DOCSLIB.ORG

QUALITY MANAGEMENT SYSTEMS What Is a QMS

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
QUALITY MANAGEMENT SYSTEMS What Is a QMS QUALITY MANAGEMENT SYSTEMS What is a QMS 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. Copyright 2015 The Center for Business Acceleration. All right reserved 6/6/2015 Why is a QMS important? “Quality management” ensures superior quality products and services. Quality management is essential for customer satisfaction which eventually leads to customer loyalty. Copyright 2015 The Center for Business Acceleration. All right reserved 6/6/2015 14 Points on Quality Management Deming’s 14 Points on Quality Management, a core concept on implementing total quality management, is a set of management practices to help companies increase their quality and productivity. 1. Create constancy of purpose for improving 8. Drive out fear. products and services. 9. Break down barriers between staff areas. 2. Adopt the new philosophy. 10. Eliminate slogans, exhortations and targets 3. Cease dependence on inspection to for the workforce. achieve quality. 11. Eliminate numerical quotas for the workforce 4. End the practice of awarding business on and numerical goals for management. price alone; instead, minimize total cost by 12. Remove barriers that rob people of pride of working with a single supplier. workmanship, and eliminate the annual rating or 5. Improve constantly and forever every merit system. process for planning, production and service. 13. Institute a vigorous program of education 6. Institute training on the job. and self-improvement for everyone. 7. Adopt and institute leadership. 14. Put everybody in the company to work accomplishing the transformation. Copyright 2015 The Center for Business Acceleration. All right reserved 6/6/2015 Quality Management Systems Standards There are many QMS Standards: International Standards Organization (ISO) Capability Maturity Model Integration (CMMI) ITIL - IT Service Management Control Objectives for Information and Related Technology (COBIT) and others Copyright 2015 The Center for Business Acceleration. All right reserved 6/6/2015 Quality Management Systems Principles 8 Principles of Quality Management 1. Customer Focus 2. Leadership 3. Involvement of people 4. Process Approach 5. System approach to management 6. Continual improvement 7. Factual approach to decision making 8. Mutually beneficial supplier relations Copyright 2015 The Center for Business Acceleration. All right reserved 6/6/2015 ISO / CMMI ISO / CMMI Similarities and Differences Maturity Level 4 Subprocesses are CMMI Maturity level 5 focuses on selected that significantly contribute to continually improving process overall process performance. These performance through both selected subprocesses are controlled using incremental and innovative statistical and other quantitative technological improvements. techniques. Level 5 Maturity Level 3, processes are well characterized and Level 4 • Quality management understood, and are system described in standards, Level 3 • Management responsibility procedures, tools, and ISO 9001 methods. • Resource management Level 2 • Product realization Maturity Level 2, • Measurement, analysis requirements, Level 1 and improvement processes, work products, and services are managed. Maturity Level 1, processes are usually ad hoc and chaotic Copyright 2015 The Center for Business Acceleration. All right reserved 6/6/2015 ISO 9001:2008 QMS ISO 9001:2008 Quality management systems — Requirements 4. Quality management system 7. Product realization The organization shall establish, The organization shall plan and document, implement and maintain a quality management system and develop the processes needed for continually improve its effectiveness in product realization. Planning of accordance with the requirements of this product realization shall be consistent International Standard. with the requirements of the other 5. Management responsibility processes of the quality management Top management shall provide evidence system of its commitment to the development 8. Measurement, analysis and and implementation of the improvement quality management system and continually improving its effectiveness The organization shall plan and 6. Resource management implement the monitoring, The organization shall determine and measurement, analysis and provide the resources needed improvement processes needed Copyright 2015 The Center for Business Acceleration. All right reserved 6/6/2015 ISO 9001:2008 QMS REF: ISO 2008 Copyright 2015 The Center for Business