Transforming an EPA QA/R-2 quality management plan into an ISO 9002 quality management system.

The Environmental Protection Agency's (EPA) Office of Emergency and Remedial Response (OERR) requires environmental data of known quality to support Superfund hazardous waste site projects. The Quality Assurance Technical Support (QATS) Program is operated by Shaw Environmental and Infrastructure, Inc. to provide EPA's Analytical Operations Center (AOC) with performance evaluation samples, reference materials, on-site laboratory auditing capabilities, data audits (including electronic media data audits), methods development, and other support services. The new QATS contract awarded in November 2000 required that the QATS Program become ISO 9000 certified. In a first for an EPA contractor, the QATS staff and management successfully transformed EPA's QA/R-2 type Quality Management Plan into a Quality Management System (QMS) that complies with the requirements of the internationally recognized ISO 9002 standard and achieved certification in the United States, Canada, and throughout Europe. The presentation describes how quality system elements of ISO 9002 were implemented on an already existing quality system. The psychological and organizational challenges of the culture change in QATS' day-to-day operations will be discussed for the benefit of other ISO 9000 aspirants.     

The integration of the standards systems of quality management,environmental management and occupational health and safety management

This paper considers the systems of Quality, Environmental and Occupational Health and Safety management. It prospectively analyses the advantages and disadvantages of integrating these systems, as opposed to the systems having independent management in a manufacturing company. Quality Management standards' (ISO 9000) evolution towards Total Quality Management is the starting point. Recent revisions embodied some of the requirements portrayed in the Environmental Management standards (ISO 14000), as well as issues pertaining to Occupational Health and Safety (OHSAS 18001). This tendency towards inclusion of material from different standards systems is expected to be even more evident in the forthcoming revision of the ISO 9000 standards. There is still a notorious absence of an integrated document; ISO has not yet adopted the OHSAS 18001 standard and there are hardships inherent in such an integrative approach. Commonalities between the three systems are emphasized. Foreseen advantages for companies pertain to economies of scale in the certification processes and a joint approach to the provision of quality, environmental responsibility and workforce protection. As a conclusion, the need to pursue standards integration is emphasized. The paper also exposes some predictive gains to be encountered in further integrating the standards system with the inclusion of ergonomics certification.     

ISO14001环境管理体系标准未来实施所面临的挑战

自1996年ISO／TC207国际标准化组织环境管理技术委员会发布《ISO14001环境管理体系要求及使用指南》国际标准以来，在全球范围掀起了环境管理体系标准的实施和认证活动，各类组织通过实施环境管理体系标准取得了良好的社会、环境和经济效益。本文在总结分析ISO14001国际标准实施经验的基础上，提出ISO14001国标准未来实施所面临的挑战。     

ISO14001:2015《环境管理体系要求及使用指南》术语变化及重要用语阐释

国际标准化组织环境管理标准化技术委员会(ISO/TC207)于2015年9月正式发布了ISO14001:2015《环境管理体系要求及使用指南》国际标准.本文对照ISO/IEC工作导则第1部分附件SL附录2《高阶结构、相同的核心文本、通用术语和核心定义》的相关规定,阐释了新版ISO14001国际标准中在术语和定义方面的修订变化,并对相关重要用语进行了说明,以帮助建立与实施环境管理体系的组织更好地理解与把握新版国际标准的变化.     

《环境管理 产品系统生态效率评价 原则要求和指南》国际标准探析

2012年5月15日,由国际标准化组织ISO/TC 207环境管理技术委员会制定的ISO 14045《环境管理产品系统生态效率评价原则要求和指南》国际标准正式发布。本文对该项国际标准所提出的关键术语和定义、生态效率评价的基本原则、主要特点、程序和步骤,以及结果的报告、披露与鉴定性评审等方法学框架及核心内容进行分析研究,以期为我国企业运用该管理工具开展产品系统的生态效率评价工作提供实用指引。     

