EN ISO 14971:2000
Contents Page
Foreword........................... ......... .......................... ............. ...... ........................................................................ ............iv
Introduction ................................ .................................................................................................................................v
1 Scope ................. ........ ....................... .... ................................. .........................................................................1
2 Terms and definitions .......... .......................................... ......................... .. ....................................................1
3 General requirements for risk management ..... ........... .... ................. .. .. ............. .........................................4
National or regional regulatory requirements .......... .. ..................... ............... ........... .................... .............4
Risk management process .......... ..................... ........ .................................... .. .. .... ........................................4
Management responsibilities ................ ................... .. ............... ........ ........... .. .. .............................. ..............4
Qualification of personnel ..................... ................. .. ................. .... .. .. ........... .. ..............................................5
Risk management plan ........... .. ........ ......................... ..................... .. .. ............. ................. .... .. ..................... ..5
Risk management file ..................... .. ........ ............... .. .. ................. .................................................................6
4 Risk analysis (Steps 1, 2 and 3 of Figure 2) ............................................................................................
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