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

2. (c) Alan Rowley Associates 2009
Laboratory Accreditation Dr Alan G Rowley
(c) Alan Rowley Associates 2009

3. (c) Alan Rowley Associates 2009
Laboratory Accreditation Dr Alan G Rowley
ISO & 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 International Standard.
2003- ISO Specific application for medical laboratories.
(c) Alan Rowley Associates 2009

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

5. ISO 17025 & Family-A-History !
Laboratory Accreditation Dr Alan G Rowley
ISO & Family-A-History !
2007- Revised version of ISO issued.
2012- ISO under revision.
(c) Alan Rowley Associates 2009

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

7. (c) Alan Rowley Associates 2009
Laboratory Accreditation Dr Alan G Rowley
(c) Alan Rowley Associates 2009

8. (c) Alan Rowley Associates 2009
Laboratory Accreditation Dr Alan G Rowley
(c) Alan Rowley Associates 2009

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

10. We tell our clients……………….
Laboratory Accreditation Dr 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

11. 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

12. Following the standard assures clients that …
Laboratory Accreditation Dr 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

13. Following the standard assures clients that …
Laboratory Accreditation Dr 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

14. (c) Alan Rowley Associates 2009
Laboratory Accreditation Dr 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

15. Laboratory Accreditation Dr Alan G Rowley
This means
ACTIVELY
managing quality and
having records to prove that you do !
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

16. 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

17. Laboratory Accreditation Dr Alan G Rowley
Review
Based on recognised
quality management
system standard
Quality Policy based on
Quality Objectives
Quality Management
System
CONTINUAL SCRUTINY AND RESPONSE TO ANY INFORMATION ABOUT PROBLEMS
IMPROVEMENT TO SYSTEM !
Audit
Document system, defined responsibilities
and procedures
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