the ISO approach to QC - Royal Society of Chemistry

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Europe and beyond – the ISO approach to QC
Sue Passmore
BSI Committee Member EH3/4
Microbiological methods
Topics for discussion in water microbiology
• UK input into European and International
Standardization
• What there is in BSI, CEN and ISO standards
• What do we need there to be?
• Questions?
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UK Input into European and International
Standardization – the context
Basic Operational Structure
Organizational structure
Simplified structure
Technical Management Board
Technical Committee
Sub-committee
Technical Committee
Sub-committee
Working Group
Technical Committee
Working Group
European
Committee for
Standardization
CEN/TC 230
Water analysis
International
Organization for
Standardization
EH/3
Water quality
ISO/TC 147
Water quality
BSI standardization organization
Industry
Trade Associations
Scientists/Engineers
Professional Bodies
H. M. Government
Ministries
Committees
ISO
Committees
(International)
CEN
Committees
(European)
Agencies
Water Quality Standardization - Structure
CEN
BSI
ISO
CEN/TC 230
EH/3
ISO/TC 147
(DIN)
Water quality
(DIN)
ISO/TC 47/SC 1
(SABS)
Water analysis
Water quality
Terminology
(WG3 is in
abeyance)
CEN/TC 230/WG 2
(BSI)
EH/3/2
ISO/TC 147/SC 2 (DIN)
Physical, chemical methods
Physical, chemical
methods
EH/3/4
ISO/TC 147/SC 4 (DIN)
Microbiological
methods
Microbiological methods
EH/3/5
ISO/TC 147/SC 5 (DIN)
Biological methods
Biological methods
EH/3/6
ISO/TC 147/SC 6 (BSI)
Sampling
Sampling
Biological
methods
CEN/TC 230/WG 2
Task groups
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Membership of EH/3 includes:
Environment Agency
Drinking Water Inspectorate
Society of Chemical Industry
Laboratory of the Government
Chemist
Royal Society of Chemistry
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Membership of EH/3/4 includes:
Environment Agency
Water Companies
Society for Applied Microbiology
GAMBICA (Thermofisher)
Contract Laboratories
HSE
Consultants (!)
Vacancies (!!)
Standards Development
• New Work Item Proposal
• Working Group Consensus
• DIS for comment
• Vote on FDIS
• Standard published
• Review ISO standards after 5 years
• Technical Specifications – review after 3 years
• Publicly Available Specification – review after 3 years
• Technical Reports – non-normative
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What there is in BSI, CEN and ISO standards
BS EN ISO 8199:2007
• Water quality: General guidance on the enumeration
of micro-organisms by culture
• Very general information on the different enumeration
techniques available
• Calculations (from ISO 7218:2001, now obsolete)
• Informative Annex A on choice of methods
• Reference to ISO/TR 13843:2000 (Validation) for
terminology
• Discussion of accuracy and uncertainty
• UNDER REVIEW CURRENTLY!
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BS EN ISO 19458:2006
• Water quality: Sampling for microbiological analysis
• Purpose of sampling (investigations)
• Sampling regimes
• Representative samples?
• Sampling procedures
• Transport, storage (maximum times) and handling
• Specific to microbiology samples
• Informative Annex A on numbers of samples relative
to confidence in results
• General information in ISO 6557 Parts 1 to 15
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BS EN ISO (DIS) 11133:2012
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Microbiology of food, animal feeding stuffs, food production
environment and water — Preparation, production, storage
and performance testing of culture media
•
The first (and last!) joint standard development with the food
microbiology committee (TC34/SC9)
•
Developed with BSI Committee AW9
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Normative Annex F detailing QC cultures for water media
•
First listing of reference cultures by WDCM (universal)
numbers
•
Emphasis on quantitative media QC methods for solid and
liquid media
•
Still at DIS stage so time for comments!
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Other ISO water QC standards
• BS 8496:2007 Water quality – Enumeration of microorganisms in water samples –Guidance on the
estimation of variation of results with particular
reference to the contribution of uncertainty of
measurement
• ISO 29201 Water quality - The variability of test
results and the uncertainty of measurement of
microbiological enumeration methods
• What do we really need when considering uncertainty
of water microbiology test results?
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Other ISO water QC standards
• ISO/TS 16489:2006 Water quality – Guidance for
establishing the equivalency of results
• Statistics to test the equivalency of results from two
different methods used for water testing
• ISO/TR 13843:2001 Water quality – Guidance on
validation of microbiological methods
• Mention of method performance characteristics and
AQC applied to microbiology
• Under review currently
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What do we need there to be in water
microbiology standards?
Requirements for water microbiology standards
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One clear standard for microbiological AQC
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Similar to ISO/TS 13530 Water quality – Guidance on AQC
for chemical and physicochemical water analysis
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Details and definitions in the many current standards
touching on AQC issues harmonized
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Definition of performance characteristics in water standard
methods so laboratories may demonstrate competence for
accreditation
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Possible collaborative trials (EU Mandate) so reliable data
is available for regulatory testing and compliance
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Faster development of standards
•
More involvement in BS, CEN and ISO work!!
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Any questions?