Design in ISO 9001:2015

Purpose: The aim of the paper is to analyse the problems connected with the design of operation processes realised within an organisation in the ISO 9001:2015 implementation process. Design/methodology/approach: Critical literature analysis. Analysis of international literature from main databases and Polish literature and legal acts connecting with the researched topic. Findings: Design and development planning refers to identifying the stages and controls for the stages to design and develop products. Stages that are appropriate for product development are decided by a design team. An organisation is required to plan and develop its design and development activities as a process. The goal of this process is to ensure that the realisation of the product or service will be according to their specification. The design and development processes, operations, activities and controls shall be planned in accordance to several requirements. The organisation should implement the planned arrangements at appropriate stages to verify that the product and service requirements have been met. The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactory completed, unless otherwise approved by a relevant authority and as applicable by the customer. Originality/value: Detailed analysis of all subjects related to the organisation of design in ISO 9001:2015.