- 1 -
- 2 -
- 3 -
- 4 -
- 5 -
- 6 -
- 7 -
- 8 -
- 9 -
..... - 10 -
- 11 -
- 12 -
- 13 -
- 14 -
- 15 -
- 16 -
-- - 17 -
- 18 -
- 19 -
- 20 -
- 21 -
- 22 -
- 23 -
- 24 -
- 25 -
- 26 -
- 27 -
- 28 -
- 29 -
- 30 -
- 31 -
- 32 -
- 33 -
- 34 -
- 35 -
- 36 -
- 37 -
- 38 -
- 39 -
- 40 -
- 41 -
- 42 -
- 43 -
- 44 -
- 45 -
- 46 -
- 47 -
- 48 -
- 49 -
- 50 -
- 51 -
---- - 52 -
-- - 53 -
- 54 -
- 55 -
- 56 -
- 57 -
- 58 -
- 59 -
- 60 -
- 61 -
- 62 -
- 63 -
- 64 -
- 65 -
- 66 -
- 67 -
- 68 -
- 69 -
- 70 -
- 71 -
- 72 -
- 73 -
- 74 -
- 75 -
-- -- -- - 76 -
-- -- - 77 -
- 78 -
-- - 79 -
- 80 -
- 81 -
- 82 -
- 83 -
- 84 -
- 85 -
- 86 -
ISO13485:2003 input ISO13485:2003 output ISO13485:2003 top management ISO13485:2003 quality policy - 87 -
ISO13485:2003 quality management system ISO13485:2003 review ISO13485:2003 resource ISO13485:2003 infrastructure ISO13485:2003 traceablity ISO13485:2003 advisory notices - 88 -
- 89 -
ISO13485:2003 4.1 General requirements ISO13485:2003 process - 90 -
ISO13485:2003 4.2.1 Documentation requirements General - 91 -
- 92 -
ISO13485:2003 4.2.1 shall be implemented and maintained - 93 -
ISO13485:2003 4.2.2 Quality manual ISO13485:2003 4.2.3 Control of documents - 94 -
- 95 -
ISO13485:2003 4.2.4 Control of records - 96 -
- 97 -
ISO13485:2003 5.1 Management commitment ISO13485:2003 commitment ISO13485:2003 customer ISO13485:2003 5.2 Customer - 98 -
ISO13485:2003 5.3 Quality policy ISO13485:2003 5.4.1 Quality objectives ISO13485:2003 5.4.2 Quality management system planning - 99 -
ISO13485:2003 5.5.1 Responsibility and authority ISO13485:2003 5.5.2 Management representative ISO13485:2003 management representative ISO13485:2003 5.5.3 Internal communication - 100 -
5 ISO13485:2003 5.6.1 Management review General ISO13485:2003 5.6.2 Review input - 101 -
ISO13485:2003 5.6.3 Review output ISO13485:2003 6.1 Provision of resources ISO13485:2003 6.2.1 Human resources - General ISO13485:2003 6.2.2 Competence, awareness and training - 102 -
ISO13485:2003 6.3 Infrastructure ISO13485:2003 associated utilities ISO13485:2003 6.4 Work environment - 103 -
ISO13485:2003 7.1 Planning of product realization ISO13485:2003 7.2.1 Determination of requirements related to the product - 104 -
ISO13485:2003 7.2.2 Review of requirements related to the product ISO13485:2003 7.2.3 Customer communication ISO13485:2003 7.3.1 Design and development planning ISO13485:2003 7.3.2 Design and development inputs - 105 -
ISO13485:2003 7.3.3 Design and development outputs ISO13485:2003 7.3.4 Design and development review - 106 -
ISO13485:2003 7.3.5 Design and development verification ISO13485:2003 7.3.6 Design and development validation ISO13485:2003 7.3.7 Control of design and development changes - 107 -
ISO13485:2003 7.4.1 Purchasing process ISO13485:2003 7.4.2 Purchasing information - 108 -
ISO13485:2003 7.4.3 Verification of purchased product ISO13485:2003 7.5.1 Control of production and service provision ISO13485:2003 7.5.1.2.1 Cleanliness of product and - 109 -
contamination control ISO13485:2003 7.5.1.2.2 Installation activities - 110 -
