{"id":138,"date":"2018-07-21T11:03:52","date_gmt":"2018-07-21T11:03:52","guid":{"rendered":"http:\/\/csp9.epgpbooks.inflibnet.ac.in\/?post_type=chapter&p=138"},"modified":"2018-07-21T11:11:20","modified_gmt":"2018-07-21T11:11:20","slug":"introduction-to-iso-9000","status":"publish","type":"chapter","link":"https:\/\/ebooks.inflibnet.ac.in\/csp9\/chapter\/introduction-to-iso-9000\/","title":{"rendered":"Introduction to ISO 9000"},"content":{"raw":"
\r\n\r\nINTRODUCTION TO ISO 9000<\/strong>\r\n\r\n \r\n

A quality assurance system may be defined as the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management. Quality assurance systems are created to help organizations ensure their products and services satisfy customer expectations by meeting their specifications.<\/p>\r\n \r\n

These systems cover a wide variety of activities encompassing a product\u2019s entire life cycle including planning, controlling, measuring, testing and reporting, and improving quality levels throughout the development and manufacturing process. ISO 9000 describes quality assurance elements in generic terms that can be applied to any business regardless of the products or services offered. The ISO 9000 standards have been adopted by many countries including all members of the European Community, Canada, Mexico, the United States, Australia, New Zealand, and the Pacific Rim. Countries in Latin and South America have also shown interest in the standards.<\/p>\r\n \r\n

After adopting the standards, a country typically permits only ISO registered companies to supply goods and services to government agencies and public utilities. Telecommunication equipment and medical devices are examples of product categories that must be supplied by ISO registered companies. In turn, manufacturers of these products often require their suppliers to become registered. Private companies such as automobile and computer manufacturers frequently require their suppliers to be ISO registered as well.<\/p>\r\n \r\n

To become registered to one of the quality assurance system models contained in ISO 9000, a company\u2019s quality system and operations are scrutinized by third party auditors for compliance to the standard and for effective operation. Upon successful registration, a company is issued a\u00a0certificate from a registration body represented by the auditors. Semi-annual surveillance audits ensure continued compliance to the standard.<\/span><\/p>\r\n\r\n<\/div>\r\n \r\n\r\nTHE ISO APPROACH TO QUALITY ASSURANCE SYSTEMS<\/strong>\r\n\r\n \r\n

The ISO 9000 quality assurance models treat an enterprise as a network of interconnected processes. For a quality system to be ISO compliant, these processes must address the areas identified in the standard and must be documented and practiced as described. ISO 9000 describes the elements of a quality assurance system in general terms. These elements include the organizational structure, procedures, processes, and resources needed to implement quality planning, quality control, quality assurance, and quality improvement. However, ISO 9000 does not describe how an organization should implement these quality system elements. Consequently, the challenge lies in designing and implementing a quality assurance system that meets the standard and fits the company\u2019s products, services, and culture.<\/p>\r\n \r\n\r\nTHE ISO 9001 STANDARD<\/strong>\r\n\r\n \r\n

ISO 9001 is the quality assurance standard that applies to software engineering. The standard contains 20 requirements that must be present for an effective quality assurance system. Because the ISO 9001 standard is applicable to all engineering disciplines, a special set of ISO guidelines (ISO 9000-3) have been developed to help interpret the standard for use in the software process.<\/p>\r\n \r\n

The requirements delineated by ISO 9001 address topics such as management responsibility, quality system, contract review, design control, document and data control, product identification and traceability, process control, inspection and testing, corrective and preventive action, control of quality records, internal quality audits, training, servicing, and statistical techniques. In order for a software organization to become registered to ISO 9001.<\/p>\r\n \r\n\r\nQUALITY MANAGEMENT PRINCIPLES<\/strong>\r\n

\r\n\r\n \r\n\r\nThe eight quality management principles are:\r\n\r\n \r\n\r\n1 Customer focus<\/strong>\r\n\r\n \r\n

Organizations can establish this focus by trying to understand and meet their customers\u2019 current and future requirements and expectations.<\/p>\r\n \r\n\r\n2 Leadership<\/strong>\r\n\r\n \r\n

Organizations succeed when leaders establish and maintain the internal environment in which employees can become fully involved in achieving the organization\u2019s unified objectives.<\/p>\r\n\r\n<\/div>\r\n\u00a0 3 Involvement of people<\/strong>\r\n\r\n \r\n

