My Company The ISO 9001:2008 Quality Manual

Table of Contents
0  Introduction ........................................................................................................................................ 4 
0.1  What is this ISO 9001:2008 Quality Manual? ............................................................................. 4 
0.2  Modifications Tutorial.................................................................................................................. 4 
1  Approval and Revision ....................................................................................................................... 6 
1.1  Approval ..................................................................................................................................... 6 
1.2  Revision History.......................................................................................................................... 6 
2  Company ........................................................................................................................................... 6 
2.1  Vision .......................................................................................................................................... 6 
2.2  Mission ....................................................................................................................................... 6 
2.3  Company Processes .................................................................................................................. 7 
3  Scope and Exclusions ....................................................................................................................... 7 
3.1  Scope ......................................................................................................................................... 7 
3.2  Exclusions .................................................................................................................................. 8 
3.3  References ................................................................................................................................. 8 
4  Quality Management System............................................................................................................. 9 
4.1  General Requirements ............................................................................................................... 9 
4.2  Documentation Requirements .................................................................................................... 9 
4.2.1  General................................................................................................................................ 9 
4.2.2  Quality Manual .................................................................................................................. 10 
4.2.3  Control of Documents........................................................................................................ 10 
4.2.4  Control of Records ............................................................................................................ 11 
5  Management Responsibility............................................................................................................. 11 
5.1  Management Commitment ....................................................................................................... 11 
5.2  Customer Focus ....................................................................................................................... 11 
5.3  Quality Policy ............................................................................................................................ 12 
5.4  Planning ................................................................................................................................... 12 
5.4.1  Quality Objectives ............................................................................................................. 12 
5.4.2  Quality Management System Planning ............................................................................. 12 
5.5  Responsibility, Authority and Communication .......................................................................... 13 
5.5.1  Responsibility and Authority .............................................................................................. 13 
5.5.2  Management Representative ............................................................................................ 13 
5.5.3  Internal Communication .................................................................................................... 13 
5.6  Management Review ................................................................................................................ 13 
5.6.1  General.............................................................................................................................. 13 
5.6.2  Review Input...................................................................................................................... 14 
5.6.3  Review Output ................................................................................................................... 14 
6  Resource Management ................................................................................................................... 14 
6.1  Provision of Resources............................................................................................................. 14 
6.2  Human Resources .................................................................................................................... 15 
6.2.1  General.............................................................................................................................. 15 
6.2.2  Competence, Training, and Awareness ............................................................................ 15 
6.3  Infrastructure ............................................................................................................................ 15 
6.4  Work Environment .................................................................................................................... 15 
7  Product Realization ......................................................................................................................... 16 
7.1  Planning of Product Realization ............................................................................................... 16 
7.2  Customer Related Processes ................................................................................................... 16 
7.2.1  Determination of Requirements Related to the Product .................................................... 16 
7.2.2  Review of Requirements Related to the Product .............................................................. 17 
7.2.3  Customer Communication ................................................................................................. 17 
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My Company The ISO 9001:2008 Quality Manual

7.3  Design and Development ......................................................................................................... 18 

7.3.1  Design and Development Planning ................................................................................... 18 
7.3.2  Design and Development Inputs ....................................................................................... 18 
7.3.3  Design and Development Outputs .................................................................................... 18 
7.3.4  Design and Development Review ..................................................................................... 19 
7.3.5  Design and Development Verification ............................................................................... 19 
7.3.6  Design and Development Validation ................................................................................. 19 
7.3.7  Control of Design and Development Changes .................................................................. 19 
7.4  Purchasing................................................................................................................................ 20 
7.4.1  Purchasing Process .......................................................................................................... 20 
7.4.2  Purchasing Information ..................................................................................................... 20 
7.4.3  Verification of Purchased Product ..................................................................................... 20 
7.5  Production and Service Provision............................................................................................. 21 
7.5.1  Control of Production and Service Provision ..................................................................... 21 
7.5.2  Validation of Process for Production and Service Provision ............................................. 21 
7.5.3  Identification and Traceability ............................................................................................ 21 
7.5.4  Customer Property ............................................................................................................ 22 
7.5.5  Preservation of Product ..................................................................................................... 22 
7.6  Control of Monitoring and Measuring Equipment ..................................................................... 22 
8  Measurement, Analysis and Improvement ...................................................................................... 23 
8.1  General ..................................................................................................................................... 23 
8.2  Monitoring and Measurement ................................................................................................... 23 
8.2.1  Customer Satisfaction ....................................................................................................... 23 
8.2.2  Internal Audit ..................................................................................................................... 23 
8.2.3  Monitoring and Measurement of Processes ...................................................................... 24 
8.2.4  Monitoring and Measurement of Product .......................................................................... 24 
8.3  Control of Nonconforming Product ........................................................................................... 25 
8.4  Analysis of Data........................................................................................................................ 25 
8.5  Improvement............................................................................................................................. 26 
8.5.1  Continual Improvement ..................................................................................................... 26 
8.5.2  Corrective Action ............................................................................................................... 26 
8.5.3  Preventive Action .............................................................................................................. 26 

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