Quality Management Systems Standards

Total Page:16

File Type:pdf, Size:1020Kb

Quality Management Systems Standards Quality Management System Standards wo studies have revealed that over- attributable to numerous factors, some that all awareness of the ISO 9000 Inter- are obvious and inherent in our business Tnational Quality Management culture, such as accelerated schedules and ISO 9000 System Standards among U.S. businesses is delivery requirements, increased labor still below 50 percent [1] [2]. This article costs, increased customer expectations, and standards are good is intended to increase general awareness international competition. Another factor for helping owners, shareholders, execu- that is significant in this evolution is the business practices tives, and project managers address “Human Factor.” Basically, people have inevitable decisions regarding the stan- pride in their work and in general do not that will improve dards. In particular, project managers are like to have it “inspected,” especially with faced with the daily responsibility for the potential fear of being wrong. communications, ensuring provisions exist for implementing The most significant factor with the requirements described in the standards entire quality management issue is: Who is efficiency, and applicable to project-specific products responsible for product or service quality and/or services. throughout the processes of performing the profits while Currently, it is true that ISO quality work internal and external to each organi- standards apply to fairly well defined busi- zation? It is this very factor that is the root reducing errors, ness sectors and applications. However, cause for some continued confusion over over time these standards will prove their ownership of quality with many companies scrap, and rework. inherent quality improvement benefits for in U.S. business sectors. The most funda- any application. Also, as more owners, mental step in starting any quality manage- executives, and project managers recognize ment effort is to formally address this issue that baseline requirements in the standards so there is no doubt about the various qual- are merely good business practices that will ity-related roles within the company. The improve communications, efficiency, and primary tool of the Quality Professional for profits while reducing errors, scrap, and assisting the company with quality efforts is rework, the standards will automatically the quality management plan (discussed become prerequisites for managing pro- later). jects and operating companies. Project The three primary quality management managers will benefit by more accurately issues that most companies are currently measuring project quality performance. addressing for their own specific reasons are Total Quality Management (TQM), International Quality Movement Malcolm Baldrige National Quality Award, The concept of quality management has and ISO 9000 Quality System Standards. rapidly evolved and matured during the Each of these has its own set of objectives, Paul W. Gladieux past decade. Quality, as it applies to the conditions and criteria. A simple review operations of a business, has moved for- and comparison of the following TQM ward from the classical “Inspection Func- principles, Baldrige values/concepts, and tion” (error detection) to the more modern ISO system elements reveals common qual- “Quality Management Systems” approach ity-related data as it applies to overall com- (error prevention). This evolution is pany performance. 22 PM Network • February 1995 Figure 1. Timeline Toward ISO 9000 Standards [6] European Spain and Removal of Coal and Steel EC Greece Portugal Trade Community Established Joins EC Join EC Barriers ’51 ’58 ’81 ’86 EC – 92 ? ? ’49 ’57 ’73 ’85 ’87 ★ ★★ NATO Treaty of Rome Denmark EC Single European Act (SEA) Belgium Ireland White Amended Treaty France and U.K. Paper of Rome Germany Joins EC Italy Luxemburg Netherlands TC – 176 ISO 9000 ISO 9000 Formed Standards Standards Published Revised ’80 ’87 ’94 ★ Treaty of Rome: Goal to create integrated community-wide market free of restrictions on movement of goods, services, people, and capital. ★★ SEA: Goal of completing the Single Internal Market by 1992 and restructuring decison-making procedures. TQM/Baldrige/ISO Principal support for the program quality system registration. Achieving Total Quality Management. During the comes from The Foundation for the registration does not guarantee defect- early and mid ’80s many events took Malcolm Baldrige National Quality free products and services; however, it place that helped shape what is now Award, established in 1988. The award does demonstrate that a company has a generally accepted as TQM principles. is named for Malcolm Baldrige, who system in place for affecting and improv- Some of the events included The served as Secretary of Commerce from ing quality—a distinct competitive Department of Defense Master Plan on 1981 until his tragic death in 1987. The advantage. System development/registra- TQM, the Commerce Department’s award criteria framework addresses tion takes 9 to 24 months, depending on concerns with foreign competition, seven core values and concepts: leader- the company scope of operations. The numerous new books on workplace ship; information and analysis; strategic 1994 revised standards include guide- changes including Japan’s work quality planning; human resource lines and contractual models: processes, and the influences of U.S. development and management; man- Guidelines quality gurus W. Edwards Deming, agement of process quality; quality and ISO 9000-01 Guidelines on Selection Joseph M. Juran, Phil Crosby, and operational results; customer focus and and Use Armand V. Feigenbaum. The principles satisfaction. ISO 9004-01 Guidelines on Manage- of TQM include determine customers’ ISO 9000 Quality Systems Stan- ment/System Elements requirements; perform to customers’ dards. The five generic quality manage- Contractual Models requirement; implement defect preven- ment standards were developed by the ISO 9001 20 Quality Management tion systems; performance measurement International Organization for Stan- Elements (full scope) by cost of quality; zero defects as com- dardization (Technical Committee TC- ISO 9002 19 Quality Management pany performance standard; everyone 176) based in Geneva, Switzerland [3]. Elements accountable for meeting requirements The committee was commissioned in ISO 9003 16 Quality Management (total employee involvement). 