...ISO 9001:2008 Internal Auditor Checklist Copyright ©2008 The 9000 Store INTERNAL AUDIT CHECKLIST ISO 9001:2008 4 Quality Management System 4.1 General Requirements Has your organization established a management system (QMS) giving consideration to: a) Identifying the processes needed and the application of the processes throughout the organization: b) Determining the sequence and interaction of the processes? c) Determining the criteria and methods for operation and control of the processes? d) Ensuring the availability of resources and information to support the processes? e) Monitoring, measuring and analyzing these processes? f) Implementing actions to achieve planned results and the continual improvement? If your organization out sources any processes that affects product conformity, are the outsourced process controlled and identified? Additional questions Observation/Comments Results 4.2 Documentation Requirements 4.2.2 Quality Manual Does your organization have a quality manual? Does it include the following: a) The scope of your QMS and justifications and details of any exclusions b) The documented procedures for the QMS or reference them? c) A description of interactions between the processes of the QMS? Additional questions ©Copyright 2008 The 9000 Store Page 2 of 23 INTERNAL AUDIT CHECKLIST ISO 9001:2008 4.2.3 Control of Documents Does your organization have a formal procedure regarding the control...
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...MetricStream ISO 9001:2015 Discovers Risk-Based Thinking Since its launch in 1987, the ISO 9001 standard has stipulated the requirements for a certifiable Quality Management System (QMS) to ensure the consistent manufacturing of reliable, high-grade products. The ISO 9000 family for QMS provides organizations with the necessary guidance and tools for increased product quality, customer satisfaction, and a sustainable methodology to identify improvement. The new version of ISO 9001:2015 QMS, due to be published by September 2015, will center on managing risks in an efficient manner. ISO 9001 over the Years The International Organization for Standardization (ISO) was founded in 1946 to establish a common set of standards in trade, manufacturing, and technology, and it comprises national standards institutes and organizations of 163 countries worldwide. Every five years, the entire suite of ISO standards undergoes an overhaul to keep it current and updated. ISO 9001 provides a quality management standard for employees, facilities, infrastructure, training, services, and equipment across the enterprise. It was first developed in 1987 from the military, American National Standards institute (ANSI), Canadian Standards Association (CSA) and British Standards Institute (BSI) standards with 20 elements, also known as ‘buckets’. In 1994, this standard went through a minor revision with many additions and changes such as new requirements for a quality manual, quality planning and design validation...
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...Systèmes certifiés de management II. LA QUALITÉ 1. Les normes ISO 9000 1.1. Historique Années 1950 : développement des premières normes de management et d’assurance qualité. ; principalement dans. Sont concernés : les grands pays industrialisés et certains secteurs (domaines militaire, nucléaire, aéronautique, spatial et médical). Années 1970 : élaboration de normes nationales conduisant à la création d’un comité technique ISO (1979) chargé de l’élaboration des normes sur le management et l’assurance qualité. Normes portant sur la mise en œuvre de systèmes de management de la qualité = normes assez anciennes (première version : 1987). Première version comprenant 4 normes : ISO 9001, 9002 et 9003 couvrant des aspects différents du management de la qualité (du plus complet au plus minimaliste) ; ISO 9004 = guide pour les entreprises souhaitant aller plus loin dans l’amélioration de leurs performances. Première révision en 1994 : introduction d’évolutions dans les domaines de la planification, de l’action préventive et des clients. 3 Seconde révision en 2000 portant sur des aspects beaucoup plus importants : écoute client, approche processus et amélioration continue. La révision de 2000 a remplacé les normes ISO 9001, 9002 et 9003 par une seule norme, la norme ISO 9001:2000. Objectif du remplacement : simplification de la structure des normes et réduction de leur nombre. Nouvelle norme = norme générique applicable à tous les organismes...
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...ISO 9001- 2008 | ISO 9001- 2015 | 8. Medición, análisis y mejora | 8. Operación | 8.1 Generalidades | 8.1 Planificación y control operacional. | 8.2 Seguimiento y medición | 8.2 Requisitos para productos y servicios. | 8.2.1 Satisfacción del cliente | 8.3 Diseño y desarrollo de productos y servicios. | 8.2.2 Auditoría interna | 8.4 Control de procesos, productos y servicios suministrados externamente. | 8.2.3 Seguimiento y medición de procesos | 8.5 Producción y provisión del servicio. | 8.2.4 Seguimiento y medición del producto | 8.6 Liberación de los productos y servicios. | 8.3 Control del producto no conforme | 8.7 Control de las salidas no conformes. | 8.4 Análisis de datos | | 8.5 Mejora | | 8.5.1 Mejora continua | | 8.5.2 Acción correctiva | | 8.5.3 Acción preventiva | | | | N/A | 9. Evaluación | N/A | 9.1 Seguimiento, medición, análisis y evaluación. | N/A | 9.2 Auditorías Internas | N/A | 9.3 revisión por la dirección. | | | N/A | 10. Mejora | N/A | 10.1 Generalidades. | N/A | 10.2 No conformidades y acciones correctivas. | N/A | 10.3 Mejora continua. | La ISO 9001 es una norma internacional que se aplica a los sistemas de gestión de calidad (SGC) y que se centra en todos los elementos de administración de calidad con los que una empresa debe contar para tener un sistema efectivo que le permita administrar y mejorar la calidad de sus productos o servicios. 8. OPERACIÓN Muestra la importancia en el funcionamiento...
