Select the term that best describes the purpose of retaining documented information in a quality management system to ISO 9001.

Select the term that best describes the purpose of retaining documented information in a quality management system to ISO 9001.
A . To facilitate auditing for proof of conformity to the standard.
B . To provide confidence in the effectiveness of the quality management system.
C . To safeguard the integrity of the quality management system.
D . To support the operation of the processes of the quality management system.

Answer: D

Explanation:

Documented information is a means by which an organization demonstrates compliance. It communicates what we do and how we do things, it communicates what happened and what results were achieved. It is, essentially, a tool for communication. ISO 9001:2015 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to determine the correct amount of documented information needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS. The standard states that the organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned. Therefore, the purpose of retaining documented information is to support the operation of the processes of the QMS, not to facilitate auditing, provide confidence or safeguard integrity, which are secondary benefits of documented information.

Reference: Guidance on the requirements for Documented Information of ISO

9001:2015, ISO 9001:2015 documented information | CQI | IRCA, Documented Information Required

by ISO 9001:2015 – 9000 Store

Subscribe
Notify of
guest
0 Comments
Inline Feedbacks
View all comments