Quality System Manual
For
Maricopa Controls Inc.
ISO9001:2000
AS9100 Rev. A
Revision Status Record
REV
NC
A
B
C
D
E
F
G
H
I
J
K
L
DESCRIPTION
Original Issue
Complete Revision
Complete Revision
Section 4 – Design Control
Section 3 – Contract Review
Complete Revision
AS 9000 Revision
NCR 3-01a/Renumbered (1)
Added 2nd tier references.
Incorporated AS9100 Requirements
Reorganization thru downsizing and incorporated
AS9100: A requirements.
Incorporated ISO9001: 2000 Requirements
Extensive Format Change
DATE
August 23, 1998
September 7, 1998
September 24, 1998
March 22, 1999
June 7, 1999
July 7, 1999
October 13, 1999
December 10, 1999
February 17, 2000
September 24, 2001
September 27, 2002
January 24, 2003
July 28, 2003
_______________MGM_________________________
Martin G. McMurry – President
_______07/28/03____________
Date
__________________PF________________________
Paula Fouts – Management Representative
_______07/28/03___________
Date
© 2003 Maricopa Controls Inc.
www.maricopacontrols.com
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MARICOPA CONTROLS – QUALITY SYSTEM MANUAL
TABLE OF CONTENTS
CONTENTS
PAGE
1.0 SCOPE .................................................................................................................... 3
2.0 EXCLUSIONS ........................................................................................................... 3
3.0 TERMS AND DEFINITIONS ......................................................................................... 3
4.0 QUALITY MANAGEMENT SYSTEM ................................................................................ 3
4.1 GENERAL REQUIREMENTS ......................................................................................... 3
4.2 DOCUMENTATION REQUIREMENTS ............................................................................. 4
4.2.1 General: Quality Management System Documentation ............................................ 4
4.2.2 Quality System Manual......................................................................................... 4
4.2.3 Procedure for the Control of Documents ................................................................. 4
4.2.4 Procedure for Control of Records ........................................................................... 6
4.3 CONFIGURATION MANAGEMENT ................................................................................ 7
5.0 REFERENCE DOCUMENTS AND LOCATION: .................................................................. 8
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MARICOPA CONTROLS – QUALITY SYSTEM MANUAL
1.0 Scope
This manual describes the Quality Management System in place at:
Maricopa Controls Inc.
328 S. Rockford Drive Ste. 3
Tempe Arizona 85281
Maricopa Controls Inc., designs, develops and manufactures test equipment, supervisory
controls and custom power supplies for commercial and aerospace industries. We strive to
provide our customers with products of exceptional quality and value, on time in order to meet
or exceed their expectations. This is achieved by maintaining a quality management system in
accordance with ISO9001: 2000 and AS9100A and a commitment to continually improve its
effectiveness. Our Quality System Manual encompasses the Quality Policy of Maricopa
Controls Inc. throughout this document.
2.0 Exclusions
Servicing product is not offered to the customers because our product is installed and serviced
by the customer or their representative. Maricopa Controls Inc. takes exception to section
7.5.1.5 Control of Service Operations.
3.0 Terms and definitions
The term “organization” used in this quality system manual refers to Maricopa Controls Inc.
“Supplier” refers to the external source used to acquire purchased material and or services by
the organization.
The term “Area Leaders” used in this quality manual also refers to Top Management and may
be singular or plural.
4.0 Quality Management System
4.1
General Requirements
Maricopa Controls Inc. documents, implements and maintains a quality management
system and continually improves its effectiveness in accordance with the requirements of
the ISO 9001:2000 and AS9100 Rev. A. International Standards.
Area Leaders ensure that appropriate communication processes are established within the
organization and that communication takes place regarding the effectiveness of the QMS.
Management Review Meetings and Training sessions are held to promote Employee
awareness, participation and input to the QMS.
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MARICOPA CONTROLS – QUALITY SYSTEM MANUAL
4.2
Documentation requirements
4.2.1
General: Quality Management System Documentation
The Quality Management System documentation for Maricopa Controls Inc.
includes the following:
 Documented statements of our Quality Policy and Quality Objectives,
 Our Quality System Manual (this document).
 Documented procedures required by these International Standards (are
either referenced included in this document).
 Documents needed to ensure effective planning, operation and control of
our processes.
 Records required by these International Standards (see 4.2.4).
