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Certificates (Suppliers)

Molding of our products, our Suppliers, our 'Manufacturing, Administration, Packaging and Sterilisation', the QC laboratory for MEA - and LAL-assays, they all are of the highest 'quality' and operating under the following Certificates: (Some certificates, we did not yet receive - or renew).

 

Moulding

Promolding B.V., located in Den Haag, the Netherlands.
'Promolding' takes care of molding the 'rings & the lids', of all our various types of WillCo-dish® polystyrene dishes in transparent, as well as in black, in a Class VII cleanroom. https://www.promolding.nl/en/injection-moulding/

Certified  
ISO 13485 : Cleanroom injection-moulding  

 

Manufacturing

Pro-Verpakken B.V. (Former Noorderkwartier N.V.), located in Schagen (NH), the Netherlands.
We have our production, all labelling and packaging of the WillCo-dish® Glass Bottom dishes, outsourced in full, at
Pro-Verpakken B.V. For the past twenty-five years Noorderkwartier N.V. and later 'Pro-Verpakken', took very good care of manufacturing and
packaging, of our various types of WillCo-dish® products. To assure we manufacture an identical glass bottom dish, each and every time, we have our 'clean room manufacturing' robotised.

Certified    
ISO 9001:2008 Administration production Management System
WillCo-dish® products : Assembly, commissioned by WillCo Wells B.V.

 

Fine Machining and Tooling

Observator Precisietechniek B.V., located in Amsterdam, the Netherlands, long term manufacturer our various types
of Assembly Devices, tools to 'Accurately/precise, Easy, Safe and Quick', assemble our WillCo-dish®KIT glass bottom
dishes. < https://observator.com/precisietechniek >

Certified :  
Integrated Quality Control      ISO 9001-2015

 

Packaging

1.:   Nelipak Corporation (Nelipak® Healthcare Packaging), located in Venray (Li), the Netherlands.

'Nelipak’, is our well respected - and long term supplier of the ‘Rigid Medical Packaging’, the transparent ‘MED BLUE PET-G packaging material’, as well as the Tyvek® 1073B (DuPont) covers, for our ‘Blister-Pack - Single unit’ packed glass bottom dishes.

Certified :   By: DEKRA Certification B.V.
EN ISO 13485:2012
ISO 9001:2008
Scope: Design, production, assembly and sales of thermoformed products, lidding material and sealing equipment, including packaging validation services. Assembly and packaging of products for the medical, pharmaceutical and consumer market.
ISO 14644 = Class VII /10.000: Clean rooms.
ISO Class VII compatible 'Nelipak' Heat-seal machines.
Tyvek® (Dupont de Nemours)
Batches
Certificate of Compliance of each and every batch, available.


2.:   Nelipak®, located (Head Quarters) in Clara, Ireland, is our long term supplier of the ‘PA/PE and Tyvek® (DuPont)’ sleeves, for our ‘Pouch-Pack’, multi-unit packed (20/sleeve and 200/case) glass bottom dishes.

Certified:                             
ISO-11607:2006- Part 1 & 2 Materials and Test methods & Pouching machines.
ISO 13485 2012 : Quality Management System
ISO/IEC1702 : Nelipak – Testing Laboratory.                

 

3.: DS Smith Packaging Nederland B.V.,
in Eerbeek, the Netherlands (Head Quarters:  Rugby, United Kingdom). DS Smith’ is our long term supplier, of all 'Blister-Pack / single unit' packed, solid ‘export carton’ packaging.

Certified:     
:                                                                              


4.: Rajapak B.V., located in Breda, the Netherlands. 
Rajapak B.V., is our long term supplier of the Export-packaging, for the'Pouch-Pack / Multi-unit' packed dishes.

Certified:    
ISO 9000 : Administration
ISO 14001             : Environmental Management System

 

Sterilization

Synergy Health Ede B.V. (A 'STERIS' company), located in Ede -, as well as in Etten-Leur, the Netherlands (Former: Isotron Nederland B.V.) takes care of the gamma
irradiation of all our various types of WillCo-dish® Glass Bottom dishes. Minimum dose of irradiation:  10 kGy. This treatment guarantees, because of the use of our high medical standard packaging products, that all our WillCo-dish® Glass Bottom Dishes are STERILE R, for a minimum period of five years.

Certified:    
ISO 13485:2003 Open Certificate
EN ISO 13485:2012 : Open Certificate
ISO 9001-2008 : Open Certificate
ISO 14001:2004 : Open Certificate

Provisions of a laboratoty testing service associated with irradiation processing.
Provisions of a chemical and microbiological laboratory testing service.



Laboratory glassware  

Thermo Fisher Scientific (Former: Menzel Gläser GmbH. & Co. KG), in Braunschweig, Germany.
Thermo Fisher Scientific (Menzel was, over 20 years) is our long term supplier, for various types of borosilicate (German) glass coverslips, type D 263® M. 
We use 'specially selected' glass (1.5H), to supply a superior thickness marging of 170 micron +/- 5 micron and 'surface flatness' (ra: 0.005mm.), according to the highest standard.

Certified:
We are looking forward to receiving a response from our Supplier.
.......

Marienfeld GmbH. & Co. KG. in Lauda-Koenigshofen, Germany.
We are registered distributor of the 'Marienfeld-superior' (microscopy & laboratory) glassware. 

Certified
: DIN EN ISO 9001-2015    < https://www.marienfeld-superior.com/certificates.html >




"ISO 13485" explained:
(ISO 13485 explained, in an Abstract, from: ISO - International Organization of Standardization).

"ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. 

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations
whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.

All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization. If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system.

It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls. If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system. The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system."
 

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