5.1 Planning of product realisation
Planning is required before new products or processes are implemented. The planning may
take place as a design project, or according to the sales order planning procedure. During
this planning, management or assigned personnel identify:
§ The business objectives and requirements for the product,
§ Processes, documentation and resources required
§ Verification, validation, monitoring, inspection and test requirements.
§ Criteria for product acceptance
§ Environmental aspects
The output of the planning includes documented work instructions and procedures