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. 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.
The documents only serve to describe the system. Implementing a quality management system affects every aspect of an organization's performance. Benefits of a documented quality management system include:. ISO is the most recognized and implemented quality management system standard in the world. ISO specifies the requirements for a QMS that organizations can use to develop their own programs. Before establishing a quality management system, your organization must identify and manage various connected, multi-functional processes to help ensure customer satisfaction.
This structure is based largely on the plan-do-check-act PDCA cycle and allows for continuous improvement to both the product and the QMS. The basic steps to implementing a quality management system are as follows:. The design and build portions serve to develop the structure of a QMS, its processes, and plans for implementation. Senior management should oversee this portion to ensure the needs of the organization and the needs of its customers are a driving force behind the systems development.
Deployment is best served in a granular fashion by breaking each process down into subprocesses and educating staff on documentation, education, training tools, and metrics. Company intranets are increasingly being used to assist in the deployment of quality management systems. Control and measurement are two areas of establishing a QMS that are largely accomplished through routine, systematic audits of the quality management system.
The specifics vary greatly from organization to organization depending on size, potential risk, and environmental impact. Review and improve detail how the results of an audit are handled.
The goals are to determine the effectiveness and efficiency of each process toward its objectives, to communicate these findings to the employees, and to develop new best practices and processes based on the data collected during the audit. The history of quality can trace its roots back centuries when craftsmen began organizing into unions called guilds. When the Industrial Revolution came, early quality management systems were used as standards that controlled product and process outcomes.
As more people had to work together to produce results and production quantities grew, best practices were needed to ensure quality results. Eventually, best practices for controlling product and process outcomes were established and documented. These documented best practices turned into standard practices for quality management systems. Quality became increasingly important during World War II, for example, when bullets made in one state had to work faudiwith rifles made in another.
The armed forces initially inspected virtually every unit of product. The importance of quality only grew after the war. The Japanese enjoyed a quality revolution, improving their reputation for shoddy exports by fully embracing the input of American thinkers like Joseph M.
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