In short, it fails the test for simplicity and ease of understanding. Some companies have taken a step toward making the Quality Manual smaller, more graphic, and easier to understand quickly. What is required in a Quality Manual? This is in place to identify the limit of the system, and is based on the scope agreed with the registrar to be placed on the ISO certificate.
However, it is not a detailed discussion of specific clauses in a given conformance standard. Quality management systems — Requirements.
There is no need to have a separate QM for each, but it is advisable to have a matrix showing how the QM addresses each set of requirements. Examples of other different areas that could be addressed in a QM include health and safety, environmental concerns, financial accounting, corporate ethics, major customer requirements, and more.
The company and location described are completely fictitious, as is the organization of the fictitious company. Digital Signatures On the cover page of the QM you will see a reference to a digital signature. The example manual does not actually have a digital signature, but one could easily be applied.
A digital signature is not a typed version of the person's name, nor is it an image of a person's signature.
A true digital signature, using a computer method called public-key encryption, is a code that becomes invisibly embedded in the document. A digital signature created using this method has two parts: The signature can be verified by anyone who has the signer's public key.
This serves two purposes. First, it authenticates the person who signed the document, since only that person has the private key.
Second, it authenticates the document, since if any part of the document has been changed since it was signed, the verification will fail. A digital signature, then, proves that neither the signature or the document is forged or altered. Typed names and graphic images cannot do either — and neither can ink on paper.
Controlled Copies 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. Page-Level Revision Control 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.
If the document is saved as an HTML file for use on a web pagethen it could potentially be one continuous scrolling screen with no page breaks.The quality manual template is a supplement to the laboratory quality management system training toolkit, Module 16 - Documents and records.
This quality manual template is based on internationally-accepted standards, and provides guidance for public health and clinical laboratories on writing. The following is an introduction to the example quality manual for “Mythical True Value Metrology.” The purpose is to introduce and describe the example manual, and to discuss some of the concepts addressed in the manual.
However, it is not a detailed discussion of specific clauses in a given. APHL How to Write a Laboratory Quality Manual | 4 PURPOSE OF THIS MANUAL Public health laboratories’ work is highly complex and requires high levels of accuracy, precision, reliability and confidentiality provided in a timely and cost-efficient manner.
including information storage and retrieval systems without the permission in writing from the California Department of Transportation). Construction Quality Assurance Program Manual Overview quality control, while the state DOTs’ testing and inspection were termed quality assurance.
Guidance on Writing a Quality Assurance Manual Excerpt from, ^Requirements for ASME NQA-1 Certification _, Issue No.: 3, Date, February 10, The Quality Assurance Manual shall not be a reiteration of the NQA-1 Standard, but rather, a.
The quality procedures further describe criteria, methods, detail activities, responsibilities and the quality assurance measures that are required to ensure the effective operation and control of the department business processes.