely that your organization does indeed set goals, respond to non-conformances, review performance, record customer complaints,”

The answer is no with the exception of where we have responsibility for completed project and there are equipment warranty issues where our intervention is required.
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Original questions as follows:

• Defining the processes that exist in the organisation

• Translating that into procedures (i.e. how to write procedures)

• Writing the Quality Manual (Need guidelines on how to structure the Quality Manual)

So, it seems I don’t need a quality manual…

The starting point for me seems to be…

Defining the processes that exist in the organisation

It would appear that these need to be defined by the different functions within the organisation, i.e. not by me! I need then to apply the principles of ISO 9001 (& ISO 9000) to the process once I see a get a first draft from someone.

 

This will be more fun to watch than (insert the name of your favorite mini-series on television or series of movies) - please keep us updated on your progress.

Yeah, get a current process state map and then line up the 9001 requirements alongside it and draw lines - you'll wind up with a gap analysis.

And when in doubt, simplest is best.