Production quality assurance Module

Explosion protected electrical equipment for zone 1 (Group II, category 2 G) and the classical firedamp-proof apparatus for coal mines (Group I, category M2) are covered by the B module (EC-type examination) and by the C module (conformity to type) or the E module (product quality assurance). Alternatively, with respect to the B module, the notified body issues an EC-type examination certificate (in German EG-Baumusterpriifbescheinigung), whose marking mainly includes ... 

That set of modules includes alongside the traditional procedures related to product control, quality assurance procedures for conformity assessment. The intervention of a third party in these procedures comprises an initial audit of the manufacturer s quality system which must include both the specific technological aspects of the products concerned and the methodology of the quality assurance procedures. Furthermore the manufacturers are subject to periodic audits to ensure that the systems are maintained. Finally, on the occasion of unexpected visits, the notified body can carry out tests on the products. 

Company name) is in compliance with the requirements of an international standard ISO 9002 1994 quality system — model for quality assurance in production and installation. However, the second edition (ISO 9002 1994), together with ISO 9001 1994 and ISO 9003 1994, is cancelled and replaced by a third edition of the ISO 9001 2000 module. It constitutes a technical revision of these documents. The quality manual QM-3 is prepared in accordance with the corresponding changes specified in the third edition of ISO 9001 2000. 

The procurement agency should ensure that the pharmaceutical products purchased are received and stored correctly and in compliance with applicable legislation and regulations. Products should be received and stored in in such a way that their quality and integrity is preserved, batch traceability is maintained and stock can be rotated. This module focuses on quality assurance and quality control during receipt and storage of products. 

Quality assurance techniques (e.g.. ISO 9(X)0 factory quality), are not relevant for modules A, Aa, or B-C and may not take the place of the safety/EMC directives for product conformity. 

As explained in Chapter 2, because of ongoing developments in the technology, MID are now used in very large numbers in series-production applications and, to an ever increasing extent, in safety- and security-relevant systems. It is clear from this range of applications that product quality of the three-dimensional interconnect devices is a crucial aspect. This in turn means that the groundwork for end-to-end quality assurance has to be laid in both the development and production of the modules. 

Prequalification procedures should provide assurance that the pharmaceutical products purchased are of acceptable quality and meet applicable international standards as described in Module II. 

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