 Quality system requirements imposed by applicable regulatory authorities.
Employees have access to QMS documentation and are aware of relevant
procedures. Customers and/or regulatory authorities representatives also have
access to QMS documentation when requested.
4.2.2
Quality System Manual
The Quality System Manual is maintained and updated by the Management
Representative. It is reviewed at minimum annually to ensure its compliance with
the ISO 9001:2000 and AS9100A standards and to the company’s continual
improvement initiatives.
The documented procedures for the control of documents (see 4.2.3) and the
control of records (see 4.2.4) are included within this Quality System Manual.
NOTE: The Management Representative may delegate matters relating to the
quality management system to other Area leaders.
4.2.3
Procedure for the Control of Documents
The purpose of this procedure is to define the controls needed to create, maintain,
approve and control Quality Management System documentation.
The Management Representative or their delegated Area Leader is responsible for
the control of QMS documentation as follows:
a) Approves QMS documentation for adequacy prior to issue.
b) Reviews, updates and re-approves QMS documentation as necessary.
c) Ensures changes and current revisions are identified.
d) Ensures QMS documentation is available at points of use with relevant versions
of applicable documentation.
e) Maintains QMS documents remain legible and readily identifiable.
f)
Maintains that QMS documents of external origin are identified and their
distribution is controlled.
g) Prevents the unintended use of obsolete documents, which are suitably
identified if they are retained for any purpose.
Evidence of review and or approval may be in the form of any one or more of the
following: revision letter, signature, date, and/or initials (hand written or typed).
Further evidence of review may be found in Management Review Meeting minutes
Training Session Records and Internal Audit Reports.
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MARICOPA CONTROLS – QUALITY SYSTEM MANUAL
Continued from previous page, section 4.2.3:
Red lining of documents is acceptable and are identified with an initial and date.
Red lined documents must be updated to incorporate the changes within 60 days
from the initial red lining.
Obsolete documents are identified to prevent their unintended use. This is
accomplished with either a red stamp or hand written with red ink, “OBSOLETE" or
"Reference Only".
Production documentation for product being built is listed on the Product Matrix
by specific part number, which is kept in 3-ring binders located in the stock room.
Customer supplied production documentation may be listed on the Product Matrix
and in the 3 ring binder and is controlled by its own authority. When revised or
new customer supplied production documents are issued, the product matrix is
updated with the change.
Employees are instructed how to get the current and correct production
documentation they need to perform a specific duty.
QMS documentation is controlled as follows:
Hard Copies are uncontrolled, or “For Reference Only”.
Originals are kept on the computer, location: \\Server\MANUFACTURING…
Changes to QMS documentation is controlled by Revision Letter and Date.
The Operational Notebook is readily available to employees to ensure their
awareness of relevant procedures and processes. It provides access to QMS
documentation or reference to them. It is located in the Quality Department and
on the computer, location: \\Server\MANUFACTURING\Operational Notebook\.
The contents of the Operational Notebook include the following:
 Maricopa Controls Inc. Quality System Manual (this document)
 Key Personnel List
 Designee List
 Source Release Representative List
 Master Index of Forms, (contains identification and location)
 Master Index of Quality Records, (contains identification, retention, and
location)
 Master Index of Controlled Documents, (contains current revisions and
locations)
 Master Index of SOP's and the referenced Standard Operating Procedures
 Master Index of QOP's and the referenced Quality Operating Procedures
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MARICOPA CONTROLS – QUALITY SYSTEM MANUAL
4.2.4
Procedure for Control of Records
The purpose for this procedure is to define the controls needed for the
identification, storage, protection, retrieval, retention times and disposition of
records.
The Master Index of Quality Records contains the document description, record
location, controlled by, retention time and how it is filed. The hard copy is located
in the Quality department in the Operational Notebook and the original on the
computer, location: Server\\MANUFACTURING\Operational Notebook\.
The Master Index of Forms contains forms that may be used to create
records used by the Quality Management System. It contains the current revision,
form number, and title. The hard copy is located in the Quality department in the
Operational Notebook, and the original on the computer, location:
Server\\MANUFACTURING\Operational Notebook\.
The Management Representative or their delegated Area Leader is responsible for
the following:
 The control and maintenance of the Master Index of Records.
 Assigns record retention periods according to contract, regulatory or
company requirements.
 Coordinates the storage of records with other Area Leaders.
 Determines the method of collection, indexing and archive to be used.