Acceleration. All right reserved 6/6/2015 CMMI Development/Services There are several versions of the CMMI. This guide will focus on the models for service delivery (CMMI-SVC) and product development (CMMI-DEV). The two models are tightly linked and complementary to each other. Each model consists of a number of Process Areas containing Specific and Generic Goals and Practices focused on improving performance in a defined area such as project planning or requirements management. Copyright 2015 The Center for Business Acceleration. All right reserved 6/6/2015 CMMI Development/Services Development Maturity Level 3 - Defined Services Maturity Level 3 - Defined DAR - Decision Analysis and Resolution CAM - Capacity and Availability Management IPM - Integrated Project Management DAR - Decision Analysis and Resolution Areas Process 12 OPD - Organizational Process Definition IRP - Incident Resolution and Prevention OPF - Organizational Process Focus IWM - Integrated Work Managements OT - Organizational Training OPD - Organizational Process Definition PI - Product Integration OPF - Organizational Process Focus RD - Requirements Development OT - Organizational Training RSKM - Risk Management RSKM - Risk Management TS - Technical Solution SCON - Service Continuity VAL - Validation SSD - Service System Development 11 Process Areas Process 11 VER – Verification SST - Service System Transition STSM - Strategic Service Management Development Maturity Level 2 - Managed Services Maturity Level 2 - Managed 8 Process Areas 8 Process CM - Configuration Management CM - Configuration Management MA - Measurement and Analysis MA - Measurement and Analysis PMC - Project Monitoring and Control PPQA - Process and Product Quality Assurance PP - Project Planning REQM - Requirements Management PPQA - Process and Product Quality Assurance SAM - Supplier Agreement Management REQM - Requirements Management SD - Service Delivery SAM - Supplier Agreement Management WMC - Work Monitoring and Control 7 Process Areas 7 Process WP - Work Planning Copyright 2015 The Center for Business Acceleration. All right reserved 6/6/2015 CMMI Development/Services Both CMMI Development and Services have the same process areas for Maturity Level 4 and 5 2 Process Areas 2 Process Services Maturity Level 5 - Optimizing CAR - Causal Analysis and Resolution OPM - Organizational Performance Management Services Maturity Level 4 - Quantitatively Managed OPP - Organizational Process Performance QWM - Quantitative Work Management 2 Process Areas 2 Process Copyright 2015 The Center for Business Acceleration. All right reserved 6/6/2015 What’s involved The three factors that impact implementing a QMS are: √ Leadership Commitment √ Effort √ Funding Copyright 2015 The Center for Business Acceleration. All right reserved 6/6/2015 What’s involved For a small to medium-sized firm, it will probably come in the range of 6 - 12 months. If you are a large organization, have a complex system, or are starting from a very low base line, you may require longer. An ISO Audit and CMMI Appraisal both observe the implementation of the QMS across your customers. Copyright 2015 The Center for Business Acceleration. All right reserved 6/6/2015 What’s involved ISO Certification CMMI Certification Internal Cost - the time your Internal Cost - the time your employees will need to employees will need to spend building and spend building and implementing the system implementing the system Initial assessment (optional) Formal Process and Certification audit (Year 1) Appraiser Training Surveillance audits (Year 2 Initial assessment and 3) Certification Appraisal (Year 1 and Year 4) Internal Surveillance audits Copyright 2015 The Center for Business Acceleration. All right reserved 6/6/2015 Why you need to get started Starting small is thinking big. Implementing a QMS that encompasses the organizational structure, policies, procedures, and processes becomes more complex the larger you become. Your employees will appreciate the structure. Especially during on ramp and turnover. Your customer will know you have establish quality processes. It’s often a requirement. It takes time – what is your competitor doing Copyright 2015 The Center for Business Acceleration. All right reserved 6/6/2015 Questions Copyright 2015 The Center for Business Acceleration. All right reserved 6/6/2015 Presenter Presenter: Phillip Selleh Phone: 703-652-0949 Email: [email protected] Over 20 years of Business Process experience ISO 9001:2008 Quality Management Systems Auditor ISO 27001 Information Security Management Auditor CMMI SEI Partner .
