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1. (c) Alan Rowley Associates 20092 Laboratory Accreditation Dr Alan G Rowley.

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Presentation on theme: "1. (c) Alan Rowley Associates 20092 Laboratory Accreditation Dr Alan G Rowley."— Presentation transcript:

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2 (c) Alan Rowley Associates 20092 Laboratory Accreditation Dr Alan G Rowley

3 (c) Alan Rowley Associates 20093 ISO 17025 & Family-AHistory ! 1990-ISO Guide 25 (3 rd ) 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. Laboratory Accreditation Dr Alan G Rowley

4 (c) Alan Rowley Associates 20094 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. Laboratory Accreditation Dr Alan G Rowley 2005-ISO 17011 Requirements for Accreditation body and assessors. ‘Corrected’ version. No substantive changes from 2004.

5 (c) Alan Rowley Associates 20095 ISO 17025 & Family-A-History ! 2007-Revised version of ISO 15189 issued. 2012-ISO 15189 under revision. Laboratory Accreditation Dr Alan G Rowley

6 (c) Alan Rowley Associates 20096 ISO 17025 & Family-A-History ! ISO/IEC 17025-CURRENT VERSION 2005 ISO 15189-CURRENT VERSION 2007. Laboratory Accreditation Dr Alan G Rowley ISO 17011-CURRENT VERSION 2005. To be replaced immanently

7 (c) Alan Rowley Associates 20097 Laboratory Accreditation Dr Alan G Rowley

8 (c) Alan Rowley Associates 20098 Laboratory Accreditation Dr Alan G Rowley

9 (c) Alan Rowley Associates 20099 ISO 9001-A Comparison ! 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. ISO 17025 or 15189 ASSESSMENT Includes Peer Review of methods and laboratory staff. Laboratory Accreditation Dr Alan G Rowley

10 (c) Alan Rowley Associates 200910 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 Laboratory Accreditation Dr Alan G Rowley

11 (c) Alan Rowley Associates 200911 Accreditation means……………. 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. The Laboratory has been externally approved as meeting defined standards of competence and quality management

12 (c) Alan Rowley Associates 200912 Following the standard assures clients that …  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. Management takes all necessary steps to assure quality ! Laboratory Accreditation Dr Alan G Rowley

13 (c) Alan Rowley Associates 200913 Following the standard assures clients that …  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. Data is quality controlled so it is consistent and globally comparable Laboratory Accreditation Dr Alan G Rowley

14 (c) Alan Rowley Associates 200914 An accredited laboratory is a marketing asset to the whole organisation since it ………… …  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. This is globally recognised if the accrediting body is carefully chosen Laboratory Accreditation Dr Alan G Rowley

15 (c) Alan Rowley Associates 200915 Laboratory Accreditation Dr 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. You must have records which allow this to be audited That quality controls were applied and confirmed results within required performance characteristics. This means ACTIVELY managing quality and having records to prove that you do !

16 (c) Alan Rowley Associates 200916 Laboratory Accreditation Dr Alan G Rowley 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 The Quality System Continually Improves ! Detection of non-conforming work Feedback from clients, both solicited and complaints.

17 (c) Alan Rowley Associates 200917 Laboratory Accreditation Dr Alan G Rowley Quality Policy based on Quality Objectives Quality Management System Communicate and Implement Document system, defined responsibilities and procedures Monitor to ensure system is implemented and being followed by all. Audit Monitor to ensure system is delivering required objectives Review Based on recognised quality management system standard CONTINUAL SCRUTINY AND RESPONSE TO ANY INFORMATION ABOUT PROBLEMS IMPROVEMENT TO SYSTEM !


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