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How to write a quality manual according to iso 9001 2015?

quality manual
ISO 9001

How to write a quality manual according to iso 9001 2015?

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Quality Manual ISO 9001:2015

A quality manual is a document that explains how a company intends to operate and execute processes inside its quality management system. It might contain policies for all aspects of your business that have an impact on your capacity to generate high-quality products and exceed consumer and ISO requirements. These regulations specify how your department’s personnel will carry out operations within the parameters set forth in the quality manual.

Many other ISO 9001-based quality management system standards still necessitate the use of a quality manual. If your standard requires it, you must keep a quality manual on hand.

The quality manual’s objective is to act as a reference for your company’s business processes. Any corporate policies that affect your ability to provide high-quality products, meet consumer requests, and adhere to ISO standards can be detailed in the manual. The document can then be used by your department managers to outline the limitations and standards they must follow when implementing procedures.

A quality manual is a crucial tool for firms implementing an ISO quality management system since it establishes the intentions for daily activities inside the system. It establishes expectations for your team’s performance and the quality of your products.

What to include in the ISO 9001 Quality manual

1) The quality management system’s Scope. This scope is established to define the system’s boundaries and is based on the scope agreed upon with the registrar for inclusion in the ISO 9001 certificates, this is a description of what your company does. The second step of the scope requirement is to determine whether the standard contains any exclusions. In many circumstances, the quality manual will not specify any, but the ISO 9001 need for “design and development” for organizations such as a machine shop that works only from customer drawings and does not design any goods is the most typical exclusion.

2) Documented processes (or references) for the quality management system: Anything written or captured in any form, such as written procedures, policies, checklists, forms or schematics, drawings, flow charts, diagrams, and computer systems, is referred to as “documentation.”

The word “documented information” in the context of ISO 9001 refers to both “written documents” that define and show how your quality system should work (e.g., flowcharts, procedures, policies, and checklists) and “written records” that show what was done.

To obtain ISO 9001 certification, a system must be documented because the standard demands that certain information is documented.

Procedures, flow charts, checklists, forms, computer systems, and any other means or format that works in your firm must all govern how things are done. However, there are no set protocols that must be followed. There isn’t even a good manual available. What many people don’t realize is that you have complete control over how your papers look, what format and structure you use, and what you include in them. As long as it satisfies these criteria. From checklists and flowcharts to intranets, wikis, and workflows embedded in IT systems, you can utilize one or more forms. You can utilize any medium, including intranet, online, Internet, or wiki, whether it’s paper or flexible.

The “quality manual” was one of the most often utilized strategies. And if you want to, you can still do it. It can be in the form of a paper copy or an electronic copy, such as web pages, help files, or computer systems. You can write your paper in a variety of styles, ranging from simple and user-friendly to bureaucratic, lengthy, and difficult to read. And a handbook like this could be the only document you have for your system, or it could be one of many. Or something in the middle.

3) A explanation of how processes interact. The simplest method is to utilize a flowchart that identifies all of the organization’s processes and shows how they are connected with arrows. While a thorough flowchart might help you better grasp the interactions between processes in your business, most people can understand the basics with just a simple, high-level flowchart.

The content of your quality handbook is totally up to you and primarily depending on your processes for ISO 9001:2015 users. You must demonstrate evidence of your QMS aims, actions, and results to ISO. Make sure your primary emphasis when deciding how to compile your quality manual and what to include is to ensure that the policies you include represent your real practices.


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  1. […] The company may well have its own internal procedures, which may be imposed on the companies whose ISO 9001 certification it is inspecting. It too will be eager to maintain a reputation for quality and […]

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