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Tailored ISO 9001 Quality ManualTable of Contents Section 1: Welcome to (Your Co) Section 1: Welcome to (Your Co) (Your Co) is a developer and producer of (insert your text here).
The Company has always applied high quality standards as guidelines for its processes and operations but has revised its systems to comply with DLA's Tailored ISO 9001. The Company is dedicated to the principle of maintaining the highest levels of quality and integrity in communicating with people inside and outside of its business operation.
Section 2: Company Vision and Governing Policies ... Section 3: Scope, Exclusions and Definitions 3.1 Scope Production of products according to Customer requirements. SIC codes: [your number(s)] 3.2 Exclusions 4.2.5 Configuration Management (except 7.3.7) 3.3 Definitions & Conventions Subordinate or external documentation is referenced in Bold Italics. Section 4: Quality Management System 4.1 General Requirements 4.1.1 Process Approach This approach emphasizes the importance of: a) .... For each process identified in use at the Company, the sequence and interaction of processes has been determined and the process controlled by way of criteria and methods specific to that process. Objectives are set for each process and then measured and monitored with appropriate data gathered and analyzed to ensure process effectiveness. Corrective and preventive action is taken to ensure the processes achieve the desired results and continually improve. The following are the processes in use by the Company: ... Every process has at least one QMS Procedure that defines it in greater detail and may include a process map. These process maps define the details of each process, including owners, inputs, outputs, check stages and objectives through the use of individual process maps. The relationship between the listed processes and their applicable ISO 9001 clauses is shown in the tables in Appendix A. Outsourced processes and their controls are defined in Appendix C. 4.1.2 Overall Process Sequence & Interaction ... 4.2 Documentation 4.2.1 Overview of Documentation ... The Company has developed a secure web-based document portal that allows authorized users to access documents anywhere in the world via internet as well as throughout the Company facilities via intranet. Only the latest approved versions of documents are available through the internet portal. The order of precedence of order-specific documentation is as follows unless otherwise directed by Customer or government requirements:
4.2.2 Quality Manual and Procedures The primary purpose of the Quality Manual and QMS Procedures is to describe and document the Quality Management System in place at the Company and to define all the processes in use within the Company. It is issued under the authority of the Operations Manager. Copies of the manual are controlled by means as described below. Uncontrolled copies may be distributed to Customers as requested and marked “Uncontrolled”. This Quality Manual has been developed by top management to define the quality system processes and policies in use at the Company. It is meant to be used by Company employees as the primary source of official Company quality policies as well as Customers and third parties that wish to verify the Company’s quality management system. Additional procedures and work instructions have been developed to further clarify specific instruction for the execution of these procedures. Where subordinate documents are referenced, they are shown in bold italics. Distributed copies will be uncontrolled and not subject to revision notification unless otherwise agreed. 4.2.3 Control of Documents 4.2.4 Control of Records Section 5: Management Responsibility The remainder of this procedure is as comprehensive as the above content but has been truncated for demo.5.1 Management Commitment
5.2 Customer Focus 5.3 Quality Policy The Quality Policy is defined in Section 2.0. The Quality Policy is contained inside the Quality Manual that is controlled according to the Document Control Procedure. The Quality Policy may also be... 5.4 Planning - N/A 5.5 Responsibility, Authority and Communication - N/A 5.6 Management Review - N/A Section 6: Resource Management 6.1 Provision of Resources - N/A 6.2 Human Resources 6.2.1 General - N/A 6.2.2 Competence, Training and Awareness The Company has implemented a training program that:
Appropriate records of education, training, skills and experience are... The internal auditing process evaluates the effectiveness of training and its affect on product and service quality. The training program is defined in the Training Procedure. 6.3 Infrastructure - N/A 6.4 Work Environment 6.5 Corrective Maintenance - N/A Section 7: Product & Service Realization 7.1 Planning of Product Realization 7.2 Customer-Related Processes 7.2.1 Determination of Requirements This process is defined in the Proposal Development and Contract Review Procedure. 7.2.2 Review of Requirements This process is defined in the Proposal Development and Contract Review Procedure. 7.2.3 Customer Communication
7.3 Design and Development - N/A 7.3.7 Control of Design and Development Changes 7.4 Purchasing Purchasing is treated as a process within the Company’s quality system. The Company accepts responsibility for the quality of products that are purchased from Suppliers including Customer designated sources. The Company does not use Customer verification as... The process is fully defined in the Purchasing Procedure. 7.4.1 Purchasing Process 7.4.2 Purchasing Information - N/A 7.4.3 Verification of Purchased Product 7.5 Production and Service Provision 7.5.1 Control of Production and Service Provision
In-process inspection is conducted according to... These activities are defined in the Production Procedure. 7.5.1.1 Production Documentation These activities are defined in the Production Procedure. 7.5.1.2 Control of Production Process Changes These activities are defined in the Production Procedure and Configuration Management Procedure. 7.5.1.3 Control of Production Equipment & Tools 7.5.1.4 Control of Work Transferred, on a Temporary Basis, Outside the Organization's Facilities
7.5.1.5 Control of Service Operations 7.5.2 Validation of Processes for Production and Service Provision - N/A 7.5.3 Identification and Traceability 7.5.4 Customer Property Government and Customer property is controlled according to the Production Procedure and... 7.5.5 Preservation of Product 7.6 Control of Monitoring and Measuring Equipment The controls for such equipment and calibration activities are defined in the Calibration Procedure. Section 8: Measurement, Analysis, & Improvement 8.1 General Where statistical techniques are used... Production and Quality collect data for determining the acceptability of this quality program, which may include, but is not limited to:
8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction - N/A 8.2.2 Internal Audit 8.2.3 Monitoring and Measurement of Processes - N/A 8.2.4 Monitoring and Measurement of Product The Quality Group is responsible for... Inspection methods may include but are not limited to:... Inspection by statistical sampling is applied, as appropriate and when specified in... Applicable MRB members can release supplies on a "Calculated Risk" in the event... A Calculated Risk Release Form is produced by... 8.2.4.1 Inspection Documentation Required inspection and test steps are defined in... Various inspection records are used to record the results of inspections and tests along with... 8.2.4.2 First Article Inspection (FAI) The inspector conducting a first article inspection... 8.2.4.3 Incoming Inspection (Receiving) 8.2.4.4 In-Process Inspection Records of in-process inspections are... 8.2.4.5 Final Inspection Records of final inspections are... 8.3 Control of Nonconformances See the Control of Nonconformances Procedure and Corrective and Preventive Action Procedure. 8.4 Analysis of Data - N/A 8.5.1 Continual Improvement - N/A 8.5.2 Corrective Action This process is defined in the Corrective and Preventive Action Procedure. 8.5.3 Preventive Action This process is defined in the Corrective and Preventive Action Procedure. Appendix A: Company Processes and Applicable ISO 9001 Clauses
Appendix B: Company Processes and Applicable Documents Production
Appendix C: Outsourced Processes The following processes are outsourced and controlled as indicated:
Appendix D: Quality Objectives ... APPENDIX E: Identification of Key Product Realization Processes ... REVISION HISTORY AND APPROVAL RECORD Quality System Policy CAGE: TBD Copyright © JnF Specialties, LLC. All rights reserved worldwide. PROPRIETARY INFORMATION; UNCONTROLLED IF PRINTED UNLESS OTHERWISE MARKED |