1980 and the standards were published Elements Malcolm Baldrige National Quality in 1987. The standards (includes three Award. This award was created by Pub- for contractual definition) provide a For example, ISO 9001, Quality lic Law 100-107 and signed into law on basis for implementing and improving Management System Elements (20 full August 20, 1987 [4]. The Award Pro- quality management and quality assur- scope), includes: gram, responsive to the purposes of ance within any product or service 4.1 Management Responsibility Public Law 100-107, led to the creation company. Ultimately the standards pro- 4.2 Quality System of a new public-private partnership. vide the basis for a company to achieve 4.3 Contract Review PM Network • February 1995 23 ■ ISO 9000 Figure 2. Timeline Toward Quality System Excellence TQM ? ? Malcolm No Quality Meet ISO 9000 Baldridge World-Class System Specifications Standards Award System Military ISOs Plus Deming Beyond Standards Industry-Specific Prize Deming Standards ??When Do You Implement TQM Principles? 4.4 Design Control require numerous products to be identi- standpoint (see historical key dates, 4.5 Document and Data Control fied with applicable CE Product Marks below). Also, ISO has not received the 4.6 Purchasing prior to entry into the European mar- visibility in the U.S. that TQM/Baldrige 4.7 Control of Customer-Supplied ket (CE—Communaute Europeene—is have, primarily because the perception Product a six-character label, the 3rd through is that ISO 9000 is only a requirement 4.8 Product Identification/Traceability 5th characters specify under which to perform work in Europe. Some 4.9 Process Control accrediting body certification was pro- companies have spent thousands of 4.10 Inspection and Testing vided) [9]. ISO 9000 quality system dollars trying to achieve Baldrige status 4.11 Inspection, Measuring, and Test implementation and registration in and then usually figure out that they do Equipment many cases will be the method used to not even have the basic quality man- 4.12 Inspection and Test Status verify, through documentary evidence, agement system that ISO addresses. 4.13 Control of nonconforming Product that products conform to specified Finally, the ironic part is that ISO will 4.14 Corrective and Preventive Action requirements. help provide the system framework for 4.15 Handling, Storage, Packaging, The standards have been adopted describing the quality data required for Presentation and Delivery by numerous countries around the TQM and Baldrige, even though ISO 4.16 Control of Quality Records globe and overwhelmingly adopted may not be a company requirement 4.17 Internal Quality Audits and implemented in the EC. U.S. rep- (see timeline towards quality system 4.18 Training resentatives from the Department of excellence) [5]. 4.10 Servicing Commerce and Office of European It is important, for perspective, to 4.20 Statistical Techniques Community Affairs are concerned that have the following key dates in mind in American companies have not posi- the development of quality concepts: tioned themselves soon enough for EC-92 Timeline Toward ISO achieving
Recommended publications
  • Facilitating Project Management Through Effective Quality Management: the Need for Implementing ISO 9000 in Construction
    Built-Environment-Sri Lanka -Vol. 03, Issue 02:2003 Facilitating project management through effective quality management: the need for implementing ISO 9000 in construction N.D. Gunawardena Abstract This paper describes the relationship between project management and quality management. It identifies the similarity between the recognised project quality management processes and the ISO 9001 quality management system; then it illustrates how ISO 9001 quality requirements could be applied to construction project management. The paper also presents the results of a survey carried out to identify quality management practices adopted by local construction companies, using ISO 9001 standard as a yardstick. According to the survey, the companies had some shortcomings with respect to quality management during the construction stage. The results indicate that the lack of proper quality management could, in turn, affect the project management adversely; this point is supported by the Project Management Process Maturity Model, which is a quality improvement model that uses five levels to determine the relative maturity of any organisation and its ability to achieve cost and schedule objectives of a project. Finally, the paper suggests that the quality managements systems based on ISO 9000 could be very effective in facilitating the project management efforts in the construction industry. Introduction A project can be defined as a complex, non-routine, parties must have mutual understanding as to what one-time effort limited by time, budget, resources and services are to be provided by the contractor in return performance specifications (Gray and Larson, 2000). for the agreed consideration; this usually is ensured by Project Management is the application of knowledge, a set of documents such as drawings and specifications skills, tools and techniques to project activities in order that define the scope and the performance aspects of to meet or exceed stakeholder need and expectations the product.
