Iso 9000 manual free download






















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. This list contains detailed and already prepared queries to find the best possible consultant for your business. There is also no requirement for page-level control in the ISO system.

In this example case, the entire QM is a single document. By the nature of electronic documents, if a single character anywhere in it is changed, then the entire document is changed. Everywhere else in the world it would normally be prepared for A4 paper x mm , which would change where page divisions occur.

If the document is saved as an HTML file for use on a web page , then it could potentially be one continuous scrolling screen with no page breaks. If the document is saved as a binary object in a database, random sections could be extracted and displayed in any format. It is strongly suggested, though, that the QM and other controlled documents be published as searchable, tamper-resistant documents.

It is never good practice to make modifiable documents available to people who have no need to modify them. Software tools for the PDF format are available for most computer operating systems, so users are not restricted to particular platforms.

The PDF format also has other advantages, including security, tamper-resistance, searchability, indexing, and more. There is no requirement that the quality manual mirror the conformance standard.

If the QM is used to demonstrate conformance to a number of requirements, it is impossible to do in a single QM. The manual should be organized in a way that is suitable for your organization, because your people are the ones using it every day.

A simple matrix can be used to reference parts of the QM to requirements in the conformance standards. Any terms that are specific to your company or industry, and used in the QM, should always be defined in the QM. Sharp readers will discover at least one acronym in the example QM that is not defined: MRO, which in this case stands for maintenance, repair and overhaul.

If the entire organization operates under the defined quality management system QMS , then there is little need to specifically define the scope. If the QMS applies to only part of an organization, then the scope must be explicitly stated.

In the example QM, only the metrology department of the organization is covered by the QMS; the assumption is that the rest of the organization does not have a system that conforms to ISO In the example QM, the scope is defined in section 2. Ever since ISO was released, there has been much discussion on how big or small the QM should be. Do not try to force it into an arbitrary small number of pages, but do not be overly verbose, either.

The QM should be a top-level overview of how the organization operates and does business. Policies, procedures, work instructions, proprietary information and the like belong in separate documents. While the QM must be reviewed regularly, if a clause or section is changed every time then that part may be a candidate to be pulled out to a separate document. When deciding what goes into the QM, remember the two main phases of an audit. First, your QM is evaluated against the conformance standard s to make sure all requirements are addressed satisfactorily.

Then, your organization's operations and records are evaluated against your QM to verify that you are doing what you say you are doing. In the second phase, anything in your QM is fair game for the auditor to look at. One advantage of electronic documents is that links to other documents, of any type, can be embedded in the document.

In the example QM, links are represented by blue underlined text, but they are simulated. In your real document, each link would actually point to a real document on your file server. This ability makes control of documents easier. Therefore, whenever someone clicks on the link, they will always — and only — see the current version of the referenced document.

The older version can be saved under a different name; the easiest way to do that is to simply add the revision date, in ISO format 2 , to the file name. For example, assume that procedure QP with the revision date of November 10, is being replaced with a new version revised today. No links have to be changed, and the date added to the old version file name uniquely identifies it. Sharp readers will also note that a version of ISO date format appears in a number of places in the example QM.

The date is always written with the biggest time unit year on the left and the smallest time unit day of month for dates on the right. One advantage is that the format is unambiguous and culture-independent. Another is that a date in this format as part of the file name is always sorted in correct order by a computer. The most common permissible exclusion is clause 7.

However, it is generally not a good idea to simply omit the excluded parts from the QM. It is much better to include reference to them, specifically state that they are excluded and why, and what the plans are if the current situation ever changes. Section 7. In some cases, such as the case of the example QM, the scope of the QMS is so tightly defined that functions normally part of the QMS are actually performed by organizational departments that are outside the defined QMS.

In the case of Mythical True Value Metrology, purchasing is an example of that. The metrology organization only has limited authority for small purchases; all others must go through the corporate purchasing department, which is not part of the QMS. In cases like this, the organization should do two things. First, the QM should describe what they can do, including the limits on it.

The QM should also state that other parts of the parent organization — the parts outside the boundary of the defined QMS — are treated as suppliers or customers, as appropriate. This is shown in section 7. In a situation like this, it is also important that the parent organization be on the approved supplier list!

In the example system, Mythical True Value Metrology has to be sure Mythical Airlines is on the approved supplier list for relevant services and products. As used in 7.



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