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Michael Lundbech A/S has developed a management and quality system which allows us to maintain flexibility and speed during prototyping, and securing the quality level and production stability during running production. Therefore the company has maintained the ISO9001 certification for Development and Tool shop, and ISO13485 for the Plastic Production.

We have selected five important areas as our quality policy which is valid for the whole company:

  • Do we meet our customers’ expectations
  • Quality performance
  • Lead time and delivery performance
  • Traceability
  • Employee work environment and training

ISO 9001:2015

In 2018 Michael Lundbech A/S was ISO9001:2015 approved and the management system has been maintained since.

Scope: Sales, Development and Manufacturing of Moulds and Injection Moulded Prototypes, for the Worldwide Market.

ISO 13485:2016

Michael Lundbech A/S got ISO 13485:2016 certified on 1. november 2022.
Scope: Sales and Production of Injection Moulded Plastic Components, which are used in Medical Devices, for the Worldwide Market.

Download certificate here.

Quality control

The quality department supporting plastic production plays a very important role in the company. The highly skilled employees in this department are responsible for preparing all quality and packing instructions, production release sheets and quality control sheets. They perform the start up control (production release) when production begins and then at least every morning after the A-service of the tool. As production lots come from the machines, they control the running of production (Quality Control) usually based on the AQL level agreed with the customer. They conduct visual inspections and measurements specified in the Quality Instructions, as agreed with our customers. Where necessary, they also perform more specialised tests, e.g. on equipment provided by the customer. The department also supports validations with controls and documentation.

The quality department is equipped with several microscopes and a fully automatic optical and tactical measuring machine, which works especially well for repeated measurements during quality controls of start-up and running production. In addition, the department uses hand measuring equipment, a light table, several weights, etc.

Our focus is to reduce the amount of scrap during production and to ensure the correct quality level of products delivered to our customers. We work with three main tracks: first, monitoring the production as it happened by checking samples from startup and running production. Second, preventive maintenance actions, where every production has its own plan for maintenance and service. Third, separation of cavities during robot takeout, and never mixing parts from different cavities or production periods, so that defective parts can easily be contained and the amount of scrap is minimised if a problem occurs.