PED认证分类.pptVIP

* Options Self Declaration by manufacturer Inspection monitoring or QA route Various options inc. inspection and QA Cat I Cat II Cat III Cat IV Various options inc. inspection and QA 0.5 bar, Must not have CE marking I n c r e a s i n g h a z a r d SEP Conformity Assessment 4 Modules Module A = Prepare technical documentation and self declare conformity Cat I Module A1 = As Module A but Notified Body monitors final test Module D1 = Production QA (ISO 9002) + Prepare technical documentation Module E1 = Product QA (ISO 9003) + prepare technical documentation Cat II Conformity Assessment 4 Module B1 = Design Examination (Design approval) Module B = EC Type Examination (DA + product exam) Module D = Production QA Module E = Product QA Module C1 = Conformity to type (random final inspection.) Module F = Product verification (final inspection) Module H = Full QA (ISO 9001) Cat III Module B1 + D, B1 + F, B + E, B + C1, H B, B1, and H all require preparation of Technical Documentation Conformity Assessment 4 Modules Module B = EC Type Examination Module D - Production QA Module F = Product verification Module G = EC Unit verification (Design Approval and in-process Inspection) Module H1 = Full QA, with design examination and special surveillance Cat IV Modules: B + D, B + F, G H1 Module G H1 require preparation of Technical Documentation Conformity Assessment 4 Modules Similar to ISO 9003, 9002, 9001 (1994) BUT NOT THE SAME Advantages Module E - Product Quality Assurance Module D - Production Quality Assurance Module H - Full Quality Assurance Details Quality System must be assessed by Notified Body, then subject to Surveillance and Unexpected Visits Reduction in participation by NoBo Conformity Assessment 4 QA Modules *