- Quality management systems. - 4 Quality management system 3. - 5.4.2 Quality management system planning 7. - 5.6.1.1 Quality management system performance 9. - 7.4.1.2 Supplier quality management system development 19. - 8.2.2.1 Quality management system audit 27. - 8.5.1.1 Continual improvement of the organization 31. - ISO Quality management systems — Requirements Introduction. - ISO Quality management systems — Requirements 0.2 Process approach. - ISO Quality management systems — Requirements 0.3 Relationship with ISO 9004. - ISO Quality management systems — Requirements 0.4 Compatibility with other management systems. - ISO Quality management systems — Requirements 1 Scope. - ISO Quality management systems — Requirements 1.2 Application. - ISO Quality management systems — Fundamentals and vocabulary. - ISO Quality management systems — Requirements 3 Terms and definitions. - 4 Quality management system. - ISO Quality management systems — Requirements 4 Quality management system. - All rights reserved The organization shall. - a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),. - ISO Quality management systems — Requirements 4.2 Documentation requirements. - ISO Quality management system — Requirements 4.2.2 Quality manual. - The organization shall establish and maintain a quality manual that includes. - ISO Quality management system — Requirements 4.2.3 Control of documents. - Documents required by the quality management system shall be controlled. - ISO Quality management system — Requirements 4.2.4 Control of records. - ISO Quality management systems — Requirements 5 Management responsibility. - ISO Quality management systems — Requirements 5.2 Customer focus. - ISO Quality management systems — Requirements 5.3 Quality policy. - ISO Quality management systems — Requirements 5.4 Planning. - 5.4.2 Quality management system planning. - ISO Quality management systems — Requirements 5.4.2 Quality management system planning. - ISO Quality management systems — Requirements 5.5 Responsibility, authority and communication. - ISO Quality management systems — Requirements 5.5.2 Management representative. - ISO Quality management systems — Requirements 5.5.3 Internal communication. - ISO Quality management systems — Requirements 5.6 Management review. - 5.6.1.1 Quality management system performance. - ISO Quality management systems — Requirements 5.6.2 Review input. - ISO Quality management systems — Requirements 5.6.3 Review output. - ISO Quality management systems — Requirements 6 Resource management. - The organization shall determine and provide the resources needed. - ISO Quality management systems — Requirements 6.2 Human resources. - ISO Quality management systems — Requirements 6.2.2 Competence, awareness and training. - The organization shall. - Applicable tools and techniques shall be identified by the organization.. - ISO Quality management systems — Requirements 6.3 Infrastructure. - ISO Quality management systems — Requirements 6.4 Work environment. - ISO Quality management systems — Requirements 7 Product realization. - ISO Quality management systems — Requirements 7.2 Customer-related processes. - 7.2.1 Determination of requirements related to the product The organization shall determine. - d) any additional requirements determined by the organization.. - ISO Quality management systems — Requirements 7.2.2 Review of requirements related to the product. - The organization shall review the requirements related to the product. - ISO Quality management systems — Requirements 7.2.3 Customer communication. - ISO Quality management systems — Requirements 7.3 Design and development. - The organization shall plan and control the design and development of product.. - ISO Quality management systems — Requirements 7.3.2 Design and development inputs. - The organization shall identify special characteristics [see 7.3.3 d)] and. - ISO Quality management systems — Requirements 7.3.3 Design and development outputs. - ISO Quality management systems — Requirements 7.3.4 Design and development review. - ISO Quality management systems — Requirements 7.3.5 Design and development verification. - ISO Quality management systems — Requirements 7.3.6 Design and development validation. - ISO Quality management systems — Requirements 7.3.7 Control of design and development changes. - ISO Quality management systems — Requirements 7.4 Purchasing. - 7.4.1.2 Supplier quality management system development. - The organization shall perform supplier quality management system development with the goal of supplier conformity with this Technical Specification. - ISO Quality management systems — Requirements 7.4.2 Purchasing information. - ISO Quality management systems — Requirements 7.4.3 Verification of purchased product. - The organization shall promote supplier monitoring of the performance of their manufacturing processes.. - ISO Quality management systems — Requirements 7.5 Production and service provision. - 7.5.1.1 Control plan The organization shall. - The organization shall use statistical methods of verification where applicable.. - ISO Quality management systems — Requirements 7.5.3 Identification and traceability. - ISO Quality management systems — Requirements 7.5.4 Customer property. - ISO Quality management systems — Requirements 7.5.5 Preservation of product. - ISO Quality management systems — Requirements 7.6 Control of monitoring and measuring devices. - testing of the product,. - ISO Quality management systems — Requirements 8 Measurement, analysis and improvement. - b) to ensure conformity of the quality management system, and. - c) to continually improve the effectiveness of the quality management system.. - ISO Quality management systems — Requirements 8.2 Monitoring and measurement. - Customer satisfaction with the organization shall be monitored through continual evaluation of performance of the realization processes. - ISO Quality management systems — Requirements 8.2.2 Internal audit. - The organization shall conduct internal audits at planned intervals to determine whether the quality management system. - 8.2.2.1 Quality management system audit. - The organization shall audit each manufacturing process to determine its effectiveness.. - ISO Quality management systems — Requirements 8.2.3 Monitoring and measurement of processes. - The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. - ISO Quality management systems — Requirements 8.2.4 Monitoring and measurement of product. - For organizations manufacturing parts designated by the customer as “appearance items”, the organization shall provide. - ISO Quality management systems — Requirements 8.3 Control of nonconforming product. - The organization shall deal with nonconforming product by one or more of the following ways:. - The organization shall maintain a record of the expiration date or quantity authorized. - ISO Quality management systems — Requirements 8.4 Analysis of data. - ISO Quality management systems — Requirements 8.5 Improvement. - 8.5.1.1 Continual improvement of the organization. - ISO Quality management systems — Requirements 8.5.2 Corrective action. - The organization shall minimize the cycle time of this process. - ISO Quality management systems — Requirements 8.5.3 Preventive action. - A.1 Phases of the control plan. - The organization shall have a prototype control plan if required by the customer.
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