The organization shall determine the methods for obtaining, monitoring and reviewing this information. NOTE Examples of monitoring customer perceptions can include customer surveys, customer feedback on delivered products and services, meetings with customers, market-share analysis, compliments, warranty claims and dealer reports.
The organization shall analyse and evaluate appropriate data and information arising from monitoring and measurement. The results of analysis shall be used to evaluate: a conformity of products and services; b the degree of customer satisfaction; c the performance and effectiveness of the quality management system; d if planning has been implemented effectively; e the effectiveness of actions taken to address risks and opportunities; f the performance of external providers; g the need for improvements to the quality management system.
NOTE Methods to analyse data can include statistical techniques. The management review shall be planned and carried out taking into consideration: a the status of actions from previous management reviews; b changes in external and internal issues that are relevant to the quality management system; c information on the performance and effectiveness of the quality management system, including trends in: 1 customer satisfaction and feedback from relevant interested parties; 2 the extent to which quality objectives have been met; 3 process performance and conformity of products and services; 4 nonconformities and corrective actions; 5 monitoring and measurement results; 6 audit results; 7 the performance of external providers; d the adequacy of resources; e the effectiveness of actions taken to address risks and opportunities see 6.
The outputs of the management review shall include decisions and actions related to: a opportunities for improvement; b any need for changes to the quality management system; c resource needs.
The organization shall retain documented information as evidence of the results of management reviews. These shall include: a improving products and services to meet requirements as well as to address future needs and expectations; b correcting, preventing or reducing undesired effects; c improving the performance and effectiveness of the quality management system.
NOTE Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation and re-organization. Corrective actions shall be appropriate to the effects of the nonconformities encountered. The organization shall consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement.
Annex A informative. The structure and content of documented information related to a quality management system can often be more relevant to its users if it relates to both the processes operated by the organization and information maintained for other purposes.
There is no requirement for the terms used by an organization to be replaced by the terms used in this International Standard to specify quality management system requirements. Organizations can choose to use terms which suit their operations e. Table A. The characteristic of services is that at least part of the output is realized at the interface with the customer.
This means, for example, that conformity to requirements cannot necessarily be confirmed before service delivery. In most cases, products and services are used together. Most outputs that organizations provide to customers, or are supplied to them by external providers, include both products and services. For example, a tangible or intangible product can have some associated service or a service can have some associated tangible or intangible product.
However, 4. As stated in the scope, this International Standard is applicable where an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction. There is no requirement in this International Standard for the organization to consider interested parties where it has decided that those parties are not relevant to its quality management system.
It is for the organization to decide if a particular requirement of a relevant interested party is relevant to its quality management system. This International Standard specifies requirements for the organization to understand its context see 4.
This represents the application of risk-based thinking to planning and implementing quality management system processes see 4.
One of the key purposes of a quality management system is to act as a preventive tool. Consequently, this International Standard does not have a separate clause or subclause on preventive action. The concept of preventive action is expressed through the use of risk-based thinking in formulating quality management system requirements. The risk-based thinking applied in this International Standard has enabled some reduction in prescriptive requirements and their replacement by performance-based requirements.
There is greater flexibility than in ISO in the requirements for processes, documented information and organizational responsibilities. Although 6. Organizations can decide whether or not to develop a more extensive risk management methodology than is required by this International Standard, e.
Under the requirements of 6. The requirements for applicability are addressed in 4. The organization can only decide that a requirement is not applicable if its decision will not result in failure to achieve conformity of products and services.
Where appropriate, text elsewhere in this International Standard has been aligned with its requirements. The organization is responsible for determining what documented information needs to be retained, the period of time for which it is to be retained and the media to be used for its retention.
In such situations, the organization can decide whether or not it is necessary or appropriate to maintain documented information. Requirements regarding organizational knowledge were introduced for the purpose of: a safeguarding the organization from loss of knowledge, e. Outsourcing always has the essential characteristic of a service, since it will have at least one activity necessarily performed at the interface between the provider and the organization.
The controls required for external provision can vary widely depending on the nature of the processes, products and services. The organization can apply risk-based thinking to determine the type and extent of controls appropriate to particular external providers and externally provided processes, products and services.
Annex B informative. Guidance or requirements contained in the documents listed in this annex do not add to, or modify, the requirements of this International Standard. Table B. The quality management principles are described in detail in ISO and have been taken into consideration during the development of this International Standard.
These principles are not requirements in themselves, but they form the foundation of the requirements specified by this International Standard. ISO also defines the terms, definitions and concepts used in this International Standard. ISO includes guidance on a self-assessment methodology for an organization to be able to evaluate the level of maturity of its quality management system.
The International Standards outlined below can provide assistance to organizations when they are establishing or seeking to improve their quality management systems, their processes or their activities. Its use can enhance customer confidence in an organization and improve customer understanding of what to expect from an organization, thereby reducing the likelihood of misunderstandings and complaints. ISO provides an open, effective and easy-to-use complaints process, including training of people.
It also provides guidance for small businesses. Dispute resolution gives an avenue of redress when organizations do not remedy a complaint internally. Most complaints can be resolved successfully within the organization, without adversarial procedures.
Such actions can strengthen customer loyalty and help retain customers. Benefits of establishing a quality plan are increased confidence that requirements will be met, that processes are in control and the motivation that this can give to those involved.
