the ISO approach to QC - Royal Society of Chemistry
Transcription
the ISO approach to QC - Royal Society of Chemistry
1 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? 2 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 8 Membership of EH/3 includes: Environment Agency Drinking Water Inspectorate Society of Chemical Industry Laboratory of the Government Chemist Royal Society of Chemistry 9 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 10 11 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! 12 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 13 BS EN ISO (DIS) 11133:2012 • 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 • 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! 14 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? 15 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 16 17 What do we need there to be in water microbiology standards? Requirements for water microbiology standards • One clear standard for microbiological AQC • Similar to ISO/TS 13530 Water quality – Guidance on AQC for chemical and physicochemical water analysis • Details and definitions in the many current standards touching on AQC issues harmonized • Definition of performance characteristics in water standard methods so laboratories may demonstrate competence for accreditation • Possible collaborative trials (EU Mandate) so reliable data is available for regulatory testing and compliance • Faster development of standards • More involvement in BS, CEN and ISO work!! 18 19 Any questions?