1. (c) alan rowley associates 20092 laboratory accreditation dr alan g rowley

(c) Alan Rowley Associates 2009 2

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.



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.



2007- Revised version of ISO 15189 issued.

2012- ISO 15189 under revision.




ISO/IEC 17025-CURRENT VERSION 2005

ISO 15189-CURRENT VERSION 2007.


ISO 17011-CURRENT VERSION 2005.

To be replaced

immanently


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 15189ASSESSMENT

Includes Peer Review of methods and laboratory staff.



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



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


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 !



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



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




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 !


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.


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 recognisedquality management

system standard

CONTINUAL SCRUTINY AND RESPONSE TO ANY

INFORMATION ABOUT PROBLEMS

IMPROVEMENT TO SYSTEM !

1. (c) alan rowley associates 20092 laboratory accreditation dr alan g rowley

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