QUALITY MANUAL TABLE OF
CONTENTS
Approvals
Revision and Approval Record
1 General
1.1 Introduction
1.2 Exclusions
1.3 Quality Policy Statement
2 Company History
3 Company Contact Information
4 Quality Management System
4.1 General Requirements
4.2 Documentation Requirements
4.2.1 General
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.4 Control of Quality Records
5 Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5 Responsibility, Authority, and Communication
5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communication
5.6 Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
6 Resources
6.1 Provision of Resources
6.2 Human Resources
6.2.1 General
6.2.2 Competence, Awareness, and Training
6.3 Infrastructure
6.4 Work Environment
7 Product Realization
7.1 Planning of Product Realization
7.2 Customer-Related Processes
7.2.1 Determination of Requirements Related to the Product
7.2.2 Review of Requirements Related to the Product
7.2.3 Customer Communication
7.3 Design and Development
7.3.1 Design and Development Planning
7.3.2 Design and Development Inputs
7.3.3 Design and Development Outputs
7.3.4 Design and Development Review
7.3.5 Design and Development Verification
7.3.6 Design and Development Validation
7.3.7 Control of Design and Development Changes
7.4 Purchasing
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision
7.5.2 Validation of Processes for Production and Service Provision
7.5.3 Identification and Traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
7.6 Control of Monitoring and Measuring Devices
8 Measurement, Analysis and Improvement
8.1 General
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring and Measurement of Processes
8.2.4 Monitoring and Measurement of Product
8.3 Control of Nonconforming Product
8.4 Analysis of Data
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action
1.1 INTRODUCTION
XYZ Company recognizes its responsibility as a developer/manufacturer of quality software products/provider of quality services. To this end, XYZ COMPANY has developed and documented a quality management system. The quality system complies with the international standard ISO 9001:2000, Quality management systems - Requirements. This manual provides comprehensive evidence to all customers, suppliers and employees of what specific controls are implemented to ensure product/service quality.
1.2 EXCLUSIONS
The XYZ COMPANY quality system is tailored to our operations/processes, including all customer and regulatory requirements. Requirements of ISO 9001:2000 that are not applicable to the nature of our business, are excluded from the scope of our quality system.
1.3 QUALITY POLICY
XYZ COMPANY accepts responsibility for the complete satisfaction of its customers. We exercise this responsibility
through adequate training of our employees, adherence to proven procedures, and total commitment to meeting and
exceeding customer requirements, and to maintaining an organizational culture that fosters continuous improvement.
__________________________________
(Name), President
5 MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
The management of XYZ COMPANY is committed to implementing, and maintaining a documented quality system. This commitment includes: ensuring that customer, regulatory and legal requirements are understood and appropriately addressed, the quality policy is understood and implemented at all levels of the organization, quality objectives and plans are established as necessary and that the responsibilities of all functions affecting quality are clearly defined. Management will make provisions for the necessary resources and personnel to maintain the system, including a management representative, who will ensure that the requirements of this manual are met. Management will review the system annually to determine its effectiveness.
5.4 PLANNING
5.4.1 QUALITY OBJECTIVES
The management of XYZ COMPANY establishes annual key initiatives, which include quality objectives. The objectives are established via the Management Review Procedure and communicated to all levels of the organization for use in establishing each function's and employee's annual key objectives. Quality objectives are measurable, include business performance indicators reflecting requirements for products/services, and are consistent with the quality policy including the commitment to continuous improvement.
5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING
The management of XYZ COMPANY ensures that the resources needed to achieve the quality objectives are identified and planned. All quality plans are documented and include: the required recourses; the processes of the quality system, permissible exclusions; continuous improvement of the quality system.
7 PRODUCT REALIZATION
7.1 PLANNING OF PRODUCT REALIZATION
XYZ COMPANY has established and maintains documented procedures to ensure that the sequence of processes is conducted in a controlled manner. Planning of the realization processes is consistent with other requirements of the organization's quality system. Plans of product and service realization determine the following:
· quality objectives for the product/service, project or contract;
· the need to establish processes and documentation, and provide resources and facilities specific to the product/service;
· verification and validation activities, and the criteria for acceptability;
· the records that are necessary to evidence conformity of the processes and resulting product/service to specified requirements.
7.3.8 Design Control Procedure
General Policy
The design process is carried out under controlled conditions. All activities are planned and documented. Designs are reviewed at appropriate stages and where applicable, validated. The design output is verified before it is released to production.
