iso15189 assessment of the main basis for which the assessment is as follows:
ISO 15189 is the international standard for quality management systems in medical laboratories, which specifies how medical laboratories should establish and maintain quality management systems to ensure that they provide accurate and reliable test results. iso 15189 review It is an audit of the quality management system of medical laboratories, which is mainly based on the following:
1. Standard Requirements: The assessors will audit the quality management system of medical laboratories according to the requirements of ISO 15189 standard. Standard requirements include organizational structure, personnel training, equipment management, document control, testing process control, quality control, non-conformity handling and other aspects of the requirements, the reviewer will review these requirements one by one.
2. Internal documents: Medical laboratories should establish a series of internal documents, such as quality manuals, procedural documents, work instructions, etc., used to standardize the laboratory's workflow. The reviewer will review these internal documents to ensure that they meet the requirements of ISO 15189.
3. Laboratory records: Medical laboratories should establish a series of laboratory records, such as testing records, quality control records, non-conformity records, etc., which are used to record laboratory test results and quality management activities. These laboratory records will be audited by accreditors to ensure their completeness, accuracy and traceability.
4. Laboratory facilities and equipment: Medical laboratories should have a range of facilities and equipment in place, such as laboratory space, testing equipment, quality control equipment, etc., to support the laboratory's testing activities. The reviewer will audit these facilities and equipment to ensure that they meet the requirements of the ISO 15189 standard.
5. Laboratory personnel: Medical laboratories should have a qualified team of personnel, including laboratory supervisors, technicians, and quality control personnel. The reviewers will audit the qualifications, training and management of laboratory personnel to ensure that the competence and quality of laboratory personnel meet the requirements of ISO 15189 standards.
In summary, ISO 15189 accreditation is mainly based on the standard requirements, internal documents, laboratory records, laboratory facilities and equipment, and laboratory personnel to ensure that the quality management system of medical laboratories meets the requirements of ISO 15189 standards.