ISO 14001环境管理体系标准与ISO 14064-1温室气体管理标准的有机联系

国际标准化组织环境管理技术委员会（ISO／TC207）于2006年正式发布ISO 14064—1,2,3温室气体管理子系列国际标准。它是近年来ISO／TC207开发的ISO14000系列国际标准的又一重要分支,是国际社会应对全球气候变化的重要标准化举措。ISO 14064使得政府和企业能够测量和控制温室气体的排放和减少活动,目前已被越来越多的国家和跨国企业采用,将其纳入组织的采购标准和供应商考核标准。那么,作为一项实用工具,它与其他环境管理工具,如“环境管理体系”之间存在着怎样的联系呢？本文将从组织层面的环境管理角度分析ISO 14064与ISO 14001之间的内在联系,并探讨建立温室气体管理体系标准的必要性。     

ISO／DIS 14001：2014《环境管理体系要求及使用指南》修订变化评析

摘要：国际标准化组织环境管理标准化技术委员会环境管理体系分技术委员会IsO／Tc207／SC1于2011年启动了对ISO 14001：2004《环境管理体系要求及使用指南》国际标准的修订工作,2014年7）1正式形成DIS国际标准草案,预计2015年7）1将正式发布新版国际标准。本文基于中国专家3年来跟踪并参与该项国际标准修订进程中所掌握和积累的信息及经验,重．如乎析Iso／DIs14001：2014的整体修订情况及主要变化。     

《环境管理建立防治土地退化和荒漠化良好实践的指南第1部分:良好实践框架》国际标准分析研究

2017年10月,国际标准化组织ISO/TC 207环境管理标准化技术委员会正式发布了ISO 14055-1《环境管理建立防治土地退化和荒漠化良好实践的指南第1部分:良好实践框架》国际标准。本文对该项国际标准所提出的关键术语和定义、良好实践指南原则、确定造成土地退化和荒漠化的因素,以及建立良好实践并监测其实施等核心内容进行分析研究,旨在为我国土地退化和荒漠化防治与管理工作提供国际标准化经验和实践指引。     

The effect of ISO quality management system standards on industrial property rights in Turkey

The aim of this study was to assess whether the systematical application of the following ISO quality management system standards: ISO 9001 (Quality Management System), ISO 22000 (Food Safety Management System), ISO 14001 (Environment Management System), ISO 13425 (Medical Device Quality Management System), ISO 27001 (Information Security Management System) and ISO 16949 (Automotive Quality Management System) have had an effect on the emergence of industrial property rights in Turkey. Information was collected about the number of ISO standard certification documents that Turkish organizations received in respect of these standards between the period of 2007 and 2013. For the same period, information about the number of granted patents, petty patents, trademarks and industrial designs in Turkey were also collected. The information was analyzed by year, industrial property right type and ISO standard. A Spearman correlation analysis was also conducted to determine the strength of association between the number of certification documents and the number of granted industrial property rights. The analysis showed that some of the ISO standards had either a positive or negative linear relationship with one or more of the granted industrial property right types. Although the total number of certification documents had decreased over the time period of the study, the number of granted industrial property rights in Turkey had increased over the same period indicating that the adoption of quality managment system standards may have led to an increase in national innovation in Turkey. This observation may help to improve innovation in other countries similar to Turkey.     

Methodology for integrated management system improvement: combining costs deployment and value stream mapping

Integrated Management System – Quality, Environment, Safety (IMS-QES) combines all related components of a business into one system for easier management and operations Quality (QMS/ISO 9001), Environmental (EMS/ISO 14001), and Health & Safety (OHSAS 18001). IMS-QES has been generally used to increase operational performance in manufacturing systems. However, the economic impact of standard approach of IMS-QES remains difficult due to the lack of alignment between IMS-QES objectives and strategic management of the company (policy of IMS-QES) and also the inadequacy between the improvement processes and the cost of losses.

