The terms and definitions relating to documents
The following terms and definitions are taken from ISO 9001:2008:
| Term | Article ISO 9000:2005 | Definition |
| Document | 3.7.2 | Information and the environment supporting it |
| Procedure | 3.4.5 | Concrete way of conducting activity or process (note: procedures can be both documentary, and not documented) |
| Quality manual | 3.7.4 | The document defining quality management system of the organization |
| Plan of quality | 3.7.5 | The document determining by whom and when procedures and resources have to be applied to the specific project, a product, process or contact |
| Record | 3.7.6 | The document stating the reached results or providing proofs of performance of work |
| Specification | 3.7.3 | The document stating requirements |
Appendix B
The records demanded ISO 9001:2008
| Article | The demanded record |
| 5.6.1 | Analysis of the management |
| 6.2.2 (e) | Education, training, qualification and experience |
| 7.1 (d) | The proof of that processes of realization and end products meet the requirements |
| 7.2.2 | Results of the analysis of the requirements relating to production and actions taken after that the analysis |
| 7.3.2 | The costs of design and development connected with requirements to production |
| 7.3.4 | Results of analyses of design and development and any necessary actions |
| 7.3.5 | Results of confirmation of need of design and development and any necessary actions |
| 7.3.6 | Results of the adoption of design and development and any necessary actions |
| 7.3.7 | Results of the analysis of changes of design and development and any necessary actions |
| 7.4.1 | Results of an assessment of suppliers and necessary actions |
| 7.5.2 (d) | Demonstration of adequacy of processes at impossibility of immediate monitoring or measurement of adequacy of production |
| 7.5.3 | Unambiguous identification of production when the requirement is the unity of measurements |
| 7.5.4 | The property of the client which is lost, damaged or is otherwise recognized unusable to application |
| 7.6 (a) | The basis used for calibration or checking of the test equipment in the absence of the international or national standards of measurement |
| 7.6 | Confirmation of accuracy of results of the taken measurements at detection of discrepancy of the measuring equipment to requirements |
| 7.6 | Results of calibration and checking of the test equipment |
| 8.2.2 | Results of internal audit and subsequent actions |
| 8.2.4 | Indication of the person responsible for production |
| 8.3 | The nature of discrepancies of production and any taken actions, including the reached concessions |
| 8.5.2 | Results of remedial actions |
| 8.5.3 | Results of the warning actions |
Control questions
1 Give definition to terms - the document, records about quality, documentary procedure
2 Requirements to documentation of ISO 9001:2008
3 Main objectives and tasks of documentation of QMS
4 Structure of documents QMS
5 Give examples of records about quality for concrete production
6 Contents of control instructions
7 Basic purpose of methodical instructions on development, coordination and approval of documentation of QMS
8 The content of provisions about divisions
9 Structure of duty regulations.
10 Give the characteristic of business processes
11 V than a difference between documentation of the enterprise of the introducing QMS and the introduced QMS
12 That you understand as definition "demonstration of compliance of ISO 9001:2008"
Literature
1 СТ РК ИСО /ТО 10013-2008. Система менеджмента качества. Руководящие указания по документированию, Астана, 2008 год;
2 Методические рекомендации по разделу 5 «Ответственность руководства» СТ РК ИСО 9001-2001 «Система менеджмента качества. Требования», Астана, 2002;
3 Методические рекомендации по разделу 6 «Менеджмент ресурсов» СТ РК ИСО 9001-2001 «Система менеджмента качества. Требования», Астана, 2002;
4 Руководство по пункту 1.2 «Применение» ИСО 9001:2000, Астана, 2001;
5 Методические рекомендации по применению принципов менеджмента качества, Астана, 2002;
6 Руководство по требованиям ИСО 9001:2000 к документации, Астана, 2002;
Lecture 10
Theme: Process and system approach. Deminga-Shukhart's cycle and process approach. Methodological bases of introduction of a process approach to QMS. System approach to management.
Lecture plan:
1 Concept about processor approach to a control system at the enterprise (organization)
2 Structure of processes of the enterprise (organization)
3 System approach
4 V. Shukharta-E.Deminga's cycle