Procedure
1.0 General
1.1 Engineering will adhere to this documented procedure that assures all designed solutions (hardware, software, service, etc.) meet market requirements and performance standards.
2.0 Design Input
2.1 Marketing/Sales will identify and document the market's needs for new solutions in a Market Requirements Statement (MRS), and a User Requirements Document (URD). The MRS and URD will serve as the input for design work. The MRS shall include the following:
· What is required (features/functions, etc.)
· Why it is needed (customer demand)
· When it is needed
· Market Segment
· Detailed product requirements (performance standards, including customer requirements, reliability, statutory and regulatory requirements, and products' life needs)
· Pricing Targets
The URD shall include the following:
· Capabilities - a description of the capabilities that are required and why
· Constraints - a description of the applicable constraints and why they exist
· User characteristics - a description of who will use the product and when
· Operational environment - a description of the effect external systems have and their interface with the product
· Assumptions and dependencies - a description of the assumptions on which the requirements depend
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.1 GENERAL
XYZ COMPANY has established and maintains a documented Continuous Improvement Procedure to define, plan and implement the measurement and monitoring activities needed to assure conformity and achieve improvement. This includes the determination of the need for, and use of, applicable methodologies including statistical methods.
8.2.3 MONITORING AND MEASUREMENT OF PROCESSES
XYZ COMPANY applies suitable methods for measurement and monitoring of those realization processes necessary to meet customer requirements. These methods confirm the continuing ability of each process to satisfy the intended purpose.
8.2.4 MONITORING AND MEASUREMENT OF PRODUCT
XYZ COMPANY measures and monitors the characteristics of the product/service to verify that requirements for the product/service are met. This is carried out at appropriate stages of the product/service realization process. Evidence of conformity with the acceptance criteria is documented. Records include the authority responsible for release of the product/service.
8.2.4.1 Inspection and Test Procedure
General Policy
Incoming, in-process, and final inspection/testing are conducted to verify that products conform to specified requirements. Materials, components, subassemblies, and finished products are prevented from use, assembly, and dispatch until the required inspections are completed. Modified products shall be fully re-inspected and re-tested. The required records of inspections/tests are established and maintained.
Procedure
1.0 Receiving Inspection and Test
1.1 All purchased material which influences the manufacture of, or is intended for use as part of, deliverable products is subject to inspection and/or testing by Receiving Inspection. Upon receipt of products, receiving personnel verify the quantity of delivered units, check marking and identification of packages, and inspect all packages for any signs of tampering or damage. If all these checks and inspections are satisfactory, receiving personnel signs the delivery receipt. If not, any shortages or damages are noted on all copies of the delivery receipts.
1.2 The received containers are then moved to the designated inspection area, a copy of the purchase order is retrieved, and the packing slips are removed from the containers. Upon opening the containers, the goods are verified against the purchase order and the packing slip, and are examined visually for any signs of damage. The purchase order is stamped "RECEIVED" and is signed and dated by the receiving inspector. All receiving inspections are logged in the Receiving Inspection Log.
2.0 In-process Inspection and Test
2.1 In-process inspection/testing is conducted to ensure that the product/process conforms to specified requirements. The inspection/testing is normally carried out by production personnel. Code reviews, peer reviews, and process walk thrus are utilized for software development projects. Random audits of the in-process inspection/testing process are conducted by quality control personnel.
2.2 The Quality Manager determines the extent and scope of in-process inspection/testing based on the importance of the item, control methods, and previous performance.
3.0 Final Inspection and Test
3.1 For acceptance of completed products, final inspection/testing is utilized. This includes a verification of satisfactory receiving and in-process inspections/tests, as well as completion of the remaining inspections/tests to assure that the finished products/processes conform to specified requirements. Products are not released and processes are not approved until all inspection/test activities have been satisfactorily completed, and the appropriate documentation is available and authorized. All final inspections are logged in the Final Inspection Log. On critical parts and components, as determined by the Quality Manager, a Final Inspection/Test & Audit Report is completed.
3.2 The Quality Manager determines the extent and scope of final inspection/testing based on the importance of the item, control methods, and previous performance.
4.0 Inspection and Test Records
4.1 Inspection/test records, which show clearly whether the product/process has passed or failed the defined acceptance criteria, are established and maintained.
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