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Control of Calibrated Equipment Procedure [ISO 9001:2015]

The purpose of this procedure is to define your organization’s responsibilities and activities in order to ensure that all inspection and test equipment used for product, service and process verification is controlled and calibrated against nationally traceable standards at specified intervals and that such devices are available to ensure continuity of measurement capability.

ISO 9001:2015 PDF is completely free to download.Thanks very much for Lucy’s generous sharing.Part of the document is described as follows: The adoption of a quality management system is a strategic decision for an organization that can helpto improve its overall performance and provide a sound basis for sustainable development initiatives. ISO 9001:2015 – For Training Only Cognoscenti Consulting Group ISO 9001:2015 Introduction Pengantar 0.1 General 0.1 Umum The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives.

Internal Audit Checklist [OHSAS 18001:2007]

The Occupational Health and Safety Assessment Series OHSAS 18001:2007 audit checklist will help ensure your audits address the necessary requirements. It stands as a reference point before, during and after the audit process and if developed for a specific audit and used correctly will provide the following benefits:

• Ensures the audit is conducted systematically
• Promotes audit planning
• Ensures a consistent audit approach
• Actively supports your organization’s audit process (OHSAS 18001:2007, Clause 4.5)
• Provides a repository for notes collected during the audit
• Ensures uniformity in the performance of different auditors
• Provides reference to objective evidence

This OHSAS 18001:2007 audit checklist comprises tables of the certifiable (‘shall’) requirements, from OHSAS 18001:2007, each required is phrased as a question. This audit checklist may be used for element compliance audits and for process audits.

Gap Analysis Checklist [OHSAS 18001:2007]

The Occupational Health and Safety Assessment Series gap analysis checklist highlights the requirements contained in OHSAS 18001:2007.

After completing the Gap Analysis you will have a list of activities and processes that comply and ones that do not comply (GAPs).

Armed with this knowledge, it allows you to establish accurate budgets, time-lines and expectations which are proportional to the state of your current management system when directly compared to the requirements of the standards.

Work Instruction Template

Work instructions are low-level documents showing operational detail. They are optional.

Work instructions might describe how to operate machinery, how to mix chemicals for a certain process, how to process a purchase order, or anything else that you feel is important enough to document and share.

Many companies avoid over-burdening their quality manual by allowing lower-level documents, such as procedures and work instructions to contain the operational detail. Then, simple reference is made to the procedures and work instructions from within the quality manual itself.

Product Realization & Planning Process

The purpose of this process is to define the activities required to ensure that product realization and planning encompasses the determination of product and process quality objectives, development of required processes, documentation and records.

Product quality objectives are defined in drawings and specifications, contracts, standards, samples, workmanship standards, and applicable legal and regulatory requirements.

Product realization planning includes the following:
• Definition and evaluation of production/service processes
• Development of suitable and capable processes
• Identification of special processes and consideration of associated risks and consequences
• Development and implementation of appropriate process control measures
• Development of instructions (where applicable) and training for process personnel
• Identification of the records required to demonstrate product/process quality

Product realization plans are generated collectively by the Production/Service, Engineering and Quality Functions. The plans are defined in associated production/service documents (e.g. process flowcharts, production/service work orders, process control plans, operator/installation instructions, process validation reports, etc.).

Calibration Process

The purpose of this process is to ensure that all inspection and test equipment used for product and process verification is calibrated against nationally traceable standards at specified intervals and that such devices are available to ensure continuity of measurement capability.

Customer Satisfaction Process

This document describes the methods for measuring, monitoring and interpreting customer satisfaction to determine if you are meeting customer requirements.

• A customer satisfaction survey form is sent to the customer with each product or at the completion of service
• If a customer does not respond within four weeks, a follow-up telephone call is made and a verbal survey is conducted
• The results customer satisfaction data will be used to determine conclusions on the quality of product
• Customer satisfaction data is analyzed by the Quality Management Representative to determine trends
• The findings are reported to management quarterly and presented at management review meetings

Customer Complaints & Feedback Process

The purpose of this process is to monitor, measuring and take appropriate corrective action from customer complaints and feedback.

