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Software
Quality Assurance Manual
Table
of Contents
Approvals
Revision and
Approval Record
1.0 General
1.1
Introduction
1.2
Exclusions
1.3 Quality
Policy Statement
2.0 Company
History
3.0 Company
Contact Information
4.0 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
5.0 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
6.0 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
7.0 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
8.0 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
5.0 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.
7.0 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
8.0 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.
Sample
Quality Form
Order
Quality Manual
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Copyright 1997, 2008 Quality Systems Innovations, Inc. |
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