Quality Systems

QUALITY SYSTEMS The International Organisation for Standardisation (ISO) was founded in 1946 in Geneva, Switzerland Its mandate is to promote the development of international standards to facilitate the exchange of goods and services worldwide. Recognising the importance of quality systems The ISO has developed a series of standards, which is popular as ISO 9000. These international standards were jointly developed by all ISO member countries and are being adopted throughout the world.

The ISO 9000 is a series of standards in quality management systems, which can be adopted by all types of organisations belonging to the government, public, private or joint sectors, producing and supplying all kinds of goods, services and software. These standards are generic and not specific to any particular product. They can be used for managing the quality of output of manufacturing and service industries. These standards were published for the first time in 1987. The aim was to effectively document quality management system requirements which needed to be implemented to attain customer satisfaction.

These standards were revised for the first time in 1994. Based on actual experiences of several thousand companies, these standards were revised again. The improved version came in 2000. The latest version would contain the following three main standards ISO 9000-2000 (Quality Management SystemsFundamentals and vocabulary) Provides fundamentals of quality management systems and specifies quality management terms and definitions.

ISO 9001-2000(Quality Management Systems Requirements) Specifies requirements for a quality management system where an organisation needs to demonstrate its capability to meet customer requirements for products and/or services and assessment of that capability by internal and external parties.

ISO 9004-2000(Quality Management Systems-Guidance for performance improvement) Provides guidance on quality management systems as a means for continual improvement of processes that contribute to the satisfaction of an organisation's customers and other interested parties.

QUALITY MANAGEMENT PRINCIPLES The quality management principles are a set of comprehensive and fundamental rules or beliefs for leading and operating an organisation. They aim at continually improving performance over long term, by focusing on customers while addressing the needs of all stakeholders.

As per the ISO, the following eight quality management principles can facilitate any organisation in creating quality work culture and successful implementation of quality management.

1. Customer-focused Organisation Organizations depend on their customers. Customer-focused organisations produce products and services that customers need and provide them satisfaction. This can be achieved by the following actions: • Identify customer needs. • Design a product that responds to customer needs. • Produce and deliver the product as per the design. • Enhance after-sales service and handle complaints quickly. • Measure customer satisfaction. • Improve quality to delight the customer.

2. Leadership Senior leaders of an organisation need to set directions and create customer orientation, clear and visible quality values and high expectations. Values, directions and expectations must address all stakeholders. The senior leaders must commit to the development of the entire workforce and should encourage participation, learning innovation and creativity by all employees. Through their personal roles in planning, communications, review or organisation performance and employee recognition, the leaders serve as role models who reinforce values and expectations and build leadership and initiative.

3. Involvement of People Involvement of the people is one way of improving quality and productivity. Involving people at all levels enables their abilities to be used for the benefit of the organisation. This can be done by providing a good corporate work culture, providing an interesting work system and environment, and building the capability of people to perform assigned tasks in the organisation. 4. Process Approach A desired result is achieved more efficiently when related resources and activities are managed as a process.

5. Systems Approach to Management Identifying, understanding and managing a system of interrelated processes for a given objective contributes to the effectiveness and efficiency of the organisation. 6. Continuous Improvement A permanent objective of the organisation is that it should continuously improve performance by addressing the needs of all the interested parties. 7. Factual Approach to Decision-making Effective decisions are based on the logical or intuitive analysis of data and information.

8. Mutually Beneficial Supplier Relationship The ability of the organisation and its suppliers to create value is enhanced by mutually beneficial relationships. The main purposes of quality management systems can be summarised as below:

• Customer satisfaction/customer delight by assuring the required minimum level of consistent quality. • Satisfying 'internal customers'. • Assuring the management of doing this at minimum possible total cost of quality. • Maximising output to input ratios of processes. • 'Prevention is better than cure' strategy to be implemented. • Improve quality of communication all around. • Develop competent sub-contractors as partners. • Make continual improvement an ongoing feature of the company's culture.

ISO 9000 series has five international standards on quality management: ISO 9000 This provides guidelines on selection and use of quality management and quality assurance standards. ISO 9001 It has 20 elements covering design, development, production, installation and servicing This is applicable for the industries which are doing their own design and development, production, installation and servicing.

