- Text
- History
1 INTRODUCTION.....................
1 INTRODUCTION..................................................................................................................................4
2 SCOPE ..............................................................................................................................................6
3 TERMS AND DEFINITIONS .....................................................................................................................7
4 MANAGEMENT SYSTEM (MS)............................................................................................................12
4.1. General requirements..................................................................................................12
4.2. Management Principles ...............................................................................................12
4.3. General documentation requirements........................................................................13
5 MANAGEMENT RESPONSIBILITY ..........................................................................................................15
5.1. Management commitment..........................................................................................15
5.2. Quality and safety policy..............................................................................................15
5.3. Responsibility, authority and communication .............................................................15
5.4. Management representative .......................................................................................16
5.5. Management review ....................................................................................................16
6 RESOURCE MANAGEMENT .................................................................................................................18
6.1. Provision of resources..................................................................................................18
6.2. Human resources .........................................................................................................18
6.2.1. Competence, awareness and training..........................................................................18
6.2.2. Personal Hygiene..........................................................................................................18
6.3. Infrastructure ...............................................................................................................19
6.3.1. Basic requirements.......................................................................................................19
6.3.2. Requirements for facilities, production areas and equipment.....................................19
6.3.3. Facilities & production Areas........................................................................................19
6.3.4. Equipment ....................................................................................................................20
6.4. Maintenance and control of monitoring and measuring devices................................20
6.5. Cleaning........................................................................................................................21
6.6. Pest control ..................................................................................................................22
6.7. Waste control...............................................................................................................23
7 PRODUCT REALISATION......................................................................................................................24
7.1. Product requirements..................................................................................................24
2 SCOPE ..............................................................................................................................................6
3 TERMS AND DEFINITIONS .....................................................................................................................7
4 MANAGEMENT SYSTEM (MS)............................................................................................................12
4.1. General requirements..................................................................................................12
4.2. Management Principles ...............................................................................................12
4.3. General documentation requirements........................................................................13
5 MANAGEMENT RESPONSIBILITY ..........................................................................................................15
5.1. Management commitment..........................................................................................15
5.2. Quality and safety policy..............................................................................................15
5.3. Responsibility, authority and communication .............................................................15
5.4. Management representative .......................................................................................16
5.5. Management review ....................................................................................................16
6 RESOURCE MANAGEMENT .................................................................................................................18
6.1. Provision of resources..................................................................................................18
6.2. Human resources .........................................................................................................18
6.2.1. Competence, awareness and training..........................................................................18
6.2.2. Personal Hygiene..........................................................................................................18
6.3. Infrastructure ...............................................................................................................19
6.3.1. Basic requirements.......................................................................................................19
6.3.2. Requirements for facilities, production areas and equipment.....................................19
6.3.3. Facilities & production Areas........................................................................................19
6.3.4. Equipment ....................................................................................................................20
6.4. Maintenance and control of monitoring and measuring devices................................20
6.5. Cleaning........................................................................................................................21
6.6. Pest control ..................................................................................................................22
6.7. Waste control...............................................................................................................23
7 PRODUCT REALISATION......................................................................................................................24
7.1. Product requirements..................................................................................................24
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1 INTRODUCTION.................................................................................................................................. 42 SCOPE .............................................................................................................................................. 63 TERMS AND DEFINITIONS ..................................................................................................................... 74 MANAGEMENT SYSTEM (MS)............................................................................................................ 124.1. General requirements.................................................................................................. 124.2. Management Principles ............................................................................................... 124.3. General documentation requirements........................................................................ 135 MANAGEMENT RESPONSIBILITY .......................................................................................................... 155.1. Management commitment.......................................................................................... 155.2. Quality and safety policy.............................................................................................. 155.3. Responsibility, authority and communication............................................................. 155.4. Management representative....................................................................................... 165.5. Management review .................................................................................................... 166 RESOURCE MANAGEMENT ................................................................................................................. 186.1. Provision of resources.................................................................................................. 