UKWF Regional Meeting National Measurement Office Notified Body 0126 26 April 2012 Paul Dixon Director of Certification Services
Introduction • Overview of NMO (and the Notified Body) • Revision of EN45501 and the 10 V/m issue • Definition of ‘Manufacturer’ • International Developments – WELMEC – OIML • Software in Weighing & Measuring Instruments • Q & A
Overview of NMO
1866 Standards Department of the Board of Trade was set up 1905 First “Notice” (“Certificate”) of Approval was issued 1978 Standards Department was renamed the National Weights and Measures Laboratory (NWML) 1987 NWML relocated to purpose built laboratory in Teddington 1989 1989 NWML became an Executive Agency of the former Department NWML became an Executive Agency of the former Department of Trade & Industry (DTI) 1992 Notified Body for NAWI Directive 2006 Notified Body for Measuring Instruments Directive (MID) 2009 NWML renamed the National Measurement Office – NWML ‘brand’ retained for Certification Services 2011 NMO ‘brand’ adopted for Certification Services
What NMO does Four main “lines of business”: • Management of the National Measurement System • Enforcement Authority • Enforcement Authority • Weights and Measures (Regulatory Directorate) • Certification Services (includes Notified Body)
The National Measurement System • Maintains and Develops Primary & National Measurement Standards • Provides traceability to National Standards • Represents the UK in the Metre Convention • Represents the UK in the Metre Convention • Carries out research to improve Standards • Develops new Measurement Techniques • Helps users to improve measurements
National Measurement System NMS Programme Management National Measurement Office (NMO) Legal Metrology LGC Ltd National Physical Laboratory Chemical & Biological (NPL) Metrology Metrology Physical Metrology Physical Metrology TUV NEL Ltd Flow Metrology
Accurate measurement is important to Government • Regulatory enforcement • Environmental monitoring • Health & Safety • Healthcare Structural integrity • Defence and Security • Collection of tax revenues Pollution monitoring Nanotechnology Diagnosis & therapy Alternative power
Enforcement National enforcement of Regulations for: • Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) • Batteries and Accumulators (placing on the market) • Batteries and Accumulators (placing on the market) • Energy Related Products (ERP) • Energy Labelling (ELF)
NMO Regulatory Directorate • Weights and Measures policy: – Consultation – International negotiation – – Implementation of European Directives Implementation of European Directives – Drafting legislation – Packaged Goods – Metrication – Sponsorship of British Hallmarking Council
NMO Regulatory Directorate • Accuracy of gas and electricity meters • Designation and monitoring of “Approved Verifiers” and “Notified Bodies” • Market surveillance under two European metrology Directives
International Role Represent UK interests in: Legal Metrology • International Organisation for Legal Metrology (OIML) • European Co-operation for Legal Metrology (WELMEC) • International Hallmarking Convention (IHC) • International Hallmarking Convention (IHC) Scientific Metrology • International Committee for Weights & Measures (CIPM)
Certification Services • Product Certification (Type Approval) • Management System Certification • Calibration Service (Mass, Length and Volume) • Calibration Service (Mass, Length and Volume) • Training
Type Approval • Type Approval of weighing and measuring instruments used in legally controlled applications – UK National (section 12 of the W&M Act 1985) – EC Directives (acting as a “Notified Body”) – EC Directives (acting as a “Notified Body”) • Non-Automatic Weighing Instruments Directive • Measuring Instruments Directive (MID) – OIML Certificates of Conformity • UK Issuing Authority for Basic and MAA Certs
Management System Certification • Placing equipment on the market is a two-stage process � Type Approval + ‘Verification’ • Certification of Quality Management Systems to: – ISO 9001 – NAWI Directive – NAWI Directive – MID – Deregulation Order (UK National) • Certification under the Directives and Dereg. Order aimed at ‘self-verification’
NMO Notified Body 0126 • Provision of conformity assessment activities under NAWI and MID • NAWI: – EC Type Examination (Annex B) – EC Unit Verification (Annex G) – EC Unit Verification (Annex G) – EC Declaration of Type Conformity (Annex D) • MID: – As per NAWI, plus Annex H1 (full quality assurance plus design examination)