ISO13485:2003 7.5.1.2.3 Servicing activities ISO13485:2003 7.5.1.3 Particular requirements for sterile medical devices - 111 -
( ) ISO13485:2003 7.5.2.1 Validation of processes for production and service provision General requirements ISO13485:2003 7.5.2.2 Particular requirements for sterile medical devices - 112 -
ISO13485:2003 7.5.3.1 Identification ISO13485:2003 7.5.3.2.1 Traceability General ISO13485:2003 7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices ISO13485:2003-113 -
ISO13485:2003 7.5.3.3 Status identification ISO13485:2003 7.5.4 Customer property ISO13485:2003 7.5.5 Preservation of product - 114 -
ISO13485:2003 7.6 Control of monitoring and measuring devices ISO13485:2003 8.1 Measurement, analysis and improvement General ISO13485:2003 8.2 Feedback ( - 115 -
ISO13485:2003 8.2.2 Internal audit ISO13485:2003 8.2.3 Monitoring and measurement of processes ISO13485:2003 8.2.4 Monitoring and measurement of product - 116 -
ISO13485:2003 8.2.4.2 Particular requirements for active implantable medical devices and implantable medical devices ISO13485:2003 8.3 Control of nonconforming product ISO13485:2003 8.4 Analysis of data - 117 -
ISO13485:2003 8.5.1 Improvement General ISO13485:2003 8.5.2 Corrective action - 118 -
ISO13485:2003 8.5.3 Preventive action - 119 -
() - 120 -
- 121 -
- 122 -
( ) - 123 -
- 124 -
- 125 -
- 126 -
- 127 -
10-6 SALSterility Assurance Level 10 -n - 128 -
- 129 -
- 130 -
- - - - - 131 -
- 132 -
i (i) (ii) ii - 133 -
- 134 -
- 135 -
- 136 -
- 137 -
- 138 -
- 139 -
- 140 -
- 141 -
- 142 -
- 143 -
- 144 -
- 145 -
- 146 -
- 147 -
- 148 -
- 149 -
- 150 -
- 151 -
- 152 -
- 153 -
- 154 -
- 155 -
- 156 -
- 157 -
- 158 -
- 159 -
- 160 -
- 161 -
- 162 -
- 163 -
- 164 -
- 165 -
10 14-166 -
- 167 -
- 168 -
- 169 -
- 170 -
- 171 -
- 172 -
- 173 -
14-174 -
- 175 -
- 176 -
14-177 -
14 () () () () () () - 178 -
- 179 -
- 180 -
- 181 -
No No No No No No No No - 182 -
No No 10 No 11 No 12 No 13-183 -
No 14 No 15 No 16-184 -
No 17 16 136 No 18-185 -
No 19 10 No 20 No 21 No 22 No 23 No 24-186 -
No 25 No 26 No 27 No 28 No 29-187 -
No 30 No 31 No 32 No 33 No 34-188 -
No 35 No 36 No 37 No 38-189 -
No 39-190 -
No 40 No 41 () () - 191 -
() () () () () () () ()()() () () () () () () () () () - 192 -
No 42-193 -
No 43-194 -
No 44 No 45-195 -
No 46 No 47-196 -
No 48 No 49 No 50 No 51-197 -
No 52 No 53 No 54 No 55 No 56 No 57 No 58 No 59 No 60-198 -
No 61 No 62 No 63 No 64 No 65 No 66-199 -
No 67 No 68-200 -
No 69 No 70 No 71-201 -
No 72 No 73 No 74 No 75 No 76 No 77 14 No 78-202 -
No 79 No 80 No 81 No 82-203 -
No 83 No 84 No 85 No 86 No 87-204 -
21 No 88 No 89-205 -
No 90-206 -
No 91 No 92-207 -
- 208 -
- 209 -
- 210 -
- 211 -
- 212 -
- 213 -
- 214 -
- 215 -
- 216 -
- 217 -
- 218 -
- 219 -
- 220 -
- 221 -
- 222 -
- 223 -
- 224 -
- 225 -
- 226 -
- 227 -
- 228 -
- 229 -
- 230 -
- 231 -
- 232 -
- 233 -
- 234 -
- 235 -
- 236 -
- 237 -
- 238 -
- 239 -
- 240 -
- 241 -
- 242 -
- 243 -
- 244 -
- 245 -
- 246 -
- 247 -
- 248 -
- 249 -
- 250 -
- 251 -
- 252 -
- 253 -
- 254 -
- 255 -
- 256 -
- 257 -
- 258 -
- 259 -
- 260 -
- 261 -
- 262 -
- 263 -
- 264 -
- 265 -
- 266 -
- 267 -
- 268 -
- 269 -
- 270 -
- 271 -
- 272 -