Load more

Recommended publications
  • Quality Management System in Trade – Internationalisation of Marketing Relations with Consumers
    UDC: 005.336.3:339.138 COBISS.SR-ID: 211604236 Original research paper Acta Agriculturae Serbica, Vol. XIX, 37 (2014);15-261 Quality Management System in Trade – Internationalisation of Marketing Relations with Consumers Gvozden Jovanović e-mail: [email protected] Katarina Marković Department of Economics, Rayerson University, 350 Victoria St Toronto ON M5B2K3 Canada e-mail: [email protected] Abstract: The aim of marketing management is to satisfy the needs and desiers of consumers. A lot of factors have influenced the consumers and their purchasing. Besides price and assortment factors there are requerements of consumers for the qualitiy of a product. It means that a product should possess physical, chemical, designing, aesthetic, ecological and other desirable properties that should be expressed before the use of products. Because of that the quality in the theory and practice of managment is beginning to affirm itself. This has been particularly expressed by the introduction of ISO 9000 which makes internationalistion of quality system and circulation of goods and services without "physical-fiscal-technical" barriers possible. Key words: internationalisation, trade, consumer, quality, marketing, management, ISO 9000(QMS), ISO 14000(EMS), TQM. Received:09.09.2013. / Accepted:20.01.2014. 16 Acta Agriculturae Serbica, Vol. XIX, 37 (2014); 15-26 New Management Paradigm: Marketing Trade Relationship with Consumers Based on Quality The understanding that the company’s succes primarily depends on the rational use of production factoes, productivity, mass production and cost has long been present in theory. Today this attitude is still not at stake,it is even actualized to the extent to which the factors of production-line goods are expensive and limited.
    [Show full text]
  • Literature Review of QM and SCM: a Perspective of Integration
    View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Universidade do Minho: RepositoriUM Literature review of QM and SCM: a perspective of integration Ana Cristina Fernandes ([email protected]), Huy Truong, Paulo Sampaio, Maria do Sameiro Carvalho Systems and Production Department, Minho University, Braga, Portugal Abstract Purpose – To explore the practices of supply chain management and quality management, in order to study the integration of both management fields by means of a structural model. Design/methodology/approach – An overview of the main concepts of supply chain management and quality management were reviewed from the literature, and some practices have been identified in order to understand how these areas are related to each other, and the benefits that this integration can bring to companies’ performance. Findings –The use of integrated approaches to quality management and supply chain management becomes necessary to accomplish some objectives as produce value and optimize sustainability. Due to similar characteristics of these two management areas as: the adoption of holistic approaches, the promotion of continuous improvement and innovation; customer satisfaction; leadership; strategic planning, among others; they can been seen as complementary, and improved global performance can be achieved from their synergies. Thus, they offer a unique framework to integrate participation and partnership between stakeholders. Research limitations/implications – This paper presents a structural model that is based on a literature review. A comprehensive validation process is required to get further insight on the subject, allowing to understand how companies implement supply chain management and quality management strategies and the way it impacts on the overall organization performance.
