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Quality Manual	4 – Quality Management System
Section 4.2	Section Revision: A	Revision Date: 7/12/2010
4.2 – Documentation and Records
Approved By: Todd Gifford		Date: 7/12/2010

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.

2. Quality Manual

2.1 The top level document defining the overall quality management system is the Quality Manual. It includes:

The scope of the quality system, including details of and justification for any exclusions (refer to Section 0.3);

Description of quality system processes, their sequence, and interrelation; and

References to documented procedures.

3. Document control

3.1  Dee Electronics has established and maintains documented procedures to control all documents and data that relate to requirements of the ISO 9001:2008 standard, including, to the extent applicable, documents of external origin (those determined by the organization to be necessary for the planning and operation of the quality management system).

3.2  Document and Data Approval and Issue – The documents and data are reviewed and approved for adequacy by authorized personnel prior to use. An electronic document control procedure identifying the current revision status of documents is readily available to prevent the use of invalid and/or obsolete documents.

3.3  The authorized functions and the rules governing the issue of documents are defined in procedures QOP-42-01, Quality System Documentation, and QOP-42-02, Control of Documents. All documents are reviewed and approved prior to issue.

3.4  The pertinent issues of appropriate documents are available electronically at all locations where operations essential to the effective functioning of the quality system are performed. Invalid and/or obsolete documents are promptly removed from electronic access, or otherwise assured against unintended use. Any obsolete documents retained for legal and/or knowledge purposes are suitably identified.

3.5  Changes to documents and data are reviewed and approved by the same functions that performed the original review and approval, unless specifically designated otherwise. The designated functions or organizations have access to pertinent background information upon which to base their review and approval. Where practicable, the nature of the change is identified in the document or the appropriate attachments.

4. Control of quality records

4.1  Dee Electronics has established and maintains documented procedures to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records.  Records maintained are legible, identifiable, and retrievable.

4.2 Quality records are established and maintained to provide evidence that: There has been conformance to specified requirements, and the quality system is operated in accordance with documented procedures and that it is effective.

4.3.  All quality records are legible, and are stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. Retention times of quality records have been established and recorded. Where agreed contractually, quality records are made available for evaluation by the customer or the customer’s representative for an agreed period.

 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