Design in ISO 9001:2015

Purpose:The aim of the paper is to analysethe problems connected with the design of 5operation processesrealised within an organisation in the ISO 9001:2015 implementation 6process.7Design/methodology/approach:Critical literature analysis. Analysis of international literature 8from main databases and Polish literature and legal acts connecting with the researched topic. 9Findings:Design and development planning refers to identifying the stages and controls for 10the stages to design and develop products. Stages that are appropriate for product development 11are decided by a design team. An organisation is required to plan and develop its design and 12development activities as a process. The goal of this process is to ensure that the realisation of 13the product or service will be according to their specification. The design and development 14processes, operations, activities and controls shall be planned in accordance to several 15requirements. The organisation should implement the planned arrangementsat appropriate 16stages to verify that the product and service requirements have been met. The release of 17products and services to the customer shall not proceed until the planned arrangements have 18been satisfactory completed, unless otherwise approved by a relevant authority and as 19applicable by the customer.20Originality/value: Detailed analysis of all subjects related totheorganisation of designin ISO 219001:2015.22Keywords: quality management, ISO 9001:2015, ISO 9001, operations, design.23Category of the paper:literature review.