Quality management systems : requirements

1 Scope ................................................................................................................................................... 1 1.1 General ................................................................................................................................................ 1 1.2 Application .......................................................................................................................................... 1 2 Normative references .......................................................................................................................... 1 3 Terms and definitions .......................................................................................................................... 1 4 Quality management system .............................................................................................................. 2 4.1 General requirements ......................................................................................................................... 2 4.2 Documentation requirements ............................................................................................................ 2 5 Management responsibility ................................................................................................................ 3 5.1 Management commitment .................................................................................................................. 3 5.2 Customer focus .................................................................................................................................. 4 5.3 Quality policy ...................................................................................................................................... 4 5.4 Planning .............................................................................................................................................. 4 5.5 Responsibility, authority and communication .................................................................................. 4 5.6 Management review ............................................................................................................................ 5 6 Resource management ....................................................................................................................... 6 6.1 Provision of resources ........................................................................................................................ 6 6.2 Human resources ............................................................................................................................... 6 6.3 Infrastructure ...................................................................................................................................... 6 6.4 Work environment ............................................................................................................................... 6 7 Product realization ............................................................................................................................... 7 7.1 Planning of product realization .......................................................................................................... 7 7.2 Customer-related processes .............................................................................................................. 7 7.3 Design and development .................................................................................................................... 8 7.4 Purchasing .......................................................................................................................................... 9 7.5 Production and service provision .................................................................................................... 10 7.6 Control of monitoring and measuring equipment .......................................................................... 11 8 Measurement, analysis and improvement ....................................................................................... 12 8.1 General .............................................................................................................................................. 12 8.2 Monitoring and measurement .......................................................................................................... 12 8.3 Control of nonconforming product .................................................................................................. 13 8.4 Analysis of data ................................................................................................................................ 13 8.5 Improvement ..................................................................................................................................... 14 Annex A (informative) Correspondence between ISO 9001:2008 and ISO 14001:2004 ....................... 15 Annex B (informative) Changes between ISO 9001:2000 and ISO 9001:2008 ....................................... 20 Bibliography .............................................................................................................................................. 26