ISO 9001:2015 requires organizations to prepare certain mandatory documented information. However, these few documents alone may not be sufficient to ensure the proper functioning of a quality system. When deciding what to document, it is essential to reflect on whether there is a risk that a process may not be executed as planned. If so, documentation is necessary to ensure the reliable implementation of the quality system.
For example, regarding the new standard requirement on determining the organization’s context, its interested parties, and their expectations, there are two strong reasons to document it: first, because this may be the first time working on this aspect unless your organization has already addressed it independently, and second, because this process could present some ambiguities. As for the scope of the quality system, it is usually a brief text that serves to determine which parts of the organization the management system applies to.
Concerning the quality policy, which represents a company’s documented commitment to meeting requirements, enhancing customer satisfaction, and continuously improving, its purpose is to communicate the organization’s goal as clearly and concisely as possible. It can be an independent document or integrated into the quality manual.
Regarding risk and opportunity management, ISO 9001 does not explicitly require any specific document. However, given that this is a new and highly significant requirement, it is recommended to document how risks and opportunities will be identified and addressed.
With respect to quality objectives, the requirements in ISO 9001:2015 remain the same as in the previous version of the standard. However, the updated standard now requires specifying plans for achieving these objectives. This means the organization must assign responsibilities and allocate resources accordingly. A single document can efficiently fulfill all these requirements.
To demonstrate personnel competence, training, and awareness, it may be useful to describe the human resource management process in a procedure that defines training needs, planning, execution, and evaluation of training effectiveness, as well as the assignment of related responsibilities.
To keep track of all rules for document and record management, including approval, updating, change management, and ensuring that the latest version is in use, it is best to define them in a documented procedure. This document should also specify how files are identified, stored, and protected so they can be retrieved quickly and efficiently if needed.
Of course, these are just a few examples, but they should give you an idea of how to proceed in documenting a quality system.
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