S3: Module D Physikalisch-Technische Bundesanstalt Session 3: Conformity Assessment Module D Peter Ulbig, Harry Stolz Belgrade, 31 October 2012

S3: Module D Structure of the Measuring Instruments Directive MID Annexes MI MI-010 Requirements, specific to measuring instrument categories Annexes MI MI-010 Requirements, specific to measuring instrument categories Articles 1 to 23 Articles 1 to 23 Annexes I and A-H1 Conformity assessment procedures Annexes I and A-H1 Conformity assessment procedures Annex I Basic Require- ments Annex I Basic Require- ments General description of the „modules“ possible „modules“

S3: Module D Conformity assessment by module D ANNEX D DECLARATION OF CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS 1. ‘Declaration of conformity to type based on quality assurance of the production process’ is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments concerned are in conformity with the type as described in the EC-type examination certificate and satisfy the appropriate requirements of this Directive.

S3: Module D Combination of conf. assessment modules Module B (type examination) Module F (product verification) + Module B (type examination) Module D (quality approval) + (= assessment of every single product) (= assessment of QM of the production line)

S3: Module D Combination of conf. assessment modules  one notified body for module D instead of several notified bodies for module F could be cheaper

S3: Module D Combination of conf. assessment modules  however, if there are several production sites, it could get very expensive with module D  every production site has to be visited

S3: Module D Requirements according to Module D The manufacturer shall operate an approved quality system for: - production, - final product inspection and - testing of the measuring instrument concerned as specified in paragraph 3 and shall be subject to surveillance as specified in paragraph 4.

S3: Module D Requirements according to Module D The manufacturer shall lodge an application for assessment of the quality system with a notified body of his choice. The application shall include: - all relevant information for the instrument category envisaged; - the documentation concerning the quality system; - the technical documentation of the approved type and a copy of the EC-type examination certificate.

S3: Module D Requirements according to Module D Which information about the QMS is necessary?

S3: Module D Requirements according to Module D How is the assessment carried out? In addition to experience in quality management systems, the auditing team shall possess appropriate - experience in the relevant field of metrology and instrument technology, and - knowledge of the applicable requirements of this Directive. The evaluation procedure shall include an inspection visit to the manufacturer's premises.

S3: Module D Requirements according to Module D What are the tasks of the manufacturer? The manufacturer has - to fulfil the obligations arising out of the quality system as approved and - to maintain it so that it remains adequate and efficient. - to keep the notified body informed of any intended change of the quality system

S3: Module D Requirements according to Module D How shall surveillance be carried out? The notified body - shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system. - may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, to verify that the quality system is functioning correctly.

S3: Module D Requirements according to Module D What about the metrology marking? The manufacturer shall affix - the ‘CE’ marking, - the supplementary metrology marking and - the notified body‘s identification number to each measuring instrument M

S3: Module D Module D and ISO 9001 ISO 9001-Certification Compliance with customer requirements Decrease of failure costs Continuous improvement Get customer confidence All processes and products of an organisation Application / audit / evaluation / decision / surveillance 3 years Annual surveillance visits Purpose of QM-Systems Purpose of certificates Scope of certificate Typical procedure Validity period Surveillance period QM-Approval Securing of the compliance of measuring instruments with legal requirements Authorisation of conformity declaration Measures of quality assurance for certain product categories (includes if necessary further organisations – i.E. subcontractors) Application / audit / evaluation / decision / surveillance 3 years Annual surveillance visits + unexpected visits

S3: Module D Module D and ISO 9001 An present ISO 9001-Certificate does not replace the approval audit by the notified body ISO 9001-Certification is not a requirement for the approval of the quality system, but helpful (lower costs, audit of notified body is restricted to the „technical delta“) Some notified bodies offer ISO 9001-Certification in addition to the approval of the quality system (not PTB) Useful WELMEC-Guide for Measuring Instrument Manufacturers: WELMEC Guide 8.6 „Measuring Instruments Directive 2004/22/EC Presumption of Conformity of the Quality System of Manufacturers with Module D or H 1 when EN ISO 9001:2000 is applied“

S3: Module D Module D procedure Provision of information Application Order confirmation Nomination of the audit team Stage 1 Audit Evaluation of the quality system Decision about QM-Approval Updating the certificates database Evaluation of notifications on changes of the quality system Annual surveillance visits + spot check, where appropriate Reassessment(after 3 years) Stage 2 Audit

S3: Module D Application for Module D Filled and signed application form + list of preliminary questions Acceptance of / agreement on the General Terms and Conditions of the certification body Copies of existing QM-Certificates (e.g. ISO 9001 certificates, accreditation certificates) List of the measuring instrument types which are designated for the Conformity Declaration with regard to the quality system approval applied (with number of design examination certificates / type examination certificates if existing) Copies of type-examination-certificates Technical documentation of the measuring instruments Quality plans for several measuring instrument types, (i.e. short description of the key elements of production to make sure that the requirements of the MID will be met, e.g. quality system approval of suppliers, 100% final inspection including calibration, justification and sealing or placing into operation on site by own service technicians) Quality Management Manual of the company List of all documents subordinated to the QMM and relevant to the quality system approval Further documents will be requested by the audit team during the approval procedure

S3: Module D Requirements according to Module D Final tasks of the manufacturer: The manufacturer shall - supply a copy of the declaration of conformity with each measuring instrument, - keep all relevant information for 10 years after the last instrument has been manufactured, including all decisions and reports of the notified body.

S3: Module D Summary More and more manufacturers choose Module D instead of Module F: - you can calculate what is cheaper: n times the fee for mod. F or one time the fee for mod. D - module D offers more flexibility  you can produce any number of measuring instruments and you save the costs for the transport of the measuring instruments to the notified bodies for module F - you have to pay special attention to the user interface, if you sell to other countries (due to the language!), a notified body for module F finds out your errors!

S3: Module D Finally … … and finally if you choose module D, then often you can get the service for module B and D from one notified body, what makes it very simple, because this notified body already knows your instrument … and if this notified body speaks your language, then it is the easiest way … but this notified body has to provide you with quality, otherwise you could run into trouble with the market surveillance authorities!!!