Therefore, the main objective of this work is to overcome this limitation. The Framework proposed approach called IM-VCF integrates concepts from IMS-QES, Value Stream Mapping and Cost Deployment tool. It is structured in ten steps. It allows a company to assure proper alignment between IMS-QES policy and business operations and identify the categories of losses. IM-VCF allows analysing critical issues and estimating the potential savings, in terms of cost. A case study taken from the application of the IM-VSF within certified QSE chemical fertiliser port is presented.     

环境管理体系阶段性实施指南(ISO14005)促进欧盟生态管理与审核计划(EMAS)与环境管理体系体系(ISO14001)的协调实施

ISO14005:2010《分阶段实施环境管理体系指南》国际标准融入了环境声明、环境绩效评价、环境信息交流等重要环境管理工具的使用,使得通过ISO14001环境管理体系认证的组织在附加实施标准中的一些要素后可实现与EMAS的符合.     

Standards Column

In this column we will review the status of the ISO project to create a family of documents related to customer satisfaction. We will discuss a new project on people aspects of quality management. We will review new projects to revise, expand, and update standards for auditing management systems. We will review the status of the ISO series on capability and performance measurement. And we will review a standard on detection and analysis of outliers.     

The historical impact of ISO 9000 on Lebanese firms.

The objective of this paper is to assess the impact of the new ISO 9001:2000 standard on the Quality Management Systems (QMS) of Lebanese firms that were already certified under ISO 9000:1994. To get an accurate feedback of stakeholders in a firm, three different questionnaires were developed and distributed to management, employees, and customers respectively. Empirical results indicate that ISO 9001:2000 has improved the QMS performance of Lebanese firms over that of the 1994 edition. Nevertheless, results showed that the new standard still has some weaknesses when it comes to improving suppliers' relationships and empowering employees.     

Evaluation of the costs and benefits of an environmental management system

The implementation of ISO 14000 certification in a company involves a set of costs and benefits that must be known in order to assess the investment effectively in terms of environmental quality. However, as will be shown, these figures can be difficult to calculate, mainly because of a lack of reference data or specific assessment criteria. Moreover, few companies have so far implemented an Environmental Management System. Investments in environment quality sometimes simply look like costs, but benefits do exist and these are often economically quantifiable. Such benefits depend on the choice and the pursuit of aims, on the respect of rules (e.g. no omissions) and on environmental efficiency (e.g. no waste), and can only be calculated following an in-depth analysis of the system. A first and approximate estimate of these costs and benefits has been obtained for a number of real industrial cases, mainly in the chemical field, and the survey results are given in this paper. The research was carried out in Italy in companies implementing an Environmental Management System in most cases in accordance with the ISO 14000 series.     

Essentials of quality in "the gold standard veterinary clinical trial".

Quality Assurance (QA) has played a pivotal role within Good Laboratory Practice (GLP) since its inception in 1976. GLP is now recognized as a quality standard, as can be seen from the introductory statement of the recently issued OECD Principles of GLP (revised in 1997) that clearly state "GLP is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported". We can, therefore, see a close comparison between GLP compliance and the ISO/EN accreditation systems that have been adopted by other institutes on a worldwide basis.     

"Power quality system," a new system of quality management for globalization: towards innovation and competitive advantages.

Knowledge Management (KM) addresses the critical issues of organizational adoption, survival and competence in the face of an increasingly changing environment. KM embodies organizational processes that seek a synergistic combination of the data and information processing capabilities of information and communication technologies (ICT), and the creative and innovative capacity of human beings to improve ICT In that role, knowledge management will improve quality management and avoid or minimize losses and weakness that usually come from poor performance as well as increase the competitive level of the company and its ability to survive in the global marketplace. To achieve quality, all parties including the clients, company consultants, contractors, entrepreneurs, suppliers, and the governing bodies (i.e., all involved stake-holders) need to collaborate and commit to achieving quality. The design based organizations in major business and construction companies have to be quality driven to support healthy growth in today's competitive market. In the march towards vision 2020 and globalization (i.e., the one world community) of many companies, their design based organizations need to have superior quality management and knowledge management to anticipate changes. The implementation of a quality system such as the ISO 9000 Standards, Total Quality Management, or Quality Function Deployment (QFD) focuses the company's resources towards achieving faster and better results in the global market with less cost. To anticipate the needs of the marketplace and clients as the world and technology change, a new system, which we call Power Quality System (PQS), has been designed. PQS is a combination of information and communication technologies (ICT) and the creative and innovative capacity of human beings to meet the challenges of the new world business and to develop high quality products.     