ISO 9002 It has 18 elements covering production and installation. It is the same as ISO 9001 without the first two tasks, viz., design and development. This is applicable for the units excluding R & D functions. ISO 9003 It has 12 elements covering final inspection and testing for laboratories and ware houses etc.

ISO 9004 This provides guidelines o interpret the quality management and quality assurance. This also has suggestions which are mandatory.

BENEFITS of ISO 9000 series ISO 9000 series provides several tangible and intangible benefits which are listed below:

– This gives competitive advantage in the global market. – Consistency in quality, since ISO helps in detecting nonconformity early which makes it possible to take corrective actions. – Documentation of quality procedures adds clarity to quality systems. – ISO 9000 ensures adequate and regular quality training for all members of the organization. – ISO helps the customers to have cost effective purchase procedure. – The customers while making purchase from companies with ISO certificate, need not spend much on inspection and testing. This will reduce the quality cost and lead time. – This will help in increasing productivity. – This will aid to improved morale and involvement of workers. – The level of job satisfaction would be more.

ISO 9001 ISO 9001 is used where a contract between two parties requires the demonstration of a supplier’s capability to deign and supply products. The requirements specified are aimed primarily at preventing nonconformity at all stages from design through to servicing. It is applicable in contractual situations when the contract specially requires design effort and the product requirements are stated principally in performance or they need to be established and confidence in product conformance can be attained by adequate demonstration of certain capabilities of supplier in design, development, production, installation and servicing.

ISO 9001 lists out the different aspects relating to: 1. Management Responsibilities. 2. Quality Systems 3. Product Identification and Traceability. 4. Inspection Status 5. Inspection and testing 6. Inspection measuring and test equipments 7. Control of Non-conforming products 8. Handling, Storage, Packaging and Delivery 9. Document Control 10.Quality Records 11.Training 12.Statistical Techniques 13.Internal Auditing 14.Contract Review 15.Purchasing 16.Process control 17.Purchaser supplied Product 18.Corrective action 19.Design Control 20.Servicing

ISO 9002 ISO 9002 is used when a contract between two parties requires demonstration of a supplier‘s capability to control the process that determine the acceptability of product specified. The requirements specified aim at preventing non-conformity during production and implementing the means to prevent recurrence.

ISO 9002 has following points:

1. Management Responsibilities. 2. Quality Systems 3. Product Identification and Traceability. 4. Inspection Status 5. Inspection and testing 6. Inspection measuring and test equipments 7. Control of Non-conforming products 8. Handling, Storage, Packaging and Delivery 9. Document Control 10.Quality Records 11.Training 12.Statistical Techniques 13.Internal Auditing 14.Contract Review 15.Purchasing 16.Process control 17.Purchaser supplied Product 18.Corrective action

ISO 9003 ISO 9003 is used when a contract between two parties requires demonstration of a supplier’s capability to detect and control the disposition of any product non-conformity during final inspection and test. It is applicable in contractual situations when the conformance of the product to specified requirements can be shown with adequate confidence providing that certain suppliers capabilities for inspection and tests conducted on the product supplied can be satisfactorily demonstrated on completion.

ISO 9003 lists out the different aspects relating to: 1. Management Responsibilities. 2. Quality Systems 3. Product Identification and Traceability. 4. Inspection Status 5. Inspection and testing 6. Inspection measuring and test equipments 7. Control of Non-conforming products 8. Handling, Storage, Packaging and Delivery 9. Document Control 10.Quality Records 11.Training 12.Statistical Techniques

ISO 9004 ISO 9004 is used when selection of appropriate elements contained in this standard and extent to which these elements are adopted and applied by a company depends upon factors such as size of company, market being served, nature of product, production processes and customer needs. ISO 9004 lists out the different aspects relating to: Terminology Management Responsibility for Quality – – – –

Quality Policy Quality Objectives Quality Systems Quality system Principles

Economics Quality related cost considerations – – – – – –

Quality in marketing Quality in design and specification Quality in procurement Quality in production Control of production Product Verification

Control of measuring and test equipment – Non conformity – Corrective action – Handling & post production functions

Quality documentation & records Personnel Product Safety and liability Use of statistical methods System for handling of customer complaints Quality Reporting & reviews

EIGHT STEPS TO ISO 9000 CERTIFICATION 1. Evaluation of existing quality procedures against the requirements of the ISO 9001-9003 standards. 2. Identification of corrective action needed to conform with ISO 9000 series standards 3. Preparation of a certifiable quality management system 4. Definition, documentation and implementation of new procedure. 5. Preparation of Quality manuals 6. Pre-assessment meeting with registrar to analyse quality manuals 7. Actual assessment visits 8. Certification/Registration.

