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Services: A Quality Management System for AM

An outline for a quality management system for AM has been developed to ensure quality of the manufactured end project. The full document on this topic can be downloaded HERE. This page gives a summary. The full document on guidelines for feedstock validation, elaborated on in chapter 5, can be found HERE.

amvaluechainservices Applications: regulations and requirements Design Machine Materials Process Post-processing Metrology & Maintenance

Keywords: Quality Management System (QMS) for AM, ManSYS QMS


Additive Manufacturing processes are growing in expectations. The potential in the medical, aerospace and dental market are hopeful due to higher payoff versus traditional manufacturing methods.

However, those markets are characterised by a legal framework for operating properly into them .Every part has to be certified according to the regulations established by the corresponding authorities.


  1. What does qualify a manufacturing process?
  2. A qualification approach for AM
  3. Case studies
  4. Design rules, process and material database
  5. Guideline for feedstock validation
  6. A Quality Management System for AM
  7. How to guarantee Quality in ManSYS?
  8. Further reading

1 What does qualify a manufacturing process?

For the certification of AM parts a new Process Qualification Procedure is necessary taking into account the critical parameters of AM as well as the material supply and the technology’s capabilities.

In ManSYS, process qualification procedures and registers are defined and a manual is implemented that specifies a method by which the components processed as it has been specified are examined to ascertain if they meet the required specifications (qualifying criteria) in a repeatedly manner to be identified as qualified.

The method developed will provide information for knowing about the variables and factors that may influence in the AM process and its relations with other post-processes. This knowledge will serve for specifying the correct operation window for process planning, and for establishing methods for component qualifying.

2. A qualification approach for AM

The development of the qualification method shall include the following items:

  • The component requirements specifications
  • Manufacturing plans
  • Feedstock
  • Bulk material
  • Component manufactured

The document describes the issues to be considered regarding the abovementioned items, presents the case studies and introduces the developed quality management system for AM.

3. Case studies

Different case studies are considered in ManSYS for researching about the AM implementation in the manufacturing process of a metal part.

  • For dental market, it is considered a prosthetic implant abutment from the company Twocare and a dental bridge for dental restoration from the company Wisildent.
  • For medical device market, it is considered an intramedullary nail from the company Smith & Nephew¡¦s.
  • For aircraft market, it is considered a bracket from the company GE Aviation.

These case studies is further elaborated on in the document and the corresponding chapters.

4. Design rules, process and material database

Manufacturability of critical features is depending on several factors, such as minimum wall thickness and minimum horizontal diameter.

A description of the process parameters settings for both technologies –SLM and EBM- has been specified and as built material characterisation has been documented for a standard set of process parameters.

All this information has been classified and stored for developing an AM knowledge database. The AM knowledge database provides information to the end users for applying in the process specification for the component such as quality, material and process conformance and data control within the supply chain.

5. Guideline for feedstock validation

The feedstock control and validation is a critical issue to be controlled in a Quality
Management System due to its influence in the part performance processed by additive

THIS REPORT described a guideline for feedstock validation considering all
the stakeholders involved in the feedstock flow, from the supplier, going through the service
bureau until the end user as part costumer.

6. A Quality Management System for AM

A quality management system for AM includes:

  • Process accuracy
  • Material requirements
  • Analysis of critical process parameters
  • Meet relevant standards and QMS (ISO)
  • Established general procedures and instructions

7. How to guarantee Quality in ManSYS?

With the aim that services offered through ManSYS guarantee such quality level according to the end users requirement specifications, it is necessary for the powder suppliers and the service bureaus comply with the following prerequisites:

  • Quality Management System (ISO 9001, etc.)
  • Quality Assurance (Manufaturing control system)
  • Part inspection (Characterisation of powder properties and testing of the manufactured product)
  • Document tracebility

8. Further reading