ISO 9001 certification with zero customers?

#1
(May have been asked before, but couldn't find anything.)

We are a small start-up currently in R&D and planning to implement and achieve certification to ISO 9001 before we go to market and have our first customer.

Any CB auditors or anyone else confirm whether it is possible to achieve certification to ISO 9001 without any actual customers to satisfy?! If it is possible, anything we should take into considering during implementation?

Here's an important point that may be relevant: The product we are developing will be tried and tested by ourselves first. So in effect we are treating ourselves as the pilot customer.

Many thanks for your input!
 
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Randy

Super Moderator
#4
It's been done before, the trick is having eveything in place to make it happen, but there are other things that won't float so make sure you've got a complete internal audit, management review and pretty much everything else other that what you might be able to claim and justify exclusion from (whic isn't too many pieces of the standard)
 
#6
Do you intend to sell a physical product or perform a specific service? If you do you will likely be required to have a product you are making for them to audit.

On a related note, I performed a Stage 1 Audit where they had not yet held a management review or performed an internal audit. They provided a "simulated" management review and internal audit. The CB would not accept it and Stage 1 had to be repeated. They didn't intend to have any production, service, management review, or internal audit prior to Stage 2. They wanted to be ISO 9001 certified before bidding for their first job.
 

somashekar

Staff member
Super Moderator
#7
(May have been asked before, but couldn't find anything.)

We are a small start-up currently in R&D and planning to implement and achieve certification to ISO 9001 before we go to market and have our first customer.

Any CB auditors or anyone else confirm whether it is possible to achieve certification to ISO 9001 without any actual customers to satisfy?! If it is possible, anything we should take into considering during implementation?

Here's an important point that may be relevant: The product we are developing will be tried and tested by ourselves first. So in effect we are treating ourselves as the pilot customer.

Many thanks for your input!
In principle NO, but in your case as you have detailed, YES..... and if you look at the scope of the standard ISO 9001:2015 at clause 1., and read more specifically the points a) and b) you will get the answer. Without a receiver of your outputs and adopting the possible controls and check points to monitor and measure your performance, your PDCA will be inadequate cycle.
Plesse also note that the customer can be internal to the organization. So you have a choice to demonstrate your complete QMS. Also note that you as the organization, in the eyes of the ISO 9001 need not demonstrate the commercial aspect of cost and payment. The rest of the customer requirements can be effectively implemented which are listed in the clause 8.2.1 / 8.2.2. / 8.2.3 / 8.6 and 9.1.2 of the standard.
The intent of the internal customer must be very clear in your test case. Please also see Figure 1 in the ISO 9001 standard.
 
#8
We are developing a service that is not a special process and we don't expect there to be any exclusions. Our approach is to fully design and fully implement the QMS as if we were up and running with customers. As we will be using the developed service ourselves, in much the same way that a customer would, it probably makes it all the more realistic.

I just wanted to make sure that there wasn't any hard requirement that stipulated external customers were necessary.

Thanks for your help!
 

John Broomfield

Staff member
Super Moderator
#10
We are developing a service that is not a special process.

But processes delivering services are inherently special are they not?

How are you planning to verify service conformity before the service is experienced by the customer?
 
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