Example of a iso 9001 quality manual




















The company and location described are completely fictitious, as is the organization of the fictitious company. On the cover page of the QM you will see a reference to a digital signature. The example manual does not actually have a digital signature, but one could easily be applied. A digital signature is not a typed version of the person's name, nor is it an image of a person's signature. A true digital signature, using a computer method called public-key encryption, is a code that becomes invisibly embedded in the document.

The signature can be verified by anyone who has the signer's public key. This serves two purposes. First, it authenticates the person who signed the document, since only that person has the private key.

Second, it authenticates the document, since if any part of the document has been changed since it was signed, the verification will fail.

A digital signature, then, proves that neither the signature or the document is forged or altered. Typed names and graphic images cannot do either — and neither can ink on paper. The degree of control for copies of the QM, and other documents in the quality system, varies from one organization to another. If the documents are electronic, control can be greatly simplified provided everyone who needs it has access to the computer system where and when needed.

As shown on this manual, any printed copy is uncontrolled, and any electronic copy that is not on the organization's main file server is uncontrolled.

On the main file server, of course, there only needs to be one copy of the current version. When your people have access to the QM and other documents on the computer system, the need for printed documents goes down. That simplifies document control and reduces the amount of paper consumed. With an electronic document, such as this one, there is no need for old-fashioned page-level revision control. 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. Designed for a service organization that is part of a larger organization which is NOT registered. Iso template excel free downloads, iso document, iso backup document, iso requirements - software for free at freeware freedownload.

For a robust quality management in the organization it should mandatorily have a quality manual. The manual will ensure implementation of new processes, improvement of existing quality management, and yielding better results.

A new version of ISO is already released and by ensuring that the present quality management system is in place it is possible for the organization to migrate to the new system. The quality manual template has the following — 26 forms, internal audit checklists, process maps, records and reports, and guidance.

The corporate manual tends to the information regarding the functioning and development schemes of a corporate company. The manual can contain various topics like the introduction the company, major purpose, related documents, quality management system, management responsibilities, resource management, and other analytics.

These can be explained by using flowcharts and diagrams or as contract points. This type of Quality Manual is designed for the employees of the manufacturing industries that have to keep in mind certain aspects before they work and tend to the specific needs of the company. This manual includes the revised history of changes in the manual and further information regarding the general contents, normative references taken by the company, Terms and conditions, Quality management systems and detailed facts about the management responsibilities of the employee and resource management.

The tree diagram of units of employees is mentioned for clear understanding. The VP quality manuals need to be dated according to the day of implementation and formation.

The document must contain the identification number of the document and the document section mentioned above every page.

The entire manual includes the details about purpose, scope, company details, engineering and product development, equipment and capacity, environmental chemical issues, quality management systems, data analysis, responsibilities, resource management and infrastructure of the company.

The Business Operating Manual is intended to demonstrate an agreement to quality management systems and requirements of the firm, systematically.



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