Documented Information Control Procedure ISO 9001 2015 | QP1000

Documented Information Control Procedure

The Documented Information Control Procedure defines the methods and responsibilities for controlling documents used to provide work direction or set policy and defines methods for document revision, approval, and distribution.

This procedure applies to all documents required by the ISO 9001 :2015 and your QMS. Documents of internal or external origin are included. (12 pages, 2304 words)

Documented Information Control Responsibilities:

Document Control is responsible for controlling the Quality Management System documents, records, procedures and work instructions related to the QMS, and all internal and external documents required by the QMS.

Department Managers and Supervisors are responsible for ensuring that the latest versions of relevant documents are available at the point(s) of use, that these documents are legible, and that they are understood and followed. They are also responsible for reviewing and responding to document change requests in a timely manner.

The Engineering Manager is responsible for control of external and internal drawings (e.g., blueprints, schematics, and technical drawings), bills of material (BOM), and customer specifications and requirements documentation.

Quality Management is responsible for ensuring that documents conform to applicable standards.

Top Management is responsible for reviewing requests and giving final approvals to the Quality Manual and QMS-related procedures.

Documented Information Control Definitions:

Controlled Document – Document that provides information or direction for performance of work within the scope of the QMS. Characteristics of control include such things as revision number (letter), signatures indicating review and approval, and controlled distribution.

Document – Information and its supporting medium. The medium may be paper, magnetic, electronic, optical, photograph, or sample product.

Documented Information – Information determined to be necessary for the effectiveness of the QMS. This may include procedures, work instructions, or evidence (record) that an event (e.g., physical or electronic document, photograph, or product sample) has occurred and, in the aggregate, can be analyzed and conclusions drawn regarding QMS effectiveness.

External Document – Document originating outside the company (e.g., customer drawings, industry and/or international standards, suppliers’ equipment maintenance manuals, or references) that provides information or direction for performing activities within the scope of the QMS.

Form – Printed, typed, or electronic document with blank spaces for insertion of required or requested information (e.g., tax form, order form).

Internal Document – Document of internal origin (developed entirely by or completed by the company) that provides information or direction for the performance of activities within the scope of the Quality Management System. Examples include, but are not limited to, the procedures contained in the company’s QMS manual.

Procedure – Process description or series of acts involved in a particular form of work; detailed elements of a process used to produce a specified result.

Quality Management System (QMS) – Ordered, well-documented system of policies, processes, procedures and records, designed to assure product quality, effectiveness, customer satisfaction and promote continual improvement of products and processes.

Quality Manual – Formal, authorized document setting out the quality policies, systems, procedures, and practices of an organization.

Uncontrolled Document – Document that is not a part of the controlled document system.  Uncontrolled documents may not be used to provide work direction or information necessary for the performance of work.

Work Instruction – Detailed description of how to perform a process in steps to allow an inexperienced person to perform the work.

Documented Information Control Activities

• Document Format
• Documented Information
• Document Approval
• Temporary Document Changes
• Document Revisions
• External Documents
• Document Distribution

Documented Information Control References

• ISO 9001:2015, “Quality Management Systems – Requirements”, International Organization for Standardization (ISO), Sep., 2015
• Statutory and Regulatory Requirements

Documented Information Control Forms

• Document Request Form
• Document Control Database Form