    [Show full text]
  • Influence of ISO 9001 Certification on Project Management Performance in Software Industry
    European Online Journal of Natural and Social Sciences 2018; www.european-science.com Vol. 7, No.3(s) Special Issue on Contemporary Research in Social Sciences ISSN 1805-3602 Influence of ISO 9001 certification on project management performance in software industry Anum Safder*, Samina Yousaf Comsats Institute of Information Technology, Lahore, Pakistan *E-mail: [email protected] Abstract For the success of software projects, the Project Management is considered as an important tool. Organizations can understand Project Management Performance in an improved way if they exercise Quality Management System. This empirical study investigates the impact of ISO 9001 certification on Project Management Performance (six constructs of PMP) and how PM Performance varies for ISO- certified software houses and Non-certifies software houses. Data was collected from project managers of both ISO-certified and Non-certificated software organizations registered under P@SHA and PSEB of Pakistan. 192 questionnaires were used for analysis. Independent Sample t- test was used for conducting the analysis and results concluded that software houses with ISO- certification show a better PM Performance than with no certification. Keywords: Project Management, ISO 9001 certification, software industry. Introduction Currently, project management is being extensively used in business. Quality management and project management are two interlinked terms and can be described in similar manner. The situation in which there is a strong influence of repetitious processes, the quality management is most successful field. In reference to the project management process, how to conduct a project is a scenario where there is a very vivid effect of QM which is slightly ignored or a limited focus is paid on its effect by academic professional.
    [Show full text]
  • IT Gurus and Gadgets
    a Volume 2, No. 10, November-December 2011 ISSN 1729-8709 IT gurus and gadgets • Guest Interview : Sony and the value of standards th • ISO 34 General Assembly INDIA a Contents Comment Sadao Takeda, ISO Vice-President (policy) Tech-timing – Creating tomorrow’s gadgets today ................................................... 1 ISO Focus+ is published 10 times a year World Scene (single issues : July-August, November-December) International events and international standardization ............................................ 2 It is available in English and French. Guest Interview Bonus articles : www.iso.org/isofocus+ ISO Update : www.iso.org/isoupdate Ken Wheatley – Sony Electronics, Inc. .................................................................... 3 The electronic edition (PDF file) of ISO Special Report Focus+ is accessible free of charge on the Daring visions – Laying the foundations for innovation .......................................... 8 ISO Website www.iso.org/isofocus+ An annual subscription to the paper edition Gurus and ICT standards – Translating visions into technical success stories ....... 10 costs 38 Swiss francs. Cloud computing – Building firm foundations for standards development ............. 12 Publisher Entertainment of the future – From 3D to virtual reality ........................................ 15 ISO Central Secretariat (International Organization for Zoomed in – The evolving landscape of digital photography .................................. 18 Standardization) 1, chemin de la Voie-Creuse Driving
    [Show full text]
  • ISO Focus, November 2008.Pdf
    ISO Focus The Magazine of the International Organization for Standardization Volume 5, No. 11, November 2008, ISSN 1729-8709 e - s t a n d a rdiza tio n • Siemens on added value for standards users • New ISO 9000 video © ISO Focus, www.iso.org/isofocus Contents 1 Comment Elio Bianchi, Chair ISO/ITSIG and Operating Director, UNI, A new way of working 2 World Scene Highlights of events from around the world 3 ISO Scene Highlights of news and developments from ISO members 4 Guest View Markus J. Reigl, Head of Corporate Standardization at ISO Focus is published 11 times a year (single issue : July-August). Siemens AG It is available in English. 