What should go in a quality manual

Wrestling with QHSE compliance. They tell stories of before and after using Mango. They tell it like it is. A quality manual is a document that defines the quality management system of an organisation and demonstrates how the quality management system should function. Quality manuals may vary in format and detail, in order to fit the scope and complexity of your organisation.

A key use of quality manuals is that your management can easily communicate to the rest of the organisation what their expectations are for quality. Therefore, your manual should be written in relatively simple terms. It should outline:. It provides a permanent point of reference that describes the profile of your quality management system. Documenting the elements of your qu ality management system system allows you to examine and analyse your current procedures in order to identify any inefficiencies.

This will reduce the chance of your quality management system from growing in an unplanned way. If your organisation is relying on an employee to remember the quality management systems and this employee may leave, taking the information with them, will leaves the rest of the organisation at risk. A quality manual will help reduce communication problems.

It gives your new employees an initial sense of your organisation's intentions and its clear vision. Having the quality manual in place will save a lot of time when it comes to auditing as this is a set piece of documentation that can be shown to the auditors — which they love!

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. Within the quality manual you describe the implementation and maintenance of the quality management system. Quality manual examples benefits include:. The quality manual is a reference for the policies and procedures. It should discuss the reasons behind your QA policies and procedures.

The QA manual proves that your QA system elements have been thought out. It also assigns the responsible parties for execution of your QA plans. The quality control or assurance manual is a textbook for training.

Train your quality control, quality assurance and inspection employees to the quality manual. You can use the manual to train other supervisors, leads, engineers and managers. In the case of employee turnover, quality manual examples provide continuity of operations.

Without a valid and stable manual, personnel changes can cause serious process changes. The manual stabilizes your QA systems. The manual provides the QA code and prevents the unwanted practice of individual management decisions. The manual provides a top level documented that can be audited.

By auditing the manual you understand which QA practices work and which ones need to be improved. ISO auditors will ask you for your Quality Manual.

The auditor starts with this document. In many cases you will mail them the manual prior to their visit. They review the audit and then will ask you about specific info from the manual during the audit.

For supplier control, ask your supplier for their quality manual. This will help you understand their QA systems. This can be very useful when you request supplier corrective action. If the supplier does not have a manual, this will force them to thinking through and documenting their procedures.