Download and Read online Iso 9001 And Lean ebooks in PDF, epub, Tuebl Mobi, Kindle Book. Get Free Iso 9001 And Lean Textbook and unlimited access to our library by created an account. Fast Download speed and ads Free!

ISO 9001 and Lean

ISO 9000 is a comprehensive set of international standards for quality management and quality assurance. These standards ensure that companies effectively document all aspects of their quality management to show transparency and efficiency within all processes. They are not industry specific and pertain to organizations of any size. Continuous improvement is a key facet of the ISO 9001 standard (the particular standard that specifies requirements for a quality management system), but it does not explain how to implement or maintain this improvement. Lean production methodologies surely provide this crucial and tactical information. Adding Lean production methodologies to quality management systems effectively focuses these improvement activities. In the long run, it will save companies much time and money. This book, written in the novel format, discusses the symbiotic relationship between ISO 9001 and Lean as both can be seamlessly integrated. It shows how Lean provides the process improvements that are required by the ISO 9001 quality management system – Lean is crucial for identifying and removing waste from your processes, which ultimately creates greater customer value. In addition, the book shows the crucial financial benefits of this integration. This novel clearly illustrates that these two systems can function effectively is one understands the complex balance of standardization and change. ISO 9001 is clearly controlled and audited while Lean is often empowering, less meticulously audited, and rarely controlled. While presenting interesting characters and interactions, this fictional story embeds real-life manufacturing speak with a message of the importance of successful synergy between Lean practitioners, production leaders, and quality departments.

Lean ISO 9001

Myriad studies have acknowledged that ISO 9001-registered companies outperform non-ISO 9001 registered companies; however, a main finding in many studies has shown that registered companies are performing at the same level regardless of their ISO 9001 registration. While many companies are mandated to be ISO 9001 certified, they are not obtaining the value from it they would like. At the same time there are tens of thousands of companies worldwide participating in a Lean journey – modeled after the Toyota Production System - to eliminate waste in their processes. One of the biggest problems organizations have with Lean implementation is sustaining the improvements they make. Author Mike Micklewright believes that implementing Lean and ISO 9001 are two complementary forces that when combined can be a powerful force in driving increased profits for any ISO 9001 registered organization. Use this book in leaning out your Quality Management System processes and provide a spark for your ineffective and sedentary system.

Lean ISO 9001

Lean 9001

In the year 7278, Lean and ISO 9001 are still being utilized by cut-throat competitors in distant galaxies. Their divergent approaches will determine their success or failure, life or death. Those involved with implementing, maintaining, or improving quality management systems will find this novel useful towards understanding ISO 9001 and lean methodology.

From a Quality Management System QMS to a Lean Quality Management System LQMS

Abstract : Purpose: This paper deals with the subject of 'Lean Normalization.' The purpose of this paper is to propose a comprehensive methodology which combines the benefits of both International Organization for Standardization (ISO) standards and Lean Management. The application of this methodology leads manufacturing or service companies to certification without creating more documentation. It guarantees agility and flexibility in the day-to-day management of the company, and induces lower costs and reduced times. This methodology provides a new way of tackling the implementation of ISO standards in a company. Design/methodology/approach: This methodology is based on the synergistic combination of both ISO standards (Quality Management System) and the key concepts of Lean Management. After a short presentation of ISO standards and Lean Management, the possibility of implementing a synergy between these two different approaches will be discussed. At this point, ISO 9001 standards will be focused on. The proposed methodology will be introduced step by step. Each step of the model will be formalized using the Structured Analysis and Design Technique graphic representation tool. Moreover, each step is associated with a key concept of Lean Management. In order to illustrate the proposed method, an example of implementation will also be presented. Findings: To show the feasibility of this methodology, this paper finishes with a summary of the results achieved in a company and draws some interesting conclusions. Companies have the possibility of achieving certification in combination with a Lean Quality Management System (LQMS): a one-page quality manual, only ten records, no major non-conformities and no customer complaints over a two-year period. Research limitations/implications: The methodology may have to be adapted to better suit the needs of companies seeking to implement the latest version of the ISO 9001 standards. Practical implications: This paper presents the deployment of ISO 9001 standards whilst simultaneously respecting key Lean Management concepts. The practical results for enterprises are the implementation of an LQMS leading to a certification. Social implications: This paper presents a new method combining both ISO standards and Lean Management concepts to achieve certification with an LQMS. Originality/value: Due to its simplicity and the relevance of its steps, the proposed methodology can be applied to companies with a guaranteed success of certification.

