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| Quality Manual |
4 – Context of the organization |
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| Section 4.3 | Section Revision: A | Revision Date: 6/19/2017 |
| 4.3 – Determining the scope of the quality management system | ||
| Approved By: Dave Zirkelbach | Date: 6/19/2017 | |
DEE Electronics is a Distributor and Value-Added Integrator who performs Sales, Customer Service, Distribution, Manufacturing, Assembly, and other Value-Added functions with components and assemblies for its Original Equipment Manufacturer (OEM) Clients/Customers.
Dee Electronics developed and implemented a quality management system to demonstrate its ability to provide consistently, product that meets customer and applicable regulatory requirements, and to address customer satisfaction through the effective application of the system, including continual improvement and the prevention of nonconformity. Dee Electronics believes that determining, implementing of, and continued improvement of processes and systems (process approach) drives desired outcomes.
The quality system complies with the international standard ISO 9001:2015.
The manual is divided into seven sections modeled on the sectional organization of the ISO 9001:2015 standard. Sections are further subdivided into several subsections representing main quality system elements or activities. Each subsection starts with a general policy statement expressing the commitment to implement the basic principles of the pertinent quality system element or activity. The general policy statement is followed by more specific procedural policies outlining how the general policy is implemented, and referencing applicable operational procedures.
The purpose of this manual is to define and describe the quality system, to define authorities and responsibilities of the management personnel involved in the operation of the system, and to provide general procedures for all activities comprising the quality system.
Another purpose of this manual is to present the quality system to our customers and other external interested parties, and to inform them what specific controls are implemented at Dee Electronics, Inc. to assure quality.
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 9001:2015 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 9001:2015 requirement may be excluded only when both of the following conditions are met:
a) The requirement must be within ISO 9001:2015 Clause 4.3
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 9001:2015 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.
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 9001:2015 Section 8.3, Design and Development of products and services, 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 9001:2015 Section 8.5.1 Control of production and service provision(subsection “f”)
Justification: Dee Electronics, Inc. does not require Validation of Processes because we have no Special Processes.