In: Business and Management

Submitted By imanhamdy55
Words 13133
Pages 53

ISO 9001
Fourth edition 2008-11-15

Quality management systems — Requirements
Systèmes de management de la qualité — Exigences

Reference number ISO 9001:2008(E)

© ISO 2008

Provided by Pronorm AS for Det Norske Veritas AS (DNV) 2008-11-19. Reproduction is not allowed.

ISO 9001:2008(E)

PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area.

Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

© ISO 2008 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyright@iso.org Web www.iso.org Published in Switzerland


© ISO 2008 – All rights reserved

Provided by Pronorm AS for Det Norske Veritas AS (DNV) 2008-11-19. Reproduction is not allowed.

Adobe is a trademark of Adobe Systems…...

Similar Documents


...Quality Associates, Inc., a consulting firm, advises its clients about sampling and statistical procedures that can be used to control their manufacturing processes. IN one particular application, a client game quality associates a sample of 800 observations taken during a time in which that client's process was operating satisfactorily. The sample standard deviation for there data was .21 ; hence, with so much data, the population standard deviation was assumed to be .21. Quality associates then suggested that random samples of size 30 be taken periodically to monitor the process on an ongoing basis. BY analyzing the new samples, the client could quickly learn whether the process was operating satisfactorily. when the process was not operating satisfactorily, corrective action could be take to eliminate the problem. the design specification indicated the mean for the process should be 12. the hypothesis test suggested Quality Associates follows. : μ=12 : μ12 Corrective action will be take any time H0 is rejected. The following samples were collected at hourly intervals during the first day of operation of the new statistical process control procedure. These data are available in the data set Quality . Sample 1 Sample 2 Sample 3 Sample 4 11.55 11.62 11.91 12.02 11.62 11.69 11.36 12.02 11.52 11.59 11.75 12.05 11.75 11.82 11.95 12.18 11.90 11.97......

Words: 588 - Pages: 3


...system is going to work best for your company. Overall an ERP will give your small business a technology solution that has the benefits of what a larger corporation uses. For the many benefits an ERP will give your small company there is very little risk. An ERP requires a minimal investment that can lead to much greater returns for your business. It is well worth it to consider implementing an ERP for your company, no matter what the size. Kayode Ajewole, PMP http://en.wikipedia.org/wiki/Cloud_computing http://en.wikipedia.org/wiki/SalesForce “You can be a large or small company and still benefit from cloud computing. We no longer have a scenario where small organisations can’t afford rich applications and can deliver high quality services and products.” ...

Words: 549 - Pages: 3


...Deming’s 14 Points – Total Quality Management #8. Drive out fear, so that everyone may work effectively for the company. Encourage effective two-way communication and other means to drive out fear throughout the organization so that everybody may work effectively and more productively for the company. Fear is a barrier to improvement: wherever there is fear, we get the wrong figures. Fear in work is opposite to joy in work. Fear of change is a big barrier to be overcome: remember, people don’t resist change, they resist being changed! The need is for everybody to be part of the change, and to own the change process. Some common expressions of fear: I am afraid that I may lose my job because the company will go out of business. I have a feeling that Dave (higher up) may move to another company. If he does, what will happen to me? I could do my job better if I understood what happens next. I am afraid that I may not always have an answer when my boss asks me something. I am afraid to admit that I made a mistake. My boss believes in fear. How can he manage his people if they don’t hold him in awe? Management is punitive. Without an atmosphere of mutual respect, no statistically based system of management will work. Deming always says that this point is one of the most important for management to work on, because it affects nine of the other points: * break down departmental barriers * cease dependence on mass inspection * institute education and......

Words: 439 - Pages: 2


...1. How is quality defined? What is the goal of total quality management (TQM)? Why is TQM important? In general, quality may be defined as meeting or exceeding the requirements, needs, and expectations of the customer—whether or not those needs have been articulated. Garvin (1988) identified eight dimensions of quality: 1. Performance: measurable primary characteristics of a product or service 2. Features: added characteristics that enhance the appeal of a product or service 3. Conformance: meeting specifications or industry standards 4. Reliability: consistency of performance over time 5. Durability: useful life of a product or service 6. Serviceability: resolution of problems and complaints 7. Aesthetics: the sensory characteristics of a product or service 8. Perceived: quality: subjective assessment of quality based on cues related to the product Parasuraman, Zeithaml, and Berry (1988), identified five dimensions to service quality: 1. Reliability: ability to perform the promised service dependably and accurately 2. Responsiveness: willingness to help customers and provide prompt service 3. Assurance: employees’ knowledge, courtesy, and their ability to inspire trust and confidence 4. Empathy: caring, individualized attention given to customers 5. Tangibles: appearance of physical facilities, equipment, personnel, and written material TQM is a philosophy that involves everyone in an organization in a......

