Quality Management System

ISO 9001:2015 Documented Information

For in-house training only

For in-house training only


The Documented Information is information required to be controlled and maintained by the organization and the medium on which it is contained.


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 results of the organization’s process activities
To allow organization’s flexibility in the way it chooses to document its quality management (QMS)
To enable each individual’s 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

Course Outline

I. Objectives of the ISO 9001 revision
II. Documented Information

1. ISO Definition
2. Uses/Benefits

III. Documented Information for ISO 9001:2015

1. Documented information to be “maintained”
2. Documented information to be “retained”

IV. Creating and Updating

1. Identification
2. Format
3. Review and approval

V. Control of Documented Information

1. Distribution
2. Access
3. Storage
4. Control of changes
5. Retention
6. Disposition

VI. Question and Answer

VII. Workshops


Document / Records Controllers or Custodians, Quality Practitioners, Quality Management Representatives, QMS Process Owners, Internal Quality Auditors, ISO Team.

Prerequisite: Participant has awareness in ISO 9001:2015 gained from training or experience


Participants will learn through lectures, case studies, group exercises and discussions.

Duration: 1 Day, 09:00 AM – 05:00 PM



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