Risk Management According to ISO/IEC 17025

Etty Feller, ISRAC-Israel Laboratory Accreditation Authority , Airport City, Israel (ettyf@israc.gov.il)

The world in which all we run in, is based on testing calibration activities accompanying products and processes. These activities, if they are performed by an accredited lab, are in accordance with international standards and national regulations.

If the developments and processes are not understood, then we should consider risk management as a process to eliminate failed potential.

Controls and quality assurance systems are designed to provide tools for managing various of professional work. These systems provide tools for the regular examination of the activities, that may affect the professional work processes, and the assimilation of the risk management system in the decision-making process.

Accreditation of an organization according to international standards ISO/IEC 17025, means the official recognition of the managerial ability, and professional competence of the organization, to perform a variety of activities in accordance with regulatory requirements and customers. The accreditation is given for testing methods performed according to standards. Accreditation allows the organization to assess whether it is performing its work correctly, and in accordance with international standards.

Since its establishment, the Israel Laboratory Accreditation Authority (ISRAC) has been working to promote accreditation processes in an agreement with the world. This is done through cooperation with international regulatory organizations.

The updated version of the standard ISO/IEC 17025 2017 illuminates and lists significant areas of laboratory work. Areas requiring the assimilation of additional activities in a competent laboratory. These activities include the integration of risk management processes into the organization's decision-making processes

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Short Biography of Presenting Author

ETTY FELLER
2011-now CEO/ General Manager of ISRAC – Israel Laboratory Accreditation authority

Responsible for ISRAC’s performance and for implementing the decisions of the board of directors. Formulating the ISRAC policies. Determining the organizational structure, authorities, responsibilities and assigning resources.

10.2013-10.2016 ILAC Chair of the Arrangement Management Committee (AMC)
10.2016 - now  ILAC Vice Chair
2008-2011 VP QA Sol-Gel Technology
2004-2008 Head of Key Client and GLP Div. at ISRAC – Israel Laboratory Accreditation authority
Among my responsibilities are the accreditation and inspection activities of organizations within their specific areas, organizing assessment committees and Chairman of the Accreditation Committee
2000-2004 : Head of Biology Chemistry and GLP Department  at ISRAC.
1998 -2000: Quality Control (Q.C). Manager in a Pharmaceutical company Omrix Ltd.
1994 -1998:  Supervisor of the Biology Laboratory of a biotech start-up Peptor Ltd.
1989-1994: QC Supervisor of a Biotech company, Interpharm Laboratories Ltd.,