The Eight Quality Management Principles -- Process approach -- Relationship with ISO 9004 -- Compatibility with other management systems -- Normative reference -- Quality Management System and General Documentation -- Quality management system -- General requirements -- Typical Audit Items for Compliance -- Documentation requirements -- Typical Audit Items for Compliance -- Quality manual -- Typical Audit Items for Compliance -- Control of documents -- Control of records -- Considerations for Documentation -- Typical Audit Items for Compliance -- Management Responsibility -- Management responsibility -- Management commitment -- Customer focus -- Considerations for Documentation -- Typical Audit Items for Compliance -- Quality policy -- Typical Audit Items for Compliance -- Planning -- Quality objectives -- Quality management system planning -- Services -- Hardware, Software and Processed Materials -- Considerations for Documentation -- Typical Audit Items for Compliance -- Responsibility, authority and communication -- Responsibility and authority -- Management representative -- Internal communication -- Typical Audit Items for Compliance -- Management review -- Review input -- Review output -- Typical Audit Items for Compliance -- Human and Other Resources -- Resource management -- Provision of resources -- Considerations for Documentation -- Typical Audit Items for Compliance -- Human resources -- Considerations for Documentation -- Typical Audit Items for Compliance -- Competence, awareness and training.
Considerations for Documentation -- Typical Audit Items for Compliance -- Infrastructure -- Services -- Hardware, Processed Materials, and Software -- Considerations for Documentation -- Typical Audit Items for Compliance -- Work environment -- Services -- Hardware and Processed Materials -- Considerations for Documentation -- Typical Audit Items for Compliance -- Planning of Product Realization and Customer-Related Processes -- Product realization -- Planning of product realization -- Considerations for Documentation -- Typical Audit Items for Compliance -- Customer-related process -- Determination of requirements related to the product -- Considerations for Documentation -- Typical Audit Items for Compliance -- Review of requirements related to the product -- Considerations for Documentation -- Typical Audit Items for Compliance -- Customer communication -- Considerations for Documentation -- Typical Audit Items for Compliance -- Design and Development -- Design and development -- Design and development planning -- Considerations for Documentation -- Typical Audit Items for Compliance -- Design and development inputs -- Considerations for Documentation -- Typical Audit Items for Compliance -- Design and development outputs -- Considerations for Documentation -- Typical Audit Items for Compliance -- Design and development review -- Considerations for Documentation -- Typical Audit Items for Compliance -- Design and development verification -- Considerations for Documentation -- Typical Audit Items for Compliance.
Design and development validation -- Considerations for Documentation -- Typical Audit Items for Compliance -- Control of design and development changes -- Considerations for Documentation -- Typical Audit Items for Compliance -- Purchasing -- Purchasing process -- Considerations for Documentation -- Typical Audit Items for Compliance -- Purchasing information -- Considerations for Documentation -- Typical Audit Items for Compliance -- Verification of purchased product -- Considerations for Documentation -- Typical Audit Items for Compliance -- Production and Service Provision -- Production and service provision -- Control of production and service provision -- Services -- Hardware and Processed Materials -- Software -- Considerations for Documentation -- Typical Audit Items for Compliance -- Validation of processes for production and service provision -- Services -- Hardware and Processed Materials -- Software -- Considerations for Documentation -- Typical Audit Items for Compliance -- Identification and traceability -- Services -- Hardware and Processed Materials -- Software -- Considerations for Documentation -- Typical Audit Items for Compliance -- Customer property -- Services -- Hardware and processed materials -- Software -- Considerations for Documentation -- Typical Audit Items for Compliance -- Preservation of product -- Services -- Considerations for Documentation -- Typical Audit Items for Compliance -- Control of monitoring and measuring devices -- Software -- Considerations for Documentation.
Typical Audit Items for Compliance -- Measurement -- Measurement, analysis and improvement -- Considerations for Documentation -- Typical Audit Items for Compliance -- Monitoring and measurement -- Customer satisfaction -- Considerations for Documentation -- Typical Audit Items for Compliance -- Internal audit -- Considerations for Documentation -- Typical Audit Items for Compliance -- Monitoring and measurement of processes -- Considerations for Documentation -- Typical Audit Items for Compliance -- Monitoring and measurement of product -- Considerations for Documentation -- Typical Audit Items for Compliance -- Control of Nonconforming Product -- Control of nonconforming product -- Considerations for Documentation -- Typical Audit Items for Compliance -- Analysis of Data -- Analysis of data -- Hardware and Processed Materials -- Services -- Software -- Typical Audit Items for Compliance -- Improvement -- Improvement -- Continual improvement -- Services, Hardware, Processed Materials, and Software -- Typical Audit Items for Compliance -- Corrective action -- Services, Hardware, Processed Materials, and Software -- Considerations for Documentation -- Typical Audit Items for Compliance -- Preventive action -- Services, Hardware, Processed Materials, and Software -- Considerations for Documentation -- Typical Audit Items for Compliance -- Correspondence between ISO 9001:1994 and ISO 9001:2000 -- Correspondence between ISO 9001:2000 and ISO 9001:1994.
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