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Introduction to ISO 9001:2008
Evolution of quality standards ISO 9001 2008 ISO 9001 1987 ISO 9001 1994 ISO 9001 2000
Quality  System Standard ,[object Object],[object Object]
ISO 9002 and 9003 ,[object Object],[object Object]
Process approach ,[object Object],[object Object]
Processes: Activities  or  set of activities Input Output Controls   Resources
Processes - understand interactions Process A Process D Process B Process C Input Output Controls   Resources
Customer satisfaction C U S T O M E R S C U S T O M E R S Management  responsibility Resource management Measurement,  Analysis and improvement Product Product realisation Continual Improvement of the Quality Management System R e q u i r e m e n t s S a t i s f a c t i o n Input Output
Relationship with ISO 9001 and ISO 9004 ,[object Object],[object Object],[object Object],[object Object],[object Object]
1 Scope (1.1 General) ,[object Object],[object Object],[object Object]
1.2 Application ,[object Object],[object Object],[object Object],[object Object],[object Object]
2 Normative reference ,[object Object]
3 Terms and definitions ,[object Object]
4.1 General requirements ,[object Object]
4.1 General Requirements ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
4.1 General Requirements ,[object Object],[object Object],[object Object],[object Object]
4.2 Documentation requirements ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
4.2.1  General ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
4.2.2 Quality manual ,[object Object],[object Object],[object Object],[object Object]
4.2.3 Control of documents ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
4.2.4 Control of records ,[object Object],[object Object],[object Object]
5 Management responsibility ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
5.1 Management commitment ,[object Object],[object Object],[object Object],[object Object],[object Object]
5.2 Customer focus Determine customer requirements Meet requirements Customer satisfaction
5.3 Quality policy ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
5.4.1 Quality objectives ,[object Object],[object Object],[object Object]
5.4.2 Quality management system planning ,[object Object],[object Object]
5.5 Responsibility, authority and communication ,[object Object],[object Object]
5.5.2 Management Representative ,[object Object],[object Object],[object Object],[object Object]
5.5.3 Internal communication ,[object Object],[object Object]
5.6 Management Review ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
5.6.2 Review input ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Management Review
5.6.3 Review output ,[object Object],[object Object],[object Object],Management Review
6 Resource Management ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
6.1 Provision of resources ,[object Object],[object Object],[object Object]
6.2 Human Resources ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
6.2.2 Competence, training and awareness ,[object Object],[object Object],[object Object],[object Object],[object Object]
6.3 Infrastructure ,[object Object],[object Object],[object Object],[object Object]
6.4 Work environment ,[object Object]
7 Product realization ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
7.1 Planning of product realization ,[object Object],[object Object],[object Object],[object Object],[object Object]
7.2 Customer related processes ,[object Object],[object Object],[object Object]
7.2.1 Determination of requirements related to product ,[object Object],[object Object],[object Object],[object Object],[object Object]
7.2.2 Review requirements related to the product ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
7.2.3 Customer communication ,[object Object],[object Object],[object Object],[object Object]
7.3 Design & development  (not applicable in L&M) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
7.3.1 Design & development (D&D) planning ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
7.3.2 Design & development inputs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
7.3.3 Design & development outputs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
7.3.4 Design & development review ,[object Object],[object Object],[object Object],[object Object],[object Object]
7.3.5 Design & development verification ,[object Object],[object Object]
7.3.6 Design & development validation ,[object Object],[object Object],[object Object]
7.3.7 Control of design and development changes ,[object Object],[object Object],[object Object]
7.4 Purchasing ,[object Object],[object Object],[object Object]
7.4.1 Purchasing process ,[object Object],[object Object],[object Object],[object Object],[object Object]
7.4.2 Purchasing  information ,[object Object],[object Object],[object Object],[object Object],[object Object]
7.4.3 Verification of purchased product ,[object Object],[object Object],[object Object],[object Object]
7.5 Production and service provision ,[object Object],[object Object],[object Object],[object Object],[object Object]
7.5.1 Control of production and service provision ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
7.5.2 Validation of processes ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
7.5.3 Identification and traceability ,[object Object],[object Object],[object Object],[object Object]
7.5.4 Customer property ,[object Object],[object Object],[object Object],[object Object]
7.5.5 Preservation of product ,[object Object],[object Object],[object Object]
7.6 Control of monitoring & measuring equipment ,[object Object],[object Object],[object Object]
7.6 Control of monitoring & measuring equipment ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
8 Measurement, analysis and improvement ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
8.1 General ,[object Object],[object Object],[object Object],[object Object]
8.2.1 Customer satisfaction ,[object Object],[object Object]
8.2.2 Internal audit ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
8.2.2 Internal audit ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
8.2.3 Monitoring and measurement of processes ,[object Object],[object Object],[object Object]
8.2.4 Monitoring and measurement of product ,[object Object],[object Object],[object Object],[object Object]
8.3 Control of nonconforming product ,[object Object],[object Object],[object Object]
8.3 Control of nonconforming product ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
8.4 Analysis of data ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
8.5 Improvement ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
8.5.2 Corrective action ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
8.5.3 Preventive action ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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9001 2008 details

  • 2. Evolution of quality standards ISO 9001 2008 ISO 9001 1987 ISO 9001 1994 ISO 9001 2000
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  • 6. Processes: Activities or set of activities Input Output Controls Resources
  • 7. Processes - understand interactions Process A Process D Process B Process C Input Output Controls Resources
  • 8. Customer satisfaction C U S T O M E R S C U S T O M E R S Management responsibility Resource management Measurement, Analysis and improvement Product Product realisation Continual Improvement of the Quality Management System R e q u i r e m e n t s S a t i s f a c t i o n Input Output
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