Words: 9796 - Pages: 40


... | Executive summary The following report outlines the quality philosophy, system and approaches of Food and Beverage department in IHG and production process of Haier; discuss similarities and evaluate the differences of them. This report also concerns on how different quality system and approaches have impact on IHG in terms of innovation, change and competitiveness. In addition, recommendation given for IHG to overcome problems they are facing. Table of contents 1. Introduction 2. Compare and contrast the different quality philosophy ,systems and approaches 3. Analyse the differences and evaluate the impact of these differences on innovation, change, and competitiveness. 3.1 analyse the differences 3.2 evaluate the differences impact on innovation, change and competitiveness 4. Recommendations 1. Adopting an external measures 4.1.1 Adopting external measures impact on change 4.2 Training and Reward 4.2.1 Training and reward impact on innovation 2. Training and reward impact on competitiveness 4.3 Further area to consider 5. Conclusion 6. Reflection 1. Introduction Quality is “the totality of features and characteristics of product or service which bears on its ability to meet stated or implied needs” (Holmes, 1992). Traditional approaches to quality were focus on inspection. In the modern commercial environment,......

Words: 3630 - Pages: 15


...reducing and preventing hospital acquired infections (Pratt, Pellowe, & Wilson, 2007). Despite CDC guidelines stating that hand washing is the single most important procedure to prevent nosocomial infection and the relative simplicity of this procedure, adherence to hand hygiene recommendations of healthcare workers is unacceptably low, usually well below 50% (Pittet, Allegrazi, & Boyce, 2009). Nursing-Sensitive Quality Indicator The use of nursing-sensitive indicators as a measure of quality care is a relatively new development in the healthcare industry. It wasn’t until the mid-1990s that many national healthcare organizations and regulatory agencies began to recognize a correlation between certain interventions performed by nurses and the overall quality and safety performance of healthcare institutions (Erickson, 2011). A broad definition of nursing-sensitive quality indicators might be: a set of standardized performance measures intended to help hospitals assess the extent to which nursing interventions have an impact on patient safety, quality, and the professional environment (Erickson, 2011). Hospital Acquired Infections Nurses play a pivotal role in preventing hospital acquired infections, not only by ensuring that all aspects of their nursing practice is evidence based, but also through nursing research and patient education. As patient advocates, nurses are in the unique position to affect change to improve patient standards. The nurse has many......

Words: 2884 - Pages: 12


...Case Study: Quality Management in the Oil Industry Assignment Questions Toyota is well known for Just-In-Time production, but this is only a building block of the larger production philosophy that it calls the Toyota Production System (TPS). In this class, we will see what TPS is about and how it applies to a specific problem. On 1 May 1992, Doug Friesen, manager of assembly at the company’s Georgetown, Kentucky Plant, is concerned about quality problems with seat installation and wonders how best to resolve them and to which he should give highest priority. With sales approaching plant capacity, it is crucial that Friesen choose the most effective path in light of TPS and the realities of the plant organization. 1. As Doug Friesen, what would you do to address the seat problem? Where would you focus your attention and solution efforts? 
 2. What options exist? What would you recommend? Why? 
 3. Where, if at all, does the current routine for handling defective seats deviate from the principles of the Toyota Production System? 
Please explain. 4. What is the real problem facing Doug Friesen? 
Please analyze carefully and provide details. Instructions 1. Work in groups of 3. i.e. Two “independent” groups. 2. Before you meet with your group, please read the case at least twice: First time a fast read, second time by paying attention to details. After your meeting, before the class, read it again. 3. Please send me a......

Words: 287 - Pages: 2


...Management Quality and Competitiveness Christoph H. Loch Stephen E. Chick Arnd Huchzermeier ● Management Quality and Competitiveness Lessons from the Industrial Excellence Award Prof. Dr. Christoph H. Loch INSEAD Boulevard de Constance 77305 Fontainebleau Cedex France christoph.loch@insead.edu Prof. Dr. Arnd Huchzermeier WHU-Otto Beisheim School of Management Burgplatz 2 56179 Vallendar Germany ah@whu.edu Prof. Stephen E. Chick INSEAD Boulevard de Constance 77305 Fontainebleau Cedex France stephen.chick@insead.edu ISBN 978-3-540-79183-6 e-ISBN 978-3-540-79184-3 Library of Congress Control Number: 2008925414 © 2008 Springer-Verlag Berlin Heidelberg This work is subject to copyright. All rights are reserved, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilm or in any other way, and storage in data banks. Duplication of this publication or parts thereof is permitted only under the provisions of the German Copyright Law of September 9, 1965, in its current version, and permission for use must always be obtained from Springer. Violations are liable to prosecution under the German Copyright Law. The use of general descriptive names, registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and...

