Software
Quality Assurance Manual
Order Software Quality
Assurance Manual
Table of Contents
Approvals
Revision and Approval Record
1.0 Scope
1.1 Introduction
1.2 Applicability
1.3 Quality Policy Statement
2.0 Company History
3.0 Terms and Definitions
4.0 Context of the Organization
4.1 Understanding the Organization and Its Context
4.2 Understanding the Needs and Expectations of Interested Parties
4.3 Determining the Scope of the Quality Management System
4.4 Quality Management System and Its Processes
5.0 Leadership
5.1 Leadership and Commitment
5.1.1 General
5.1.2 Customer Focus
5.2 Policy
5.2.1 Developing the Quality
Policy
5.2.2 Communicating
the Quality Policy
5.3 Organizational Roles, Responsibilities and Authorities
5.4 Management Responsibilities
6.0 Planning
6.1 Actions to Address Risk and Opportunities
6.2 Quality Objectives and Planning to Achieve them
6.3 Planning of Changes
6.4 Work Environment
7.0 Support
7.1.1 General
7.1.1.1
Responsibilities for Determination of Required Resources
7.1.1.2 Provision
of Resources
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the Operation of
Processes
7.1.5 Monitoring and Measuring Resources
7.1.6 Organizational Knowledge
7.2 Competence
7.2.1 General
7.2.2 Competence, Awareness, Training
7.3 Awareness
7.4 Communication
7.4.1 General
7.4.2 Internal Communication
7.4.3 External Communication
7.5 Documented Information
7.5.1 General
7.5.2 Creating and Updating
7.5.3 Control of Documented Information
8.0 Operation
8.1 Operation Planning and Control
8.1.1 Planning of Product and Services
Realization
8.2 Requirements for Products and Services
8.2.1 Customer Communications
8.2.2 Determining the Requirements
Related to Products and Services
8.2.3 Review of Requirements
Related to Products and Services
8.2.4 Changes to Requirements for
Products and Services
8.3 Design and Development of Products and
Services
8.3.1 General
8.3.2 Design and Development
Planning
8.3.3 Design and Development
Inputs
8.3.4 Design and Development Controls
8.3.4.1 General
8.3.4.2 Design and Development
Review
8.3.4.3
Design and Development
Verification
8.3.4.4
Design and Development
Validation
8.3.5
Design and Development Outputs
8.3.6 Design and Development Changes
8.4 Control of Externally Provided Processes, Products and Services
8.4.1 General
8.4.2 Type and Extent of Control
8.4.2.1 Verification of Purchased Product
8.4.3 Information for External Providers
8.5 Production and Service Provision
8.5.1 Control of Production and Service Provision
8.5.1.1 Validation of Processes for Production
and Services Provision
8.5.2 Identification and Traceability
8.5.3 Property Belonging to Customers
and External Providers
8.5.4 Preservation
8.5.5 Post Delivery Activities
8.5.6 Control of Changes
8.6 Release
of Products and Services
8.7 Control of Nonconforming Outputs
9.0 Performance Evaluation
9.1 Monitoring,
Measurement, Analysis, and
Evaluation
9.1.1 General
9.1.2 Customer Satisfaction
9.1.3 Analysis and Evaluation
9.2 Internal Audit
9.3 Management Review
10.0 Improvement
10.1 General
10.2 Nonconformity and Corrective Action
10.3 Continual Improvement
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.
__________________________________
(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
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.
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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