Quality Manual ISO 9001-2015
Custom Components & Assemblies, Inc.
ISO 9001:2015 Quality Manual Quality Management System Manual
Issued By: Quality Manager Issued Date: 9-01-17 Approved by: President
Revision: B
Page 1 of 42
If this document is printed and not signed by the approved personnel, then it is an uncontrolled reference document and not to be used other than the intent it was printed for.
Quality System Manual
QMS1
Issued by: Quality Manager
Revision Date: 9-01-17
Revision: B
Approval
The signatures below certify that this management system manual has been reviewed and accepted. Demonstrates that the signatories are aware of all the requirements contained herein and are committed to ensuring their provisions.
Description Prepared By Reviewed By
Approved By
Name Cory Norris Greg Toellner
Mark Cruze
Signature V??? a???|? Z?xz g?x???x?
`t?~ V???x
Position Quality Manager Purchasing Manager President/Owner
Date 9-01-17 9-01-17
9-01-17
Amendment Record
This quality manual is reviewed to ensure its continuing relevance to the systems and process that it describes. A record of contextual additions or omission is given below:
Page No. ALL PAGES
Reason Revised to the ISO 9001:2015 Standard
Revision B
Date 09-01-17
Company Proprietary Information
The Electronic Version of this document is the latest revision. It is the responsibility of the individual to ensure that any paper material is the current revision. The printed version of this manual is uncontrolled except when provided with a reference in the field below:
Document Reference:________QMS1____________
Revision:__B__________
Uncontrolled Copy
0
Controlled Copy
1
Page 2 of 42
If this document is printed and not signed by the approved personnel, then it is an uncontrolled reference document and not to be used other than the intent it was printed for.
Quality System Manual
QMS1
Issued by: Quality Manager
Revision Date: 9-01-17
Revision: B
Table of Contents
Page
1. Scope.................................................................................................................................05-7 2. References..............................................................................................................................7 3. Definitions..........................................................................................................................7-11 4. About Our Organization......................................................................................................11-13
4.1 Organizational Context.................................................................................................11-13 4.2 Relevant Interested Parties...........................................................................................13-14 4.3 Quality Management System.............................................................................................14 4.4 Quality Management System & Its Processes..................................................................14-16 5. Leadership & Governance....................................................................................................16-18 5.1 Leadership and commitment..........................................................................................16-17
5.1.1 General ..........................................................................................................16-17 5.1.2 Customer Focus..............................................................................................17-18 5.2 Quality Policy..................................................................................................................18 5.2.1 Establishing the Quality Policy..............................................................................18 5.2.2 Communicating the Quality Policy...........................................................................18 5.2.3 Quality Policy Statement ..................................................................................18-19 5.3 Roles, Responsibilities and Authorities..............................................................................19 5.4 Communication...........................................................................................................20-22 5.4.1 Internal Communication....................................................................................20-21 5.4.2 External Communication...................................................................................21-22 6. Management System Planning.............................................................................................22-24 6.1 Addressing Risks & Opportunities.................................................................................22-24 6.2 Quality Objectives........................................................................................................22-23 6.3 Planning For Change....................................................................................................23-24 7. Support................................................................................................................................24-27 7.1 Resources.......................................................................................................................25 7.1.1 General...............................................................................................................25 7.1.2 People.................................................................................................................25 7.1.3 Infrastructure.......................................................................................................26 7.1.4 Operational Environment.......................................................................................27 7.1.5 Organizational Know.............................................................................................27 8. Product & Service Development..............................................................................................28 8.1 Operational Planning & Control....................................................................................28-30 8.2 Customer Requirement................................................................................................28-30 8.2.1 Customer Communication................................................................................28-29 8.2.2 Determining Requirements.....................................................................................29 8.2.3 Review Of Requirements.......................................................................................29 8.2.4 Changes in Requirements.....................................................................................30 8.3 Design & Development....................................................................................................N/A 8.4 Control Of Suppliers & External Process.............................................................................30-31 8.4.1 General...........................................................................................................30-31 8.4.2 Purchasing Controls.............................................................................................30 8.4.3 Purchasing Information....................................................................................30-31 8.5 Production & Service Provisions....................................................................................31-33
Page 3 of 42
If this document is printed and not signed by the approved personnel, then it is an uncontrolled reference document and not to be used other than the intent it was printed for.
Quality System Manual
QMS1
Issued by: Quality Manager
Revision Date: 9-01-17
Revision: B
8.5.1 Control of Production & Service Provision..........................................................31-32 8.5.2 Identification & Traceability...................................................................................32 8.5.3 3rd Party Property.............................................................................................32-33 8.5.4 Preservation........................................................................................................33 8.5.5 Post-Delivery Activities.........................................................................................33 8.5.6 Control of Changes...............................................................................................33 8.6 Release of Products & Services....................................................................................33-34 8.7 Control of Non-Conforming Outputs..................................................................................34 9. Performance Evaluation.....................................................................................................35-36 9.1 Monitoring, Measurement, Analysis & Evaluation................................................................35 9.1.1 General...............................................................................................................35 9.1.2 Customer Satisfaction..........................................................................................35 9.1.3 Analysis and Evaluation.....................................................................................35-36 9.2 Internal Audits.................................................................................................................36 9.3 Management Review....................................................................................................37-38 9.3.1 General...............................................................................................................37 9.3.2 Inputs.................................................................................................................37 9.3.3 Outputs...............................................................................................................37-38 10. Improvement.....................................................................................................................38-39 10.1 General...........................................................................................................................38 10.2Non-Conformity & Corrective Action....................................................................................38-39 10.3 Improvement....................................................................................................................39
Appendices.......................................................................................................................40-41
A.1 Sequence & Interaction of Processes..................................................................40 A.2 Organization Chart............................................................................................41
Page 4 of 42
If this document is printed and not signed by the approved personnel, then it is an uncontrolled reference document and not to be used other than the intent it was printed for.
Quality System Manual
QMS1
Issued by: Quality Manager
Revision Date: 9-01-17
Revision: B
1. Scope 1.1 Introduction
1.1.1 It is our policy at Custom Components & Assemblies, Inc. hereinafter called CCA, to procure, manufacture and service our customer's products that comply with contractual and regulatory requirements in a controlled, safe and environmentally conscious manner while constantly aiming to increase efficiency by continuously improving methods and processes.
1.1.2 CCA has developed and implemented a quality management system to demonstrate its ability to consistently provide product that meets customer requirements, and to address customer satisfaction through the effective application of the system including continual improvement and prevention of nonconformities.
1.1.3 The quality system complies with the International Standard ISO 9001:2015.
1.1.4 This manual is divided into sections modeled on the sectional organization of the ISO 9001:2015 standard. Sections are further divided into several subsections representing main quality system processes. Each subsection defines general policies and basic principles for the pertinent quality system process; summarized responsibilities and methods; and references relevant operational procedures and other documents.
1.1.5 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 a general description of all processes comprising the quality system.
1.1.6 Another purpose of this manual is to present the quality system to customers, suppliers, regulators and interested parties, and to inform them to what specific controls are implemented at CCA to ensure a high level of quality performance.
1.1.7 The figure below illustrates our methodology for the development of our QMS, Using the plan, do, check and act process approach, to implement and deliver management system objectives, stakeholder requirements and environmental compliance.
Page 5 of 42
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