LinkTech Quick Couplings Inc. QUALITY MANUAL Based on ISO 9001:2008

Transcription

LinkTech Quick Couplings Inc. QUALITY MANUAL Based on ISO 9001:2008
QUALITY MANUAL
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LT-422-001
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QUALITY MANUAL
LinkTech Quick Couplings Inc.
3000 Bunsen Ave. #A
Ventura, CA 93003
Based on ISO 9001:2008
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INTRODUCTION:
This Quality Manual establishes the quality system and related practices used by LinkTech
to manage its Quick Couplings business, to continually improve both its operations and
the quality management system and to meet its customer’s requirements.
Additional procedures have been established and implemented for certain processes to
establish additional process control. These procedures are referenced within this document
where appropriate.
The quality management system described within this Quality Manual, combined with all
other documents and/or processes identified by LinkTech has been developed to meet
LinkTech’s needs as well as those established by the ISO 9001:2008 International
Standard.
This Quality Manual is controlled through the LinkTech procedure for establishing and
controlling changes within the systems documentation. The history of changes to this
document is retained in accordance with the LinkTech documented quality records
procedure.
1.0
SCOPE
The scope of this document is to demonstrate the capability of LinkTech to develop,
supply, and maintain their products and services through the compliance and application
of the requirements outlined in the ISO 9001:2008 standard.
1.1
COMPANY BACKGROUND
LinkTech established operations in 2005 from its newly constructed facility in Ventura,
CA. All engineering, product development, customer service and quality assurance are
based at its California headquarters. LinkTech maintains a worldwide distribution network
to support its rapidly growing customer base which spans from a single user to fortune
100 world class manufacturers.
LinkTech’s management team has over 26 years’ experience in producing and marketing
plastic couplings, valves and fittings to the world market. It is LinkTech’s mission to
provide customers the best product available, with on-time delivery and excellent
customer service, at the best possible cost. Because of its dedication to excellence,
LinkTech is rapidly becoming the number one choice for quick coupling solutions.
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EXCLUSIONS
The following clauses and/or sub-clauses have been identified for exclusion from the scope
of LinkTech quality management system.
All production and service processes are capable of verification through monitoring and
measurement systems. Therefore, LinkTech has identified Clause 7.5.2 Validation of
processes for production and service provision for exclusion from its Quality
Management System.
4.2
DOCUMENTATION REQUIREMENTS
LinkTech has documented, established and maintains six procedures as required by the
ISO 9001:2008 International Standard as:






