Analysis of structure of ISO 9001:2008 standard via PDCA

Element 1

Element 2

Element 3




Introduction

0.1 General






0.2 Process approach






0.3 Relationship with ISO 9004






0.4 Compatibility with other management




1 Scope

1.1 General






1.2 Application






2 Normative references






3 Terms and definitions




Plan

4 Quality
management
system

4.1 General requirements


4.2 Documentation
requirements

4.2.1 General


4.2.2 Quality manual


4.2.3 Control of documents


4.2.4 Control of records


5 Management responsibility

5.1 Management commitment


5.2 Customer focus




5.3 Quality policy




5.4 Planning

5.4.1 Quality objectives


5.4.2 Quality management system planning


5.5 Responsibility,
authority and
communication

5.5.1 Responsibility and authority


5.5.2 Management representative


5.5.3 Internal communication


5.6 Management
review

5.6.1 General


5.6.2 Review input


5.6.3 Review output


6 Resource
management

6.1 Provision of resources


6.2 Human resources

6.2.1 General


6.2.2 Competence, training and awareness


6.3 Infrastructure




6.4 Work environment




Do

7 Product realization

7.1 Planning of product realization


7.2 Customer-related
processes

7.2.1 Determination of requirements related to the product


7.2.2 Review of requirements related to the product


7.2.3 Customer communication


7.3 Design and
development

7.3.1 Design and development planning


7.3.2 Design and development inputs


7.3.3 Design and development outputs


7.3.4 Design and development review


7.3.5 Design and development verification


7.3.6 Design and development validation


7.3.7 Control of design and development changes


7.4 Purchasing

7.4.1 Purchasing process


7.4.2 Purchasing information


7.4.3 Verification of purchased product


7.5 Production and
service provision

7.5.1 Control of production and service provision


7.5.2 Validation of processes for production and service provision


7.5.3 Identification and traceability


7.5.4 Customer property


7.5.5 Preservation of product


7.6 Control of monitoring and measuring equipment


Check

8 Measurement analysis and
improvement

8.1 General




8.2 Monitoring and
measurement

8.2.1 Customer satisfaction


8.2.2 Internal audit


8.2.3 Monitoring and measurement of processes


8.2.4 Monitoring and measurement of product


8.3 Control of
nonconforming product




Action

8.4 Analysis of data




8.5 Improvement

8.5.1 Continual improvement


8.5.2 Corrective action


8.5.3 Preventive action