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...México, reconocida por su calidad en el servicio, su personal, su equipo y sus procesos internos, con presencia en todo el País, manteniendo un crecimiento constante y controlado. Valores • Seguridad • Calidad en el servicio • Compromiso • Disciplina operativa • Desarrollo del personal • Responsabilidad • Respeto • Relaciones a largo plazo En el tema calidad menciona lo siguiente: Nos especializamos en el transporte de material peligroso y refrigerado a nivel nacional e internacional. Nuestra calidad es respaldada por certificaciones como ISO 9001, C-TPAT y Sari, por la ANIQ. En conclusión esta empresa muestra en su página de Internet un herramienta de mercadotecnia más que una descripción objetiva de le empresa, se muestra como una gran empresa con grandes capacidades sin embargo en el tema de Valores y calidad tiene una descripción sencilla, como la empresa anterior muestra que cuanta con al norma ISO 9001 la cual es un modelo para documentar los procedimientos actuales y en su página web no describe que por medio de la calidad busque el éxito. Tercera empresa Analizada: http://www.larmex.com/certificaciones/ En su página de Internet en cuanto a calidad y valores menciona lo siguiente: Nuestra Polí¬tica de la Calidad. En Transportes LAR MEX estamos comprometidos en ofrecer un servicio de Autotransporte de Carga con calidad, para satisfacer las necesidades y requerimientos pactados con nuestros clientes,...
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...Another important function of the IEEE standards is collision detection. Before data is transferred in a network, there ought to be a check whether the network line if free. Once the network is free, then data can be transferred from one user to another. The IEEE 802 detects fragments of transmission in the network and signifies the users. The above functions justify the importance of IEEE 802 in a network system (Lu et al., 2015). Standards Organizations ISO is the international organization for standardization. ISO 9001:2000 standard is critical for quality systems that outside auditors analyze. The standard is based on design, documentation, testing, production, and servicing among others. ANSI is the American national standards institute, which is the main standards body in the United States. It works together with ASQ and IEEE to ensure the provision of the best...
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...future decisions. The ISO 9000 and MBNQA standards and criteria are the two most frequently used audit standards in the United States. Can John conduct an audit of his company’s quality management system given its present state? Discuss - A quality management system (QMS) is a collection of business processes focused on achieving quality policy and quality objectives to meet customer requirements. It is expressed as the organizational structure, policies, procedures, processes and resources needed to implement quality management. Business success may simply be the extent to which your organization can produce a higher-quality product or service than your competitors are able to do at a competitive price. When quality is the key to a company’s success, quality management systems allow organizations to keep up with and meet current quality levels, meet the consumer’s requirement for quality, retain employees through competitive compensation programs, and keep up with the latest technology. So no I don’t think John can conduct a proper audit. He’s missing too much important paper work. What are some of the documentation requirements that John must address on order to develop his quality management system so that they comply with ISO9001? - Quality Manual - The quality manual defines how each requirement of the rather generic ISO 9001:2008 standard is applied at the company. In a sense, the ISO 9001 quality manual is a company specific version of the ISO 9001:2008 standard. The...
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...Pittsburgh Headquarters 105 Bradford Road Suite 400 Wexford, PA 15090 724.934.9000 724.935.6825 Fax info@SRIRegistrar.com www.SRIRegistrar.com Six Sigma, ISO 9001 and Baldrige Many organizations ask “How Do these programs, processes and standards support each other?” These initiatives are not mutually exclusive, in fact, understanding and applying all, some or part can greatly improve your business performance. The following is an overview of how they work together. What is Six Sigma? Six Sigma is a statistically-based process that strengthens organizational capacity for ongoing process improvement. “Six Sigma” or “six standards of deviation” aims to reduce defects to a rate of 3.4 defects per million defect opportunities by identifying and eliminating causes of variation in business processes. In defining defects or errors, Six Sigma focuses on developing a clear understanding of customer requirements and is therefore very customer focused. The DMAIC Methodology. The Six Sigma process is based on a concept called DMAIC: • Define – clearly identify the problem, the requirements of the project and objectives of the project • Measure – to fully understand the current performance • Analyze – the measurements collected to determine and validate the root cause(s) • Improve – developing ideas to remove the root causes of variation and implement the solutions • Control – to establish standard measures to maintain performance and to correct problems as needed Motorola invented this...
