congatec Quality Management System

congatec AG is certified according to the ISO9001 since 2005. All relevant revisions of this international standard are fully implemented and the management system is maintained accordingly. In 2017 congatec was certified including all entities under the directive DIN ISO 9001:2015.

<<Certificates>>

congatec requires for all of our supplier to maintain a Quality Management System of the current valid revision of ISO9001 as minimum or equivalent. For contract manufacturer congatec additionally requires the implementation of an Environmental Management System such as ISO14001.

congatec Quality Policy

<<Quality Policy>>

congatec AG is obliged to develop and manufacture environment-friendly products which fulfill the Directive 2011/65/EU for the Restriction of Hazardous Substances (RoHS) and the Directive regarding Waste Electrical and Electronic Equipment (WEEE). 

The members of the European Union transfer these Directives according to their own strategies in local regulations. That is the reason for many different laws and provisions along the different countries of the EU. Countries which do not belong to the EU such as China, Japan and the USA have established similar regulations like RoHS to restrict the use of hazardous substances for environmental-friendly products.  RoHS commonly is understood as “lead-free” but additional substances are restricted as well.

The RoHS Directive (2002/95/EC) was published first in February 2003 by the European Union and was set effective by 1- July-2006. This RoHS-Directive limited the use of six dangerous substances usually used in electronic products and equipment and its manufacturing processes. 

These substances are:

• Lead
• Mercury
• Cadmium
• Chrome
• PBB and
• PBDE

The maximum concentration of the above named substances is limited to 0,1 percent by weight (except for Cadmium which is limited to 0,01 percent by weight) based on the homogeneous material. It follows that the limit does not relate to the weight of the product or a component. 

The next update of the RoHS Directive was also the next step to larger restrictions of dedicated substances used in electrical/ electronical products. The Directive 2011/65/EU replaces the previous Directive 2002/95/EC and is commonly known as RoHS 2. Now RoHS 2 is part of the CE-Marking Directive. RoHS 2 added categories 8 and 9 plus new requirements on data and safekeeping.  

Together with the Addendum 2015/863 to the Directive 2011/65/EU there are 4 new substances listed to be restricted. The new substances are Phthalates (details see below). The Addendum gets effective by the 22.07.2019 and will be called RoHS 3. 

These are the new substances:

• DEHP (Di(2-ethylhexyl) phthalate),
• DBP (Di-n-butyl phthalate) and
• BBP (Butyl benzyl phthalate),
• DIBP (Diisobutyl phthalate)

congatec is fully aware of the new requirements of RoHS 3. These requirements are implemented in our development processes as well as clarified with our contract manufacturers. Currently we will declare conformity according to RoHS 2. The declaration of products conforming RoHS3 will start with the second quarter of 2019.

RoHS is closely related to the Waste of Electrical and Electronic Equipment Directive (WEEE) 2012/19/EU. WEEE targets on the collection of electr(on)ics to be recycled after return to the manufacturer. congatec is not affected in the fulfilment of WEEE at the moment.

RoHS compliant Product Design and Manufacturing

All congatec products are designed and as well manufactured according to the current valid Directive. The requirements for the selection of material are considered in the early project phase and ensured in the industrialization.  

congatec’s Electronic Manufacturing Service (EMS) partners are legally obliged to fulfill the material compliance requirements for purchased material for the product and its processes in production. The evidence of the material conformity is to declare.

Material declarations are based on the information we receive from our manufacturers and supplier and are requested for each component. Material analysis can be assigned if the material declaration is recommended to be proven by an independent laboratory. 

