The ISO 9001 documentation is at the core of any ISO 9001 quality management system. What makes the ISO 9001 documentation so important? There are two important aspects:
(2) your company has to actually do everything that is contained in your company's ISO 9001 documentation.
ISO 9001:2008 requires the following documents whose content is precisely specified:
The quality manual defines how each requirement of the rather generic ISO 9001:2008 standard is applied at the company. In a sense, the ISO 9001 quality manual is a company specific version of the ISO 9001:2008 standard.
The requirements for the content of the quality manual are defined in ISO 9001:2008 section 4.2.2.
The quality procedures are the essence of the ISO 9001 documentation. The ISO 9001 quality procedures explicitly describe how certain key processes within the company must be performed, and who is responsible for them. Ideally, the quality procedures and the quality manual are combined in a single user-friendly document.
ISO 9001:2008 sets the requirements on the quality procedures and their content in sections 4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2, and 8.5.3.
The quality policy is the company's policy defining its stance towards quality and customer satisfaction. As such, the ISO 9001 quality policy is the overall guiding principle.
The content of the quality policy must meet the requirements of ISO 9001:2008 section 5.3.
The quality objectives define measurable goals relative to the company's quality management system. Requirements on the quality objectives are in ISO 9001:2008 section 5.4.1.
The process flowchart is a description of how the various processes of the ISO 9001 QMS interact with each other. The process flowchart is required in ISO 9001:2008 section 4.2.2.
Work instructions are the most detailed and most company-specific of all ISO 9001 documents. Work instructions describe in detail how particular tasks must be performed. Work instructions are typically written by the people who perform the actual work. ISO 9001:2008 requires work instructions only where they add real value to the company; it is a common misconception that every task in the company needs to be documented.
Work instructions are required by ISO 9001:2008 section 7.5.1.
Records are different from the above documents, all of which provide directions on how to conduct business. Records, on the other hand, are evidence of things done. ISO 9001:2008 contains numerous explicit requirements on records plus requirements for many more undefined records.
Forms are optional
There are many requirements in ISO 9001:2008 regarding the content of the above mentioned documents. On the other hand, there are many things that ISO 9001:2008 does NOT require, for example:
ISO 9001:2008 does not require any particular format or layout;
referencing every document and form to each other is not required;
there are no requirements regarding introductory paragraphs to procedures;
and there are certainly no requirements in ISO 9001:2008 saying that the documentation needs to be complicated and hard to read!
Remember that the ISO 9001 documentation is supposed to provide instructions on how to operate your company's ISO 9001 quality management system. The best documentation is easy to understand and user-friendly; the easier it is to follow the instructions, the better.
We have seen many companies making the mistake of creating various different documents and then referencing in each document all the other pertinent documents. This approach not only causes redundancies, but it is also simply burdensome and not user-friendly. Creating the ISO 9001 documentation in this way is usually the beginning of a cumbersome and bureaucratic ISO 9001 quality management system.
We recommend to create user-friendly ISO 9001 documentation by combining the different documentation requirements (i.e., quality manual, quality procedures, quality policy and objectives) as much as possible into one comprehensive manual. This reduces repetition and bureaucracy, and it saves time implementing the ISO 9001 quality management system.
Good ISO 9001 documentation always keeps the user of the document in mind, and different users have different preferences. Some users prefer instructions in form of pictures, others like flowcharts. Not many like long and convoluted text.
A word of caution...