<ul><li>EU “New Approach” Directives – Affixing CE Mark – Conformity Assessment – Manufacturer’s Declaration of Conformity...
<ul><li>Affixing CE Mark to Product is declaring compliance to the Essential Requirements of the Directive(s) </li></ul><u...
A. (Internal production control ) D. (Production quality assurance) B.  (Type examination) G. (Unit verification) H. (Full...
<ul><li>Module A – Internal Production Control (Notified Body [NB] Not Required) </li></ul><ul><li>Module Aa – Same as abo...
<ul><li>Module F – Verification of Product: Used with Module B, Responsibility of NB </li></ul><ul><li>Module G – Unit Ver...
<ul><li>Declaration of Conformity and, where applicable, the Certificate of Conformity must cover individual or several pr...
Author’s Bio – Jeff Tuthill, Sr. <ul><li>Associate Engineer with Underwriters Laboratories for ITE </li></ul><ul><li>U.S. ...
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CE Compliance

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Explanation of Conformity Assessment Rules for Affixing the CE Mark on Product entering the EU Single Market

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CE Compliance

  1. 2. <ul><li>EU “New Approach” Directives – Affixing CE Mark – Conformity Assessment – Manufacturer’s Declaration of Conformity </li></ul><ul><li>Conformity Assessment Modules A thru H </li></ul><ul><li>Technical File and 3 rd Party (Notified Body) Attestation </li></ul>
  2. 3. <ul><li>Affixing CE Mark to Product is declaring compliance to the Essential Requirements of the Directive(s) </li></ul><ul><li>Manufacturer’s Declaration of Conformity must be provided </li></ul><ul><li>Regulated Directives require Notified Body involvement for affixing the CE Mark </li></ul>
  3. 4. A. (Internal production control ) D. (Production quality assurance) B. (Type examination) G. (Unit verification) H. (Full quality assurance) Notified Body - Does surveillance To quality system - Verifies conformity of design - Issues EC examination certificate of design Aa Notified Body <ul><li>Specific tests to </li></ul><ul><li>products </li></ul><ul><li>Product random </li></ul><ul><li>verifications </li></ul>C. (Conformity to type) E. (Product quality assurance) F. (Product verification) - Specific tests to products - Product random verifications Notified Body Notified Body - Approves QS - QS surveillance Notified Body - Approves QS - QS surveillance Notified Body - Verifies conformity - Issues certificate of conformity - Verifies conformity with essential requirements - Issues certificate of conformity Notified Body - QS surveillance Notified Body Manufacturer <ul><li>Submits technical </li></ul><ul><li>documentation </li></ul>OVERVIEW OF CONFORMITY ASSESSMENT MODULES D E S I G N P R O D U C T I O N 1 1 1 1 1 Notified Body - Assures conformity to essential requirements - Does testing, if necessary - Issues CE Type Examination Certificate ISO 17020 (+requirements of ISO 17025 for tests), or ISO Guide 65 (+requirements of ISO 17025 for tests) 1ª and 2ª options EN45001 (+capacity to Decide on conformity) or EN 45004 (+follows Requiremnets of EN 45001for testing) or EN 45011 (+follows Requirements of EN 45001 for testing 1ª and 2ª options: EN45001 (+ capacity to Decide on conformity ) or EN 45004 (+ follows Requiremnets of EN 45001for testing ), or EN 45011 (+ follows Requirements of EN 45001 for testing) EN 45012 (+knowledge of product) EN 45012 (+ knowledge of product) H EN 45012 (+knowledge Of product) Hbis EN 45012 (+ knowledge of product) and EN 45004, or EN 45011 EN 45001 (+ (+ capacity to Decide on conformity), or EN 45004 (+ follows Requiremnets of EN 45001for testing), or EN 45011 (+ follows Requiremnets of EN 45001for testing) EN 45004 (+ follows Requiremnets of EN 45001for testing) or EN 45011 (+ follows Requiremnets of EN 45001for testing)
  4. 5. <ul><li>Module A – Internal Production Control (Notified Body [NB] Not Required) </li></ul><ul><li>Module Aa – Same as above + Tests under responsibility of NB </li></ul><ul><li>Module B – EC Type-Examination: Responsibility of NB </li></ul><ul><li>Module C – Conformity to Type: NB Not Required, but must be used with Module B) </li></ul><ul><li>Module D – Production Quality Assurance: Used with Module B, Responsibility of NB </li></ul><ul><li>Module E – Product Quality Assurance : Used with Module B, Responsibility of NB </li></ul>
  5. 6. <ul><li>Module F – Verification of Product: Used with Module B, Responsibility of NB </li></ul><ul><li>Module G – Unit Verification: Covers design and production. Each product is examined individually by the NB that issues a conformity certificate. </li></ul><ul><li>Module H – Full Quality Assurance: Covers design and production. NB certifies ISO 9001, final inspection of product and testing </li></ul>
  6. 7. <ul><li>Declaration of Conformity and, where applicable, the Certificate of Conformity must cover individual or several products and shall either go with product or be kept with manufacturer. </li></ul><ul><li>Module C is to be used with module B (EC type examination). Modules D, E and F may be used on their own. </li></ul><ul><li>Module H is the most viable for affixing the CE Mark in most cases , if the Manufacturer is implementing, or has an ISO 9001 quality management system. </li></ul>
  7. 8. Author’s Bio – Jeff Tuthill, Sr. <ul><li>Associate Engineer with Underwriters Laboratories for ITE </li></ul><ul><li>U.S. Managing Technical Consultant for the National Standards Authority of Ireland (NSAI) </li></ul><ul><li>- Learned Rules on affixing CE Mark per “New Approach” Directives </li></ul><ul><li>- Learned of the European approach to Conformity Assessment and Testing </li></ul><ul><li>- Received ISO 9001 Lead Auditor Training & audited for Firm Registrations </li></ul><ul><li>EU Technical Compliance Consultant </li></ul><ul><li>- Provided ISO Awareness training and EU Compliance Seminars </li></ul><ul><li>- Took ten US Firms through ISO 9001 QMS Registration process </li></ul><ul><li>Sr. Compliance Engineer with TUV Essen </li></ul><ul><li>- Provided IEC testing, CE Mark investigations and GS Certification services </li></ul><ul><li>- Worked with IEC 1010, IEC 60950, IEC 60601-1, etc. and the European Norms (EN) </li></ul><ul><li>- Evaluated and verified Technical Files and Design Dossiers for compliance with EU Directives </li></ul><ul><li>Technical Advisor to the US National Committee (USNC) of IEC for the following </li></ul><ul><li>- TC (Technical Committee) 62 for IEC 60601-1 Safety of Medical Electrical Equipment </li></ul><ul><li>- TC 66 for IEC 61010-1 Safety of electrical equipment for measurement, control, and laboratory use </li></ul><ul><li>- TC 74 for IEC 60950 Safety of Information Technology Equipment </li></ul>

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