Iso9001 2008 quality manual


















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.

In many industries, such as aviation, this is important to prevent the introduction of inferior counterfeit parts into the manufacturing or maintenance operations. As used by metrology calibration organizations and in section 7. These are similar concepts, but in the first case traceability refers to the origins of a physical item, and in the second case it refers to the documented uncertainty of a measurement result — a number. The example QM is for an organization that is hypothetically registered to ISO and also operates in a regulated industry.

This means that there are cases where regulatory requirements may need to be addressed in the QM. A specific regulatory requirement has been added to the QM in a logical place. The same can be done for other requirements — add them to the QM in a location where it makes sense in the organization of the manual.

For example, if Sarbanes-Oxley compliance is a requirement, the logical place to add it might be the Management Responsibility section of your QM. The example quality manual for Mythical True Value Metrology, a service-providing organization, is presented as an example and training aid.

It demonstrates several issues of a quality management system, especially issues that may arise in a regulated industry or in a small department that is registered separately from the rest of the parent organization. While this is written to demonstrate how the organization meets the requirements of ISO , the concept can be extended to any conformance or compliance requirement, or simply as a recognized best business practice.

The current version is dated Cart Total: Checkout. Quality Resources. Magazines and Journals search. Learn About Quality. Featured Industries. Quality Glossary. Publication Types. Magazines and Journals. Become an Author. From Topic and Industry Communities. Webcasts and Podcasts. On YouTube. Digital Signatures On the cover page of the QM you will see a reference to a digital signature. Controlled Copies The degree of control for copies of the QM, and other documents in the quality system, varies from one organization to another.

Page-Level Revision Control With an electronic document, such as this one, there is no need for old-fashioned page-level revision control. Organization of a Quality Manual There is no requirement that the quality manual mirror the conformance standard. Definitions Any terms that are specific to your company or industry, and used in the QM, should always be defined in the QM.

Scope of the Quality Management System If the entire organization operates under the defined quality management system QMS , then there is little need to specifically define the scope. References to Other Documents in the QMS One advantage of electronic documents is that links to other documents, of any type, can be embedded in the document.

Traceability Section 7. These manuals usually follow the layout of ISO with similar headings and layout. Because of the structure of ISO it is possible to create generic Quality Manuals, Policies and procedures that can then be modified to match your companies profile, structure and processes.

Whilst these may not be perfect they are an ideal way to kick start a system, it saves a huge amount of work in creating them completely from scratch. If you consider the approach of most consultants; this is exactly how they work, putting your information into a set of pre-prepared documents that they have either developed themselves or purchased to use.

Once you have the basics of a system in place you can use your auditing process to build on and improve your system. However, should you use a company that offers this service and certification; check that they are approved by UKAS links below as there are a number of disreputable companies that offer this service and give you a worthless ISO certificate at the end of it!

The following are some useful links that will help you gain additional information regarding the ISO standards;. Lloyds Register Quality Assurance Lloyds Register Quality Assurance is probably the oldest of the certification bodies who will audit your quality management system to ensure your quality manual and policies meet the requirements of ISO They also offer training for developing your system and auditing.

They also offer certification and training for ISO Content is for informational or entertainment purposes only and does not substitute for personal counsel or professional advice in business, financial, legal, or technical matters. Glad to provide you with some useful information, good luck with your quality manual and ISO implementation. Thank you. Thank you for reading and commenting Jeddex, nice to get positive feedback about the ISO Quality manual and quality policy hub.

I have written a few Quality Manuals and Quality Policies over the years as I have had a few jobs in Quality Management as well as business improvement. Thanks for your comments Dobson. It is ovious you use this stuff on a regular basis as you speak from experience and with authority. Interesting to know how our industries are regulated. Personal Finance. ISO Documentation. Related Articles.

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