Software Quality Assurance Manual

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Table of Contents

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 9001:2015, Quality management systems - Requirements and is implemented in accordance with ISO 26000:2010 - Guidance on social responsibility.  This manual provides comprehensive evidence to all customers, suppliers and employees of what specific controls are implemented to ensure product/service quality.

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.

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(Name), President

5.0 LEADERSHIP

5.1 Leadership and Commitment

XYZ COMPANY'S top management maintains a leadership role and is committed to implementing, and maintaining a quality management 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.  Management will review the system annually to determine its effectiveness.

6.0 PLANNING

6.1 Leadership and Commitment

When planning for the quality management system, XYZ COMPANY considers the risks and opportunities that need to be addressed.  Actions for addressing risks and opportunities are proportionate to their potential impact on the conformity of products and services.

For details, refer to the Risk Management Procedure.

6.2 Quality Objectives and Planning to Achieve Them.  

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.

7.0 SUPPORT

7.1 Resources

XYZ COMPANY management determines and provides adequate resources for the establishment, implementation, maintenance and continual improvement of the quality management system.  

The required resources for implementation and improvement of the quality system, and for addressing customer satisfaction, may include any of the following:  suppliers, information, infrastructure, work environment, and financial funds.  The principal means for determining and communicating resource requirements are management reviews of the quality system.  For details, refer to the Management Review Procedure.

9.0 PERFORMANCE EVELUATION

9.1 Monitoring, Measurement, Analysis, and Evaluation

Measurement and analysis activities that are required to assure product/services quality and contribute to continual improvement are planned, and defined statistical techniques are used for analyzing measurement data.

9.1.2 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.

9.1.3 Monitoring and Measurement of Product 

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

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.

Sample Quality Form

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