    [Show full text]
  • The Nexus Between Supplier Quality Management and Organization’S Competitive Advantage: an Empirical Evidence
    LogForum 2020, 16 (1), 161-170 > Scientific Journal of Logistics < http://doi.org/10.17270/J.LOG.2020.389 http://www.logforum.net p-ISSN 1895-2038 e-ISSN 1734 -459X ORIGINAL PAPER THE NEXUS BETWEEN SUPPLIER QUALITY MANAGEMENT AND ORGANIZATION’S COMPETITIVE ADVANTAGE: AN EMPIRICAL EVIDENCE Khairul Anuar Mohd. Ali Universiti Kebangsaan Malaysia, Selangor, Malaysia ABSTRACT . Background: Due to the increasing demand on product quality and operation efficiency, supplier quality management has become increasingly important in supporting organizations to achieve the desired excellence. With the rapid globalization happening in these few decades, the business world is experiencing a higher complexity phase. However, there are only a limited number of studies that has been conducted on supplier quality management (SQM) and organization’s competitive advantage (OCA) in the context of multinational corporations (MNC). The purpose of this study is to identify critical elements in supplier quality management as well as testing the significance of supplier quality management in affecting organization’s competitive advantage. Methods: This study employed self-administered questionnaire that has been distributed to 355 respondents and the data is analyzed using Statistical Program for the Social Science (SPSS) software version 23. The population of study is concentrated on multinational corporations in Malaysia. Results: The results revealed that 5 elements have been identified as critical elements for supplier quality management namely Tracking of Cost of Supplier Quality, Supplier Audit, Supplier Scorecard, Close Loop Corrective Action and Engagement of Suppliers in Quality System. Conclusions: The findings of the study show that supplier quality management is found to be significantly affecting organization’s competitive advantage in positive direction.
    [Show full text]
  • Quality Management
    DEPARTMENT OF HEALTH AND HUMAN SERVICES ENTERPRISE PERFORMANCE LIFE CYCLE FRAMEWORK <OPDIV Logo> PPPRRRAAACCCTTTIIICCCEEESSS GGGUUUIIIDDDEEE QUALITY MANAGEMENT Issue Date: <mm/dd/yyyy> Revision Date: <mm/dd/yyyy> Document Purpose This Practices Guides is a brief document that provides an overview describing the best practices, activities, attributes, and related templates, tools, information, and key terminology of industry-leading project management practices and their accompanying project management templates. This guide is focused on practices that should be applied to ensure the project will satisfy business needs, objectives, and requirements. Background The Department of Health and Human Services (HHS) Enterprise Performance Life Cycle (EPLC) is a framework to enhance Information Technology (IT) governance through rigorous application of sound investment and project management principles and industry’s best practices. The EPLC provides the context for the governance process and describes interdependencies between its project management, investment management, and capital planning components. The Quality Management Plan is an important component of a Project Management Plan deliverable. The discipline of quality management complements project management with its focus on customer satisfaction, prevention of defects over inspection, management responsibility, and continuous improvement. Practice Overview Project Managers should assume responsibility for the development of quality policies for the project and the coordination of related activities, in compliance with any organizational and/or regulatory standards. A Quality Management Plan documents this information and describes the authorities, policies, tools and techniques that are specific to ensuring project excellence, reducing cost and eliminating unnecessary corrections and/or changes. It is important to note that the concept of quality does not necessarily require perfection.
    [Show full text]
  • Export Quality Management
