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CE Compliance

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jeff_tuthill

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

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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 ,[object Object],[object Object],[object Object],[object Object],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 ,[object Object],[object Object],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)
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Author’s Bio – Jeff Tuthill, Sr. ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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CE Compliance

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