engleski

Internal audit

Quality is very important factor in life of many people in industrial societies. To ensure product of quality or service, organization apply quality management systems. In order to simplify implementing of quality management systems, standards have been introduced to describe requirements of quality management systems. Audits are used to check level of fulfilment of requirements which are described by relevant standard. Generally, audit is systematic, independent and documented process by which level of fulfilment of defined requirements is evaluated. Requirements are defined by audit criteria. Audit criteria is group of regulations, procedures and requirements used as reference. Most often case is performing audit related to requirements of standard ISO 9001, but audits are performed for other standards and regulations such as ISO 14001, ISO 22000, HACCP. Organization and performing of audit process is mostly the same, non-related to standard against which audit is performed, but there are some differences related to requirements of relevant standard and regulation. This paper deals with performing of internal audits, particularly related to requirements of standard ISO 15189. Croatian standard HRN EN ISO 15189, medical laboratories - requirements for quality and competence, is based on standards HRN EN ISO/IEC 17025 and HRN EN ISO 9001. Accreditation of medical laboratories is performed related to requirements of HRN EN ISO 15189. During implementation of HRN EN ISO 15189 some difficulties were noticed at process of internal audit. Internal audit is audit performed by organization on their management system. Standard HRN EN ISO 15189 define internal audit as requirement 4.14 Internal independent assessment. In this paper phases of internal audit, audit techniques, requirements for internal auditors and documentation used during internal audit process, are described. Process of creating high level and low level check lists is described. Non-conformities noticed at internal audit are explained. At practical examples, documenting and monitoring of corrective actions process is explained. Internal audit report for laboratory management is described, too. Internal audit is one of the most important requirements of any management system. Objective of this work is to achieve easier performing of internal audits in organizations that implement requirements of standard HRN EN ISO 15189.

Internal audit, ISO 15189

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