    Export Quality Management A Guide for Small and Medium-Sized Exporters SECOND EDITION USD 70 ISBN 978-92-9137-399-4 United Nations Sales No. E.12.III.T.2 © International Trade Centre 2011 Physikalisch-Technische Bundesanstalt Technical Cooperation The International Trade Centre (ITC) is the joint agency of the World Trade Organization and the United Nations. Address: Bundesallee 100 38116 Braunschweig, Germany A free PDF of this publication is available on ITC’s website at: Street address: ITC www.intracen.org/publications 54-56, rue de Montbrillant Telephone: +49 531 592-82 20 1202 Geneva, Switzerland Printed copies of ITC publications can be purchased from ITC’s website: Fax: +49 531 592-82 25 www.intracen.org/eshop and from: Postal address: ITC Palais des Nations E-mail: [email protected] ► United Nations Publications 1211 Geneva 10, Switzerland Sales and Marketing Internet: www.ptb.de/q5 300 E 42nd Street Telephone: +41-22 730 0111 9th Floor, IN-919J New York, NY 10017 Fax: +41-22 733 4439 United States of America https://unp.un.org E-mail: [email protected] Tel: 1-800-253-9646 Fax: 212-963-3489 Internet: http://www.intracen.org E-mail: [email protected] EXPORT QUALITY MANAGEMENT A GUIDE FOR SMALL AND MEDIUM-SIZED EXPORTERS SECOND EDITION Geneva 2011 ii ABSTRACT FOR TRADE INFORMATION SERVICES ID=42653 2011 F-09.03 EXP International Trade Centre (ITC) Physikalisch-Technische Bundesanstalt (PTB) Export Quality Management: A Guide for Small and Medium-sized Exporters. Second edition. Geneva: ITC, 2011. xii, 270 pages Guide seeking
    [Show full text]
  • Quality Control
    Topic Gateway Series Quality control Quality Control Topic Gateway Series No. 37 1 Prepared by Bill Haskins and Technical Information Service July 2007 Topic Gateway Series Quality control About Topic Gateways Topic Gateways are intended as a refresher or introduction to topics of interest to CIMA members. They include a basic definition, a brief overview and a fuller explanation of practical application. Finally they signpost some further resources for detailed understanding and research. Topic Gateways are available electronically to CIMA members only in the CPD Centre on the CIMA website, along with a number of electronic resources. About the Technical Information Service CIMA supports its members and students with its Technical Information Service (TIS) for their work and CPD needs. Our information specialists and accounting specialists work closely together to identify or create authoritative resources to help members resolve their work related information needs. Additionally, our accounting specialists can help CIMA members and students with the interpretation of guidance on financial reporting, financial management and performance management, as defined in the CIMA Official Terminology 2005 edition. CIMA members and students should sign into My CIMA to access these services and resources. The Chartered Institute of Management Accountants 26 Chapter Street London SW1P 4NP United Kingdom T. +44 (0)20 8849 2259 F. +44 (0)20 8849 2468 E. [email protected] www.cimaglobal.com 2 Topic Gateway Series Quality control Definition Definitions
    [Show full text]
  • Pm4dev, 2016 –Management for Development Series ©
    pm4dev, 2016 –management for development series © Project Quality Management PROJECT MANAGEMENT FOR DEVELOPMENT ORGANIZATIONS Project Quality Management PROJECT MANAGEMENT FOR DEVELOPMENT ORGANIZATIONS A methodology to manage development projects for international humanitarian assistance and relief organizations © PM4DEV 2016 Our eBook is provided free of charge on the condition that it is not copied, modified, published, sold, re-branded, hired out or otherwise distributed for commercial purposes. Please give appropriate citation credit to the authors and to PM4DEV. Feel free to distribute this eBook to any one you like, including peers, managers and organizations to assist in their project management activities. www.pm4dev.com Project Quality Management PROJECT QUALITY MANAGEMENT Quality management is the process for ensuring that all project activities necessary to design, plan and implement a project are effective and efficient with respect to the purpose of the objective and its performance. Project quality management (QM) is not a separate, independent process that occurs at the end of an activity to measure the level of quality of the output. It is not purchasing the most expensive material or services available on the market. Quality and grade are not the same, grade are characteristics of a material or service such as additional features. A product may be of good quality (no defects) and be of low grade (few or no extra features). Quality management is a continuous process that starts and ends with the project. It is more about preventing and avoiding than measuring and fixing poor quality outputs. It is part of every project management processes from the moment the project initiates to the final steps in the project closure phase.
