The ISO 9001 Standard requirements are as follows:
- The QMS documentation shall include documented information required by this international standard.
- The QMS documentation shall include documented information defined by the organization as needed to provide evidence of the effective operation of the QMS and of conformity of products and services.
- Note: The extent, scope, and size of documented information in organizations are affected by the following factors:
- The intended outcomes and results of the QMS
- The size of the organization
- The level of complexity, functionality, and interrelations between its processes
- The qualifications of the employees
- The quality objectives
A principle that must be considered when defining your documented information is as follows: the amount and details of the documented information must be relevant the intended outcomes and results expected of the QMS.
Documented Information Required by the ISO 9001 Standard
Throughout the standard, there are requirements for documentations needed to support and operate the QMS. The last version was relatively clear and specified, where the ISO 9001:2008 Standard expected procedures, documentations, and records. The ISO 9001:2015 Standard does not put itself anymore in the position of telling you which procedures to maintain, which procedures not to write, or which records are necessary. You will decide what is necessary for you to maintain the standard requirement. It is a harder task because it leaves more room for interpretations and debates for you and your auditor. I propose in this chapter (as a recommendation only) a way to analyze the standard textually and assess whether documentation is required. Normally, the text of the standard implies with clear statements where documentation is expected. But sometimes you must read between the lines and figure it out. Let us look at some example statements:
- Clause 4.3 “The scope shall be available as documented information”: It is clear that documentation here is required.
- Clause 8.1 “Establishing criteria for the processes”: On the one side, it is not specifically stated that documentation is required, but, on the other hand, I cannot think of other ways to meet these requirements without maintaining documented information of the mentioned criteria.
- Clause 9.1.2: It is required to determine methods for obtaining and using data relating to customer perceptions of the degree to which requirements have been met— There is no need to provide documented information regarding those requirements, but there is a requirement to prove that these activities were planned and are being performed. There is also no need to develop a process or procedure that describes which methods are used, which tools are used to collect the data, and which tools are used to analyze the data. But it is required to prove that those were considered, planned, and are being performed.
Structure of the Documentation
A QMS must have a structure for the documentation it uses. The idea is to develop a structure that demonstrates the relations and interrelations between the various documents throughout the QMS and enables tracing back a process through the documented information; some documents relate to other documents, outputs of one document are the inputs for another document, and so on. The structure should be effectively planned and should present the relations between the different types of the documents in the organization. These relations are based on your organizational needs and will support your activities. In other words, let your organizational needs and operational activities dictate the structure of the documentation. A good example for relations and interrelations of documented information is a work instruction and the references to specific forms; a work instruction describes an activity of some kind and refers to a specific form that the employee must fill out in order to provide evidence and effectiveness of that activity. The traditional and most common method to analyze the structure of the documented information in the organization will be to arrange, classify, categorize, and set levels to the types of the documented information used in the organization according to their characteristics and role in the QMS. I prepared here a diagram that suggests one way of defining the structure of documentation.
This webpage contains only a fragment of the chapter 7.5 – Documented Information from the book: ISO 9001: 2015 – A Complete Guide to Quality Management Systems published by:
Why choose the book ISO 9001:2015?
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