ISO is to be used by personnel managing projects and who need to ensure that their organization is applying the practices contained in the ISO quality management system standards. Configuration management can be used to meet the product identification and traceability requirements specified in this International Standard. ISO provides quality management criteria for a measurement management system to ensure metrological requirements are met.
It provides guidelines for realizing financial and economic benefits through the application of quality management principles. It facilitates application of management principles and selection of methods and tools that enable the sustainable success of an organization.
Statistical techniques allow better use of available data to assist in decision making, and thereby help to continually improve the quality of products and processes to achieve customer satisfaction.
A quality management system depends on the involvement of competent people and the way that they are introduced and integrated into the organization. It is critical to determine, develop and evaluate the knowledge, skills, behaviour and work environment required.
ISO is intended to apply to auditors, organizations implementing management systems, and organizations needing to conduct audits of management systems. BSI is incorporated by Royal Charter.
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Jump to Page. Search inside document. ISO , Quality management systems — Fundamentals and vocabulary 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO apply. NOTE Infrastructure can include: a buildings and associated utilities; b equipment, including hardware and software; c transportation resources; d information and communication technology.
NOTE A suitable environment can be a combination of human and physical factors, such as: a social e. These factors can differ substantially depending on the products and services provided. NOTE 2 Organizational knowledge can be based on: a internal sources e. The organization shall conduct a review before committing to supply products and services to a customer, to include: a requirements specified by the customer, including the requirements for delivery and post- delivery activities; b requirements not stated by the customer, but necessary for the specified or intended use, when known; c requirements specified by the organization; d statutory and regulatory requirements applicable to the products and services; e contract or order requirements differing from those previously expressed.
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WVXU News. Juclyde Cespedes Cababat. Zayn Maurya. Poison Ivy. Janee Jane. Sutanu Pati. Azhar Hassan. Tito Banerjee. Melissa Jane Vivero. Completing your ISO transition project before the deadline, when time is an issue, can be challenging — even to the most streamlined businesses. This case study aims to help speed up the process, with a real example showing the timeframe and the steps to follow. It also shows the options that exist for the transition and how this company resolved their doubts in the transition process.
This white paper clarifies the benefits of completing the transition early, including the positive effect it will have on your business. It also outlines the steps to follow for a successful transition.
When implementing ISO you may find it daunting deciding which method to follow. This white paper outlines the pros and cons of both going it alone, and hiring a consultant.
It offers detail on both techniques, helping you make an informed decision as to which is the most suitable approach for your business. Growing your business is essential if you want to remain competitive. This white paper outlines how ISO could help your enterprise perform better, and increase customer satisfaction. This white paper is intended for companies that have implemented the ISO revision, and are planning to transition to the revision.
The paper describes the suggested steps in the process. This matrix shows relationships between the requirements of ISO and the new ISO , and gives an overview of common requirements of these versions with tips on how to make the transition to the new version with as little stress as possible. This document explains what the process approach is and why it is important, and provides an example of a process flowchart that can be used as a guideline for creating a flowchart for your own company.
This document explains each clause of ISO standard and provides guidelines on what needs to be done to meet each requirement of the standard. It also gives an insight on how to apply process approach and how to plan and analyze processes within organization. White paper. This checklist show exactly which documents are mandatory, and which are optional in the revision of ISO Before now, there were only two ways to become certified in ISO one could either track down dozens of resources and patch them together, or bring in an expert consultant to do all the work.
Presentation MS PowerPoint. Transitioning to ISO can be challenging, so finding the best way to apply the standard is essential. Luckily, there are several approaches to choose from, including hiring a consultant or doing it yourself. When presenting your implementation strategy for ISO , important sponsors and stakeholders will want to see key components from the Project Plan. With our PowerPoint template, you can create and format an effective presentation for your ISO implementation project.
Templates 3 Template MS Word. Implementing a project like ISO is easier with the support of management. Use our project proposal template to help achieve the approval and commitment necessary from top management to progress. Template MS Word. Implementing a project like ISO will be much easier with the support of management. Use our presentation template to help you gain the approval and commitment you need from top management. Checklists 8 Checklist MS Word. This checklist is intended for internal auditors in manufacturing companies that need to perform an ISO internal audit.
It outlines the specific questions to be asked for the manufacturing process in order to check if the process is compliant with the requirements of the ISO standard. Checklist PDF. This diagram presents the four basic steps in the ISO risk management process, starting with defining how to assess the risks, and ending with creating the controls to decrease the risk. Checklist MS Word. This checklist will enable you to easily keep track of all the steps of your ISO implementation project.
There are 12 major steps and 44 tasks, starting with obtaining management support all the way through to your certification audit. Completing your ISO transition project before the deadline, with as little stress as possible, can be daunting. This checklist aims to simplify the procedure, by identifying all the required steps to follow. It also provides guidance on how to implement the changes in a straightforward manner, aimed at easing the workload for all those involved in Quality Management Systems.
This easy-to-follow diagram offers step-by-step guidance for your ISO implementation, with particular focus on the changes required by the revision. View the whole project at a glance, from the start right through to the certification process. One method of implementing ISO is to hire a consultant. To help you decide whether this is the right option for your company, you need to first ask potential consultants relevant questions.
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