Abstract: . . .  where, for example, processing deficiencies may become apparent only after the product is in use, the processes shall be carried out by qualified operators and/or shall require continuous monitoring and control of process parameters to ensure that the specified requirements are met. The requirements for any qualification of process operations, including associated equipment and personnel (see 4.18), shall be specified. NOTE 16 Such processes requiring pre -qualification of their process capability are frequently referred to as special processes. Records shall be maintained for qualified processes, equipment and personnel, as appropriate (see 4.16). Page 23 ISO /FDIS 9000 -3:1997(E) 19 As stated in guidance for the design control element of ISO 9001, a software development project should be organized according to a set of processes which transform the requirements into a software product. The "process control" element, as applied to software development, is applicable to the replication, delivery and installation of software items or products. Where required by contract, the supplier should establish and perform the replication procedures, considering the following, to ensure that replication is conducted correctly: a) identification of the master and the copies including forma t, variant and version; b) the number of copies of each software item to be delivered; c) disaster recovery plans including custody of master and back -up copies where applicable; d) the period of obligation . . .
. . .  off-the-shelf software; - subcontracted development; - computer and communications hardware; - a tool intended to assist in the d evelopment of software; - contract staff; - maintenance and customer support services; - training courses and materials. NOTE - For further information, see ISO /IEC 12207:1995, subclause 5.1. 4.6.2 Evaluation of subcontractors The supplier shall: a) evaluate and select subcontractors on the basis of their ability to meet subcontract requirements including the quality system and any specific quality assurance requirements; b) define the type and extent of control exercised by the supplier over subcontractors. This shall be dependent upon the type of product, the impact of subcontracted product on the quality of final product and, where applicable, on the quality audit reports and/or quality records of the previously demonstrated capability and performance of subcontractors; c) establish and maintain quality records of acceptable subcontractors (see 4.16). No further software-related guidance is provided. 4.6.3 Purchasing data Purchasing documents shall contain data clearly describing the product ordered, including where applicable: a) the type, class, grade or other precise identification; b) the title or other positive identification, and applicable issues of specifications, drawings, process requirements, inspection instructions and other relevant technical data, including requirements {or approval or qualification of product, procedures, process . . .
--3000,2,750,3149,56206