Advanced Manufacturing and Sustainable Logistics

Intimesofdecliningeconomicgrowth,companieshavetocontroltheircostsmore than ever to saveresources needed in the future. Regardless of the economic size of the company, the processes of production and logistics play a decisive role in stabilizing procedures and avoiding waste. Both are important cost drivers in manufacturing companies and therefore they o?er large potential savings. Pervasive networking in the last years has contributed to a hitherto unknown transparency of global markets. This harmonization opened up new possibilities of entering foreign markets for procurement and sales to the companies. The emerging global procurement strategy was understood as a chance to rethink the relocation of existing production facilities to pro?t from existing di?erences in price and performance as a resource-saving factor. Many companies tended towards a reduction of their vertical integration by outsourcing sections of their value chain. These contracted services of production result in higher transport volumes, increased complexity of supply processes and new requirements on - gistic networks. This trend of outsourcing has not stopped, but is slowing down noticeably. Additionally,thereisanincreasingproportionofcompaniesrestoring business units that were outsourced before. Reasons for turning back decisions are often to be found in missed goals. It is not unusual that important cost f- tors were disregarded in the original basis of decision-making. In the meantime many companies have realized that it is easier to achieve stability of processes and therewith a control of costs by increasing their own contribution to p- duction. Especially in times of under-utilized capacities like in the current crisis, insourcingcanbeastrategicoption.

Lean and Agile Project Management

When project managers are faced with budget cuts and fewer resources, waste elimination becomes a priority in maintaining effectiveness. This does not mean shortening or abandoning traditional project cycles. In fact, fast results on critical assignments can only be completed with strong plans and a detailed work breakdown structure. The connections, or lack thereof, are what strongly impact performance and quality. Lean and Agile, as covered in this book, are meant to enhance traditional project management, not replace the science. A strong foundation in traditional project management is necessary to appreciate the benefits of adopting Lean and Agile. Lean and Agile Project Management: How to Make Any Project Better, Faster, and More Cost Effective defines the wastes and issues found in project management and demonstrates how they can be addressed by engaging Lean thinking and Agile techniques. This book also: • Shows how to apply Lean principles to project management (PM) • Teaches the application of simple Six Sigma metrics in PM • Discusses the adoption of Agile techniques in PM in order to stay on task and remain flexible • Helps readers discover the theoretical synergies between popular PM programs • Promotes an understanding of how Lean people skills can help a person become a better leader and manager Since the publication of the first edition of this book, the bodies of knowledge have all been systematically updated. In addition, through conducting peer groups and detailed workshops, the Author has simplified many of the basics, and they are now much easier to understand. Essentially, the Author believes traditional project management can benefit from adding Lean and Agile, but she has simplified the model for greater efficiency.

Fusion Management

Fusion Management cuts through the confusion and hype surroundingSix Sigma, TQM, and other high-profile quality initiatives.Authoritative global quality guru Stanley Marash drawson more than 40 years of experience to reveal how and whymany of these initiatives fail, and discuss which elements fromeach have proven over time to be most effective. He then showsmanagers and executives how to integrate these elements intoan innovative quality program, one that is certain to improvetheir organizations’ quality, competitiveness, and profitability.

The Role of Sarbanes Oxley and ISO 9001 in Corporate Management

Pdf Iso 9001 2015 Free Download

At the turn of the 21st century, corporate scandals at major companies like Enron, Tyco International, and WorldCom cost investors billions of dollars and shook public confidence in the securities market. In 2002, in direct response to these scandals, Congress passed the Sarbanes-Oxley Act, a sweeping set of new standards for the operation of all U.S. public company boards, management, and public accounting firms. Among its many reforms was the requirement that senior officials take personal responsibility for corporate finances. This book’s exploration of the relationship between corporate governance and operations uses the requirements of the Sarbanes-Oxley law as a guide and the internal controls of the ISO 9001 Quality Management System as the interface medium to unite the strategic and tactical functions of the corporation. In the process, it introduces new concepts of process liability and materiality and stresses management ethics and responsibility, as well as efficient and effective governance.