Control of Documents
Control of Records
Internal Audit
Control of Nonconforming Product
Corrective Action
Preventive Action
Other documents established by LinkTech are identified through the Master Revision List
and controlled through the Control of Documents procedure.
Some, but not all, of these documents may be referenced within this Quality Manual as
well as the Process Interaction and Planning flowcharts that appears in the Appendices of
this Quality Manual.
5.0
MANAGEMENT RESPONSIBILITY
Top management of LinkTech is committed to establishing, maintaining and continually
improving the effectiveness of a quality management system that fully complies with all of
the requirements outlined in the ISO 9001:2008 International Standard.
Through the totality of the processes that comprise the LinkTech quality management
system customer, regulatory and/or statutory requirements are identified and met.
The top management of LinkTech with regard to quality is identified through the
organization chart shown in Appendix 1 of this Quality Manual.
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5.4.1 QUALITY OBJECTIVES
Top management of LinkTech establishes and communicates its quality objectives through
a documented process. These objectives are designed to support the activities and quality
policy of LinkTech. All quality objectives shall be measurable and pertinent with regard to
meeting customer requirements as well as fostering an atmosphere of continual
improvement throughout the organization.
5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING
LinkTech embraces a “process approach” while planning, developing and improving its
quality management system. In addition LinkTech uses the process interaction and
quality planning flowchart shown in Appendix 2 of this quality manual as a quality system
planning tool.
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Appendix 1
Operations Manager
Accounting
President
Manager
Eastern Sales
Customer Service
Manager
Customer Service
Representative
Shipping Clerk
Manager
Vice President
Receiving Clerk
Western Sales
Manager
International Sales
Manager
Assembly Technician
Assembly Technician
Design Engineer
Manufacturing
Engineer
Procurement
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Marketing
Coordinator
QUALITY MANUAL
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Process Interaction Chart
Quality Management System Planning Chart
4.0
Quality management System
General Requirements
Doc. Requirements
Quality Manual (LT-422-001)
Control of Documents (LT-423-001)
Control of Records (LT-424-001)
5.0
Management Responsibility
6.0
Management Commitment
Customer Focus
Quality Policy (LT-530-001)
Quality Objectives (LT-541-001)
Management Review (LT-560-001)
Resource Management
Provision of Resources
Human Resources
Competence Awareness/Training (LT-622-001)
Infrastructure
Work Environment
7.0 Product Realization
Management Team
Purchasing
Product Requirements (LT-722-001)
Customer Communication (LT-722-001)
Purchasing Process (LT-742-001)
Supplier Evaluation (LT-741-001)
Quality
Control of Production
Identification & Traceability
Preservation of Product
Design & Development (LT-730-001)
Verification of Product (LT-743-001)
Monitoring & Measurement (LT-760-001)
Planning of Product
CUSTOMER
Operations
8.0 Measurement, Analysis & Improvement
Management Team
Operations
Quality
Customer Satisfaction
Nonconforming Product (LT-830-001)
Analysis of Data (LT-840-001)
Internal Audit (LT-822-001)
Monitoring & Measuring
Continual Improvement
Corrective Action (LT-852-001)
Preventive Action (LT-853-001)
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SUPPLIER
Customer Requirements
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CLAUSE 6.0 RESOURCE MANAGEMENT
LinkTech is committed to identifying training needs and providing training for personnel
whose activities within the quality management system can affect product quality.
LinkTech identifies those competencies required for personnel to perform their jobs at the
highest possible efficiency and effectiveness. Job descriptions, outlining requirements
such as education, experience and training, are documented for positions affecting
product quality.
LinkTech provides and maintains the work environment and infrastructure in a manner
that consistently ensures product conformity.
6.1 Provision of Resources
7.0 Product Realization
6.2 Human Resources
6.2.1 General
6.2.2 Competence, Awareness
& Training
Training Process (LT-622-001)
Training Sign In Sheet
Job Descriptions
Employee Training Log
(LT-622-002)
6.3 Infrastructure
6.4 Work Environment
Maintenance Log
Maintenance Log
Records
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PRODUCT REALIZATION
LinkTech ensures product quality throughout the product realization phase by identifying
and planning the processes required to produce quality product. This includes the
documentation of processes, inspection steps and records identified by LinkTech as critical
to the organization. The planning and linkages of these processes is outlined in the
Product Realization Planning Flowchart located in this quality manual.
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Appendix 3: Product Realization Planning
7.1 Planning of Product Realization
CUSTOMER
7.2 Customer Related Processes
7.2.1 Determination of
Requirements (LT-722-001)
7.2.2 Review of Requirements
(LT-722-001)
7.2.3 Customer Communication
Customer Complaints
Corrective Action (LT-852-001)
7.4 Purchasing
7.4.2 Purchasing Information
Approved Supplier List
7.4.3 Verification of Purchased Product
Receiving/Inspection (LT-743-001)
7.5.1 Control of Production & Service
7.5.3 Identification &
Traceability
7.5.4 Customer Property
7.5.5 Preservation of
Property
7.6 Control of Monitoring and
Measuring Equipment
Calibration (LT-760-001)
Records
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7.6 Control of Monitoring &
Measuring Devices
7.3 DESIGN & DEVELOPMENT
(LT-741-002)
SUPPLIER
7.4.1 Purchasing Process
Supplier Evaluation(LT-741-001)
Supplier Evaluation Form
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DESIGN AND DEVELOPMENT
Design and Development activities are planned based upon the requirements of the ISO
9001:2008 international standard and the fundamentals of project management. All
requirements, verification and validation activities and changes are controlled in
accordance with planned arrangements. All records of reviews, design changes, and
acceptance criteria are stored in the Design Notebooks for each project.
Appendix 4:
Design and Development Planning
7.3.4
7.3.2 Design & Development
Inputs
(LT-730-001)
7.3.3 Design & Development
Outputs
(LT-730-001)
Product Characteristics
Acceptance Criteria
Performance Requirements
7.3.5 Design & Development
Verification
(LT-730-001)
7.3.6 Design & Development
Validation
(LT-730-001)
Meets Product & Customer
Requirements
Records
Design Project File
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SUPPLIER & CUSTOMER REQUIREMENTS
Design & Development Review
7.3.7 Control of Design &
Development Changes
7.3.1 Design & Development Planning
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MEASUREMENT, ANALYSIS & IMPROVEMENT
LinkTech plans and conducts monitoring and measurement activities as a tool for
improving the effectiveness of the quality management system. LinkTech determines
applicable measurement systems and the extent of their use to measure and analyze
areas important to the success of our business such as customer satisfaction, product
quality and process capability.
LinkTech uses quality tools such as internal audits, corrective actions and preventive
actions to perform an evaluation of the quality management system.
Corrections,
corrective actions and preventive actions are used to continually improve the effectiveness
of the quality management system.
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Measuring and Monitoring Planning
8.1 General
8.2.1 Customer Satisfaction
8.2.2 Internal Audit
Customer Complaints
Internal Audit Procedure (LT-822-001)
Corrective Action (LT-852-001)
8.2.3 Monitoring &
Measurement of Processes
8.2.4 Monitoring & Measurement
of Product
Control of Non-Conforming Product
Procedure (LT-830-001)
Nonconforming Product Tag (LT-830-002)
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective Action
Management Review
(LT-560-001)
Corrective Action (LT-852-001)
CAR/PAR Form (LT-852-002)
Product Characteristics
Acceptance Criteria
8.5.3 Preventive
Action
Performance
Requirements
Preventive Action (LT-853-001)
CAR/PAR Form (LT-852-002)
Records
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8.3 Control of Nonconforming Product
8.4 Analysis of Data (LT-840-001)
8.2 Monitoring & Measurement
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DOCUMENT RELEASE HISTORY
Revision
A
B
C
D
E
Rev. Date
05/09/2011
12/12/11
3/20/12
8/24/12
1/23/13
Change Description
IR
Updated organization chart
Updated Header Logo
Updated organization chart: added Materials Manager, Sales Manager etc..
Updated organization chart: removed Materials Manager, added operations
manager; changed company name.
Date Printed: February 19, 2014 This document only valid on date printed