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B E S T. B E S T. B E S T. Laboratory Accreditation Dr Alan G Rowley. Laboratory Accreditation Dr Alan G Rowley. ISO 17025 & Family-AHistory !. 1990- ISO Guide 25 (3 rd ) Linked to National Laboratory Accreditation Standards.

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B E S T

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  1. B E S T B E S T B E S T

  2. Laboratory AccreditationDr Alan G Rowley (c) Alan Rowley Associates 2009

  3. Laboratory AccreditationDr Alan G Rowley ISO 17025 & Family-AHistory ! 1990- ISO Guide 25 (3rd) Linked to National Laboratory Accreditation Standards. 1993- ISO Guide 58 Requirements for Accreditation body and assessors. Basis for MRAs. 1999- ISO 17025 International Standard. 2003- ISO 15189 Specific application for medical laboratories. (c) Alan Rowley Associates 2009

  4. Laboratory AccreditationDr Alan G Rowley ISO 17025 & Family-A-History ! 2005- Minor modification to ISO 17025 to improve consistency with ISO 9001:2000 2004- ISO 17011 Requirements for Accreditation body and assessors. Replaces Guide 58. 2005- ISO 17011 Requirements for Accreditation body and assessors. ‘Corrected’ version. No substantive changes from 2004. (c) Alan Rowley Associates 2009

  5. Laboratory AccreditationDr Alan G Rowley ISO 17025 & Family-A-History ! 2007- Revised version of ISO 15189 issued. 2011- Further revision of ISO 15189 will be issued (c) Alan Rowley Associates 2009

  6. Laboratory AccreditationDr Alan G Rowley ISO 17025 & Family-A-History ! To be replaced immanently ISO/IEC 17025-CURRENT VERSION 2005 ISO 15189-CURRENT VERSION 2007. ISO 17011-CURRENT VERSION 2005. (c) Alan Rowley Associates 2009

  7. Laboratory AccreditationDr Alan G Rowley (c) Alan Rowley Associates 2009

  8. Laboratory AccreditationDr Alan G Rowley (c) Alan Rowley Associates 2009

  9. Laboratory AccreditationDr Alan G Rowley INTERNATIONAL DIMENSION Based on individual national accreditation bodies. Many national bodies work internationally but do not trespass ! Bi-lateral & multi-lateral recognition agreements based on ISO 17011. Global co-ordination by ILAC and regional bodies, e.g. APLAC. Try to achieve internationally consistent interpretation of standards and provide basis for multi-lateral recognition. (c) Alan Rowley Associates 2009

  10. Laboratory AccreditationDr Alan G Rowley ISO 9001-A Comparison ! ISO 9001 Deals only with quality management system. ISO 9001 External Audit does not establish:- Whether the methods used by the laboratory are scientifically sound and fit for purpose. Whether the staff conducting the tests and calibrations are appropriately skilled and trained. (c) Alan Rowley Associates 2009

  11. Laboratory AccreditationDr Alan G Rowley ISO 9001-A Comparison ! ISO 17025 or 15189 ASSESSMENT Includes Peer Review of methods and laboratory staff. ISO 9001 Deals only with quality management system. ISO 9001 External Audit does not establish:- There is evidence that the laboratory’s data is consistent and accurate, e.g. internal and especially external quality control. ISO 9001 External Auditors are not normally experts in the technical aspects of the laboratory’s operations. (c) Alan Rowley Associates 2009

  12. Laboratory AccreditationDr Alan G Rowley We tell our clients………………. “We have an ISO 17025/15189 Accredited Laboratory” What does this mean to them ? • A buzz phrase word they have heard ! • This is a reliable laboratory ! • A precise understanding of the nature of quality management in the laboratory. CONFIDENCE IN LABORATORY (c) Alan Rowley Associates 2009

  13. Accreditation means……………. The Laboratory has been externally approved as meeting defined standards of competence and quality management There is pro-active quality management in the laboratory based on a pattern in the standard which anyone can consult. The laboratory quality system is audited regularly by an external body whose credentials are publicly available. The competence of the laboratory with regard to defined methods is assessed and accredited by the external body. (c) Alan Rowley Associates 2009

  14. Laboratory AccreditationDr Alan G Rowley Following the standard assures clients that … Management takes all necessary steps to assure quality ! • Test methods are validated and suitable for purpose. • Work is performed on equipment which is calibrated traceably and properly functioning. • Staff working in the laboratory are appropriately qualified and trained for the work they conduct. • The laboratory is managed so as to maintain quality at an adequate and consistent level. (c) Alan Rowley Associates 2009

  15. Laboratory AccreditationDr Alan G Rowley Following the standard assures clients that … Data is quality controlled so it is consistent and globally comparable • There is internal quality control of data and functioning/ calibration of equipment to provide confidence in results on a routine basis. • There is external quality control of data, e.g. use of recognised/certified references, Proficiency Testing • Where problems do occur prompt and effective corrective action, which addresses the root cause, is taken to avoid recurrence. (c) Alan Rowley Associates 2009

  16. Laboratory AccreditationDr Alan G Rowley An accredited laboratory is a marketing asset to the whole organisation since it ………… … This is globally recognised if the accrediting body is carefully chosen • Establishes that any research and development effort which relies on measurements is soundly based. • Ensures that any production quality control based on laboratory measurements has a sound basis. • Provides external support for any data on products supplied to any client or government agency; accreditation mark. (c) Alan Rowley Associates 2009

  17. This means ACTIVELY managing quality and having records to prove that you do ! Laboratory AccreditationDr Alan G Rowley You must be able to show that results were produced By a properly validated method. Using equipment that was properly functioning and in calibration By staff who are appropriately trained. That quality controls were applied and confirmed results within required performance characteristics. You must have records which allow this to be audited (c) Alan Rowley Associates 2009

  18. Laboratory Accreditation Dr Alan G Rowley The Quality System Continually Improves ! You must respond to any problems which occur by carrying out corrective action which addresses the ‘root cause’ of the problem and thus improves the quality system How do we find out about problems ? By auditing the system regularly By being pro-active in looking for weaknesses-Preventive Action Detection of non-conforming work Feedback from clients, both solicited and complaints. (c) Alan Rowley Associates 2009

  19. Quality Policy based on Quality Objectives Review Quality Management System Document system, defined responsibilities and procedures Audit Based on recognised quality management system standard Laboratory Accreditation Dr Alan G Rowley CONTINUAL SCRUTINY AND RESPONSE TO ANY INFORMATION ABOUT PROBLEMS IMPROVEMENT TO SYSTEM ! Communicate and Implement Monitor to ensure system is implemented and being followed by all. Monitor to ensure system is delivering required objectives (c) Alan Rowley Associates 2009

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