Quality Management for Organizations Using Lean Six Sigma Techniques

The next step in the evolution of the organizational quality field, Lean Six Sigma (LSS) has come of age. However, many challenges to using LSS in lieu of, in conjunction with, or integrated with other quality initiatives remain. An update on the current focus of quality management, Quality Management for Organizations Using Lean Six Sigma Techniques covers the concepts and principles of Lean Six Sigma and its origins in quality, total quality management (TQM), and statistical process control (SPC), and then explores how it can be integrated into manufacturing, logistics, and healthcare operations. The book presents the background on quality and Lean Six Sigma (LSS) techniques and tools, previous history of LSS in manufacturing, and current applications of LSS in operations such as logistics and healthcare. It provides a decision model for choosing whether to use LSS or other quality initiatives, which projects should be selected and prioritized, and what to do with non-LSS projects. The author also details an integration model for integrating and developing integrated LSS and other quality initiatives, and common mathematical techniques that you can use for performing LSS statistical calculations. He describes methods to attain the different Six Sigma certifications, and closes with discussion of future directions of Lean Six Sigma and quality. Case studies illustrate the integration of LSS principles into other quality initiatives, highlighting best practices as well as successful and failed integrations. This guide gives you a balanced description of the good, bad, and ugly in integrating LSS into modern operations, giving you the understanding necessary to immediately apply the concepts to your quality processes.

The Global Quality Management System

The Global Quality Management System: Improvement Through Systems Thinking shows you how to understand and implement a global quality management system (GQMS) to achieve world-class business excellence. It illustrates the business excellence pyramid with the foundation of management systems at the system level, Lean System at the operational level, Six Sigma methodology at the tactical level, and business excellence at the strategy level. Throughout the book, the author stresses the importance of the process—its identification, definition, improvement, and control using 'turtle diagrams' and its extension to supplier, input, process, output, and customer (SIPOC) diagrams. The processes discussed include the human resource (HR) process, finance process, project management process, and the important 'process of improving the process.' The author also includes advanced processes to comply with ISO 9001, ISO/TS 16949, and AS 9100 standards, and elaborates on management improvement through extensive plan–do–check–act (PDCA) analysis and the problem-solving methodology involving the famous eight disciplines process ('8D'). As you put this book of knowledge into practice, you will discover the shifting roles of leaders and managers in your organization. It is not enough for leaders to merely continue past practices or support the work of others. Rather, leaders must lead the cultural transformation and change the mind-sets of their associates by building on the principles behind these excellent tools.

Praktijkhandboek Innovatiemanagement

Dit boek zal u laten kennismaken met de strategische keuzen die tijdens het innovatieproces genomen moeten worden en u een handreiking geven om de ondernemingsprocessen voor innovatie vorm te geven. Hiermee kan u innovatieprojecten snel, effici nt, kostenbewust en succesvol uitgevoeren. Het resultaat van deze werkwijze zal moeiteloos aansluiten op de laatste ISO 9001 norm en Design for Lean Six Sigma methodiek en zullen kostenbesparing en duurzame ontwikkeling elkaar verder versterken.

The Psychology of Lean Improvements

Fear of change we all experience it. Some accept change immediately, some gradually adapt, while others may never get there. Whether it‘s poor leadership, the inability to change, or pure ego, this Shingo Prize-winning book explores this perplexing commitment to inefficiency.Winner of a 2013 Shingo Prize!The Psychology of Lean Improvements: Why Org

ISO 9001

What is risk based thinking? Do you know how to address risks and opportunities? Did you ever analyzed risks? Are you sure it is that what the ISO 9001 expects? What do you really know about knowledge management? Can you identify the types of knowledge in your organization? How do you maintain knowledge? What is awareness in the eyes of the ISO 9001 Standard? Can you tell the relation between awareness and the effectiveness of the QMS? This book explains in details all the new issues and topics required by the ISO 9001:2015 Standard and gives you the tools and tricks to answer the new requirements. Just read and do. The table of contents in the book are identical to the table of contents of the standard so you can orient yourself quite easily and find the specific advice you are looking for.

