Resumen de The risk-based approach in organization quality management systems

Oksana Zhemchugova, Violetta Levshina

• English

  The relevance of the study is associated with the problem of introducing a risk-based approach in the quality management systems (QMS) of organizations from various sectors according to the requirements of ISO 9001:2015. It hereby offers a new feature of risk classification based on their application in management systems concerning various aspects of organizations activity, in particular, risk in QMS (quality risk). The authors’ definition of the term “quality risk” is presented, and the concept of the “risk-based approach in QMS” is clarified. Methodical approaches to the choice of the complexity of the risk-based approach depending on the QMS maturity in an organization and the factors of its environment are developed and tested in 46 organizations from various industries.

• galego

  A relevancia do estudo está asociada co problema de introducir un enfoque baseado no risco nos sistemas de xestión de calidade (SXC) de organizacións de diversos sectores de acordo cos requisitos da norma ISO 9001:2015. Ofrécese un novo criterio de clasificación de riscos baseado na súa aplicación en sistemas de xestión en relación con diversos aspectos da actividade das organizacións, en particular o risco en SXC (risco de calidade). Preséntase a definición dos autores do termo “risco de calidade” e aclárase o concepto do “enfoque baseado no risco no SXC”. O enfoque metodolóxico para a elección da complexidade do enfoque baseado no risco, dependendo da madureza do SXC nunha organización e dos factores do seu medio, esenvólvense e próbanse en 46 organizacións de diversas industrias.