2008-QM 0.3 – Exclusions

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Quality Manual

0 – General

Section 0.3 Section Revision: A Revision Date: 7/12/2010
0.3 – Exclusions
Approved By: Todd Gifford Date: 7/12/2010

GENERAL POLICY

The quality management system shall be relevant to the nature of our organization and products, and to customer and regulatory requirements. For this reason, those requirements of ISO 9001:2008 that do not apply are excluded from the scope of our quality system.

PROCEDURAL POLICIES

The following rules and criteria are used for excluding irrelevant requirements:

1. An ISO 9001:2008 requirement may be excluded only when both of the following conditions are met:

a) The requirement must be within ISO 9001 Clause 7, Product Realization; and

b) The exclusion may not affect our ability, nor absolve us from the responsibility, to provide product that meets customer and applicable regulatory requirements.

2. The President is responsible for identifying those requirements of ISO 9001 that do not apply to our organization or products, and to propose exclusions of such requirements from the scope of the quality system.

3. Top executive management has the responsibility and authority for evaluating whether the proposed exclusions are appropriate, and for approving them. Evaluation and approval of exclusions are conducted within the framework of management reviews of the quality system (refer to Operational Procedure QOP-56-01, Management Review).

4. Any exclusions taken are documented in this section of the quality manual. The excluded requirements are precisely identified with reference to specific clauses and/or statements in the standard. There is also a brief justification why the exclusion is taken and why it is appropriate.

EXCLUSIONS

1. Exclusion: ISO 9001:2008 Section 7.3, Design and/or Development, including all subsections

Justification: Dee Electronics, Inc. does not design or develop products. All principal product characteristics are specified by the customers or their consultants.  Dee Electronics is a Distributor and Contract Manufacturer which buys, assembles, and resells products designed by other companies.

2. Exclusion: ISO 9001:2008 Section 7.5.2, Validation of Processes, including all subsections

Justification: Dee Electronics, Inc. does not require Validation of Processes because we have no Special Processes.