Quality
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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.
The quality department supporting the Plastic Production have a very important role in the company.
The highly skilled employees in this department are preparing all Quality- and Packing Instructions, Production Release sheets, Quality Control sheets.
They perform the start up control (Production Release) when production is started and then at least every morning after A-service of the tool.
As production lots come from the machines, they perform the control of running production (Quality Control) usually based on AQL level agreed with the customer.
They are performing visual control and measurements as specified in the Quality Instructions, as agreed with our customers.
Where needed they will also perform more special tests, e.g. on equipment provided by the customer. The department is also supporting the validations with controls and documentation.
The quality department has several microscopes and a fully automatic optical and tactical measuring machine, which functions especially well for repeated measurements during quality controls of start-up and running production. In addition the department is using hand measuring equipment, 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 are working 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 defect parts can easily be contained and the amount of scrap is minimized if a problem occurs.
