QM 7.5.1 General

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Quality Manual

7 – Support

Section 7.5.1 Section Revision: A Revision Date: 3/30/2017
7.5.1 General
Approved By: Dave Zirkelbach Date: 3/30/2017

GENERAL POLICY

The quality system described in this section of the Quality Manual conforms to the requirements of the standard: Element 4.2 Documentation Requirements.

Scope of the quality system documentation is defined. Establishment and revision of documents, and their distribution, are controlled. New documents and revisions are reviewed and approved prior to issue; and are identified with respect to their revision level. Appropriate documents are available at locations where they are used. Obsolete documents are removed from points of use. Documents of external origin are identified and their distribution is controlled.

Quality records are identified and indexed to facilitate their retrieval, and are stored in a suitable environment to minimize deterioration. Quality records are retained for a period of time at least equivalent to the lifetime of the product.

PROCEDURAL POLICIES

1. Scope

1.1 Dee Electronics, Inc. quality system documentation comprises the following types of documents and records:

Quality manual (including a documented quality policy); Documented statements of quality objectives; Operational procedures; Work instructions; Product realization and control plans.

The documentation structure that is used in this quality system consists of four tiers:

  • The first tier of the quality system documentation structure is the quality manual (including documented Quality Policy), which covers all requirements of the standard, makes reference to quality system procedures, outlines the documentation structure and illustrates Dee Electronics’ positive commitment to fulfill these requirements.
  • The second tier consists of documented procedures, which are specified methods for managing activities. These procedures are consistent with the requirements of the standard and DEE’s quality policy, and are to be implemented effectively.
  • The third tier is work instructions, which are highly specific ways to perform activities.
  • The fourth tier consists of records, forms, tags and other documentation.

A single document may include the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.

Purpose, scope, and responsibility for controlling various types of documents are defined in Operational Procedure QOP-42-01, Quality System Documentation.

 

ASSOCIATED DOCUMENTS

Operational Procedure QOP-42-01: Quality System Documentation

Operational Procedure QOP-42-02: Control of Documents

Operational Procedure QOP-42-03: Control of Quality Records