Certification nightmare: how quality standards can kill an AM company
AM Survivor #28
In the industrial AM sector, there has always been a belief that certification is a passport to major contracts and the global market. ISO, AS, and NADCAP standards are supposed to open the doors to medical, aerospace, and automotive sectors, where clients expect not only quality but also full traceability of the process.
Unfortunately, in practice, having a certificate often turns out to be the beginning of problems that can eat a company from the inside out.
AM is one of the sectors where the rigor of standards grows faster than the capabilities of the manufacturers themselves, and small and medium service bureaus feel this pain most acutely.
The most obvious and at the same time the most painful issue is the cost of obtaining a single certificate. ISO 13485 for the medical sector, AS9100 for aerospace or NADCAP for special processes often exceed the annual revenue of a small bureau printing custom parts.
To this must be added the cost of preparing documentation, training employees, implementing procedures and purchasing additional measuring equipment, without which no certification body will issue a positive assessment.
As a result, a small company operating on margins of 10-20 percent must accept that for the next few years it will work mainly to cover quality-related costs.
This is also the first moment when an important question arises: is pursuing certification really worth it?
The real drama begins later, when after months of preparation and hard work, the company finally obtains the coveted certificate, only to hear from a major customer: “Great that you’ve got it – but we’ll still place the final order in Asia.”
Large corporations or even medium-sized manufacturers in the automotive and aerospace sectors are required to audit and qualify their suppliers but are not required to place orders with them.
In practice, local companies sometimes invest thousands of EUR or USD only to discover that their prices are too high compared with large Asian facilities that obtained the same certificate for a fraction of the local cost.
AM companies thus become qualified suppliers only on paper, while real orders pass them by.
Even if contracts do appear, certification does not mean the end of expenses or stress. A certificate is only the beginning of living in a permanent audit mode.
Every production batch must be documented, every sample archived, every screw in the machine tied to a service procedure.
Annual audits by certification bodies are a significant cost, but even more burdensome can be unannounced customer inspections, during which they may arrive at any moment and demand to review any stage of production.
A single nonconformity means the risk of losing the certificate, which immediately translates into the loss of most contracts, because regulated sectors operate in a binary way: either you meet the standard, or you are out of the supply chain.
Another problem is that standards evolve faster than the technology itself
It may seem that implementing the requirements of one edition of a standard secures a company for several years, but reality is very different.
A clear example is the medical sector, where updates to ISO 13485 may require a complete overhaul of the quality management system, and on top of that come regularly updated FDA guidelines regarding additively manufactured implants and devices.
A company typically gets 12-18 months to implement all changes, which require new procedures, training and testing.
The cost of such a transformation can be comparable to purchasing a new production machine and often exceeds the capabilities of smaller firms that have just finished paying off the previous round of modifications.
Even more destructive is the phenomenon known as“death by commoditization”
If the only advantage a company has is holding a certificate, then the moment all competitors also have it, any competitive advantage disappears. A price war begins, and customers choose the lowest offer because “everyone has the same ISO.”
The company loses its ability to differentiate, and price pressure pushes it down to operating margins where any fluctuation in energy or material costs can mean a loss.
Small firms must compete with giants who have their own quality departments, laboratories and certification teams. Corporations such as GE, Airbus or Siemens treat standards as everyday routine because they have the resources to maintain a dozen or more quality systems simultaneously.
Meanwhile, a small AM bureau must rely on expensive external laboratories and certification bodies, which drives costs to absurd levels. It is a battle of David versus Goliath — except this time David has his hands and feet tied.
Finally - the certificate domino effect
A company starts innocently with ISO 9001, then a major automotive client demands IATF 16949, an aerospace contract requires AS9100 and subsequent processes require NADCAP for welding, heat treatment or non-destructive testing.
At some point, the business owner realizes they are juggling five, six or even eight quality systems. This is the moment when the certified company starts to resemble an auditing institution more than a production facility.
Paradoxically, most customers across the CEE region place orders in quantities of 10-50 units - segments that do not require any certifications at all.
The problem is that a company that has already invested in certification must maintain an expensive system even when handling orders that will never recover a single euro of the investment.
Entrepreneurs therefore live with the hope that “a big contract will come someday,” but often it never does.
There are few ways out of this situation…
One is deliberate specialization in areas free from certification requirements, such as prototyping, design, art or education.
Another option is to become a subcontractor for a larger company that already holds full certification and can formally take responsibility for the final product, though this comes with lower margins.
A third path is to fully abandon regulated markets and focus on less demanding segments where speed, creativity and quality matter more than formal compliance.
Certificates in AM are sometimes a one-way ticket - either you become an expensive certified supplier for major players and pray for the next order, or you go bankrupt trying to maintain standards needed only to execute contracts you will never actually receive.