ISO 9001 Quality Management Systems

verfasst von: Dhanasekharan Natarajan

Verlag: Springer International Publishing

Buchreihe : Management and Industrial Engineering

Enthalten in: Springer Professional "Wirtschaft+Technik" , Springer Professional "Technik" , Springer Professional "Wirtschaft"

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Über dieses Buch

This book explains the requirements of ISO 9001 for establishing quality management system (QMS) for an organization. The requirements are illustrated with examples from industries for understanding the requirements and preparing the documents of QMS with high clarity. Methods of integrating ISO 9001 requirements with enterprise resource planning (ERP) software are presented. The software integrated approach enables process owners to focus on their core tasks of achieving the planned outputs of processes and the software generates quality records automatically.

Inhaltsverzeichnis

Frontmatter

Chapter 1. Introducing Quality Management System

Abstract

Organization is a chain of internal suppliers and customers, who are collectively responsible to deliver finished products to end customer. The supplier-customer process relationship is used for understanding quality. The relationship is illustrated with two examples for understanding that quality is the fulfilment of the needs and expectations of internal and end customers. ISO 9001 quality management system (QMS) is introduced for fulfilling the needs and expectations of customers consistently.

Dhanasekharan Natarajan

Chapter 2. Establishing ISO 9001 QMS Documentation

Abstract

Every organization, however small it is, practices the requirements of a documented quality management system (QMS) for processing customer orders. The existing practices and the documents of the organization are improved and aligned to the requirements of ISO 9001 for establishing QMS. The benefits and the considerations for establishing the QMS are presented. Process characterization, sequence of processes and their interactions are fundamental for establishing QMS and they are illustrated with examples. Expertise required for preparing QMS documents and the needs for having quality manual for organization are also presented.

Dhanasekharan Natarajan

Chapter 3. Management Processes

Abstract

The benefits of implementing QMS are presented. External and internal issues could affect the ability of organization to achieve the intended benefits of QMS. Guidance for identifying the internal and external issues that are relevant to organization and monitoring the issues is presented. Guidance is also provided for monitoring the needs and expectations of interested parties to provide products meeting customer requirements. The requirements for determining the scope and establishing the QMS of organization, leadership and planning are explained. Planning actions to address risks and opportunities and integrating the actions with QMS processes are illustrated for three operational processes.

Dhanasekharan Natarajan

Chapter 4. Support Processes

Abstract

In addition to the commitment of top management and planning, support processes are needed for implementing QMS processes. Resources, monitoring and measuring resources, organizational knowledge and documented information are required for the operation of QMS processes. The requirements of the support processes, competence and communication are presented.

Dhanasekharan Natarajan

Chapter 5. Operational Processes

Abstract

Operational processes contribute significantly for the growth of organization. Planning, understanding customer requirements for products, design & development, control of external providers and production are the operational processes. The requirements of the operational processes and other related processes are explained with practical examples for deeper understanding. The other related processes are identification and traceability, customer property, preservation, post-delivery activities, control of changes, release of products and nonconformity control.

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Chapter 6. Performance Evaluation and Improvement

Abstract

The planning and operational requirements of QMS are implemented for processing customer requirements. Planning is done for processing customer requirements and the outcomes of planning are implemented by the internal operational processes of QMS. The outcomes of the QMS are products delivered to customers, satisfying their requirements. The outcomes of planning and QMS and the performances of the internal processes of the QMS are assessed to evaluate the effectiveness of the QMS of organization. The performance evaluation requirements are monitoring, measurement, analysis, evaluation, customer satisfaction internal audit and management review. The outputs of performance evaluation are the inputs for continually improving the effectiveness of QMS. Adequate information with illustrations is provided for the requirements of performance evaluation and improvement. Key performance indicators are suggested for measuring the performance of QMS processes.

Dhanasekharan Natarajan

Chapter 7. Implementing QMS with ERP Software

Abstract

The requirements of QMS should be amalgamated i.e. integrated with the operational processes of the organization from the receipt of customer requirements to the delivery of products to customers for achieving and sustaining business growth. Integrating QMS requirements with ERP or other software is the most effective method and it provides valuable benefits to organization. The methods of integrating the QMS requirements with ERP software are illustrated for three operational processes in Chap. 8. Software system engineering is briefly introduced. Requirements analysis with abbreviated activity diagrams and user acceptance testing are presented for providing inputs for developing software for the control of measuring resources.

Dhanasekharan Natarajan

Chapter 8. Operational Processes with ERP Software

Abstract

Organizations use ERP (Enterprise Resource Planning) software or other software systems for processing customer orders from their receipt to completion. The requirements of operational processes of QMS could be integrated with the ERP software. Integrating QMS requirements is illustrated for three operational processes, namely, Requirements of products, Operational planning and control and Production. Process flow diagrams representing the operations, interactions, monitoring and outputs of processes, requirements analysis with abbreviated activity diagrams and user acceptance test plans are presented for integrating the requirements of the three processes with ERP software.

Dhanasekharan Natarajan

Chapter 9. QMS Planning with Indian Classic, Thirukkural

Abstract

Thirukkural is an Indian classic literature in Tamil, one of the ancient languages of India. The classic literature is generally accepted as more than 2000 years old. The literature is secular and some of the earliest translations in French (1848 & 1889), German (1856) and English (1886) indicate its universal acceptance. The ideas of Thirukkural are applied for planning the actions to address risks and opportunities in QMS processes, design and development of products and production processes.

Dhanasekharan Natarajan

Backmatter

Titel: ISO 9001 Quality Management Systems
verfasst von: Dhanasekharan Natarajan
Verlag: Springer International Publishing
Electronic ISBN: 978-3-319-54383-3
Print ISBN: 978-3-319-54382-6
DOI: https://doi.org/10.1007/978-3-319-54383-3