8.4--VERIFICATION Design validation 7.3.6 P1 4.1.8 35,36 35 820.30g AND VALIDATION Verification of purchased product 7.4.3 All 2.5.6 44 39 820.80b Customer communication 7.2.3 7.2 66,71 29 Production and service provision Contamination control 7.5.1.2.1 6.2.1 48 41 820.70e All Installation 7.5.1.2.2 8.1 65 42 820.17 Distribution 7.5.5 6.3 62 820.16 8.5—DEPLOYMENT Servicing 7.5.1.2.3 8.2 64 43 820.2 Customer communication 7.2.3 7.2 66,71 29 Production and service provision Servicing 7.5.1.2.3 8.2 64 43 820.2 8.6--MAINTENANCE All Customer property (confidential health 7.5.4 51 information) Monitoring & measuring devices 7.6 5.4 56-58 53 820.72 Feedback 8.2.1 66 55 Control of records 4.2.4 3.1.6 24 820.186 Documentation requirements - General 4.2.1 24 6 820.20e Quality manual 4.2.2 2.2.1 24 7 820.20e Document control 4.2.3 3.1 25,26 8 820.4 All Control of records 4.2.4 3.1.6.2 27 9 820.18 Production and service provision - 7.5.1.1 4.2 50 6-2 820.181 General requirements Product realization 7 The following clauses are not specifically addressed in this document: Japan ISO Brazil China Australia MHLW US 21 N23 Topic 13485:2003 RDC MD GMP 15 QMS CFR 13, 14 16/2013 ([2014]64) Ordinance
8.4--VERIFICATION AND VALIDATION Design validation 7.3.6 P1 4.1.8 35,36 35 820.30g Verification of purchased product 7.4.3 All 2.5.6 44 39 820.80b 8.5—DEPLOYMENT Customer communication 7.2.3 All 7.2 66,71 29 Production and service provision Contamination control 7.5.1.2.1 6.2.1 48 41 820.70e Installation 7.5.1.2.2 8.1 65 42 820.17 Distribution 7.5.5 6.3 62 820.16 Servicing 7.5.1.2.3 8.2 64 43 820.2 8.6--MAINTENANCE Customer communication 7.2.3 All 7.2 66,71 29 Production and service provision Servicing 7.5.1.2.3 8.2 64 43 820.2 Customer property (confidential health information) 7.5.4 51 Monitoring & measuring devices 7.6 5.4 56-58 53 820.72 Feedback 8.2.1 66 55 Control of records 4.2.4 All 3.1.6 24 820.186 Documentation requirements - General 4.2.1 24 6 820.20e Quality manual 4.2.2 2.2.1 24 7 820.20e Document control 4.2.3 3.1 25,26 8 820.4 Control of records 4.2.4 3.1.6.2 27 9 820.18 Production and service provision - General requirements 7.5.1.1 4.2 50 6-2 820.181 Product realization 7 The following clauses are not specifically addressed in this document: N23 Topic ISO 13485:2003 13, 14 Australia 15 Brazil RDC 16/2013 China MD GMP ([2014]64) Japan MHLW QMS Ordinance US 21 CFR