Quality manual of any university

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. Well the answer is YES. This is likely to be due to the fact that when Chapter 4 was last updated June there was no mention of a Quality Manual in Chapter 1 at that time, which was then later updated in January Hopefully any future update of Chapter 4 will include more detail of what should be contained in a Quality Manual.

Clause 1. A Quality Manual or equivalent documentation approach should be established and should contain the description of the pharmaceutical quality system. The description should include:. Process maps and flow charts can be useful tools to facilitate depicting pharmaceutical quality system processes in a visual manner. Poor Quality Manuals normally involve simply copying the requirement of the standard into the manual itself.

This is of little value. A good Quality Manual covers HOW an organisation intends to achieve the requirement of the standard that it is based on, for example:. If designed well it can be used as a tool to sell an organisation, to show what a positive quality ethos they have and can show how good an organisation is and how seriously it takes its Quality Management System.

To try a free taster of our online courses to see if they are of interest visit this page. Thanks for the information. This site uses Akismet to reduce spam. Learn how your comment data is processed. We help people in pharma organisations to continually improve their regulatory systems to gain competitive advantage and ensure compliance.

How we govern registration, attendance and study; including Fitness to Practise procedures. Ensuring students are fully involved, represented and engaged in their learning experience. Includes information on the Learning Community Fora. Recognition of other learning, partnerships, placements and distance learning information. Our key Committees, quality assurance and professional accreditation area; includes a guide to the Quality Manual.

Connect with the University of Nottingham through social media and our blogs. Campus maps More contact information Jobs. You are here: University of Nottingham Quality Manual. 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. What should you include in your QA Manual?