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7.5 Documented Information

7.5.1 Quality System Manual

The Quality Manager is responsible for the issue of amendments to the Quality System Manual (this document), withdrawal of obsolete information and the maintenance of the master copy of the manual.

  • Uncontrolled copies may be distributed to organizations or persons at the discretion of the Quality Manager. These will be current at the date of issue only and will not be subject to amendment action. Uncontrolled copies are annotated β€œUncontrolled Copy.”
  • Controlled copies of the Manuals may be revised as necessary to meet the requirements of the ISO 9001:2015 standard and the AGE Logistics Corporation quality requirements
  • Revisions to this manual will be reviewed and approved for use by the Quality Manager together with the President or the Vice President Operations

7.5.2 AGE QMS Documented Information Structure

The AGE QMS is structured in three levels:

Level Document Type Identifier Description Distribution
Level 1 Quality System Manual QSM Company policies and implementation methods Employees, customers, business partners
Level 2 Quality System Procedures QSP Day-to-day routines carried out within the facility to ensure consistency and compliance Employees (need-to-know)
Level 3 Work Instructions, Forms, Records, Inspection/Test Plans QSI, QSF Task-level documents; amplify system procedures, detail how specific tasks are carried out, used for quality planning, used to record results Employees with need-to-know; vendors/business partners under NDA

Level Two and Level Three documented information may contain proprietary or Company Confidential information. Their release shall be limited to employees of AGE with a β€˜need to know’ and to vendors/business partners who have executed an NDA covering the specific information.

7.5.3 Control of Documented Information

The QMS documentation includes both documented information and records.

Procedures for controlling all documents and data that relate to AGE Logistics Corporation quality system shall be documented including, to the extent applicable, documents of external origin such as standards and customer drawings. Documents and data may be in the form of hard copy or electronic media.

(QSP-7.5.3) Control of Documented Information defines document control for:

  • Approving documents for adequacy prior to issue
  • Reviewing, updating and re-approving as necessary
  • Ensuring that changes and the current revision status of documents are identified
  • Ensuring that relevant versions of applicable documents are available at points of use
  • Ensuring that documents remain legible and readily identifiable
  • Ensuring documents of external origin are identified and their distribution controlled
  • Preventing the unintended use of obsolete documents, and applying suitable identification to them if retained

7.5.4 Control of Quality Records

A documented procedure Control of Quality Records has been established to define the controls needed for the identification, storage, retrieval, protection, retention time, and disposition of quality records. This procedure also defines the methods for controlling records created by and/or retained by suppliers.

Quality records are maintained to provide evidence of conformity to requirements and of the effective operation of the QMS. Records are maintained according to the Control of Quality Records Procedure (QSP-7.5.4).

This procedure requires that quality records remain legible, readily identifiable, and retrievable. The procedure defines the controls needed for:

  • Identification
  • Storage
  • Protection
  • Retrieval
  • Retention time
  • Disposition of quality records

Configuration documents are subject to additional controls per QSM-8.1.2.

Reference Documents

Document Description
QSF-7.5.3 Document Change Request
QSP-7.5.3 Control of Documented Information
QSP-7.5.4 Control of Quality Records