Compliance Declaration

congatec products comply with all relevant EU-Regulations. We will provide on request information regarding compliance with:

• CE
• RoHS
• REACH
• Conflict Minerals (CMRT) – on company level
• UL (congatec products are not listed, but recognized components can be declared regarding UL)

<<Material Compliance Information>>

congatec declares the material compliance according to the valid directives of the European Union for all of our congatec products are subject to this regulation.

congatec declares the conformity without detailed listing of substances and the corresponding amount of a substance within the components. Exemptions are considered where applicable. congatec AG does not prepare Full-Material-Disclosure: Neither for RoHS nor for REACH. 

congatec AG works on improvement for collecting data and related preparation of declarations in terms of efficiency. The use of a component database is just a subsequent decision for us which is going to support our intention best in the future. In the meantime we will prepare all requested declarations as PDF documents. congatec cannot and will not enter or maintain compliance data in various tools of any customer.

RoHS/ REACH

The declaration regarding RoHS as well as for REACH-compliance is based on part numbers. With every update of the substance list for REACH the conformity is checked again. The same is valid for revision updates of our products for both RoHS and REACH.

Conflict Minerals

Every year all relevant information is collected to evaluate the conflict minerals which are to consider with congatec products. The corresponding reporting will be published as soon as the reasonable amount of data is available.

UL 

congatec products are not UL listed. congatec uses UL recognized components which are relevant for UL listing of products such as connectors. congatec will provide this information on request for any congatec product.

CE

All congatec products are CE marked. The CE declaration can be provided for each product group on request.

CoC

On request a Certificate of Conformance can be provided together with the delivery papers. This CoC is created automatically by the system and will not be signed.

Letter of Volatility

The letter of volatility can be provided on request for dedicated part numbers of congatec products.

Export Regulation

congatec holds an AEO Certificate.

congatec Product Lifetime Policy

All congatec products within the status of serial production are qualified in design and manufacturability. 

congatec has a strong engineering team and partners representing experts for the manufacturing of electronic hardware and mechanical parts. 

The electronic manufacturing service is usually provided by two different partners (EMS). This ensures the stability of the manufacturing of congatec boards with second source suppliers. 

Each and every module is tested with our own developed functional test equipment and software. Each test is documented in a corresponding log file. Only when successful tested congatec boards can be packed for delivery. The delivery of serial products to our customers depends on the passed-tested result of our latest functional test. Additional outgoing inspection e.g. “out-of-the-box-audit” is done for each production lot.

Congatec ensures traceability of components from delivery – by serial number of the module – back to the manufacturers date code or batch.

Product Service

Defects are subject for analysis regardless if occurred during production, in the filed or elsewhere. Our Customer Service provides a 4D-equivilant report for repaired board which has been returned by our customers. If recommended as well as feasible, congatec Customer Service Engineers go into deeper analysis and are usually supported by the relevant component manufacturer to clear dedicated root cause mechanism. 

<<RMA Procedure>>

The congatec Quality Management Team will support different quality topics either reported by the Customer Service Team or from the Field Application Engineers on request. 

All congatec products are designed for industrial as well as for commercial embedded computer technology. The use of the modules for medical, automotive, aviation, railway and similar applications is subjected to low risk evaluation regarding thread to life or physical condition.

All congatec products are supposed to be available for a minimum of 5 years. 

The availability of components can change fast and with short notice. This is a common fact in the field of embedded computing.  Changes of the product are done by congatec for the replacement of components due to their availability, to maintain compliance to different regulations and to improve the product’s function, performance and reliability.

Significant product changes are announced such as e.g. the change of a component or another technical change of the product which affects form, fit and function.  Product changes as well as the change of the BIOS will be communicated via Product Change Notification (PCN). PCNs are available for our customers online. Additionally we directly inform all of the relevant customers regarding the change directly.

There may be different reasons why a product is end of life (EOL). When it is confirmed that a congatec product has reached the end of life, customers will be informed immediately. The information is distributed via Product Discontinuation Notification (PDN), which includes all relevant information regarding last time buy and last time delivery. Depends upon various aspects, individual agreements regarding the product phase out may be established at this time.

congatec Engineering supports all congatec products until last time delivery is reached. Further engineering support can be offered for a fee equivalent to fair market value. 

Feel free to contact us for any feedback or improvement idea.