Lean Management System LMS 2012

The success of a Lean manufacturing program depends far more on organization-wide leverage of Lean manufacturing tools than it does on the tools themselves. To this the organization must add the human relations aspects that earn buy-in and engagement by all members of the workforce, to the extent that workers will react immediately and decisively to the presence of waste. The synergy of the human and technological aspects of Lean form what Henry Ford called a universal code for the achievement of world-class results in any enterprise, and which he put into practice to deliver unprecedented bottom line results. This book expands upon and systemizes this universal code into a structure or framework that promotes organizational self-audits and continuous improvement. The book's first section offers a foundation of four simple but comprehensive Lean key performance indicators (KPIs): waste of the time of things (as in cycle time), waste of the time of people, waste of energy, and waste of materials. The Toyota Production System's seven wastes are all measurable in terms of these four KPIs, which also cover the key metrics of Eliyahu Goldratt's theory of constraints: throughput, inventory, and operating expense. The first section then adds a proactive improvement cycle that sets out to look for trouble by isolating processes for analytical purposes and measuring and then balancing inputs and outputs to force all wastes to become visible. It is in fact technically impossible for any waste of material or energy to hide from what chemical engineers call a material and energy balance. Application of this book's content should therefore satisfy most provisions of the ISO 14001 environmental management system standard and the new ISO 50001 energy management system standard. The second section consists of an unofficial (and therefore customizable) standard against which the organization can audit its Lean management system. The unofficial standard is designed to be compatible with ISO 9001:2008 so internal auditors can assess both systems simultaneously. Each provision includes numerous examples of questions that promote audits in a narrative form as opposed to yes/no checklists or Likert scale ratings. The unofficial standard can also be downloaded (without the assessment questions) from the publisher's Web site. The third section elaborates in detail on the second and provides numerous real-world examples of applications.

Lean Production for the Small Company

A hands-on guide to adapting Lean principles and the Toyota Production System to high-mix/low-volume environments, Lean Production for the Small Company uses charts, pictures, and easy-to-understand language to describe the methods needed to improve processes and eliminate waste. It walks readers through the correct order of implementation and desc

Lean for Banks

Most banking institutions suffer from numerous inefficiencies, such as poor planning; inadequate coordination and communication; ineffective processes, tools, and workflow; and excessive bureaucracy. Lean for Banks describes in easy language how to use Lean and Six Sigma management practices to significantly improve the efficiency of bank operations. This book shows how to use Lean and Six Sigma management practices to improve the normal daily work in a bank, typically executed in the so-called 'back offices.' This work involves about 90 percent of bank employees and generates 90 percent of costs. Lean for Banks explains how to organize bank operations better, increase work productivity and quality by working smarter and not harder, make fewer mistakes and decrease rework, and elevate jobs from mundane and repetitive to creative and pleasantly challenging. Most importantly, it shows how to increase the satisfaction of bank customers and in turn enhance bank competitiveness and market share. Lean for Banks is intended for all levels of bank employees: back-office workers, first-level supervisors, middle- and higher-level managers, and corporate executives. It is also intended for all levels of students at schools that teach banking skills—short courses intended for tellers, college courses in advanced banking operations, and continuing education for bank managers and line employees. This book is an entry-level text on Lean and should give readers enough understanding to prepare them for active participation in Lean deployment activities.