8 Main Focus Annual subscription 158 Swiss Francs Individual copies 16 Swiss Francs Publisher ISO Central Secretariat (International Organization for Standardization) 1, ch. de la Voie-Creuse CH-1211 Genève 20 Switzerland Telephone + 41 22 749 01 11 Fax + 41 22 733 34 30 E-mail [email protected] Web www.iso.org Manager : Roger Frost e-standardization Acting Editor : Maria Lazarte • The “ nuts and bolts” of ISO’s collaborative IT applications Assistant Editor : Janet Maillard • Strengthening IT expertise in developing countries Artwork : Pascal Krieger and • The ITSIG/XML authoring and metadata project Pierre Granier • Zooming in on the ISO Concept database ISO Update : Dominique Chevaux • In sight – Value-added information services Subscription enquiries : Sonia Rosas Friot • Connecting standards ISO Central Secretariat • Standards to go – A powerful format for mobile workers Telephone + 41 22 749 03 36 Fax + 41 22 749 09 47 • Re-engineering the ISO standards development process E-mail [email protected] • The language of content-creating communities • Bringing the virtual into the formal © ISO, 2008.
    [Show full text]
  • ISO 9000: Is It Worth It? ISO 9000: an Ineffective Quality System Chris Heffner, Steven C
    ISO 9000: Is It Worth It? ISO 9000: An Ineffective Quality System Chris Heffner, Steven C. "Swede" Larson, Barney "Tim" Lowder and Patti Stites ISO 9000 was created as a family of models in 1987, based on a wartime British manufacturing standard, as the answer to perceived manufacturing problems with quality and safety. The program was originally published in 1987 by the International Organization for Standardization (ISO), which is a specialized international agency that focuses on the standardization of organizational processes. The organization is composed of standards from organizations representing 90 countries. ISO 9000 was quickly adopted as the premier standard to ensure uniform manufacturing and auditing processes. The program went through a major revision in 2000 and now includes ISO 9000:2000 (definitions), ISO 9001:2000 (requirements) and ISO 9004:2000 (continuous improvement). But even after these major revisions, the program is often criticized as ineffective for a wide variety of reasons. We agree. Overemphasis on Inspection First, many researchers believe ISO 9000 is ineffective because it is based on conservatism, overemphasizes inspections and audits, and fails to encourage real improvement. Barnes (2000), for example, said that the current commercial certification process results in a "pursuit of quality certificates, as opposed to a pursuit of quality." Johannsen (1995) also asserted that the ISO concept does not incorporate the advances of Total Quality Management because it is "narrow, static and emphasize[s] conformance to specifications" (p. 234). After overseeing more than 50 ISO registrations, Bill Robinson (cited in Clifford, 2005), argued that ISO is not one of the better systems that can be used for process improvement.
    [Show full text]
  • NGDA Baseline Standards Inventory Companion Guide
    The Companion Guide: Achieving an NGDA Baseline Standards Inventory A Baseline Assessment to Meet Geospatial Data Act, Federal Data Strategy, and Other Requirements Federal Geographic Data Committee August 31, 2020 Contents Introduction .................................................................................................................................................. 1 Approach ....................................................................................................................................................... 2 Outcomes ...................................................................................................................................................... 2 How to Use this Document ........................................................................................................................... 2 Geospatial Data and Metadata Standards .................................................................................................... 3 Data Standards Categories ............................................................................................................................ 5 Data Content Standards Category Definitions .......................................................................................... 5 Data Exchange Standards Definitions ....................................................................................................... 8 Metadata Standards Categories ..................................................................................................................
