UKWF Regional Meeting National Measurement Office Notified Body - - PowerPoint PPT Presentation

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 NWML became an Executive Agency of the former Department 1989 NWML became an Executive Agency of the former Department

• f 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

National Physical Laboratory (NPL) Physical Metrology National Measurement Office (NMO) Legal Metrology LGC Ltd Chemical & Biological Metrology NMS Programme Management Physical Metrology Metrology TUV NEL Ltd Flow Metrology

Accurate measurement is important to Government

• Regulatory enforcement
• Environmental monitoring
• Health & Safety
• Healthcare
• Defence and Security

Structural integrity

• Collection of tax revenues

Nanotechnology Alternative power Diagnosis & therapy Pollution monitoring

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)

Enforcement

• Batteries and Accumulators (placing on the market)
• Energy Related Products (ERP)
• Energy Labelling (ELF)

• Weights and Measures policy:

– Consultation – International negotiation – Implementation of European Directives

NMO Regulatory Directorate

– Implementation of European Directives – Drafting legislation – Packaged Goods – Metrication – Sponsorship of British Hallmarking Council

• Accuracy of gas and electricity meters
• Designation and monitoring of “Approved

Verifiers” and “Notified Bodies”

NMO Regulatory Directorate

• 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

• f 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

Definition of ‘Manufacturer’

• Conformity assessment procedures (B+D or B+F)

seen as a single process

• WG8 view that manufacturer must therefore be the

same for both

• NMO have argued against this interpretation
• NMO have argued against this interpretation
• Implications for businesses in the UK who utilise
• ther manufacturer’s TAC’s
• Discussions at WELMEC Committee
• Parallel TACs may be required

International Developments

WELMEC

• WELMEC Committee Meeting – 26/27 April –

including discussions relating to ‘manufacturer’

• WG2 - Revision of Guides:

– 2.2 for Point of Sale Systems – sub-group meeting to discuss POS systems in the ‘cloud’ discuss POS systems in the ‘cloud’ – 2.4 for Load Cells

• Two stage process
• Stage 1 – administrative aspects
• Stage 2 – technical aspects – await revision to R60
• WG2 - New Guide for AWIs under MID

OIML

• Peter Mason (NMO CE) now CIML President
• Revision of D11
• Revision of R60 (load cells)
• Conformity to Type (CTT)

– Two seminars → new committee (TC3/SC6) – Two seminars → new committee (TC3/SC6) – First project to produce guidance document:

“scope for pre-market surveillance activities focussed on the

conformity assessment of measuring instruments to give assurance that manufactured (or production) instruments meet their approved type”

OIML

• NMO Secretariat of OIML TC9/SC2 (AWIs)
• Current projects:

– Revision of R50 in progress – Revision of R61 – comments by 30 May – Publication of R106-1 – Publication of R106-1 – R106-2 circulated for comments – Error in R51 identified by WG2

OIML

• Basic Certificate System
• Mutual Acceptance Arrangement (MAA)

– R49 (water meters) – R60 (load cells) – R76 (NAWIs) – R76 (NAWIs)

• New versions of B3 (Basic) and B10 (MAA)
• Agreement in principle to include manufacturer

test labs (MTLs) in MAA

OIML MAA & MTLs

• Requirements for inclusion of MTLs are being

defined

– Accreditation – Peer assessment – Inter-comparisons – Issuing Authority ‘control’ of test programme

• Will need to be agreed by TC3/SC5 and included

into B10

• Acceptance of MAA Certificates using MTL results

will be voluntary!

Software in Weighing & Measuring Instruments

• Control through application of WELMEC Guides:

– 2.3 for NAWI – 7.2 for AWIs under MID

• Suggestion to incorporate NAWIs into Guide 7.2
• Suggestion to incorporate NAWIs into Guide 7.2
• WG5/WG7/WG8 Sub-group for ‘Software Control’
• Sub-group to make an inventory of problems

associated with control of software identified by:

– Market Surveillance Authorities (MSA), inspection bodies, verification authorities and Notified Bodies

Sub-group on software control

• Evident that when software is updated a change
• f version number alone is not considered

sufficient to fulfil MID requirements

• Sub-group to issue a report (before summer) to

identify solutions, e.g. Checksum identification identify solutions, e.g. Checksum identification

• Feeling that Risk Class B is not sufficient
• Concerns that MID does not specify risk classes
• Bigger issues regarding how to check that the

software is actually the approved software

Thank you for your attention Any Questions?

Contact details Web site: www.bis.gov.uk/nmo E-mail: paul.dixon@nmo.gov.uk Telephone: 020 8943 7282 Telephone: 020 8943 7282