Appendix I CONTENTS OF A SITE OR PLANT MASTER FILE The manufacturer shall prepare a succinct document in the form of site master file containing specific information about the production and/or control of device manufacturing carried out at the premises. It shall contain the following information:— 1. General Information: (i) brief information on the site (including name and address), relation to other sites; (ii) manufacturing activities; (iii) any other operations carried out on the site: (iv) name and exact address of the site, including telephone, fax numbers, web site URL and e-mail address; (v) type of medical devices handled on the site and information about specifically toxic or hazardous substances handled, mentioning the way they are handled and precautions taken; (vi) short description of the site (size, location and immediate environment and other activities on the site); (vii) number of employees engaged in production, quality control, warehousing, and distribution; (viii) use of outside scientific, analytical or other technical assistance in relation to the design, manufacture and testing; (ix) short description of the quality management system of the company; (x) devices details registered with foreign countries; (xi) brief description of testing facility.