ABC QualityManual
ABC QualityManual
ABC QualityManual
Quality Manual
QMG
Document Info
DOC ID
DOC NAME
FILE NAME
CONTROLLER
VERSION
RELEASE DATE
AUTHORED BY
REVIEWED BY
APPROVED BY
ABC-QualityManual
Quality Manual of ABC Company
ABC-QualityManual.doc
QMG
2.0
(Date baselined after approval)
History
VERSION
DATE
AUTHORED/
REVISED BY
REVIEWED
BY
1.0
APPROVED
BY
REASON FOR
AMENDMENT
Quality
objectives made
measurable
2.0
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QUALITY MANUAL
Position
Produced by
QMG
Approved by
Management
Representative
(MR)
Authorized by
CEO
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Signature
Date
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REVISION HISTORY
Revision
No.
1.1
1.2
1.3
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Date of
Revision
Revised By
QMG
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Table of Contents
Message from the President.............................................................................................................3
1.
Introduction............................................................................................................................3
1.1. Scope..................................................................................................................................3
1.2. Application/ Inclusion/ Exclusion......................................................................................3
1.3. Definitions, Abbreviations and Acronyms.........................................................................3
2.
Company Profile....................................................................................................................3
2.1. Contact Information............................................................................................................3
3.
Quality Policy and Quality Objectives..................................................................................3
3.1. Quality Policy.....................................................................................................................3
3.2. Quality Objectives..............................................................................................................3
4.
Quality System.......................................................................................................................3
4.1. Quality System Model........................................................................................................3
5.
Management Responsibility..................................................................................................3
5.1. Management Commitment.................................................................................................3
5.2. Customer Focus..................................................................................................................3
5.3. Quality Policy.....................................................................................................................3
5.4. Quality Planning.................................................................................................................3
5.5. Responsibility, Authority and Communication..................................................................3
5.6. Management Reviews........................................................................................................3
6.
Resource Management...........................................................................................................3
6.1. Provision of Resources.......................................................................................................3
6.2. Human Resources...............................................................................................................3
6.3. Infrastructure......................................................................................................................3
6.4. Work Environment.............................................................................................................3
7.
Product Realization................................................................................................................3
7.1. Planning of Product Realization.........................................................................................3
7.2. Customer-related processes................................................................................................3
7.3. Design and Development...................................................................................................3
7.4. Purchasing..........................................................................................................................3
7.5. Production and Service.......................................................................................................3
8.
Measurement, Analysis and Improvement............................................................................3
8.1. General...............................................................................................................................3
8.2. Monitoring and Measurement............................................................................................3
8.3. Control of nonconforming product.....................................................................................3
8.4. Analysis of Data.................................................................................................................3
8.5. Improvement.......................................................................................................................3
9.
Appendices............................................................................................................................3
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1. Introduction
This document describes the overall quality system at ABC and is a mandatory
requirement of the system. It includes all requirements of ISO 9001: 2000. It also includes
additional requirements necessary for ABC to be a world-class provider of software solutions.
The ABC Quality System has three interrelated objectives:
1.1.
Scope
The ABC Quality Management System satisfies the full range of requirements of ISO
9001:2000. ABC does not subcontract work presently. If we do subcontract work in future, the
subcontractors will be included in the Quality System to the extent that their contract stipulates
that they follow ABC Quality System procedures.
1.3.
1.3.1.
Definitions
Customer
Customer Agreement
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Approving Official
Objective Evidence
Product
Program Plan
Project Plan
Quality Policy
Quality Objectives
Quality Record
Quality System
Responsible Manager
Service
Shall
Will
1.3.2.
QMS
QMG
MR
HR
SEPG
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Abbreviations
Quality Management System
Quality Management Group
Management Representative
Human Resources
Software Engineering Process Group
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SQA
TM
PM
PL
DP
SRS
CI
CRM
2. Company Profile
ABC Infosystems is a global IT solutions company with expertise in the business of
providing high quality software solutions across a broad spectrum of technologies.
Since its inception in year, ABC has grown into a multinational company that focuses on
converting technology potential into real business value. ABC has evolved from an organization
providing software services to a value added software solutions provider. ABC provides its
services through its locations, and supports these services with its state of the art development
center in location of HQ.
ABC information technology consultants provide expertise to meet customers exacting
standards. They are skilled professionals with authority in computing technologies and possess
immense experience to execute complex software projects. They have a disciplined, yet flexible
approach to developing solutions.
Aggressive pricing clubbed with superior quality of services, has seen ABC build strong
relationships with its customers. Further, ABC works on flexible pricing models including the
fixed price model, time & material contracts, retainer-ship or the virtual office concept and the
revenue sharing model.
The key to ABC success has been the ability to deliver to their customers what they need
at very competitive prices. High emphasis is laid on the quality and timeliness of the deliverables
and ISO 9001 2000 standards are followed to maintain the same.
2.1.
Contact Information
ABC Infosystems Pvt. Ltd,
Address
Tel:
Email:
Website:
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3.1.