Words: 62386 - Pages: 250


...Task 1 Quality is an important aspect in any business. Quality is what makes an organisation stand out from their competitors. I have been saying that quality is important but what is really quality. According to ISO (9000:2005) states: “Degree to which set of inherent characteristics fulfil requirements”. Therefore in other words MFS ltd to set such characteristics in their supermarket outlets and make sure that these characteristics are being followed; so that MFS ltd will achieve quality. This is further supported by Dale, Wiele and Iwaarden (2013) where in their book they wrote that quality “is the process of transformation by which all parts of the organisation has to focus on quality with the ultimate objective of customer satisfaction and delight.” Therefore this is basically stating that for an organisation such as MFS ltd so that they reach the ultimate goal i.e. customer satisfaction. Additionally Haigh and Morris (1994) state that quality “is a process that embraces conscious striving for zero defects”. From this one can understand that MFS ltd should aim for zero defects in their service in the supermarkets which will help them get the best quality that they can reach. They are also saying that even when MFS ltd thought they have the best quality they should try to aim to improve it more (Allotey, 2013) Therefor from the above one can see that quality is a type of lifestyle that MFS ltd should adopt so that it can have the best service that can be achieve......

Words: 258 - Pages: 2


...Total Quality Pioneers Paper MGT/449 August 29, 2011 Total Quality Pioneers Paper Quality, its elements, and how together made made the pioneer successful. These elements of quality are useful in today’s environment and the future of quality. Quality is defined in many ways. Although there is not just one accepted definition of quality there are enough similarities that do exist among the definitions. Quality involves meeting or exceeding the customer’s expectations. It applies to products, services, people, process and the environment. Quality is an ever-changing state, what is considered quality today may not be good enough to be considered quality tomorrow (Goetsch & Davis, 2010). General Electric is a company that has been succeeding since the early 1900’s. It uses the Six Sigma strategy. It is a highly disciplined process that helps focus on developing and delivering near-perfect products, and services. Sig Sigma focuses on three key elements of quality: Customer, Process and Employee. The “Customer” expects performance, reliability, competitive prices, on-time delivery, service, clear and correct transaction processing and more. The “Process” requires for the company to look at their business from the customer's perspective, not theirs. The “Employee” quality is the responsibility of every employee. Every employee must be involved, motivated, and knowledgeable if any company is to succeed (General Electrics, 2011). Many people have contributed......

Words: 571 - Pages: 3


...PENILAIAN PENGIKTIRAFAN PENGURUSAN KUALITI MENYELURUH BERDASARKAN TOTAL QUALITY FAST TRACK MODEL (TQFTM) untuk: Universiti Tenaga Nasional (UNITEN) SDN. Tarikh Penilaian : 1 & 3 Jun 2011 Penilai : Dr. Mohd. Azman Idris En. Safuan Idris En. Idrus Ali Pn. Faizah Baba Pn. Aliza Zainal Munir Disediakan oleh; PUSAT PENGURUSAN KUALITI & PERUSAHAAN, SIRIM Berhad Segala maklumat yang terkandung dalam laporan ini adalah milik penuh SIRIM Berhad dan merupakan maklumat komersial yang khusus untuk UNITEN.  (17 Jun 2011) SIRIM Berhad Penggunaan atau pendedahan segala maklumat adalah tertakluk kepada perkara yang dinyatakan di muka surat hadapan dokumen ini PENGENALAN Penilaian Pengiktirafan Pengurusan Kualiti Menyeluruh berdasarkan Total Quality Fast Track Model (TQFTM) dilaksana pada 1 Jun 2011 di Kolej Pengurusan Perniagaan & Perakaunan (COBA) di UNITEN Kampus Sultan Haji Ahmad Shah, Bandar Muadzam Shah, Pahang, manakala pada 3 Jun 2011, penilaian dilaksanakan di UNITEN Kampus Putrajaya bagi Bahagian Pengurusan Universiti, Kolej Kejuruteraan, IT dan Asas & Pengajian Am. Penilaian bertujuan untuk mengenalpasti amalan dan pelaksanaan di UNITEN berbanding kriteria penilaian TQFTM sebelum UNITEN dianugerahkan dengan sijil TQFTM SIRIM Berhad. Hasil penilaian ini juga akan membantu UNITEN mengenalpasti ruang - ruang peningkatan dalam pengurusan kualiti operasi keseluruhan organisasi untuk membantu UNITEN dalam usaha yang berterusan ke......