186.2. Human resources ......................................................................................................... 186.2.1. Competence, awareness and training.......................................................................... 186.2.2. Personal Hygiene.......................................................................................................... 186.3. Infrastructure ............................................................................................................... 196.3.1. Basic requirements....................................................................................................... 196.3.2. Requirements for facilities, production areas and equipment..................................... 196.3.3. Facilities & production Areas........................................................................................ 196.3.4. Equipment .................................................................................................................... 206.4. Maintenance and control of monitoring and measuring devices................................ 206.5. Cleaning........................................................................................................................ 216.6. Pest control .................................................................................................................. 226.7. Waste control............................................................................................................... 237 PRODUCT REALISATION...................................................................................................................... 247.1. Product requirements.................................................................................................. 24
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1 INTRODUCTION ................................................ .................................................. ................................ 4
2 SCOPE ............... .................................................. .................................................. ........................... 6
3 TERMS AND DEFINITIONS .................. .................................................. ................................................. 7
4 MANAGEMENT SYSTEM (MS) ............................................ .................................................. .............. 12
4.1. General requirements ................................................ .................................................. 12
4.2. Management Principles ................................................ ............................................... 12
4.3. General documentation requirements ............................................... ......................... 13
5 MANAGEMENT RESPONSIBILITY ..................... .................................................. ................................... 15
5.1. Management Commitment ................................................ .......................................... 15
5.2. Quality and safety policy .............................................. ................................................ 15
5.3 . Responsibility, authority and communication ............................................. ................ 15
5.4. Management Representative ................................................ ....................................... 16
5.5. Management review ................................................ .................................................. ..16
6 RESOURCE MANAGEMENT ............................................ .................................................. ................... 18
6.1. Provision of resources ............................................... .................................................. .18
6.2. Human resources ................................................ .................................................. ....... 18
6.2.1. Competence, MRE and training ............................................. ............................. 18
6.2.2. Personal Hygiene ................................................ .................................................. ........ 18
6.3. Infrastructure ................................................. .................................................. ............ 19
6.3.1. Basic requirements ................................................ .................................................. ..... 19
6.3.2. Requirements for facilities, production equipment which areas and ..................................... 19
6.3.3. Facilities & production Areas .............................................. .......................................... 19
6.3.4. Equipment ................................................. .................................................. ................. 20
6.4. Maintenance and control of monitoring and measuring devices ................................ 20
6.5. Cleaning ................................................. .................................................. ..................... 21
6.6. Pest control ................................................ .................................................. ................ 22
6.7. Waste control ................................................ .................................................. ............. 23
7 PRODUCT REALISATION ................................. .................................................. ................................... 24
7.1. Product requirements ................................................ .................................................. 24
2 SCOPE ............... .................................................. .................................................. ........................... 6
3 TERMS AND DEFINITIONS .................. .................................................. ................................................. 7
4 MANAGEMENT SYSTEM (MS) ............................................ .................................................. .............. 12
4.1. General requirements ................................................ .................................................. 12
4.2. Management Principles ................................................ ............................................... 12
4.3. General documentation requirements ............................................... ......................... 13
5 MANAGEMENT RESPONSIBILITY ..................... .................................................. ................................... 15
5.1. Management Commitment ................................................ .......................................... 15
5.2. Quality and safety policy .............................................. ................................................ 15
5.3 . Responsibility, authority and communication ............................................. ................ 15
5.4. Management Representative ................................................ ....................................... 16
5.5. Management review ................................................ .................................................. ..16
6 RESOURCE MANAGEMENT ............................................ .................................................. ................... 18
6.1. Provision of resources ............................................... .................................................. .18
6.2. Human resources ................................................ .................................................. ....... 18
6.2.1. Competence, MRE and training ............................................. ............................. 18
6.2.2. Personal Hygiene ................................................ .................................................. ........ 18
6.3. Infrastructure ................................................. .................................................. ............ 19
6.3.1. Basic requirements ................................................ .................................................. ..... 19
6.3.2. Requirements for facilities, production equipment which areas and ..................................... 19
6.3.3. Facilities & production Areas .............................................. .......................................... 19
6.3.4. Equipment ................................................. .................................................. ................. 20
6.4. Maintenance and control of monitoring and measuring devices ................................ 20
6.5. Cleaning ................................................. .................................................. ..................... 21
6.6. Pest control ................................................ .................................................. ................ 22
6.7. Waste control ................................................ .................................................. ............. 23
7 PRODUCT REALISATION ................................. .................................................. ................................... 24
7.1. Product requirements ................................................ .................................................. 24
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