2. Standardisation - What to expect from it?
1st EAQC-WISE Workshop: Towards an improvement of QA/QC in water monitoring within the Water Framework Directive Paris, November 17th 2006
Ulrich Borchers

3. Disclaimer EAQC-WISE is an EC FP6 funded project
Contract N° (STREP)
The views expressed in this presentation are purely those of the author and may not in any circumstances be regarded as stating an official position of the European Commission

4. What can we expect from standardisation in the field of QA/QC?
The answer is quite easy:
Based on your demand and input you receive
commonly accepted
in Europe and Worldwide
harmonised and
validated
tools or procedures
on the basis of
existing standards or
new work items (projects)

5. Why do we need standardisation?
Standardisation supplies commonly accepted and validated tools where needed
Standards can support
policy making
legislative activities
harmonisation
e.g. by filling gaps (concerning technical issues) in guidance documents of the Commission

6. Philippes point of view
General statements (1)
The results of chemical monitoring activities under the WFD have to be
comparable
reliable
validated
A fitness-for-purpose approach for analytical methods is
commonly accepted (AMPS and CMA group)
state of the art
For this approach standardised analytical methods are not essential (but recommended)
Philippes point of view

7. General statements (2)
But, to make this approach successful, standardisation of some items is crucial
for general QA/QC requirements or procedures
for proving the comparability and reliability of results
for operationally defined parameters/procedures
A common understanding of the terms
Fitness-for-purpose
validated, comparable and reliable
is essential  this means standardisation

8. The sustainable QA/QC system to support WFD Monitoring (Draft Com
The sustainable QA/QC system to support WFD Monitoring (Draft Com. Decision)
Art. 4)
Results shall be produced using methods validated and documented according to the principles of ISO/IEC-17025
In the cases of operationally defined quantities for particular chemical substances or groups of chemical substances, the use of a specific standard method is mandatory
Art. 5)
…. verification of the measurement traceability to common measurement standards
Laboratories must be able to demonstrate their competence for analysing the relevant chemical and physico-chemical parameters … by, where appropriate, (successful!?) participation in an appropriate interlaboratory comparisons in accordance with…
Results of participations in interlaboratory comparisons shall be evaluated on the basis of scoring according to ISO-13528

9. General QA/QC tools (standards)
What we have:
competence of labs (ISO 17025)
QM-Systems (ISO 9000/9001)
competence of PT providers (ISO 17024)
requirements for PT schemes (ISO Guide 43-1/-2)
evaluation of PT results (e.g. ISO 13528)
comparability of methods/results

10. Acceptance of ISO 17025 and ISO 9001
The ISO 9001 is the most applied (successful) standard in the world
Many thousands of companies have introduced QM/QC systems according to the requirements of this standard
The ISO follows a competence-based approach suitable for testing labs and is also established in most labs involved in surveillance activities
All MS have national (public) accreditation bodies
1408 labs in Germany are accredited for Water or environmental analysis

11. General QA/QC tools (standards)
What we still need:
Validation of methods (criteria and approaches)
Validation concepts for methods will be elaborated within NORMAN network (SP Validation)
It is intended to incorporate the outcome to a new standard (technical specification)
Traceability of results
Calculation of uncertainty (easy applicable approach)
LOQ / LOD / recovery

12. General QA/QC tools (standards)
What we still need:
A specific standard for PT’s in the field of water analysis
A new approach is in the pipeline on ISO level:
ISO/CD 20612: Water quality — Interlaboratory comparisons for proficiency test of laboratories (ISO TC 147/SC 2/WG 48 N 0031)

13. What to expect ?
State of the art standards covering QA/QC aspects which are crucial for the proofing of the fitness of a method/lab for purpose
But, standardisation work is only be started if somebody asks for a new standard by a new work item proposal (NWIP)
Production of standards on demand!
“Somebody” is usually a standardisation body of an EU MS (AFNOR, BSI, NEN, DIN….)
Standardisation bodies have fixed procedures to collect and accept national proposals from authorities and/or end users of the wished methods

14. CMA Activity of DG ENV (2007-2009) Tasks / Deliverables / Links
STRATEGIC CO-ORDINATION GROUP
PLENARY CMA
(GW, SW/MW)
WG C
(joint meetings)
Practical works
Supporting CMA
QA_QC
Standardisation
(CEN TC/230)
Sharing best practices
Identification of gaps and needs
Practical exercises
Follow-up of COM decision
Follow-up of EAQC-WISE
Discussion of common strategy
Identification of standards
Follow-up of CEN work
Links with RTD
WG B
(PRB)
Sci-Pol PS
PS,
Sci-Pol

15. Activity CMA-3 Standardisation
Discussion on standardisation needs related to WFD chemical monitoring and evaluation of expressed needs
Establishment of list(s) of existing standards and/or standards that should be developed for communication to both the CIS SCG and the WG 1 of CEN/TC 230 and for decision on further action
On the basis of the above, proposal of existing standards to the WFD Committee for adoption by comitology and/or
development of new standards (possibly involving pre- or co-normative research) mandated to CEN, followed by adoption by comitology