Quality Policy
QUALITY POLICY
<State companys quality policy here.>
ABC Management ensures that the companys quality policy:
Is appropriate for the purpose of ABC activities
Includes commitments to comply with the requirements of all applicable standards
and regulations and continually improve the effectiveness of the QMS
Provides a framework for establishing and reviewing quality objectives
Is communicated and understood within the organization
Is reviewed for continuing suitability
The goal of ABC is to provide customers with high quality products. It accomplishes this
goal by listening to customers needs and translating these needs in to continuously improved
products and services. The Management Representative is responsible for ensuring that the
quality policy is understood, implemented and maintained at all levels. This is accomplished
through one on one and/ or group training of all employees. The above quality policy describes
ABC overall intentions and directions with regard to quality.
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3.2.
Quality Objectives
QUALITY OBJECTIVES
<State companys quality objectives here.>
4. Quality System
To achieve our quality goals, it is necessary that everybody in ABC use the same
processes, procedures and practices and has the same understanding of executing a project. This
is possible only if all the procedures and practices are easily available in one place. This is
achieved by maintaining the Quality System.
Quality System is a documented engineering process that identifies the steps followed in
the development process, the practices and procedures used to support those steps and all the
organizational elements and individuals involved in the process with their roles and
responsibilities.
4.1.
Quality System Management Process includes the procedures and practices for setting up
the Quality System, controlling the changes to the Quality System (like Quality Manual,
Procedures, Guidelines, Checklists, Templates and Standards) and to ensure that all the defined
processes, procedures and practices in the Quality System are being implemented. This also
includes a procedure for improving the Quality System depending on the problems identified.
Development Processes include the processes and activities required to execute the
processes successfully.
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See the figure above. These processes and activities are grouped as:
Supporting Activities
These are the other activities apart from the Software Lifecycle and Management
activities, which are used by ABC as and when required to execute the projects
successfully. An example is the System Administration process.
Supporting Processes are processes connected with the Marketing Department, Finance
Department and the Human Resources Department.
Note: All the QMS procedures are listed in Appendix C.
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4.1.1.
ABC has established and documented a Quality System and maintains it as a means of
ensuring that our products and services conform to specified requirements.
The requirements of this Quality System are defined in the following controlled documents:
a. ABC Quality Manual
This is an overview of the Quality System. It addresses the requirements for achieving
the company objectives, as well as ISO 9001 2000 requirements. This manual includes the
companys quality policy, mission statement, quality objectives and outlines of the procedures
and practices defined in the Quality System.
b. Procedures
In order to effectively implement the Quality System, ABC maintains documented
procedures, which will be strictly followed by all ABC employees.
c. Guidelines, Templates, Checklists, Standards and Forms
Wherever necessary, Guidelines, Templates, Checklists, Standards and Forms are
provided for the Quality procedures in order to define how an activity is performed so that ABC
employees can follow it with clear guidelines for each task.
d. Records
To ensure that the Quality System is implemented, forms are prepared to record the
performance and will be maintained as Quality Records. These records will be used in the future
to improve the processes and to demonstrate the effective implementation of the Quality System.
In the case of the Technical Department, this will be handled by the SEPG.
4.1.2.
Documentation Hierarchy
The hierarchy of the Quality System documentation is shown in the figure given below:
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4.1.3.
ABC has established a documented procedure to control the changes to all the quality
documents (like the Quality Manual, Procedures, Guidelines, Templates, Checklists, Standards
and Forms) and data to ensure that the most recent revision of these documents, with correct and
appropriate information is always available at the point of use.
Issuance of Documents and Data
All quality documents in ABC are created/ modified, reviewed, approved and baselined
according to a documented procedure (Procedure Id). All latest QMS documents are available
for viewing as well as downloading at the intranet web site. The QMG/ SEPG maintains this site.
In case any one in ABC needs to refer an obsolete document, this will be available with the MR,
as per retention period.
To ensure that only the latest revisions of documents are available at the required
locations, obsolete documents will be removed. Changes to documents will be reviewed and
approved by the same group that performed the original review (or the people in the same role in
case original reviewers are not working for ABC any more). Upon approval, these documents
will replace the old ones in the intranet site. Users have to implement these in place of the old
ones. The Management Representative will keep one hard copy of all the documents, latest and
obsolete (as per retention period), for his/ her reference. The intranet site also will have the
historical data of ABC for reference.
Document IDs
For better control of documents, all documents have document ids. The rule for applying
the document ids is set up by the QMG and all the authors have to follow this rule for their
documents. The document naming convention followed is explained in detail in the Document
Naming Conventions document (Doc Id).
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Master List
A list of quality documents, which clearly shows the version number, the location and the
controller of the documents, is kept by the Management Representative for quick access at any
time.
This master list, lists all documents of the Quality System such as Quality Manual,
Procedures, Guidelines, Templates, Checklists, Standards and Forms.
To ensure that appropriate documents are available at the point of use, obsolete
documents should be clearly identifiable to show which one is currently used and which is
discarded. Obsolete documents are promptly deleted or removed to the Obsolete folder in the
Quality Documents database (as per retention period). The MR is responsible for discarding
obsolete documents.