Area leaders and employees are responsible for assisting in collecting and
archiving records pertaining to the Quality Management System, production,
design and development.
Employees are informed on how to use, retrieve gain access to customer supplied
and internal forms used to create quality records.
Instructions for filling out some of the forms are found in SOP 1-Manufacturing
Documentation. It is located in the Operational Notebook and on the server.
Quality Records are made available for review by customers and regulatory
authorities, when contractually agreed upon.
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MARICOPA CONTROLS – QUALITY SYSTEM MANUAL
4.3
Configuration Management
Maricopa Controls Inc.
Quality Management System's
Interaction and Relationship Map
Design?
5.4
YES
NO
7.3
Order Entry
Customer
Order/RFQ
7.1
Customer
Requirements
7.2
7.2.2
Human
Resources
Design and
Development
Generate
Work Order
7.3.2
7.6
6.2.1
7.3.4
7.5.3
8.2.4.1
8.2.4.2
Quality Assurance
7.2.3
Customer
Satisfaction
Purchasing
7.2.1
7.4
7.4.1
7.4.3
7.5
6.3
7.5.1.1
1.0
Quality Management
4.0
System
4.1
4.2
4.2.1
4.2.2
4.2.3
4.2.4
General Requirements
Documentation Req.
General
Quality Manual
Control of Documents
Control of Records
Product
Realization
7.3.1
7.3.3
7.3.5
7.3.6
7.3.6.1
7.3.6.2
7.3.7
7.5.1.2
7.5.1.3
7.5.1.4
8.2.4
Production Control
*Facilities
Scope
8.2.1
Receive
Material
7.4.2
7.0
7.5.1
7.5.2
7.5.3
Normative
Reference
Management
Responsibility
5.1
5.2
5.3
5.4.1
5.4.2
5.5.1
5.5.2
5.5.3
5.6
5.6.2
5.6.3
Ship
Build
Order
Test
7.5.5
Accounting
8.4
7.5.4
2.0
5.0
Terms and
Definitions
Resource
Management
3.0
6.0
6.1
Provision of Resources
Management Commitment
6.2.2 Competence, Awareness and Training
Customer Focus
6.4
Work Environment
Quality Policy
Quality Objectiives
Quality Management System Planning
Resoponsibility, Authority and Communication
Management Representative
Internal Communication
Management Review
Review Input
Review Output
Design and Development
Measurement, Analysis
Planning
8.0
and Improvement
Design and Development
Outputs
8.1
General
Design and Development
8.2.2 Internal Audit
Verification
8.2.3 Monitoring and Measurement of Processes
Design and Development
8.3
Control of Nonconforming Product
Validation
8.5
Improvement
Documentation of Design
8.5.1
Continual Improvement
and/or Development
8.5.2 Corrective Action
Verification and Validation
8.5.3
Preventive Action
Design and/or Development
Verification and ValidationTesting
Control of Design and Development Changes
Control of Production Process Changes
Control of Prod. Equip. Tools and Numerical Control Machine Programs
Control of Work Transferred, on a Temp. Basis, Outside the Organization's Facilities
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5.0 Management Responsibility
5.1
Management Commitment
Area Leaders are committed to the development and implementation of our QMS and its
continual improvement and effectiveness.
5.2
Customer Focus
Area Leaders ensure that customer requirements are determined and met with the aim of
enhancing customer satisfaction.
5.3
Quality Policy
Our Quality System Manual encompasses the Quality Policy of Maricopa Controls Inc.
throughout this document. It is appropriate to the purpose of this organization, includes
a commitment to comply with requirements and continually improve the effectiveness of
the QMS. Provides a framework for establishing and reviewing quality objectives. It is
reviewed for continuing suitability, communicated and understood within the
organization.
5.4
Quality Objectives
Maintain and Enhance Customer Satisfaction.
Provide on time delivery to our customers.
Monitor Supplier performance.
Monitor Internal PPM.
6.0 Reference Documents and location:
QOP 13 - Control of Nonconforming Product: \\Server\MANUFACTURING\Operational
Notebook\Quality Operating Procedures
QOP 14 – Corrective and Preventive Action: \\Server\MANUFACTURING\Operational
Notebook\Quality Operating Procedures
QOP 17 – Internal Audits: \\Server\MANUFACTURING\Operational Notebook\Quality Operating
Procedures
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