core concepts of ISO 9001:2015
The organization operates under the influence of internal and external factors that shape its strategies regarding products, services, investments, and stakeholder interactions. Issues, whether positive or negative, arise from conditions that affect or are influenced by the organization. Interested parties, commonly known as stakeholders, include suppliers, customers, and competitors, all of whom can be impacted by the organization’s decisions. Leadership is characterized by top management, which consists of individuals or groups tasked with directing and controlling the organization at the highest level. The concept of risk is pivotal, incorporating both threats and opportunities, with an emphasis on refined planning processes that address uncertainties that may impact anticipated results. Effective communication is vital as it stipulates the necessity for clear internal and external messages, which are explicitly detailed to ensure understanding. Documented information is maintained to underpin the Quality Management System (QMS), emphasizing the importance of critical data. Performance evaluation is a systematic approach focused on measuring quality performance and the effectiveness of the QMS. This involves monitoring, measurement, analysis, and evaluation methods to guarantee valid results. Additionally, there is a concentrated effort on assessing nonconformities and instituting corrective actions to address them adequately. The management review process is integral, with necessary evaluations that comprise specific requirements for the inputs and outputs during the review, ensuring systemic improvements and adherence to quality standards.