Download iso 9001

Download File. File Size: kb. 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:. This audit checklist may be used for element compliance audits and for process audits. After completing the Gap Analysis you will have a list of activities and processes that comply and ones that do not comply GAPs.

Buy this standard. This standard was last reviewed and confirmed in Therefore this version remains current. Abstract Preview ISO specifies requirements for a quality management system when an organization: a needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

Status : Published. Publication date : Corrected version fr : This standard contributes to the following Sustainable Development Goals :. CHF Buy. ISO Quality management systems. Fundamentals and vocabulary. ISO Environmental management systems. 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.