    [Show full text]
  • Models, Techniques and Indicators of Quality Management Assessment in Manufacturing Industries Over the Past Decade
    International Journal of Applied Research in Management and Economics ISSN 2538-8053 Models, Techniques and Indicators of Quality Management Assessment in Manufacturing Industries Over the Past Decade Atieh Tavakoli1, Amir Azizi2 1 Science and Research Branch, Islamic Azad university, Iran 2 Science and Research Branch, Islamic Azad university, Iran ([email protected]) ARTICLE INFO ABSTRACT Keywords: In this study 36 articles from reputable databases; "Scopus", Quality "TPBin", "google Scholor", and "Research Gate" have been Quality management considered. The focus of this paper was on manufacturing Quality Criteria industries key issues of quality management has been recited and Quality Assessment analyzed in this research ways. Therefore, on the basis of previous studies and evaluations, the involved components in the field of quality management have been investigated as the competitive advantages. During a period of 10 years since 2008 to 2018 as well as 1386 to 1396, various researches have been carried out in the field of manufacturing industries which indicate the importance of this managerial aspect and preference of top managers to improve production and optimization of the resources of their companies. Finally, models, common techniques and various measurement indicators of Quality Management along with important points and efficiency level of each of them have been identifies and presented. Introduction Service is a kind of product that has a significant share in the business and has enjoyed high qualitative and quantitative development in the third millennium. Services and quality have become a key tool in achieving competitive differentiation and promoting loyalty of customers. Today, the issue of products and services is a major problem that has affected all societies.
    [Show full text]
  • The Relationships Between Quality Management Practices and Purchasing
    9c THE RELATIONSHIPS BETWEEN QUALITY MANAGEMENT PRACTICES AND PURCHASING Elisabete Maria da Fonseca Correia Profesora de Gestión y Contabilidad Estudiante de doctorado en Ciencias Empresariales Instituto Superior de Contabilidade e Administração de Coimbra Instituto Politécnico de Coimbra Área temática: C) Dirección e Organization Key-words: Purchasing, TQM, supplier management, quality practices 1 THE RELATIONSHIPS BETWEEN QUALITY MANAGEMENT PRACTICES AND PURCHASING Resumen Como resultado del creciente interés en la gestión de la cadena de suministro, la calidad se convirtió en un factor importante en el proceso de valor añadido que participan en la producción y entrega de productos a lo largo de la cadena de suministro. Además, la función de compras ha comenzado a desempeñar un papel más estratégico de las organizaciones, especialmente en la aplicación de conceptos de la gestión de la cadena de suministro y externalización de sus actividades. Curiosamente, en este nuevo contexto, ya pesar de la creciente importancia de estos dos temas en la literatura, la relación entre estas dos cuestiones no se aborda exhaustivamente. El objetivo principal de este trabajo es llenar este vacío. Se examina cómo las prácticas de gestión de la calidad se puede implementar en Compras, y el impacto que puede tener Compras en la consecución de la calidad. Con este fin, se realizó una revisión inicial de las principales cuestiones en la gestión de calidad permitiendo además analizar y comprender las relaciones entre estos dos aspectos Abstract As a result of the increased interest in supply chain management, quality became an important factor in the value-adding process involved in the production and delivery of products along the supply chain.
    [Show full text]
  • Just in Time, Value Chain, Total Quality Management, Part of Technical Strategic Management Accounting
    INTERNATIONAL JOURNAL OF SCIENTIFIC & TECHNOLOGY RESEARCH VOLUME 5, ISSUE 04, APRIL 2016 ISSN 2277-8616 Just In Time, Value Chain, Total Quality Management, Part Of Technical Strategic Management Accounting Lesi Hertati, Dr. Rumbiandini Sumantri Abstract: This article aims to determine, Just In Time, Value Chain Total Quality Management ( tqm ) as a technique in management accounting stategis.Tujuan Just In Time, value chain or value chain, Total Quality Management (TQM ) is strategic for customer satisfaction in the long term obtained from the information. Quality information is the way to continuous improvement in order to increase the company's financial performance in the long term to increase competitive advantage. Strategic Management Accounting process, gather competitor information, explore opportunities to reduce costs, integrate accounting with emphasis on the strategic position of the competition is a great plan. An overall strategic plan, interrelated and serves as the basis for achieving targets or goals ahead. Keywords: Just In Time,Value Chain, Total Quality Management, Strategic Management Accaunting. ———————————————————— 1. INTRODUCTION More anjut Garrison et al (2013: 9) says 1) proximity to the The strategy is how a company align its capabilities with the customer intends menyanpaikan you should choose us opportunities available in the market to achieve their end because we are better than competitors in adapting our (Horngren et al 2006: 4). Further Horngren et al (2004: 6) products and services to your individual needs, 2) says the strategy is a decision that is the most important operational excellence intended to convey to pelamggan part of the task manager, management accounting shoulder them "you should choose us because we send the products to shoulder with managers formulate strategies by providing and services faster, more accurate, and less expensive 3) information about the source competative advantage.
