Certificates of Conformity

Where you have required your subcontractors to send a certificate of conformity (CofC) testifying the consignment s conformity with the order, you cannot omit all receiving checks. Once supplier capability has been verified, the C of C allows you to reduce the frequency of incoming checks but not to eliminate them. The C of C should be supported with test results. Therefore you need to impose this requirement in your purchasing documents. However, take care to specify exactly what test results you require and in what format you require them presented, as you could be provided with attribute data when you really want variables data. 

Assembly and installation instructions License and copyright notices Certificates of conformity... 

A process by which organizations are authorized to conduct certification of conformity to prescribed standards. 

EC verification provides an alternative to the model of establishing a certified production QA system. Independent testing of either all devices, or a statistically representative sample of each batch, is conducted by or on behalf of the Notified Body, which then issues a certificate of conformity for the tests conducted. This is not a popular option due to the costs involved. The procedure is not capable of providing adequate assurance as to the sterility of devices. Instead, an assurance of sterility must be based on the application of a production QA system to the sterilisation process. 

This process generates subsequent sets of Harmonized European Norms, forming the basis for a harmonized certification procedure in all EC member states. Table 3.7 gives an overview, condensing the different standards and their amendments to generations of certificates of conformity. 

A certificate of conformity (there should be a supplement with Harmonized European Norms ) is the usual procedure for type testing and approval... 

Besides the certificate of conformity, there is a rather less common way of certification the control certificate. This relates to apparatus not complying with Harmonized European Norms (HN). It is the decision of a notified body to ensure the equivalent level of safety with respect to well-defined types of protection according to the HN. The notified body informs all other notified bodies after an appropriate safety assessment. If there is no contradiction within a 4-month period, the notified body issues the control certificate. 

Apparatus approved by a notified body (certificate of conformity, control certificate) shall be marked by the manufacturer with an Ex in a hexagon according to Fig. 3.1(a). This mark ensures the compliance of the individual apparatus with the specimen tested by the notified body and ensures that all routine tests according to the relevant Harmonized European Norms (if a certificate of conformity has been issued) or all routine tests prescribed in the control certificate have been carried out and passed successfully. According to Directive 82/130/EEC, apparatus with a control certificate shall be marked with an additional S in a circle (see Fig. 3.1 (b)). 

Table 3.8 gives a list of notified bodies according to Directives 76/117/EEC and 82/130/EEC, referring to article 14 (bodies issuing certificates of conformity or control certificates). 

The notified body affixes the identification number on each product and provides a written certificate of conformity. 

A notified body inspects the item and carries out the relevant tests to ensure the compliance with the relevant requirements given in the directive. The notified body affixes the identification number on each product and provides a certification of conformity. 

If the apparatus has been type tested and certified (certificate of conformity, control certificate) according to the old article 100 directives, the identification mark of the notified body and the certificate number shall be affixed on the apparatus. In the same way, a component (with a component certificate) shall be marked. 

Factory cahbration certificates (full certificate or batch certificate of conformance)... 

It is advisable to use a color-coded labeling system to keep track of the test stages. In our case, a yellow spot was added after successful heat cycling with test software loaded, and a green spot half covering the yellow spot was added once the validated software had been loaded and the board tested successfully no device could be shipped unless both spots are present. The manufacturer will be expected to supply a certificate of conformity for the devices produced and packed with each batch. 

At the early stages of development, for example, to support Phase I studies, pharmaceutical companies often accept excipient and packaging raw materials based on a certificate of analysis (CofA) or Certificate of Conformance provided by the supplier. This is especially the case if it is a reputable supplier of an established material used by the industry. This reduces the pressure on the pharmaceutical company s Analytical Department to develop methods to test the materials at this early stage. The supplier may also provide useful information such as details of the critical dimensions and drawings for packaging materials. 

There are options to sample and test each delivery of labels or, through confidence in the printer, accept a certificate of conformance and only randomly sample occasional deliveries. Labels, once delivered and accepted, should be stored in individual, segregated and secure closed bins, one bin per part number. They should be issued on a first in first out (FIFO) system. 

Hazardons area certificates and certificates of conformity, see Chapter 10. 

Documented responsibility for release of product, such as certificate of conformity, authorization to ship (including evidence that testing has been accepted with/without reservations) (see Section 8.1.5)... 

Since the original adoption of the ISO 9000 standards in 1987, the registration of companies to the standards has become an accepted practice throughout the world. As of the end of 1998, there were 271,966 certificates of conformance issued in 143 countries on every continent, according to data... 

Fibers and base resins are supplied against certificates of conformance and often property test certificates. On-line control during the manufacture of prepreg revolves around the correct ratio of fiber to resin. This is done by a traversing Beta-gauge, which scans the dry fiber (either unidirectional of fabric) and then the impregnated fiber and provides a continuous real-time plot of the ratio across the width of the material. This can be linked back to the resin system application point for continuous adjustment. 

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