17025_Principles.ppt

1. Motivating Best Practice in Lab QMS 1
Principles behind
ISO/IEC 17025
J.E.J. (Ned) Gravel, CD, PEng, CAE, CA-LS, IPL
Principal, MOTIVA Training Inc.
www.motiva-training.com

2. Motivating Best Practice in Lab QMS 2
Outline
• Brief history of development
• What the accreditation process
requires of assessors
• How the use of principles benefits labs
and assessors
• The eight principles
• Technical competence

3. Motivating Best Practice in Lab QMS 3
About ISO/IEC 17025
“General requirements for the
competence of testing and calibration
laboratories”
It sets specific requirements for
laboratories to produce competent
(valid) results.

4. Motivating Best Practice in Lab QMS 4
Development of 17025
• Prepared by ISO/CASCO WG 10 and amended by
WG25. Is now 5th version of the original standard
developed within ISO (ISO/IEC Guide 25).
• Groups of experts from around the world – some
have 30 years of experience – national and
international inputs: e.g., ANSI - NCSLI - SCC
(Canada) - most of Europe – other national and
international organizations
• Competence is the issue
• Also used for accreditation

5. Motivating Best Practice in Lab QMS 5
Definition of Accreditation
• ISO/IEC 17000: third-party attestation that a
conformity assessment body fulfils specified
requirements and is competent to carry out specific
conformity assessment tasks
= recognition of competence
• Laboratory Accreditation: The formal recognition of
the competence of a laboratory to carry out specific
tests or specific types of tests

6. Motivating Best Practice in Lab QMS 6
What does accreditation
require of assessors?
• A determination of competence
• Assessment of technical competence by trained
assessors
• Assessor must be fully cognizant of each requirement
which applies to the scientific discipline within the scope

7. Motivating Best Practice in Lab QMS 7
17025 Assessor vs 9000 Auditor
9000 Auditor:
• Have you defined your
processes, policies and
procedures?
• Are they documented in
accordance with the
standard?
• Are you following them?
17025 Assessor
• Have you defined and validated your
technical procedures? Are they
documented in accordance with the test
standard or method? Are you following
them?
• Do your procedures ensure valid
results?
• Do you understand the science behind
the procedures?
• Can you foresee and cope with any
technical problems that may arise?
• Do you have the correct equipment? Do
you have adequate personnel?
• Have you calculated your uncertainties or
do you know the uncertainty inherent
in your testing procedure?

8. Motivating Best Practice in Lab QMS 8
A concern:
Assessors may be required to defend a
requirement to the applicant but may not
be able to articulate why the
requirement exists.

9. Motivating Best Practice in Lab QMS 9
Principles: if no map, need compass!
• Principles that underlie the requirements were
developed and presented to ISO/CASCO/WG25
• Ned Gravel represented Canada on this Committee

10. Motivating Best Practice in Lab QMS 10
How Principles Benefit Assessors and Labs
• Principles replace blind adherence to the
requirements of 17025
WITH
• Understanding that instills confidence in a system that
should produce competent (valid) results
= VALUE ADDED

11. Motivating Best Practice in Lab QMS 11
Value added, cont’d
• Principles are not requirements and
CANNOT be used to justify ANY
assessment finding
• Principles help us understand why a
specific requirement exists.

12. Motivating Best Practice in Lab QMS 12
• ISO 9000:2005: “MODEL FOR
EXCELLENCE”…has great strength in its
clear basis on principles
• ISO/IEC 17025:2005 PRINCIPLES…
give an understanding of the basis for
requirements

13. Motivating Best Practice in Lab QMS 13
Principles behind ISO/IEC 17025
• Capacity
• Exercise of Responsibility
• Scientific Method
• Objectivity of Results
• Impartiality of Conduct
• Traceability of Measurement
• Repeatability of Test
• Transparency of Process

14. Motivating Best Practice in Lab QMS 14
Capacity
Concept that a laboratory has the resources
(PEOPLE with the required skills and
knowledge, the ENVIRONMENT with the
required facilities and equipment, the QUALITY
CONTROL, and the PROCEDURES) in order to
undertake the work and produce competent
results.

15. Motivating Best Practice in Lab QMS 15
Exercise of Responsibility
Concept that persons in the organisation have the
authority to execute specific functions within the overall
scope of work – and that the organisation can
demonstrate accountability for the results of the work.

16. Motivating Best Practice in Lab QMS 16
Scientific Method
Concept that the work carried out by the organisation
is based on accepted scientific approaches,
preferably consensus-based, and that any deviations
from accepted scientific approaches can be
substantiated in a manner considered generally
acceptable by experts in that field.

17. Motivating Best Practice in Lab QMS 17
Objectivity of Results
• Concept that the results produced within the scope
of work of the organisation, are mainly based on
measurable or derived quantities.
• Concept that subjective test results are produced
only by persons deemed qualified to do so and that
such results are noted as being subjective or are
known by experts in the field of testing to be mainly
subjective.

18. Motivating Best Practice in Lab QMS 18
Impartiality of Conduct
Concept that the pursuit of competent results
through the use of generally accepted scientific
approaches is the primary and overriding influence
on the work of persons executing tests - all other
influences being considered secondary and not
permitted to take precedence.

19. Motivating Best Practice in Lab QMS 19
Traceability of Measurement
• Concept that the results produced, within the scope of
work of the laboratory, are based on a recognised
system of measurement that derives from accepted,
known quantities (SI system) or other intrinsic or well-
characterised devices or quantities.
• Concept that the chain of comparison of measurement
between these accepted, known quantities or intrinsic
devices or quantities, and the device providing the
objective result, is unbroken for the transfer of
measurement characteristics, including uncertainty, for
the whole of the measurement chain.

20. Motivating Best Practice in Lab QMS 20
Repeatability of Test
Concept that the test which produced the objective
results, will produce the same results, within accepted
deviations during subsequent testing, and within the
constraints of using the same procedures, equipment
and persons used during a previous execution of the
test.

21. Motivating Best Practice in Lab QMS 21
Transparency of Process
Concept that the processes existent within the
laboratory producing the objective results, are open to
internal and external scrutiny, so that factors which
may adversely affect the laboratory's pursuit of
objective results based on scientific method, can be
readily identified and mitigated.

22. Motivating Best Practice in Lab QMS 22
Tools to help you
(http://www.motiva-training.com/index.php/tools-for-labs-qms/free-publications-for-labs)
• Free sample Feedback Procedure and forms
• Free sample Continual Improvement Procedure
and forms
• Free sample Internal Audit and Management
Review Procedure and forms
• Free implementation guide for 17025

23. Motivating Best Practice in Lab QMS 23
Want More Information?
Drop us a line at info@motiva-training.com or call (613) 834-0712
J.E.J. (Ned) Gravel, CD, PEng, CA-LS, CAE, IPL
Principal
MOTIVA Training - Reaching People
nedgravel@motiva-training.com
See us on LinkedIn at http://ca.linkedin.com/in/nedgravel/