9001 2008 details

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]

8.2.3 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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