Lean Quality Manual Example | What is Lean Quality Manual | Understanding Lean Quality Manual
This video discusses a Lean Quality Manual Example. The bar chart on the left is not a decoration; it shows my statistics on manuals. During my twenty-plus years of auditing and consulting, I worked with some three-four hundred companies around the World. All of them, except for two, had quality manuals. The paradox is that almost all companies create quality manuals, but no standards have specifically required them since the 2015 revision! There is a solution to solve this puzzle. Interested? Let’s get started!
Going back in history, in 1959, the U.S. DoD released its Military Specification MIL-Q-9858. This document did not mention the word “manual.” In 1970, the British Standards Institution introduced the World’s first commercial standard for quality systems, BS 5750. This standard did not refer to a “manual,” either. The first mention of the term “quality manual” appeared in the first revision of the ISO 9001 in 1987. While the standard introduced this term, it did not require a manual to be a stand-alone document. All the standard required was that a quality manual “shall” include the following:
• the scope of the QMS with the details of and justification for any exclusions,
• the documented procedures or reference to them, and
• the interaction between the processes
Similar requirements for the manual specify the ISO 13485 standard. Despite simple requirements as, “we need a procedure.” Since then, almost all businesses have followed this interpretation and created thirty-forty-page manuals for their quality and even environmental and safety systems. By the way, environmental and safety system standards never required manuals. As a rule, manuals accurately copy the content of the standard, only replacing the words “shall” with “we will.” These manuals bring zero value to organizations and should be considered waste. One of my clients, a Class I medical device manufacturer, had a 68-page manual. It referenced or copied the most unexpected parts of the 13485 standard, FDA regulations, and the European Medical Device Directive. Whenever I came across that manual, I wondered if anybody in the company had ever read that thing. We should agree that manuals are a tradition and not a requirement, so let’s look at a Lean Quality Manual Example.
Debates about the need or requirement for a quality manual ended in 2012 when ISO introduced its Annex SL. The Annex presents a structure for all management system standards and harmonizes the content of quality, environmental, safety, and other standards. In 2019 Annex SL became Annex L with practically no changes and no mention of a “manual.” Regretfully, even after the 2015 revisions of the standards, businesses continue updating and maintaining their manuals.
Old habits die hard: what if a client or a prospect asks us for a “manual”? Nearly all supplier qualification forms I have seen had this checkbox: “Does the organization maintain a Quality Manual?” For this purpose, a manual may be helpful. So, it looks like the only reason a business may need a manual is for marketing and promotional purposes, and it definitely should not be a thirty-page book! Let’s experiment!
By now, I hope we agree that a company may need a business marketing brochure instead of a traditional manual. We can create a three-or four-page document; let’s call it a “Business Manual.” The document will contain the following:
• Company identity: name, logo,
• Vision:
• Mission:
• Values:
• Short History:
• Policies: quality, environmental, and others;
• Management System Scope, with exclusion and non-applicable elements:
• A list of documents to support the operation:
You can find a Lean Quality Manual Example on our website: click on the Academy tab, and download a complimentary copy. If you are intrigued by the three-page manual, how about no manual at all? We can create a top-level document, like a table of contents, that lists all the management system documents that also include:
• Scope of the Management System
• Exclusion and Non-applicable Requirements, and
• Process Interaction Matrix
This is precisely what one percent of my customers did, which is what one may call a super Lean Business Manual! Think about this Lean Quality Manual Example and simplify your QMS. Best of luck!
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