ISO 14000 The ISO 14000 document is titled 'Environmental Management System-General Guidelines on Principles, Systems and Supporting Techniques '. It outlines system elements, with advice on how to initiate, implement, improve and sustain the system. By following its guidelines and the core elements of the EMS specification-ISO 1400l-your organisation will have a framework to balance and integrate environmental and economic interests. Doing so will improve your competitive advantage. ISO 14000 stipulates a set of 10 management principles for organisations considering an environmental management system.

These are: 1. Recognize that environmental management is one of the topmost priorities of any organisation. 2. Establish and maintain communications with interested parties- both internal and external. 3. Determine legislative requirements and environmental aspects associated with your activities, products and services. 4. Get everyone in the organisation to commit to environmental protection and clearly assign responsibilities and accountability. 5. Promote environmental planning throughout the life cycle of the product and the process.

6. Establish a management discipline for achieving targeted performance. 7. Provide the right resources and sufficient training to achieve performance targets. 8. Evaluate performance against policy, environmental objectives and targets, and make improvements wherever possible. 9. Establish a process to review, monitor and audit the environmental management system to identify opportunities for improving performance. 10. Encourage vendors to also establish environmental management systems.

Benefits of an Environmental Management System What does ISO 14000 say regarding the benefits to an organization if the latter implements an effective environmental management system? Corporations and organizations can 1. Protect human health and environment from the potential impacts of their activities, products and services. 2. Assist in maintaining and improving the quality of the environment. 3. Meet customers' environmental expectations. 4. Maintain good public and community relations. 5. Satisfy investor criteria and improve access to capital.

6. provide insurance at a reasonable cost. 7. gain an enhanced image and market share. 8. satisfy vendor certification criteria. 9. improve cost control. 10. limit liabilities. 11. provide resource conservation. 12. provide effective technology development and transfer. 13. provide confidence to interested parties (and shareholders) that (a) policies, objectives and targets are met, (b) emphasis is on prevention first, (c) reasonable care and regulatory compliance regularly occur, and (d) system design includes continual improvement.

ISO 14000 series ISO 14000 Environmental management systems. General guidelines on principles, systems and supporting techniques. ISO 14001 Environmental management systems. Specifications with guidance for use. ISO 14004 Environmental management systems. General guidelines on principles, systems and supporting techniques. ISO 14010 Guidelines for environmental auditing. principles of environmental auditing.

General

ISO 14011 Guidelines for environmental auditing. Audit procedures-Part I: auditing of environmental management systems. ISO 14012 Guidelines for environmental auditing. Qualification criteria for environmental auditors. ISO 14013 Guidelines for environmental auditing. Management of environmental management system audit programmes. ISO 14014 Guidelines for initial environmental reviews.

ISO 14015 Guidelines for environmental site assessments. ISO 14020 Environmental labelling. Principles of all environmental labelling. ISO 14021 Environmental labelling. Self-declaration, environmental claims-terms and definitions. ISO 14022 Environmental labelling. Symbols. ISO 14023 Environmental labelling. methodologies.

Testing

and

verification

ISO 14024 Environmental labelling. Practitioner guiding principles, practices and procedures of multiple criteria.

programmes, certification

ISO 14030 Environmental performance evaluation. ISO 14031 Evaluation of the environmental performance of the management system and its relationship to the environment. ISO 14040 Environmental management-life-cycle principles and guidelines.

assessment

ISO 14041 Environmental management-life-cycle assessment. Goal definition/scope and inventory analysis.

ISO 14042 Environmental management-life-cycle Impact assessment.

assessment.

ISO 14043 Environmental management-life-cycle assessment. Improvement assessment (or evaluation and interpretation). ISO 14050 Terms and definitions. ISO 14060 Guidelines for the inclusion of environmental aspects in product standards.