The ISO 9001 documentation is at the core of any ISO 9001 quality management system (QMS). 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 9001:2015 requires the following documents:
The procedures are the essence of the ISO 9001 documentation. The ISO 9001 procedures explicitly describe how numerous processes within the company must be performed, and who is responsible for them. Ideally, the procedures are combined in a single user-friendly document (a "procedures manual" or "quality management manual" or similar.
ISO 9001:2015 sets the requirements on the procedures and their content in many clauses; the requirements are not always explicit. We recommend you have procedures covering most or all applicable ISO 9001:2015 requirements.
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 9001:2015 section 5.2.
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 9001:2015 section 4.4.
The scope statement defines the application and boundaries of the ISO 9001 quality management system within the company. The scope statement is required in ISO 9001:2015 section 4.3.
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 9001:2015 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 9001:2015 section 8.5.1.
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 9001:2015 contains numerous explicit requirements on records plus requirements for many more undefined records.
Forms are optional
ISO 9001:2015 does NOT contain requirements on using forms. In fact, it would not be a violation of ISO 9001:2015 requirements not to have any forms at all. However, good forms provide many benefits to any business, ranging from time savings to consistency. Using forms can be a tremendous help creating the various records that ISO 9001:2015 requires. The best forms even act as instructions when they guide the user through the process of providing the requested information.
How about the Quality Manual?
There are many requirements in ISO 9001:2015 regarding the content of the above mentioned documents. On the other hand, there are many things that ISO 9001:2015 does NOT require, for example:
ISO 9001:2015 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 9001:2015 saying that the documentation needs to be complicated and hard to understand!
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., procedures, quality policy, scope and process flowchart) as much as possible into one comprehensive manual (an "ISO 9001 QMS manual" or "procedures manual" or "quality management manual" etc). 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...