Quality - D.H. Lamina Engineering Plastic

Quality Management: ISO 9001:2015

ISO 9001:2015 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

We are certified ISO 9001:2015 since March 2018, in “Machined parts in plastic materials as per customer’s drawing”.

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Declaration of Conformity according order

According UNI Standard EN 10204 we can supply two declarations, which specifies the different types of inspection documents supplied to the purchaser, in accordance with the requirements of the order.

Even if UNI Standard refers to metal parts, most of those are also available for quality control on plastic materials.

We can supply:

UNI EN 10204:2.1

Certification of delivery in compliance with the order specifications.

UNI EN 10204:2.2

Certification of delivery through manufacturer’s quality-control department, with non-specific quality control on plastic, semi-finished products

Certifications and declarations on semi-finished materials.

We work together with the most important European Producers of Thermoplastic materials; so, we assure a first quality level of all our plastics.

Most of our materials are compliant to the certifications below.

For further information about a specific law or if you need any other kind of certifications on semi-finished materials, please contact our experts.

FDAU.S. Food and Drug Administration.
EC 1935/2004Regulation (EC) No 1935/2004 of the European Paliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC.
EU 10/2011Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food.
NSFThe NSF mark assures consumers, retailers and regulators that certified products have been rigorously tested to comply with all standard requirements.
ISO 10993-1:2018 - USP Class VIBiological evaluation of medical devices Evaluation and testing within a risk management process.

In-Line and End-of-Line quality control

All production batches are subject to critical controls during every production step. During machining (In-line), each operator has to check dimensions on 1st piece and each 10% of the entire production batch. A spot control on 1 part is done by our Quality Manager when machining is finished (End-of-Line).

All these operations are certified on our production sheet and according a double control with barcode in our ERP and MES.

D.H. Lamina can supply a various number of documents to testify the Quality Control during production, for example:

Dimensional reportsA deeply accurate document, where all dimensions are numbered and checked. This document and written control can be issued both of First Samples, both each production batch and can be done on ust 1 piece or whatever quantity customer needs.
PPAP (Production Part Approval Process)PPAP is nowadays used in a various kind of industries supply chain for establishing confidence in suppliers and their production processes. The purpose of any Production Part Approval Process (PPAP) is to 1) Ensure that a supplier can meet the manufacturability and quality requirements of the parts supplied to the customer; 2) Provide evidence that the customer engineering design record and specification requirements are clearly understood and fulfilled by the supplier and 3) Demonstrate that the established manufacturing process has the potential to produce the part that consistently meets all requirements during the actual production run at the quoted production rate of the manufacturing process.

Production process according EC 2023/2006

Commission Regulation (EC) No 2023/2006 of 22 December 2006 defines good manufacturing practice for materials and articles intended to come into contact with food. Our Company declares that the production process method has been integrated to our Quality System, which complies to UNI EN ISO 9001.

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