QUALITY CONTROL PLASTIC MATERIALS: CERTIFICATIONS AND DECLARATIONS

If you need that your supplier of plastic materials assures you a predefined quality control and assurance, D.H. Lamina could be the one.

We can count on a prepared staff which assure the highest quality level at each production step, from incoming material to the shipment. Meanwhile we are able to offer you assistance before and after the order, to fulfil each declaration and documentation you need.

 

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

 

You can download our certifications here:

IQ NET CERTIFICATE NO. IT-58726

Download Document

IIP CERTIFICATE NO.1041

Download Document

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.

Quality control plastic: certifications and declarations on semi-finished products.

We work together with the most important European Producers of Thermoplastic materials; so, we are able to supply a huge variety of certifications and declarations. All of those can be required before order and they are all issued on semi-finished products which we machine.

Main certifications / declarations required are:

FDA

U.S. Food and Draug Administration.

EC 1935/2004

Regulation (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.

EC 2023/2006

Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food.

EU 10/2011

Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food.

NSF

The NSF mark assures consumers, retailers and regulators that certified products have been rigorously tested to comply with all standard requirements. Attention: only on certain semi-finished products.

ISO 10993-1:2018 - USP Class VI

Biological evaluation of medical devices Evaluation and testing within a risk management process. Attention: only on semi-finished products, we do not assure the same on finished parts. 

Soon available.

 

MACHINED PARTS CERTIFICATION

According EC 1935/2004, EC 2023/2006 and EU 10/2011.

A guaranteed process allows us to supply a full traceability of semi-finished material and machining too. We take care of each production step. Moreover, thanks to laboratory exams and migrations tests, we are able to assure you the correct suitability between the machined parts and the food that will come in contact with it in your machinery.

This service will be soon available. Contact us for more accurate information.