Business Manual

Business Manual

“Simplicity is the ultimate sophistication.”
— Leonardo de Vinci  

By Mark Kaganov

The article explores opportunities in the application of Lean methods to ISO 9001, ISO 13485, and ISO 14001 Management Systems, specifically Quality and Business Manuals. According to research by the Lean Enterprise Research Centre, 60% of production activities in a typical manufacturing operation are waste! Through my consulting and auditing career, I have worked with hundreds of businesses. In various countries, in different industries, in companies large and small, I keep on finding, again and again, the same problem: ISO 9001, ISO 13485, ISO 14001 management systems are over documented. Regretfully, very few companies apply Lean methods to their management and documentation systems.

No ISO management system standard requires a stand-alone quality or business manual. Despite this fact, most of the companies continue maintaining their old manuals, updating them to the new revisions of the standards. Often, these manuals mirror the content of the standard replacing “shall” with “we will” and delivering near-zero value to the organization. One of my clients, a Class I medical device manufacturer, had a 68-page “Quality Management Systems Quality Manual,” that was the title, referencing or copying the most unanticipated parts of the standards, FDA Quality System Regulations (QSRs), and European Medical Device Directive (MDD). I seriously doubt that anybody in the company ever read that document.

OK, standards do not require a stand-alone manual. But what if a client or a prospect asks us for a “manual”? Near all supplier qualification forms that I have seen had this checkbox: “Does the organization maintain a Quality Manual”? What are we going to answer? “Sorry, we do not have a manual.” With this answer, they may think that we are not qualified to do business with them. Hold on: there as a way around it.

Once I browsed a trade show in Hong Kong. One of the displays attracted my attention with impeccable composition and very professional color coordination. As I approached the booth, I saw a Chinese woman talking to a group of visitors. While enjoying the artistic displays, I noticed a thin book on the counter. The cover contained a few artistically arranged Chinese characters and the logo of one of the World’s largest registrars. I leafed through the book wondering what business this company was in — lighting fixtures, as it appeared from the displays, or perhaps publishing books in Chinese for that registrar.

Meanwhile, the woman ended the conversation with the visitors and approached me. We introduced ourselves, and she enthusiastically started to tell me about her company. At some point, I asked her about the booklet. “This is our Quality Manual!” she proudly replied. She said that the company put a lot of effort into it. “And,” she continued, “It’s paid for itself many times over by generating business for us.” One day, I’d like to frame that manual and put it on the wall — it’s a beautiful piece of art!

Following this example, maybe we can, too, make everybody happy: the customers, the prospects and our Marketing, and define the top-level documentation structure. We can create a three-, four-page document, let’s call it “Business Manual” that contains:

  • Company identity: the name, the logo
  • Vision (strategic direction and marketing)
  • Mission (marketing)
  • Values (marketing)
  • History (marketing)
  • Quality policy (5.2.2 and marketing)
  • Scope (4.3)
  • Exclusions and non-applicable elements (4.3)
  • List of crucial management system documents (4.4.2)

Bingo! We addressed all the requirements of the 9001 2015 standard, and we have created a beautiful marketing brochure for our business! Look, how slick and Lean it is.

The article was originally published by Master Control on October 6, 2010. This revision is an update to reflect on the new requirements of ISO 9001 2015 and ISO 13485 2016.

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