The Cell Manufacturing Playbook

Cell manufacturing takes traditional process-based production environments and creates right-sized smaller work areas that have all of the essential workstations and equipment needed to produce the product. Until now, there has been a need for a book with step-by-step guidelines on how to implement cell manufacturing, also known as work cells. Complete with color images, The Cell Manufacturing Playbook: A Step-by-Step Guideline for the Lean Practitioner fills this need. This new book in The LEAN Playbook Series is ideal for Lean practitioners and facilitators looking for a training tool that can be used in the work area while improvements are being made. Like a football coach, you can use this playbook for quick reference to convey what’s needed to facilitate effective work cell implementation. If for some reason you forget a 'play', you can easily reference the playbook. You can follow page by page and use the playbook to facilitate successful work cells, or you can go directly to certain topics and use it to help you implement that particular 'play.' The playbook includes color pictures, examples, and 3D models from actual work cell implementations. In addition to the images, a combination of short paragraphs and bulleted points walk you through the process of implementing work cells to bring about remarkable changes in your organization. Although the book wastes little time on high-level theory, it does include an introductory portion that provides the foundation in the 8 Wastes and Lean metrics needed to fully benefit from this playbook. Coverage includes time studies, line balancing, standard work, single piece flow, takt time, and workstation design. Looking for supplemental information or Lean coaching from Chris Ortiz? Go to www.leanplaybooks.com to receive ongoing support and advice on how to use The LEAN Playbook Series for training and implementation.

Making the Case for Change

The best time to stop projects or programs that will not be successful is before they are ever started. Research has shown that the focused use of realistic business case analysis on proposed initiatives could enable your organization to reduce the amount of project waste and churn (rework) by up to 40 percent, potentially avoiding millions of dollars lost on projects, programs, and initiatives that would fail to produce the desired results. This book illustrates how to develop a strong business case which links investments to program results and, ultimately, with the strategic outcomes of the organization. In addition, the book provides a template and example case studies for those seeking to fast-track the development of a business case within their organization. Making the Case for Change: Using Effective Business Cases to Minimize Project and Innovation Failures provides executive teams and change agents with the information required to make better business case decisions. This book can be used throughout the life cycle of the project to assist with gaining a better understanding of the following key knowledge areas for developing a business case: Understanding the present problem/improvement opportunity Documenting how the project, program, or initiative will add value to the organization Validating the data and the assumptions that the projected improvements are based upon Calculating the level of confidence that can be placed upon the conclusions that are reached Assessing the alternative solutions that were considered Weighing the costs vs. the benefits of the proposed initiative Analyzing and mitigating the risks to completing 100 percent of the project’s goals Eliciting and prioritizing the requirements of key stakeholders and subject matter experts Identifying the key people that are involved in the proposed project and the skills needed to implement the proposed change Obtaining consensus on the decision to move forward, as well as on the methods used and the conclusions specified in the analysis Ideal for executives and project/initiative managers seeking approval of an activity, initiative, program, or project, the book presents proven tips, advice, suggestions, and recommended courses of action for developing effective business cases. In addition, suggestions for recruiting a responsible senior officer or sponsor for the project and for engaging an audience are provided. The authors combine their own experience in business case development with approaches used by world-class organizations. They provide a general range of assessment criteria that can be applied to almost any type of project business cases. The text discusses each of the 8 activities and the 35 tasks that make up the business case development process. This process supplies you with a proven approach for creating comprehensive and well-constructed business case evaluations that will either ensure the success of your project, or eliminate unsuccessful projects, programs, and initiatives before they start.

Applying the Kaizen in Africa

Iso 9001 Version 2008 Pdf Free Download

Iso 9001 Pdf Free Download

At present, how to develop industries is a burning issue in Africa, where population growth remains high and economic development has thus far failed to provide sufficient jobs for many, especially young people and women. The creation of productive jobs through industrial development ought to be a central issue in steering economic activity across the continent. The authors of this book, consisting of two development economists and five practitioners, argue that the adoption of Kaizen management practices, which originated in Japan and have become widely used by manufacturers in advanced and emerging economies, is decisively the most effective first step for industrial development in Africa. This open access book discusses what Kaizen management is, why it is applicable to Africa, and why it can provide Africa with a springboard for sustainable economic growth and employment generation. - Chapter 1. How Kaizen Brightens Africa's Future? -- Chapter 2. Role of Kaizen in Japan's Overseas Development Cooperation -- Chapter 3. Kaizen in Practice -- Chapter 4. Kaizen and Standardization -- Chapter 5. Kaizen as a Policy Instrument: The Case of Ethiopia -- Chapter 6. Kaizen as a Key Ingredient of Industrial Development Policy