Major changes will take place on ISO15189 "Medical laboratories: requirements for quality and competence" / 中华检验医学杂志

Since the first edition of ISO15189"Medical laboratories: requirements for quality and competence" was published in 2003, it has been rapidly and widely used in the world under the promotion of the International Laboratory Accreditation Cooperation Organization (ILAC), and has become the basic standard for the quality management, capacity-building and capacity attestation of medical laboratories. The Mutual Recognition Arrangement (MRA) of ILAC for ISO15189 is the most authoritative international permit for examination results, which is accepted by international organizations. Since the establishment of ISO15189 medical laboratory accreditation system in 2004 in China, more than 530 medical laboratories have been accredited, which plays an important role in improving the quality and competence of medical laboratories in China, and improves the influence of Chinese medical laboratories in the world. ISO 15189:2012 is currently being revised by the International Organization for Standardization/Technical Committee on Clinical Laboratory Testing and in vitro diagnostic test systems (ISO/TC212). This revision will bring significant changes and the medical laboratory shall pay attention to these changes. In order to help medical laboratories understand the new ideas in advance, this paper summarizes and analyses the draft of the new international standards, and provides references for users.

Analysis of nonconformities in medical laboratory accreditation and status quo of clinical laboratory quality management / 中华检验医学杂志

Objective According to the analysis on nonconformities which were found from on-site assessmentin medical laboratory ISO15189accreditationcarried on byChina National Accreditation Service for Conformity Assessment(CNAS) during years 2004to 2013,to study current status of quality management in domestic medical laboratory.Methods By means of retrospective analysis, nonconformities found in 171 times of on-site audit of 133 clinical laboratories in ISO15189 accreditation during 2004 to 2013 were collected and then classified according to requirements of ISO 15189.Results Among 1 501 nonconformities involved in 171 times of on-site audit, management and technical requirements accounted for 28.5%(428) and 71.5% ( 1073 ) respectively.The mainly clauses of nonconformity were 4.3 ( 26.2%) and 4.6 (12.6%) in management requirements and 5.3 ( 25.2%), 5.4 ( 13.1%), 5.5 ( 16.0%) and 5.6 (20.2%)in technical requirements.The mainly subclauses of technical requirements were 5.3.2, 5.3.7, 5.4.3, 5.4.9, 5.5.2, 5.5.3, 5.6.1, 5.8.3 and 5.8.10.Conclusion The weakness for the medical laboratory quality management is mainly process control(5.4, 5.5 ,5.6), laboratory equipments (5.3), document control (4.3) and external services and supplies (4.6), which werethe main directions need to be improved in current medical laboratory quality management.

Interpretation of ISO 15189:2012“Medical laboratories-Requirements for quality and competence” -Requirements for IVD manufacturers / 中华检验医学杂志

In vitro diagnostic ( IVD) manufacturers were important suppliers of external servicesto medical laboratories .There equipment , reagents , calibration and maintenauce services played an important role in ensuring the quality of medical laboratory tests .It is also helpful for IVD manufacturers to establish and maintain a good reputation and credibility .ISO 15189:2012“Medical laboratories -Requirements for quality and competence” was issued onNovember 1, 2012, which replaced the second edition (ISO 15189:2007).Requirements related to IVD manufacturers are involved in the new edition standard .The article aimed to help medical laboratories and IVD manufacturers understand the requirements ; therefore , laboratories would know how to select suppliers based on their ability to supply external services , IVD manufacturers would know how to meet the needs of laboratories , and the cooperation between IVD manufacturers and laboratories would be facilitated .

Introduction of new international requirements for medical laboratory through comparison of ISO 15189∶2012 and ISO 15189 ∶2007 / 中华检验医学杂志

ISO 15189:2012Medical laboratories-Requirements for quality and competence was issued on November 1,2012,which replaced the second edition (ISO 15189:2007 Medical laboratoriesParticular requirements for quality and competence).A study on changes in new edition standard will facilitate medical laboratories,regulatory authorities,accreditation bodies to have a good understanding of requirements of this new edition.An implementation of new edition will assist medical laboratory to improve their management to continually meet requirements of international standards.To enable stakeholders mentioned above have a good understanding and application of this new edition,changes in new edition were discussed in depth in this article.

Study on the proficiency testing program of pharmaceutical preparation analysis / 药学学报

This proficiency testing program is established to evaluate the pharmaceutical preparation analysis capacity of laboratories recommended by 18 countries and economies. It was authorized by Asia Pacific Laboratory Accreditation Cooperation (APLAC), and organized by Shanghai Institute for Food and Drug Control (SIFDC) and China National Accreditation Service for Conformity Assessment (CNAS). The 0.3sigma test is used to evaluate the homogeneity and stability of the proficiency testing sample. The results of the laboratories were assessed by Z-score. The robust average and the robust standard deviation of the participants' results were calculated as assigned value and standard deviation for performance assessment of hydrochlorothiazide and captopril using robust statistics. Thirty-three of 38 laboratories recommended by 18 countries and economies sent their results back. Twenty-four laboratories' results were observed as satisfactory. Five laboratories were identified as having reported at least one questionable result. Four laboratories were identified as having reported at least one unsatisfactory result.

Recent development of the medical laboratory accreditation in China and the related international standards / 中华检验医学杂志

Medical laboratory accreditation with ISO 15189 has brought up concerns from various interest parties in China. It is a common concern for both Accreditation Body (AB) and Medical Laboratory (ML) on how to ensure and improve the accreditation work scientifically and effectively. It will help us to find a way to solve the problem and to find the right way for the development of the medical laboratory accreditation if we study the drafting, implementation and apphcation of the international standards which found the basis of the accreditation scheme. This article will give the reader a brief introduction of the ISO/ TC212, which is the technical committee of international standard organization responsible for drafting and revising ISO 15189, medical laboratory accreditation related international standard documents, and the recent status and the future development of the medical laboratory accreditation in China. We hope this article can give some information for the medical laboratory stuffs and the professionals in laboratory medicine on their research work of the technique and the trend of development in medical laboratory management and medical laboratory accreditation.