ABSTRACT

A quality plan is a list of specications or activities for the organization to follow, meet, or maintain in order to realize a product according to requirements (customer’s or regulatory). The objective is to carry out the requirements given earlier in clause 4.1 (Quality Management System: General Requirements):

1. Identifying all the required processes for product realization 2. Dening the relations between the various processes 3. Dening the required resources 4. Dening the acceptance (or rejection) criteria 5. Dening the validation and verication of products and processes (control and

monitoring processes) 6. Evaluation of effectiveness

These are the principles with which the manufacturer shall plan its realization activities. Quality planning integrates the relevant requirements for resources and information concerning the realization of a product and makes them available to any involved party. It may also be viewed as a guideline for the product’s realization processes; it consists of all the necessary information that would assist the participants to produce a product that meets its requirements.