ISO/TC176最新战略计划及我国对策研究

本文介绍了ISO/TCl76针对目前ISO 9000族标准所面临的情况提出的最新战略计划草案,并对中国在质量管理领域实质参与国际标准化工作进行了初步探讨。     

How can Cleaner Production practices contribute to meet ISO 14001 requirements? Critical analysis from a survey with industrial companies

The companies’ needs to adopt changes in their way of production to maximize the environmental performance required by their stakeholders, and at the same time, to maximize their economic and market performance, have made them seek for environmental strategies and certifications. In this sense, the Cleaner Production and the Environmental Management System based on ISO 14001 have been, respectively, presented, since the main objective of this research is to identify and analyze Cleaner Production contributions to comply with ISO 14001 requirements. For such, a survey research has been carried out in Brazilian industrial companies certified by ISO 14001. We have identified the main performance factors by leading practices and variables of Cleaner Production that contribute to the compliance with the standard requirements by companies. Thus, it has been noted that Cleaner Production is an important strategy for the preparation of companies for certification as well as for improving their environmental performance.     

Quality assurance growing pains: a state perspective on implementing an organizational-wide quality system in environmental laboratories.

To implement an effective and efficient quality system in a network of established environmental testing laboratories requires a committed long-term effort that is potentially fraught with multiple obstacles. This presentation discusses one state's ongoing efforts at implementing such a system. First is the need to convince management of the rationale for a quality systems-based approach versus the traditional QA/QC program. Once development of a quality system has been sanctioned, a team-based approach utilizing project planning tools is a good way to approach the effort. Resources are assigned to the development of key quality system components, and generally a phased-deployment or roll-out works best. Once implementation is underway, assuring operational utilization and compliance with the quality system are vital steps in the process. Important to successful implementation is ongoing assessment and refinement of the quality system. Fundamental and key elements of the laboratory quality system are numerous and need to work in concert with each other. Quality system elements to be discussed in the presentation range from management and QA roles and functions to the typical documentation of laboratory policies and procedures. Numerous QA assessment tools and other vital quality system practices that play an important role in making a complete quality system are addressed. In addition, efforts must be undertaken to integrate the laboratory quality system with other management systems within the organization. The bottom line is that all environmental laboratories need a quality system more now than ever. Data users need it. Customers' expectations for data quality are high. USEPA policy and/or programs call for it. Additionally, good quality systems can benefit the organization in multiple ways and help avoid the "pay-me-now or pay-me-later" syndrome. In conclusion, all environmental testing laboratories (i.e., academic, private, commercial and especially governmental) need to invest in and implement a quality system based on a recognized standard (e.g., NELAC, ISO 17025, ANSI/ASQC E-4). The author recommends pursuing NELAP laboratory accreditation with a NELAP-recognized accrediting authority.     

Doe's quality system program: cooperative development and implementation.

Implementation of a Quality Systems approach to making defensible environmental program decisions depends upon multiple, interrelated components. Often, these components are developed independently and implemented at various facility and program levels in an attempt to achieve consistency and cost savings. The U.S. Department of Energy, Office of Environmental Management (DOE-EM) focuses on three primary system components to achieve effective environmental data collection and use. (1) Quality System guidance, which establishes the management framework to plan, implement, and assess work performed; (2) A Standardized Statement of Work for analytical services, which defines data generation and reporting requirements consistent with user needs; and (3) A laboratory assessment program to evaluate adherence of work performed to defined needs, e.g., documentation and confidence. This paper describes how DOE-EM fulfills these requirements and realizes cost-savings through participation in interagency working groups and integration of system elements as they evolve.