NMO Notified Body 0126 • Type Approval engineers and auditors are experts on weighing instruments and legal metrology • Direct access to NMO Regulatory Directorate – input to development of policy and legislation • Direct access to OIML Technical Secretariat for AWIs • Participation in OIML, WELMEC and NoBoMet – influencing Global and European policy, guidance, recommendation and standards • Viable alternative to NMi offering cost effective, timely and pragmatic approach to certification • Partnership approach with pre-assessment service
Revision of EN 45501 and the 10 V/m issue
Revision of EN 45501 • EN 45501 is a Harmonised Standard • Nominally identical to OIML R76:1992 • EN 45501 provides presumption of conformity to the essential requirements of the NAWI Directive • Details the technical and metrological requirements • Details the technical and metrological requirements and test methods • Used as the basis for issuing EC Test Certificates for ‘modules’
Revision of EN 45501 • Revision of OIML R76 led to new version R76:2006 being published • European Commission mandated CEN/CENELEC to revise EN 45501 to align with R76:2006 • Working Group convened to progress revision • Draft revision of EN 45501 produced which copied R76:2006 • Delays arose with the revision process
10 V/m issue • Concerns raised by the European Commission that radiated immunity at 3 V/m was not sufficient • Delay in revision of EN 45501 resulted in Commission intending to publish a ‘Note’ stating that 3 V/m did not give presumption of conformity • ‘Note’ was going to indicate that NAWIs should satisfy: • ‘Note’ was going to indicate that NAWIs should satisfy: – 10 V/m for radiated immunity – 10 V (e.m.f.) for conducted immunity • Intention that all new NAWI approvals must satisfy this requirement from date of publication of the ‘Note’ • Intention that instruments covered by existing approvals would need to comply by 31 December 2013
10 V/m issue • Intention to publish the ‘Note’ was considered by 98/34 Committee (Standards and Technical Regulations) • Commission unable to provide evidence of problems with NAWIs tested at 3 V/m • Concerns regarding costs of compliance for manufacturers (especially SMEs) manufacturers (especially SMEs) • MDD only requires 10 V/m for life-saving equipment • Commission decided to withdraw objection to 3 V/m and will await publication of revised EN45501 • Questions now raised regarding the necessity to increase to 10 V/m
10 V/m issue • Generic IEC standards: – Residential, commercial and light industrial – Industrial • Industrial severity: – 10 V/m (to 1 GHz), 3 V/m (up to 2 GHz) and 1 V/m above 2 GHz • No evidence of problems at 3 V/m & MDD comparison • NMO proposal to adopt MID principles (E1, E2 and E3) – E1 = 3 V/m – E2 = 10 V/m (to 1 GHz), 3 V/m (up to 2 GHz) • Manufacturer will define electromagnetic environment
EN 45501 Revision – next steps • CEN/CENELEC confirmed ‘fast-track’ (UAP) approval of new version – envisaged no technical changes • UAP started 11 November 2011 • UAP closed (voting and comments) on 13 April 2012 • Five negative votes (with technical comments) have been • Five negative votes (with technical comments) have been received – further draft and formal vote will be required
EN 45501 Revision – next steps • Proposal for a “comments resolution” meeting to be held in mid-June • Attempt to reach agreement on the issues raised and develop an agreed text • 5 month period for vote and comments (end of Jan 2013) • Publication of new EN 45501 to follow • Publication of new EN 45501 to follow • Questions have been raised (at NoBoMet) about the transitional period and possible retrospective application of the new standard • If EN 45501 differs from R76 – opportunity to revise R76?
Definition of ‘Manufacturer’
Definition of ‘Manufacturer’ • UK (NMO) interpretation that the person placing the instrument on the market under Annex D (or F) can be different from the owner of the Type Approval Certificate (TAC) • Person placing on the market takes responsibility • Person placing on the market takes responsibility and signs ‘DofC’ • Requires written agreement with owner of the TAC • Typical approach for NAWIs where indicator connected to approved load cells
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