Master of Business Administration- SMU MBA Semester 4 QM0015 ISO/QS 9000 Elements - 4 Credits Assignment Set- 1 (60 Marks)

Note: Each question carries 10 Marks. Answer all the questions. 1. Describe the eight quality management principles on which the quality standards of the ISO 9000 are based.
There are eight quality management principles which can be used to base efficient, effective and adaptable QMS. They are customer focus, leadership, people involvement, process approach, system approach, continuous improvement, factual decision making and mutually beneficial supplier relationships. Sufficient audits and reviews are important for the QMS to function properly. Audits are performed to make sure that the actual methods follow the documented procedures. The system reviews can be carried out regularly and systematically to make sure that the system will achieve the necessary effect. The basic steps in audits are initiation, preparation, execution, reporting and completion. A QMS review will take place, once a year, which should cover outcome of audits, customer feedback, process and product conformity, status of preventative and corrective actions, follow up actions from other management reviews, changes that can impact the QMS and recommend improvements. There are three kinds of assessments. They are first-party assessment, second-party assessment and independent third-party assessment. If the assessment is done by an internal audit team then it is called the first-party assessment. If the assessment is made by an external audit team then it is called the second-party assessment. If the assessment is done by an independent organisation which is not connected to the customer or supplier and is acceptable to both of them, then it is called independent third-party assessment. The various tools and techniques of QMS are cause-and-effect diagram, Pareto analysis, statistical process control, quality costing, departmental purpose analysis, failure mode and effect analysis, flow-charting, check sheet, histogram, scatter plot, graphs and mistake proofing. Plan-DoCheckAct cycle is a four step model used to carry out change. The four steps are: Plan - Used for recognising an opportunity. Do - To test the change. Check - Review the test, analyse the result. Act - Action based on the check step. The advantages of implementing a Quality Management System will include: Involvement of top management will help to understand their responsibility. Proactively understanding customers needs with a view to achieve customer satisfaction.

 Improved internal and external communications. Better monitoring and management of the organisations processes. Understanding how the statutory and regulatory needs can impact the organisation and the consumers.

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Clear tasks and authorities for all staff. Improved use of time and resources. Greater consistency and traceability of services. Improved morale and motivation of staff. A Quality Management System, in accordance with ISO 9001:2000 will bring in consistency in the work flow and improvement of working practices which in turn can result in products and services that will meet the patients needs. ISO 9000 is the most commonly used international standard that gives a framework for an effective Quality Management System. ISO 9000 is a generic name given to a family of standards developed to provide a framework around which a Quality Management System can effectively be implemented. One of the series of Quality Management System is ISO 9001 which helps to bring out the best in an organisation. ISO 9001 series of standards consist of: ISO 9000 (Fundamentals and vocabulary) - It introduces a user to the concepts behind the management systems and mentions the terminology used. ISO 9001 (Requirements) - It sets out the criteria required to operate according to the standard and obtain certification. ISO 9004 (Guidelines for performance improvement) - It is based on eight quality management principles which are designed to be used by senior management as a framework to guide the organisation towards improving performance by considering the requirements of the interested parties and not just consumers. ISO 9001 is suitable for organisations looking to improve the way it is operated and managed irrespective of the size or sector. However, the best returns on investment come from the organisations that are prepared to implement it throughout their organisation rather than at particular sites, departments or divisions.

2. What is QS 9000? Discuss the background of QS 9000. 3. Describe the importance of Quality manual. 4. Write a note on purchasing in QS 9000. Explain the importance of purchasing. 5. What is meant by product identification with respect to QS 9000? Explain its importance. 6. Write a note on in-process inspection and testing.

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Master of Business Administration- SMU MBA Semester 4 QM0015 ISO/QS 9000 Elements - 4 Credits Assignment Set- 2 (60 Marks)

Note: Each question carries 10 Marks. Answer all the questions. 1. Discuss the importance of handling of inventory. 2. What is meant by contract review? Explain.

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3. What is meant by documentation? What are the main objectives of documentation? 4. Write a note on traceability and its importance. 5. How do you evaluate and deal with non-conforming products? 6. Explain the importance of training. What is training needs assessment? What are the activities performed during and aftertraining?