Can a specific in-house manufacturing process be excluded from the QMS?

I am in the early stages of establishing my QMS and need some advice/expertise. As background, I own and operate a very small job shop that provides foundry (we have 3 in-house casting methods) and cnc machining services (primarily limited to finish machining of our castings). We are a 4-person operation which means that everyone wears multiple hats, no one is overhead. We started in 2010 by marketing ourselves as a supplier of complete-to-print rapid prototypes but intentionally shifted our focus to high-precision, short-run production components a few years ago. We build to our customer's spec/print; we do not have our own product.

We are extremely customer-focused and provide excellent service; I have issued exactly 2 RMAs in 6 years and over 170 jobs completed (internal yield and efficiency is a different story but still quite good). My goal in adopting an ISO QMS is to formally develop the processes and controls that will allow us to scale and improve efficiency; I fully recognize that, as/if my business grows, not every person will be a "key" person with the same aptitude, dedication or ambition as myself or my existing employees. I must also acknowledge that I'm finding ISO certification (at a minimum) with some AS9100 flowdown requirements are necessary for me to win new customers who have low-volume production components that are well-suited for my casting processes.

For a variety of reasons, I would like to implement my QMS for my casting services only, to specifically not include CNC machining in it. The main reasons for this are: 1) focus and ease of implementing the QMS 2) the metrology requirements for inspecting castings is far, far more limited and easy to maintain. I have several Tier 2 customer's that have approved me for prototype casting work, that would also give me production casting work if I become ISO certified. They represent the short-term growth plan. That said, I do want to become certified for machining as well, just not day 1. However, and this is critical, I must continue to supply CNC machining services because approximately 70% of my recurring revenue is from producing 6 parts to 3 key customers, and these require finish machining. Frankly, I suspect that many Tier 2 companies will have no problem giving me cnc machining work also, even if it isn't part of my QMS, as long as I can present ISO certs for my core casting business.

Now that I have written this novel, can I become ISO certified for my casting work only? My machining area is tucked into a corner of my shop floor, but it is still open to the rest of the shop. If it matters, it wouldn't be too difficult to section off the machine shop and its related inspection equipment with partions (my ceilings are too high to easily wall it off). If that isn't enough, can I establish a separate LLC for machining services, that resides within my building, that my current company can sub-contract machining to? Thank you in advance for your consideration.

 

Here is the requirement from ISO 9001:2015: This is what the auditor willfoolow to agree or disagree with your established scope.

The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.
The scope of the organization’s quality management system shall be available and be maintained as documented information.

The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.

Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.

 

Primarily, when an organization determines its scope of the QMS, the following must be considered:

• the external and internal issues relevant to the organization's purpose (see 4.1 of ISO 9001:2015);
• the requirements of interested parties (see 4.2 of ISO 9001:2015);
• the products and services of the organization.

 

I am a little unclear. In reading David's response, it is my understanding that, if I limit my scope to providing "precision non-ferrous castings" and don't include CNC machining services in my scope, then I am fine; I will be audited on my processes/controls related to my casting operation but can continue with cnc machining off in the corner, unaudited.

However, Tony's response says "the products and services of the organization" must be considered in determining the scope. What does it mean "to consider"? Is it truly a "consideration" or is it a mandate that, if you provide the service, it must be part of your QMS? I have considered it in relation to the context of my organization and of interested parties, and I don't want it in my scope. However, I do provide CNC machining services and will continue to do so; I just don't want it in my QMS today.

 

To simplify this

If the product that you are providing requires machining then - it need to be part of the scope - thus no exclusion...

If the machining aspect of your shop does not involved products - then it is OK to take an exclusion

 

Ok, thank you for the clarification!

 

I will have to side with the above reason for establishing a QMS than the reason below.

 

Brad - There are several reasons, but they almost all boil down to: as a small owner-operator in which I perform all overhead functions, as well as the key production functions, every effort I make must be evaluated in terms of opportunity cost. There is undoubtedly value in having the machine shop be ISO registered from day 1, but it is that many more processes that I must carefully consider, define, document, etc while I am trying to scale my business... And then there is the additional cost of the vast array metrology and verifying machines etc... But it really is more of a time issue and the reality that my immediate growth opportunities are with customers that will only want my casting service anyhow.

 

I've been in similar situations as yours and have had good success in applying ISO across the board without causing unnecessary paperwork or systems. I believe it's doable. Feel free to PM me for my phone number and give me a call any time to pick my brain.