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...Date: 10th March 2014 Lecturer: Paul Tracey | | | | Table of Content Item Page Introduction 2 What is ISO 9001 - Quality management system........................................2 ISO 9001:2008…………………………………………….........................2 The Concept of Quality Management……………..…………………...….3 The major clauses and sub-clause are:…....………….…………………....4 Quality Management Principles:…………………………………………..5 Audits, reviews and assessments…………………………………………..6 Single-Loop Learning Model……………………………………………...6 Double-Loop Leaning Model………………………………………….......7 References………………………………………………………………....8 Appendix…………………………………………………………………..8 Assess how a quality management system standard is supposed to work to aid the relationship or relationships between a buying organisation and its supplying organisations. Introduction Any organisation can benefit from implementing an effective quality management system. The foundation of a quality organisation is the concept of the customer and supplier working together for their own benefit of receiving the end product in the way in which they want the product to be. For this to be effective, the customer-supplier interfaces must extend internally and externally in the organisation. What is ISO 9001 - Quality management system? The ISO 9001 addresses certain aspects of quality management and contains some of ISO’s standards. The standards provide guidance and tools for companies and organizations...
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...ISO 9000 From Wikipedia, the free encyclopedia The ISO 9000 family of standards relate to quality management systems and are designed to help organizations ensure they meet the needs of customers and other stakeholders (Poksinska et al, 2002 [1] ). The standards are published by ISO, the International Organization for Standardization and available through National standards bodies. ISO 9000 deals with the fundamentals of quality management systems (Tsim et al, 2002 [2] ), including the eight management principles (Beattie and Sohal, 1999;[3] Tsim et al, 2002 [2]) on which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill. Third party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over a million organizations worldwide [4] are independently certified, making ISO 9001 one of the most widely used management tools in the world today. Contents [hide] 1 Reasons for use 2 Background 3 Global adoption 4 Contents of ISO 9001 4.1 Summary of ISO 9001:2008 in informal language 4.2 1987 version 4.3 1994 version 4.4 2000 version 4.5 Certification 5 Auditing 6 Industry-specific interpretations 7 Effectiveness 7.1 Advantages 7.2 Problems 8 See also 9 References 10 Further reading 11 See also 12 External links [edit]Reasons for use The global adoption of ISO 9001 may be attributable to a number of factors. A number of major...
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...A STRATEGIC ANALYSIS OF FARIDABAD METAL UDYOG PVT LTD A STRATEGIC ANALYSIS OF FARIDABAD METAL UDYOG PVT LTD ------------------------------------------------- SUBMITTED BY:- ------------------------------------------------- HARSHITA VERMA () ------------------------------------------------- ISHITA BHUYAN (12810038) ------------------------------------------------- NIKHIL () ------------------------------------------------- JYOTI NALKHALIYA () ------------------------------------------------- KARUN SETHI () ------------------------------------------------- KAMAL DEEP () ------------------------------------------------- ------------------------------------------------- SUBMITTED BY:- ------------------------------------------------- HARSHITA VERMA () ------------------------------------------------- ISHITA BHUYAN (12810038) ------------------------------------------------- NIKHIL () ------------------------------------------------- JYOTI NALKHALIYA () ------------------------------------------------- KARUN SETHI () ------------------------------------------------- KAMAL DEEP () ------------------------------------------------- Contents INTRODUCTION FARIDABAD METAL UDYOG PVT LTD is largely into manufacturing of high quality LPG cylinders. The main focus is being committed to customer satisfaction adhering to the highest standards of quality. Faridabad...
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...INTERNATIONAL STANDARD 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. COPYRIGHT PROTECTED DOCUMENT © 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...
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...ration manag ISO 9000 - Quality management The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved. Standards in the ISO 9000 family include: * ISO 9001:2015 - sets out the requirements of a quality management system * ISO 9000:2015 - covers the basic concepts and language * ISO 9004:2009 - focuses on how to make a quality management system more efficient and effective * ISO 19011:2011 - sets out guidance on internal and external audits of quality management systems. ISO 9001:2015 ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001. This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement.Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits. ...
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...ISO 9000 1.0. WHAT IS ISO 9000? ISO, an abbreviation for International Organization for standardization, is a global network of bodies that identifies the standards required by businesses, government and society, develops them in collaboration with sectors that will use them, and adopts them as stipulated international standards. The organization “is located in Switzerland and was established in 1947 to develop common international standards in many areas. Its members come from over 120 national standards bodies.” (Praxiom research group limited, 2005). ISO 9000 is concerned with the quality of production of goods and services by individuals or corporate bodies. It stipulates standards and mandates compliance with them from such individual or corporate bodies as have signified to the ISO their interest to deliver high-quality goods and services. The ISO standards apply to a very extensive range of services and production, including “manufacturing, processing, printing, legal and financial services, publishing, health care, utilities, education, instrumentation, farming, consultation, horticulture…” (Ibid) Compliance with ISO 9000 streamlines the structure of an organization or company towards guaranteed vitality and sustainability. “Your organization can output faster, reduce costs, and be more competitive in the marketplace. … Compliance makes you a more attractive trading partner, in that it demonstrates your ability to meet standards and deliver on...
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...ISO (the International Organization for Standardization) ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. ISO 9000 The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved. Standards in the ISO 9000 family include: * ISO 9001:2008 - sets out the requirements of a quality management system * ISO 9000:2005 - covers the basic concepts and language * ISO 9004:2009 - focuses on how to make a quality management system more efficient and effective * ISO 19011:2011 - sets out guidance on internal and external audits of quality management systems. ISO 14000 The ISO 14000 series of standards was developed by ISO Technical Committee...
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