In the latest revision of the ISO 9000 series of standards we found two of the most important objectives, they are :
- To develop a simplified set of standards that will be equally applicable to small as well as medium and large organizations, and
- For the amount and detail of documentation required to be more relevant to the desired result of the organizations process activities.
ISO 9001:2015 allows organizations flexibility in the way it chooses to document its Quality Management System (QMS). This enable us or any individual organizations whom implemented ISO 9001 to determine the correct amount of documented information needed in order to demonstrate the effective planning, operation and control of its process and the implementation and continual improvement of the effectiveness of its QMS.
What is Documented Information ?
In ISO 9001, documented information is defined as “information that is required to be controlled and maintained by an organization and the medium on which it is contained”. This includes documents, such as procedures, work instructions, and quality plans, as well as records, such as inspection reports and test results.
Why is Documented Information is Important in ISO 9001 ?
Documented Information is important aspect that need to be addresses by all organization that want to implement ISO 9001 to their organization. Documented information helps any organization to communicate its quality policy and quality objectives to its employees, it also ensure that its processes are consistently implemented and controlled during all stages of operation in the organizations. It also being used to demonstrate compliance with the requirements of ISO 9001 and the last is they provide evidence of its ability to meet customer requirements.
Does There any Differences between Documented Information held by organizations ?
Please take note that ISO organizations gives organizations full access on how they want to interpreted the implementations of ISO 9001 in their organizations. This also make it clear that the extent of the QMS documented information can differ from one organization to another due to multiple reason, such as the size of the organization and its type of activities, processes, product and services. The complexity of processes and their interactions, and the last is the competence level of the employee, this would affect for the implementation of the organization and also during the operational, which could affect greatly on the quality of the product and/or services produce.