    [Show full text]
  • The Impact of Applying the Total Quality Management Model on the Performance of the Telecom Organizations in Romania
    A Service of Leibniz-Informationszentrum econstor Wirtschaft Leibniz Information Centre Make Your Publications Visible. zbw for Economics Busu, Cristian; Busu, Mihail Article The impact of applying the total quality management model on the performance of the telecom organizations in Romania Amfiteatru Economic Journal Provided in Cooperation with: The Bucharest University of Economic Studies Suggested Citation: Busu, Cristian; Busu, Mihail (2017) : The impact of applying the total quality management model on the performance of the telecom organizations in Romania, Amfiteatru Economic Journal, ISSN 2247-9104, The Bucharest University of Economic Studies, Bucharest, Vol. 19, Iss. Special Issue No. 11, pp. 1035-1049 This Version is available at: http://hdl.handle.net/10419/196407 Standard-Nutzungsbedingungen: Terms of use: Die Dokumente auf EconStor dürfen zu eigenen wissenschaftlichen Documents in EconStor may be saved and copied for your Zwecken und zum Privatgebrauch gespeichert und kopiert werden. personal and scholarly purposes. Sie dürfen die Dokumente nicht für öffentliche oder kommerzielle You are not to copy documents for public or commercial Zwecke vervielfältigen, öffentlich ausstellen, öffentlich zugänglich purposes, to exhibit the documents publicly, to make them machen, vertreiben oder anderweitig nutzen. publicly available on the internet, or to distribute or otherwise use the documents in public. Sofern die Verfasser die Dokumente unter Open-Content-Lizenzen (insbesondere CC-Lizenzen) zur Verfügung gestellt haben sollten,
    [Show full text]
  • Quality Management System (QMS) for Apis
    Quality Management System (QMS) for Active Pharmaceutical Ingredients (API) Manufacturers integrating GMP (ICH Q7a) into ISO (9001: 2000) September 2005 APIC / CEFIC Quality Management System - integrating GMP (ICH Q7a) into ISO (9001: 2000) Page 2 of 73 Table of Contents I. Introduction II. Objective and Scope III. Quality Management Systems for API manufacturers 1. Quality Management System 2. Management responsibility 3. Resource management 4. Product realization (Manufacturing Operations) 5. Measurement, analysis and improvement (Evaluation Activities) IV. Supplementary Information 1. Identification of system approaches in Q7a 2. Description of processes 3. Structure of a Quality Manual 4. Cross-reference of APIC QMS documents (from “old” to “new”) 5. Assistance for implementation of a QMS 6. Matrix GMP(Q7a) / ISO (9001:2000) V. Glossary VI. Abbreviations VII. References VIII. Acknowledgements APIC / CEFIC Quality Management System - integrating GMP (ICH Q7a) into ISO (9001: 2000) Page 3 of 73 I. Introduction The changing regulatory environment In a Science Board Meeting held in November 2001, FDA raised some concerns regarding the efficiency of the pharmaceutical industry. The factors contributing to this situation were identified as follows: • Pharmaceuticals are complex, multivariate physicochemical systems that are - Often treated (during development) as univariate systems (one-factor-at-a-time, trial- and-error experimentation) - Physical properties of materials normally not well characterized - Equipment selection based on tradition - Process factors are not well understood • Development is done under time crunch • Post approval changes require regulatory oversight It was said that a higher efficiency is required in order to provide high quality drugs to the market in a timely manner, to successfully take advantage of the new drug development opportunities offered by advances in chemistry and biology.
    [Show full text]