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1.1 General This European Standard specifies particular requirements and information for establishing and maintaining a quality system in accordance with the requirements of Annex IV and Annex VII of Directive 94/9/EC. It is intended for use by manufacturers, notified bodies and regulatory authorities. Therefore, when notified bodies assess the quality systems of manufacturers this document is intended to be the basis of the initial assessment and subsequent visits. 1.2 Application Only those requirements in clause 7 of this European Standard pertaining to the difference between Annex IV and VII of the Directive may be excluded, provided that conformity of the product can still be demonstrated. Permissible exclusions with respect to Annex VII of Directive 94/9/EC are as follows: 7.1 Planning of product realisation; 7.2.3 Customer communication; 7.4 Purchasing; 7.5.1 Control of production and service provision; 7.5.2 Validation of processes for production and service provision; 7.5.3 Identification and traceability. No explicit requirements in Annex IV and VII relate to the concept of “continuous improvement”. As a consequence, references in this European Standard to the requirements of EN ISO 9001:2000 exclude this concept.