    [Show full text]
  • ISO 9000 Standards, a Baseline for Excellence
    ISO 9000 Standards, A Baseline for Excellence Companies, like Durace// and Foxboro, that move rapidly today and get registered will find they have asignificant edge. Asbj0rn Aune and Ashok Rao As the European Community (EC) lurches happened when mandatory standards related toward its January 1993 unification deadline, it to health, safety, and environmental issues are "Some customers let us skip is requiring each member country to adopt a not satisfied. These standards are in the process the audit because we are single national quality standard, ISO 9000, as of being written for a variety of products. Some ISO certified. We hope some­ a baseline for excellence. In 1987 the Euro­ of the products for which they have already day to have a list ofthose pean Committee for Standardization (ECS) been written are toys, some pressure vessels, adopted the ISO 9000 standards, renaming gas appliances, electro-medical deVices, and certified companies ­ them EN29000 standards. construction products. When toys not meeting Foxboro might be able to Atruly international organization, ISO these standards were admitted by British Cus­ skip their audit. We could (The International Organization for Standard­ toms, the Local Trading Standards Officers cut down on everybody's ization) is made up of representatives from the were able to ban distribution. work. " standards boards of 91 countries, including the American companies planning to do Dick Anderson, The Foxboro Company United States. business in the EC and those already involved The ECS objective? The patchwork of need to understand these standards and the each country's multiple technicai standards certification process. hindered the free flow of goods.
    [Show full text]
  • Selection and Use of the ISO 9000 Family of Standards Selection and Use of the ISO 9000 Family of Standards
    ISO 9000 Selection and use of the ISO 9000 family of standards Selection and use of the ISO 9000 family of standards The ISO 9000 family of international qual- ity management standards and guidelines has earned a global reputation as a basis for establishing effective and efficient qual- ity management systems. The need for International Standards is very important as more organizations operate in the global economy by selling or buying products and services from sources outside their domestic market. This brochure provides This brochure has been developed by ISO you with : technical committee ISO/TC 176, Quality management and quality assurance, which • An of overview is responsible for developing and main- the ISO 9000 family of taining the ISO 9000 family. Supporting core standards guideline standards and other documents • A step-by-step process are developed and updated on a continual to implement a quality basis to meet the needs and expectations management system of users and the market itself. This publication was developed • Examples of typical appli- The brochure provides a general perspec- by ISO/TC 176, the ISO technical cations of the standards, tive on the ISO 9000 family and explains committee specialized in quality and how you can use it to improve your quality management system. It gives an overview management. For further information • A bibliography listing the of the standards and demonstrates how, on ISO 9001 and related standards, ISO 9000 family of standards collectively, they form a basis for continual visit https://committee.iso.org/tc176sc2.
    [Show full text]
  • Risk Management in Iso 9000 Series Standards
    RISK MANAGEMENT IN ISO 9000 SERIES STANDARDS Evgeny Avanesov Working Party on Regulatory Cooperation and Standardization Policies ECONOMIC COMMISSION FOR EUROPE Groupe de travail des politiques de coopération en matière de réglementation et de normalisation COMMISSION ÉCONOMIQUE POUR L’EUROPE Рабочая группа по политике в области стандартизации и сотрудничества по вопросам нормативного регулирования ЕВРОПЕЙСКАЯ ЭКОНОМИЧЕСКАЯ КОМИССИЯ The papers carry the names of the authors and should be cited accordingly. The findings, interpretations, and conclusions expressed in this paper are entirely those of the authors. They do not necessarily represent the views of the United Nations, or those of the governments they represent. © The Authors. All rights reserved. No part of this paper may be reproduced without the permi ssion of the authors. RISK MANAGEMENT IN ISO 9000 SERIES STANDARDS Evgeny Avanesov D.B.A., Member of Russian delegation in ISO/TС 176, ISO/TC 207 Introduction The international community has developed a number of documents in some way related to the standardization of approaches to risk management. The International Organization for Standardization (ISO), together with the International Electrotechnical Commission (IEC) are the lead organizations in the development of international standards. Some national standardization bodies and non-governmental organizations also have contributed to the development and use of standardized approaches to risk management. The most important national and international standards for the risk management
    [Show full text]
  • Customer Focus
    Customer whom it solves basic problems in production and distribution, but to the focus whole of society. Although ISO is an organization whose principal activity is Organizations depend the development of technical standards, on their customers and those standards also have important economic and social repercussions. therefore should understand current and “The International Standards which ISO develops are useful to business future customer needs, organizations in all sectors, to govern- should meet customer ments and other regulatory bodies, to requirements and strive conformity assessment professionals, to their customers and, ultimately, to exceed customer to ordinary people in their roles as expectations. consumers and the end users of products and services.” Quality Management Principle 1: Customer focus Two actions in particular highlighted ISO 9000:2000 ISO’s efforts to enhance the satisfaction of its customers and other interested parties: the introduction of business plans for the developers of ISO standards, and SO’s performance in 2000 was marked I the conference for the chairpersons of by determination to put into practice ISO’s standards-development committees. the customer focus which is one of the principles underlying the revised ISO 9000:2000 series of quality management system standards whose publication on 15 December was one of the major business events of the year. For the more ambitious organization, the revised standards offer a framework for going even beyond customer focus to identifying and meeting the needs and expectations of other interested parties, such as employees, investors, suppliers and society as a whole. This evolution of the ISO 9000 series mirrors the wide range of groups that benefit from ISO standards.
