5.1. A Brief History of ISO 9001:20005.1.1. ISO 90005.1.2. ISO 9001:20005.1.2.1. 1. Understand the requirements5.1.2.2. 2. Establish processes to meet the requirements5.1.2.3. 3. Provide resources to run the processes5.1.2.4. 4. Monitor, control, and measure the processes5.1.2.5. 5. Improve continuously based on the results5.2. ISO 9001 Ownership5.3. The Structure and Design of ISO 9001:20005.3.1. Shall Statements5.3.2. Required Records5.3.3. Common Structure5.4. ISO 9000: Sections 1 Through 35.4.1. Section 1. Scope5.4.1.1. 1.1. General (documents the specification as an official standard)5.4.1.2. 1.2. Application (defines the Standard as “generic”; applicable to many industries)5.4.2. Section 2. Normative Reference (the Latest Issue of This Standard Can Be Used As a Legal Reference)5.4.3. Section 3. Terms and Conditions (Some Modification of Terms from Previous Versions)5.5. Section 4. Quality Management System5.5.1. 4.1. General5.5.2. 4.2. Documentation Requirements5.5.2.1. 4.2.1. General5.5.2.2. 4.2.2. Quality Manual5.5.2.3. 4.2.3. Control of documents5.5.2.4. 4.2.4. Control of records5.5.3. Required Records5.6. Section 5. Management Responsibility5.6.1. 5.1. Management Commitment5.6.2. 5.2. Customer Focus5.6.3. 5.3. Quality Policy5.6.4. 5.4. Planning5.6.4.1. 5.4.1. Quality objectives5.6.4.2. 5.4.2. Plan the QMS5.6.5. 5.5. Responsibility, Authority, and Communication5.6.5.1. 5.5.1. Identify stakeholders5.6.5.2. 5.5.2. Appoint management representatives5.6.5.3. 5.5.3. Establish communication channels5.6.6. 5.6. Management Review5.6.6.1. 5.6.1. General5.6.6.2. 5.6.2. Review input5.6.6.3. 5.6.3. Review output5.6.7. Required Records5.7. Section 6. Resource Management5.7.1. 6.1. Provide Resources5.7.2. 6.2. Human Resources5.7.2.1. 6.2.1. General5.7.2.2. 6.2.2. Competence, awareness, and training5.7.3. 6.3. Infrastructure5.7.4. 6.4. Work Environment5.7.5. Required Records5.8. Section 7. Product Realization5.8.1. 7.1. Planning of Product Realization5.8.1.1. Product requirements5.8.1.2. Required QMS processes5.8.1.3. Verification, validation, monitoring, and test activities5.8.1.4. Identify control records5.8.2. 7.2. Customer-Related Focus5.8.2.1. 7.2.1. Determination of requirements related to the product5.8.2.2. 7.2.2. Review the requirements related to the product5.8.2.3. 7.2.3. Customer communication5.8.3. 7.3. Design and Development5.8.3.1. 7.3.1. Design and development planning5.8.3.2. 7.3.2. Design and development inputs5.8.3.3. 7.3.3. Design and development outputs5.8.3.4. 7.3.4. Design and development review5.8.3.5. 7.3.5. Design and development verification5.8.3.6. 7.3.6. Design and development validation5.8.3.7. 7.3.7. Control of design and development changes5.8.4. 7.4. Purchasing5.8.4.1. 7.4.1. Purchasing process5.8.4.2. 7.4.2. Purchasing information5.8.4.3. 7.4.3. Verification of purchased product5.8.5. 7.5. Production and Service Provision5.8.5.1. 7.5.1. Control of product and service provision5.8.5.2. 7.5.2. Validation of processes for production and service provision5.8.5.3. 7.5.3. Identification and traceability5.8.5.4. 7.5.4. Customer property5.8.5.5. 7.5.5. Preservation of product5.8.6. 7.6. Control of Monitoring and Measuring Devices5.8.7. Required Records5.9. Section 8. Measurement, Analysis, and Improvement5.9.1. 8.1. General5.9.2. 8.2. Monitoring and Measurement5.9.2.1. 8.2.1. Customer satisfaction5.9.2.2. 8.2.2. Internal audit5.9.2.3. 8.2.3. Monitoring and measurement of processes5.9.2.4. 8.2.4. Monitoring and measurement of product5.9.3. 8.3. Control of Nonconforming Product5.9.4. 8.4. Analysis of Data5.9.5. 8.5. Improvement5.9.5.1. 8.5.1. Continual improvement5.9.5.2. 8.5.2. Corrective action5.9.5.3. 8.5.3. Preventive action5.9.6. Required Records5.10. For a Deeper Look5.11. Summary