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There are two schools of thought in the industry concerning the origin of quality manuals. One categorically declares that a single, common quality manual will not work and that each company should develop its own. This conviction stems from the belief that if documents are not written within the company, its personnel will not have accountability for them and will not follow them.

If one were to carry this thought to the next level, one might find it necessary to reject such common tools as Newton’s laws, multiplication tables, Microsoft® Word and others not written by end users. It is often valuable to use a sample to achieve a desired outcome. It isn’t always necessary to reinvent the wheel. Writing your own documents does not necessarily mean that your personnel will follow them. I have worked with companies that wrote their own manuals and procedures and still did not use them, not having a clue as to what was written in them!

Another point of view, to which I adhere, is that a quality manual is a generic document. Virtually any company can use a model of a quality manual to develop its own “from scratch,” or to enhance an existing one. I have seen proof of this in a number of companies of various sizes in different parts of the world. Based on the thousands of template procedures that have been sold, there are also very strong indications that many second-level processes are generic enough to use a model as a tool for their construction.

One of my clients recently demonstrated the benefits of this approach. This client purchased templates for the top-level documentation. Key personnel had experience in and were quite familiar with the QMS concepts. The company was a small start-up of approximately 30 people. It took them only three months to implement a functional system and achieve ISO 13485 certification.

If you adhere to the first school of thought and believe that a company should develop its own quality manual “from scratch,” you may not need this book. However, you still may want to use it later to check how well you have done the job. You may create your own manual by toiling through numerous, difficult-to-read and understand standards, figuring out various cross-elemental specifics and implied references, finding interpretations and learning through your own experience.

There is nothing wrong with this approach. As a matter of fact, I went the same route when I was learning the trade. I have studied the standards for years, interpreted them by communicating with experts in the field, reviewed dozens of manuals and assessed dozens of companies. There is no wrong or right way – you can rely on the experience of experts, or make a significant investment in becoming an expert yourself. It is you choose…

To assess the cost of developing a quality manual for ISO 9001 standard, I surveyed about three dozen of my customers to estimate the time they spent preparing their quality manuals. All surveyed personnel reported average to high levels of expertise in quality management systems. Responses indicated that the time span was between four and eight weeks, with an average of six weeks.

Based on a U.S. salary survey data, a quality manager on the average makes approximately $86,000 a year. This translates, for six weeks, into about $11,000 for direct time only. Add to this number approximately 100 percent overhead, which is typical for a medium- to large-sized company, and you may easily end up paying about $25,000 for a document that contains roughly 30 pages. For this price, it’d better be good! If you agree that cost is too high, let’s talk about how this book can help you develop your quality manual for a small fraction of that cost.

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Check our Product page to see how our products can help you developing your management system.