    [Show full text]
  • The Engineering, Design, and Fabrication Facility: a Unique APL Resource
    H.K.CHARLES,JR.,ANDJ.A.WEINER The Engineering, Design, and Fabrication Facility: A Unique APL Resource Harry K. Charles, Jr., and Joel A. Weiner The Engineering, Design, and Fabrication (EDF) Facility is a unique resource providing a wide range of development, engineering, design, fabrication, and testing services for APL and its external customers. The facility consists of modern laboratories and specialized equipment and processes. It is staffed by skilled engineers, scientists, technicians, and craftspeople, all dedicated to the production of high-quality electronic, electromechanical, and mechanical hardware. The EDF is a flexible, dynamic resource that responds rapidly to customer needs in both traditional and new business arenas. With its technology and personnel, the EDF is poised to deliver advanced services and hardware for many years to come. (Keywords: Electronic services, Engineering design, Fabrication, Hardware, Mechanical and material services, Prototyping.) INTRODUCTION The Engineering, Design, and Fabrication Facility from the Department’s computer and information sys- (EDF) of the Technical Services Department (TSD) is tems services (especially computer-aided engineering) an integrated Laboratory resource for the development, and fiscal administration. The groups are functionally design, fabrication, testing, and qualification of proto- aligned, with a minimum of overlap and service dupli- type, one-of-a-kind, and limited-quantity advanced cation. Figure 1 illustrates the major facility capabilities electronic, electromechanical, and mechanical hard- and service functions. Further details of EDF services ware. The facility consists of extensive equipment and can be found in articles by Hider et al. and Wilson et laboratory resources, coupled with the expertise of al., this issue, and Ref.
    [Show full text]
  • A Review of Existing Operational Risk Management Decision Support Tool
    2669 A REVIEW OF OPERATIONAL RISK MANAGEMENT DECISION SUPPORT TOOL Hood Atan Lead Auditor/Principal Consultant Exergy Management Consultant PLT, Malaysia [email protected] Edly F. Ramly Certification Director EFR Certification Sdn Bhd, Malaysia e.ramly@efrcertification Musli Mohammad, Mohd Shahir Yahya Department of Manufacturing and Industrial Engineering, Faculty of Mechanical and Manufacturing Engineering, Universiti Tun Hussein Onn Malaysia (UTHM), Batu Pahat, Johor [email protected] , [email protected] Abstract The new requirements of ISO 9001: 2015 quality management system standard clause 0.3.3 required the organization to implement a risk based thinking for achieving an affective quality management system. The definition of risk as stated in the standard is “the effect of uncertainty’ which could be positive or negative. Thus, ISO 9001 certified organization requires to demonstrate objective evidence of the implementation of risk based thinking such risk analysis and risk mitigation plan not only to satisfy the need of ISO 9001:2015 standard, but also widely accepted that organization requires risk management activities to stay competitive. However, there many initiative, tools and approach for the operational risk management activities have been subjected to little research and are not well understood. This paper reviewed and discussed the available literatures on operational risk management decision support tools. Based on an extensive literature review, the issues relevant to operational risk management support tools are examined, and discussed the several issues to identify the decision support tools to satisfy the intended requirements of the ISO 9001:2015 standard. Keywords: ISO 9001:2015, Risk Management, Risk Assessment, Risk Analysis, Decision support tools, 1.
    [Show full text]