ISO 9000 & TOTAL QUALITY

1. ISO 9000 & TOTAL QUALITY ISO 9000 refers to a group of quality assurance standards established by the International Organization for Standardization.This group, which is made up of representatives from 91 countries,adopted the standards in 1987. ISO 9000 standards are aimed at quality systems,not at the quality systems, not at the quality of goods and services. ISO certification means that a company has a detailed, documented approach to achieving consistency of output. It doesn’t mean that they can be made as durable as specified, and that the level of defects will be controlled.

2. ISO 9000 & TOTAL QUALITY MANAGEMENT While ISO 9000 can be an integral part of a TQM program, it’s important to recognize the distinction between the two ideas. The ISO 9000 standards are mainly concerned with quality assurance; TQM focuses on quality management. The ISO 9000 approach sets minimum standards for guaranteeing quality. It does not go beyond those minimums to promote customer awareness, team activities,or continuous improvement,all of which are essential to TQM. TQM almost always requires some changes in a company’s structure & culture. With ISO 9000, the emphasis is not on change .Preparation may require only careful documentation of systems already in place. TQM promotes the types of practices, such as focusing on the internal customer, that assure quality.Once you have successfully adopted TQM, you will have the systematic approach to quality that the ISO 9000 standards call for. TQM improves internal operations it facilitates cost cutting, improves employee moral, and provides a focus for revolutionary, as well as incremental, leaps in productivity.

3. The ISO 9000 concept The idea behind the ISO 9000 concept is quite simple. Every customer wants to buy high-quality goods and services-products which consistently conform to expectations or to contractual specifications. How does the customer know that suppliers are capable of providing consistent quality ? One way is to audit each supplier’s quality systems. Many firms now perform such audits of their suppliers. In Europe, the idea was proposed to establish a uniform standard for quality systems. This would give every company a well- defined model for its quality program.It would also mean that a company could be certified by a third-party auditor. Each of its customers would then be assured of consistent quality without having to audit the supplier independently.

4. The ISO 9000 standards The ISO 9000 series actually consists of categories. A company seeking registration will choose one of three levels represented by ISO 9001, 9002, or 9003. All the ISO standards are generic. They can be adapted to any industry, and to both product and service firms. The ISO 9000 certification process is usually applied to individual sites. If a company wants complete certification, it proceeds on a site-by-site basis.

5. ISO 9000 It provides guidelines for selection and use, definitions and concepts regarding the ISO 9000 It’s a quality management and quality assurance standards It provide the basis for the implementation of quality system and their assessment and verification. In establishing a quality system it is essential that the organization clearly defines the personnel who are responsible for functions affecting quality. The quality system will generally be codified in a series of documents which are commonly known as Quality Manual. All aspects relating to quality should be identified in these documented procedures which would include all reference to work instructions and records. The manual should also contain procedures for specific actions which need to be taken as part of the quality control procedures.

6. ISO 9001 The most comprehensive standard. It assures all aspects of quality from the design stage through production and servicing. This standards specifies quality system requirements for use where a contract between two parties requires the demonstration of a supplier capability to design and supply product. The requirements specified in this international standard are aimed primarily at preventing non-conformity at all stages from design through to servicing.

7. Summary of ISO 9001 Standards 4.1 Management Responsibility 4.2 Quality System 4.3 Contract Review 4.4 Design Control 4.5 Document Control 4.6 Purchasing 4.7 Purchaser Supplied Product 4.8 Product Identification & Traceability 4.9 Process Control 4.10 Inspection & Testing 4.11 Inspection , Measuring and Test equipment 4.12 Inspection and Test Status 4.13 control of Nonconforming Product 4.14 Corrective Action 4.15 Handling ,Storage,Packaging, and Delivery

8. Summary of ISO 9001 Standards 4.16 Quality Records 4.17 Internal Quality Audits 4.18 Training 4.19 Servicing 4.20 Statistical Techniques Note :- Various sections of the standards are interrelated. For example, training is covered in paragraph 4.18. But training procedures will have an impact on almost every other category. The same is true for concepts like document control (4.5) or quality records (4.16)

9. ISO 9002 This Standard leaves out the design phase of ISO 9001.It focuses on production and delivery.It is used mainly by commodity companies, such as chemical or paint producers. This standard is applicable in contractual situations when The specified requirements for products are stated in terms of an established design or specifications; Confidence in product conformance can be attained by adequate demonstration of a certain supplier’s capabilities in production and installation.

10. ISO 9003 This standard is less detailed than the two above. It does not include a comprehensive quality system, but focuses on testing and inspection. It is useful for companies like equipment distributors. This standards specify quality system requirement for use where 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.

11. ISO 9004 This is not a standard that applies to relations with outside customers, but suggests internal methods for meeting the quality measurements in the other standards. It describes methods for approaching areas such as procurement , corrective action , and the use of statistical process controls. This standards provides guidelines on the technical, administrative and human factors affecting the quality of products or services, at all stages of the quality loop system. In this standard, emphasis is laid on the satisfaction of the customer’s need the establishment of functional responsibility and the importance of assessing the potential risks and benefits

12. The Growth of ISO 9000 • ISO 9000 registration has become a fundamental marketing tool,particularly for companies doing business internationally. It gives assurance of quality and provides a competitive advantage. • The ISO 9000 standards are meeting with widespread acceptance. They are scheduled, for example, to replace similar standards in the U.S. military market. • The European Community (EC) already requires ISO 9000 registration for certain products (e.g., toys, personal protection devices, gas appliances) and planned to widen this list to items such as medical devices and lifting equipment.

13. CONCLUSION ISO is the International Organization for Standardization, set up with the objective to promote the developments of standards and related activities for facilitating international exchange of goods and services. ISO 9000 series of standards developed in 1987, relate to quality systems. It has evolved from the standardization of quality assurance system standards of several nations all over the world. The standards allow a wide flexibility, but, at the same time are rigid too. They permit a supplier to formulate his own quality policy and write the quality manual, procedures and instructions in his own way, within the framework of the system elements, but does not allow rendering of non-conforming products or services.