Comparative characteristics of Standards ISO 15189:2012 and EN ISO/IEC 17025:2005 – detalization and peculiarities of accreditation process. Ioannis Sitaras ESYD Laboratories Accreditation Division Director

ISO and ISO/IEC ISO is a standard dedicated for medical laboratories Description of requirements and terminology fit for purpose for the medical sector Focusing on sectors/functions of the medical laboratory Additional requirements (regarding ethics, contingency plan, risk assessment, referral laboratories, organization structure,LIS) 3 editions 2003,2007 and 2012: technical and metrological requirements were gradually approached current status of testing laboratories

The structure and the context of ISO/IEC are transferred/aligned and interpreted according to the needs of the medical laboratories in the ISO Table A.2 of ISO 15189:2012 shows the correlation and the cross reference for each set of requirements Does it mean that we can use the same Lead Assessors/accreditation managers/decision making procedures? Does it mean that ISO/IEC assessors could participate into ISO assessments Is the implementation of ISO by a Laboratory already accredited by ISO/IEC a simple procedure? ISO and ISO/IEC 17025

Management System Requirements Both standards have the same requirement for legal entity Need for structure and organization in case of Laboratories being part of larger organizations In ISO/IEC 17025: arrangements for impartiality, confidentiality, freedom from other pressures while in ISO a clause for “ethical” conduct goes further: declaration of conflicts of competing interest, if exist In ISO/IEC the laboratory has technical and managerial personnel while ISO mainly focus and emphasize the role of Laboratory Director Both standards require a quality manager, in ISO duties are further specified ISO and ISO/IEC 17025

Management System Requirements In ISO additional requirements for quality policy No significant differences for document control In ISO 15189:2012 edition the concept of “Service Agreements” is much more aligned with the general requirements of ISO/IEC for Contracts/tenders/Requests Still the concept of “Referral” Laboratory is different than this of the subcontractor-an expertise is sought not only a “testing/or calibration” service No significant differences for the general requirements for Services/Suppliers. In ISO it is recognized that a medical lab will probably have its suppliers selected by other parts of the organization, while this is not so clear in the ISO/IEC Additional requirements exist regarding notifications to suppliers and authorities in case of incidents ISO and ISO/IEC 17025

Management System Requirements Advisory Service is totally different than the general concept of ISO/IEC “service to the customer” and the way this requirement is interpreted in testing and calibration laboratories The concept of non-conforming work, corrective actions, internal audits and management reviews is almost the same. ISO further analyses these processes regarding the medical laboratories. The term of potential non-conformity is introduced regarding preventive actions. Additional requirements exist for staff suggestions, handling of results of external assessments and risk assessment. ISO and ISO/IEC 17025

Τechnical Requirements Personnel In ISO requirements for personnel are very detailed presented and there are all the necessary elements for the evaluation of competence, training and evaluation of the effectiveness of training. In addition to ΙSO/IEC training is required for health & safety and ethics, records for immunization status (where relevant), accidents and occupational hazards. ISO and ISO/IEC 17025

Τechnical Requirements Facilities In addition to ΙSO/IEC requirements facilities are expanded for staff and storage facilities, are very detailed regarding the purpose of the laboratory and the concept of “quiet and uninterrupted work” is introduced. In addition to ΙSO/IEC health staff is included in the requirements ISO and ISO/IEC 17025

Τechnical Requirements Equipment and Traceability-Reagents and consumables Requirements of ISO/IEC have been transferred to ISO while the concept of traceability is referred to the equipment clause of the standard. In addition there are requirements for adverse incident reporting. Requirements for reagents and consumables, otherwise dealt by 4.6 of ISO/IEC are in detail presented in of ISO ISO and ISO/IEC 17025

Τechnical Requirements Pre-examination Processes-Examination Process Pre-examination Process is presented in far more detailed way than sampling in ISO/IEC In the new edition of ISO 15189:2012 an excellent presentation of what the standard requires regarding verification and validation is given, while in the ISO/IEC 17025:2005 a lot of “grey” areas still exist Requirements for uncertainty have been aligned Reference for biological intervals exist in ISO in ISO/IEC this cannot be easily handled ISO and ISO/IEC 17025

Τechnical Requirements Ensuring the quality examination results The reference in the external and internal quality control is very comprehensive in ISO but in general, requirements are the same with testing laboratories. There are additional requirements for PTs and how laboratories take part to external control programs ISO and ISO/IEC 17025

Τechnical Requirements Reports Apart from the requirements for reports which are dedicated for medical labs, in ISO there are detailed requirements for the release of results and the use of LIS for automated selection and reporting of results LIS This an additional to ISO/IEC requirement ISO and ISO/IEC 17025

ISO and ISO/IEC Accreditation Bodies ABs need to assure access to expertise regarding the assessors’ pool, technical competence and the decision management process They need to have effective and continuous communication with the medical profession and relative scientific unions in the country they operate They need to take into account the health sector in their interested parties (State, medical profession, public)-it depends on how they deal their interested parties regarding decision management process

ISO and ISO/IEC Access to expertise and selection of assessors Technical Assessors from the medical profession and relative sciences have to be selected according to their competence in specific examinations and trained according to ISO Lead Assessors from ISO/IEC cannot be used without training for ISO 15189

ISO and ISO/IEC Accreditation Procedure-Documents Accreditation Procedure for medical laboratories does not have to be different than the other laboratories Traceability, Calibration of Equipment have to be the same as in testing laboratories Requirements for participation in PTs have to be reviewed in order to be fit for purpose for the medical laboratories Multi-site accreditation procedure might be needed Flexible scope accreditation policy is also needed