Organizations succeed by retaining competent employees, encouraging continuous enhancement of their knowledge and skills, and empowering them, encouraging engagement and recognizing achievements.<\/p>\r\n \r\n\r\n4 Process approach<\/strong>\r\n\r\n \r\n

Organizations enhance their performance when leaders manage and control their processes, as well as the inputs and outputs that tie these processes together.<\/p>\r\n \r\n\r\n5 System approach to management<\/strong>\r\n\r\n \r\n

Organizations sustain success when processes are managed as one coherent quality management system.<\/p>\r\n \r\n\r\n6 Continuous improvement<\/strong>\r\n\r\n \r\n

Organizations will maintain current levels of performance, respond to changing conditions, and identify, create and exploit new opportunities when they establish and sustain an ongoing focus on improvement.<\/p>\r\n \r\n\r\n7 Factual approach to decision making<\/strong>\r\n\r\n \r\n

Organizations succeed when they have established an evidence-based decision making process that entails gathering input from multiple sources, identifying facts, objectively analyzing data, examining cause\/effect, and considering potential consequences.<\/p>\r\n \r\n\r\n8 Mutually beneficial supplier relationships<\/strong>\r\n\r\n \r\n

Organizations that carefully manage their relationships with suppliers and partners can nurture positive and productive involvement, support and feedback from those entities.<\/p>\r\n\r\n

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These principles form the conceptual foundation for the ISO portfolio of quality management standards and serve as the basis for the Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) required by most government regulatory bodies. But these principles are not just the backbone of quality systems; they\u2019re also simply good business principles to put into practice across an enterprise. The standardization of management approach based on them will be driving global improvement and process excellence for at least the next 10 years.<\/p>\r\n\r\n<\/div>\r\n

\r\n\r\nISO 9000 based Quality<\/strong>\r\n\r\n \r\n

Quality is <\/strong>defined by customer needs, defined in terms of fitness for purpose, achieved through continuous improvement, managed through prevention not detection, getting it right at the first time\u2019 measurable.<\/p>\r\n \r\n\r\nISO defines Self Manageable P-D-C-A Plan <\/strong>what you do, Do <\/strong>what you planned & record <\/strong>what you did Check<\/strong> the results, Act<\/strong> on the difference.\r\n\r\nPlan<\/strong>\r\n\r\n \r\n

The first logical step in the PDCA cycle is planning. You have to sit down and think. You have to think about the final outcome <\/a>you want to achieve or the problem you want to solve.<\/p>\r\n \r\n

By planning, you want to clarify what kind of improvements you want to implement, decide which opportunity to follow, and write down your assumptions <\/a>(hypotheses or educated guesses) about what kind of a behavioral change will probably lead you to the desired result.<\/p>\r\n \r\n

You need to set measurable and attainable goals, and you need a strong why <\/a>that emotionally empowers you and reminds you why you want to achieve something.<\/p>\r\n \r\n

The basic idea of the planning phase is to design a set of controllable experiments, where you implement a change on a manageable scale, so you can analyze possible effects on a greater level.<\/p>\r\n \r\n

The fact is that only by doing and putting the assumptions to the test and then reflecting on the results, are they able to see if their assumptions in the plan are right or wrong. By doing and reflecting, they can decide to validate or reject (confirm or negate) the hypotheses. That leads us to the do and check phases of the PDCA cycle.<\/p>\r\n \r\n\r\nDo<\/strong>\r\n\r\n \r\n

In the doing phase, you implement the plan. In a very controlled way, you change your behavior that will potentially lead to a different result. With doing, the plan meets reality. When you change your behavior, you interact differently with your environment and that reshapes the relationships and the direction in which the environment is evolving. Thus any change causes friction and stress to the established system, and consequently that leads to a polarization of external factors.<\/p>\r\n \r\n

Polarization means that every external factor has to become a blocker or a backer of your change. When you act differently, you have supporters of change and forces that want to put\u00a0things back as they were. And you never know how polarization will happen. That means your plan mustn\u2019t consider only how the change will affect you and your life, but also how it will affect your environment. But only when you do things in real life and you get the first-hand experience <\/span>(Genchi Genbutsu), <\/a>you finally see things as they are in reality and then you can compare them to your plan and assumptions.<\/span><\/p>\r\n\r\n<\/div>\r\nThe properly executed do phase is very easy to spot. You always:\r\n