Example of procedure for use of External documents in Product Realization


To define the methodology followed by XXX for the regular change, updating, maintenance and control of External documents. The documented procedure includes:

  • Standards, Directive, and Customer Specifications.
  • External specification requirements, including addenda, errata, and updates are used in the design or manufacture of the product.
  • Integration of these requirements into the product realization and other affected processes.


This procedure is applicable to all the following systems and standards

  • API Spec Q1, 9th edition/ ISO 29001: 2020
  •  API Spec ….
  • API Spec ……
  • API Spec ……
  • API Spec …..
  • API Spec ……


  • Drawings, Specifications
  • Purchase Orders
  • Customer Standards
  • International Standard
  • Document request form


  • Management Representative / Quality Systems Manager
  • All concerned process heads


Competent Manpower, Computers, Printer & Internet connection, Stationery, International standards & specifications, XXX Procedures          


Document: Information (meaningful data) and supporting medium

Procedure: XXX’s documented method for performing an activity under controlled conditions to achieve conformity to specified requirements.

NOTE this definition was previously identified as a “control feature” in earlier editions of this specification.

Specifications: Document stating requirements


7.1 External Origin Standard

  • A Master list of External Origin Documents is maintained which is essential for the planning and operation of the Quality Management System.  The master list of external origin document is identified, controlled and updated as and when changes are made to the standard.
  • API product or other external specification requirements including addenda, errata & advisory details (revisions and updates) are updated and maintained by checking www.api.org website monthly wise
  • MR keeps tab on the versions of standards mentioned in master list of External origin standards on respective websites once in 6 months and updated if necessary.
  • Regarding revision of legal standards, once in three month, it is checked with authorized like PCB, Inspectorate of  Factories etc. and updated
  • Based on the Updation of External standards, the Technical Procedures are updated
  • All standards are collected by MR and review with Engineer – Design & Development, Operations, Quality Control in monthly basis
  • System related changes in Standards is identified and done by MR
  • Technical changes like design & development, Quality are identified by related Personnel (Engineer) and inform to MR
  • If any changes required from management side and those will be discussed in the Management Review Meeting and MR takes responsibility of it.


  1. External Document are following,
    • Drawings
    • Specifications
    • Purchase Orders
    • Customer Standards
  2. Issue control of external documents lies with the QA/QC Engineer.
  3. Machine shop Manager/Operations Engineer shall ensure the latest editions of the drawings/specifications/other documents are available prior to the commencement of the work.
  4. If the copies of the Customer/OEM/Internal drawings are lost or damaged by the user departments, the department head makes a request to the QA/QC Engineer for issue of fresh copy of the drawings.
  5. Once the product realization process completed relevant documents shall be handed-over to the QA/QC Engineer.
  6. Copies of the external documents shall be disposed after use in controlled conditions and appropriate records shall be maintained.


Master List of External Origin Standards

9.0 Key performance indicator

All external origin documents available as per requirements & controlled.


Master List of External Origin StandardsXXX/MR/D 04Management Representative

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