Words: 3398 - Pages: 14


...Quality Improvement Implementation Paper The following paper we will learn about the manufacturing process of Hartman Industries. We will also learn about what the organization should do in order to improve its business processes with the help of quality management system. The paper will also tell what quality management system the organization should implement. We will also learn about the manufacturing process of Hartman Industries while discovering how the organization can benefit from application of our chosen recommendations. Quality Management System Quality management system process is a method by which an organization can easily improve its processes. It is a part of quality management system and is a business excellence process. This process will be very useful in improving processes of Hartman Industries. Hartman Industries are the leader of plastic injection molding industry. It specializes in creating innovative plastic designs and has earned international acclaim for these designs. The attributes which give competitive edge to this organization are attention to detail, good quality control standards and precision in work. If quality management system processes are applied to this organization then the organization can further improve its processes (Gitlow, 2001). The organization has incorporated the use of best practices and components in its manufacturing system. It uses high quality of polymer in manufacturing; it has a well maintained R&D......

Words: 1075 - Pages: 5


...Quality Management Businesses need to provide quality service to be successful. Many of them, however, struggle to retain their customers, seasoned employees and market share among other vital elements due to the poor quality of their goods and services. Deciding, implementing and execution of quality management initiatives are challenging tasks to many managers of small businesses but it can be easy with good planning. Failure to get this right can spoil the operating environment and destroy businesses’ belief in meeting customers’ need. Businesses and firms need therefore to define and measure their goals, update service tools, motivate employees, and use customer feedback to serve them appropriately. When the management involves all employees, it can engage in tactical quality management approaches such as conducting audits, compliance management, preventive and corrective actions, and statistical process control that drive improvements. When employees are not engaged, they do not feel to be part of the process and, therefore, the firm may lose direction. This paper discusses ten quality management improvement initiatives to improve companies’ poor performances. First, management that is committed to improving quality of its company should provide internal education (Shah, 2013). The modern technology is changing very fast, and so are customers' needs, preferences and tastes. Employees should be educated regularly as a way of making sure they are updated. Existing and......

Words: 2361 - Pages: 10


...notes for quality from quality book HEALTHCARE QUALITY AND THE PATIENT Maulik S. Joshi and Donald Berwick Quality in the U.S. healthcare system is not what it should be. People were aware of this issue for years from personal stories and anecdotes. Around the end of the last century, three major reports revealed evidence of this quality deficiency: • The Institute of Medicine’s (IOM) National Roundtable on Health Care Quality report, “The Urgent Need to Improve Health Care Quality” (Chassin and Galvin 1998) • To Err Is Human (Kohn, Corrigan, and Donaldson 2000) • IOM’s Crossing the Quality Chasm (IOM 2001) These three reports made a tremendous statement and called for action on the state of healthcare, its gaps, and the opportunity to improve its quality in the United States to unprecedented levels. Before we begin discussion of these reports, however, let us begin by defining quality, its evolution, and its implications on our work as healthcare professionals. Avedis Donabedian, one of the pioneers in understanding approaches to quality, discussed in detail the various definitions of quality in relation to perspective. Among his conceptual constructs of quality, one view of Donabedian’s (1990) rang particularly true: “The balance of health benefits and harm is the essential core of a definition of quality.” The question of balance between benefit and harm is empirical and points to medicine’s essential chimerism: one part science and one part art......

Words: 374 - Pages: 2


...GM588 Final Project Proposal Outline Gary Silva Title - “Quality for Life through Best in Quality Practice” Name of Organization and Background - Diabetes Care is a rapidly growing and emerging company which employs approximately 30, who appear to either meet or exceed their company’s expectations, with net sales of approximately $3.2 million. Classified as a medical device manufacturer. To be more specific their Primary SIC Code is Medicinals and botanicals (2833), in simpler terms, they manufacture medical devices. Primary products are Insulin delivery systems. Some of the major components of the assembly are made from and injection molding process using thermal plastics then moved to a secondary plastics joining assembly operation using a unique process technology offered by BRANSON Ultrasonics Corp. called Radiance Laser Welding. Introduction of the Problem - Quality is essential. They must produce product under the scrutiny of FDA guidelines, which in itself is a very costly and extensive process. Therefore it is imperative that they get things right. Goal is similar to any other company, which is, increased sales and market share. Out of their many challenges, what may be one of the biggest is to build good product without generating any plastics flash and particulate matter, thereby reducing potential risk of some type of loose foreign body being introduced into the human body through injection then flowing along the blood stream possibly...

Words: 550 - Pages: 3