All QMS documents and data of ABC are available for employees in the intranet website.
The Management Representative maintains all quality documents and data in the Quality
Documents database.
Management of Records
Records are established and maintained to provide evidence of conformity to
requirements, the effective operation of the Quality Management System and to demonstrate
conformance to the requirements of all applicable standards. Mechanisms are established for
records to remain legible, readily identifiable and retrievable. A documented Records Control
Procedure has been established to define the means needed for the identification, storage,
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protection, retrieval, retention time and disposition of records. ABC requires that Quality
Records must be
Identified, collected, filed, stored, maintained, and dispositioned according to
documented procedures,
Retained for established retention times,
Legible,
Stored in an appropriate environment to prevent deterioration,
Readily retrievable, and
Available to customers when required by customer agreement.
The Responsible Manager shall ensure that Quality Records are identified in appropriate
procedures, that procedures are documented to control Quality Records, and that Quality Records
are developed and maintained in accordance with those documented procedures. The
Management Representative shall ensure proper disposition of all Quality Records and provide
guidance regarding specific retention periods. The Quality Records Custodian shall ensure
legibility of Quality Records. The Quality Records Custodian shall collect, store, and maintain
Quality Records for the minimum retention period or for the period designated by the
Management Representative/ Responsible Manager.
Control of External Documents
A librarian controls all external documents, which are related to the quality system, in the
companys library. Any loan or return is recorded in the Library Information System (intranet
website) in order to control all items of the library.
Related Procedures
4.1.4.
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The product will be coded as per the design specifications. During coding, the specified
coding standards will be followed.
Reviews
Various kinds of reviews (design reviews, code reviews and SQA audits) will be carried
out to ensure that the design and implementation is according to the requirements and following
all the predefined standards.
Related Procedures
d. Testing
Testing will be conducted to ensure that the product has been developed as per the
requirements and all the possible errors are detected and rectified.
The software developed will be tested at various levels of development, to test the
different categories of defects.
Test Plan(s)
There will be a test plan (or test plans) which address the types of testing the software
needs to undergo, entry and exit criteria for each phase or levels of testing depending on the
requirement, test environment, resources required, schedule for conducting the tests and test
tools that need to be used. Tests are planned depending on where it will be easier to detect and
least costly to fix the problem. Test plan(s) can be separate or part of the Software Project Plan.
Test Cases and Defect Logs
Test cases derived by the testers from the requirements shall be documented in the test
case documents. Test plans and test case documents are reviewed by the PM, PL, the Quality
Coordinator or the SQA group, to ensure that they enable testers to thoroughly test whether the
customer requirements are satisfied by the software. Defects identified during testing are
documented in defect logs and tracked to closure.
Related Procedures
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e. Customer Acceptance
Acceptance testing is conducted by the customer in the manner specified in the contract,
to ensure that the software satisfies the criteria specified in the requirements document. This will
be done after ABC has completed internal testing and fixed all defects identified.
f. Delivery and Installation
Delivery and installation are processes, which are performed after the software has been
developed and is ready to be sent to the customer. These processes need coordination with the
customer, and the level of coordination depends on the complexity of the software developed.
Delivery
Before delivery of the product, all the deliverable items will be checked and approved by
the concerned people. All the delivery specifications if any (for example packaging and type of
delivery) will be followed. Before delivery, all software deliverables will be checked for possible
viruses.
Installation
Supplier and customer responsibilities will be defined before the installation. Resources
required (hardware, software and skilled personnel), access to customer facilities if any and
schedule for installation should be specified. During installation, it should be ensured that the
specified resources are present and installation instructions are followed. After installation, there
should be confirmation from the customer about its successful completion.
Related Procedures
g. Maintenance
Products Maintenance
All maintenance service requests will be send to the Project Manager. The PM will assign
the tasks to the appropriate team members (like designers, programmers and testers). When the
team completes the task, the PM will review the results to see whether it is adequate to satisfy
the customers request. Then he/ she will submit it to the customer.
Filing/ Storage of records and documents
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All the requests from the customer will be entered in the Requirements Change Request/
Log document. These will be tracked to closure. All data and work done will be stored in the
appropriate folder in the project directory, and accessed by the responsible staff. The
communication with the customer will be kept in the folder for customer communication.
Related Procedures
4.1.5.
A software development project consists of two integral parts, development of the project
and management of this development. The latter is composed of three concurrent tasks that can
be considered as three concurrent processes. They are the Project Management process, Quality
Assurance process and Configuration Management process.
a. Project Management
The project management process starts when the Project Manager is appointed by the TM
in the Project Kickoff meeting. The process gets over when the Project Closure meeting is
conducted. Project Management is primarily carried out by the PM with the help of the Project
Leader(s), the Configuration Manager, the Quality Coordinator and the SQA group. The Project
Management process is implemented in parallel with the Quality Assurance and Configuration
Management processes. This process consists of three stages: Project Planning, Project
Execution and Project Closure.
Project Planning
Project Planning is to review project commitments as expressed by user requirements,
proposal, contract and other project-related information, and to create a project plan accordingly
to meet those commitments.
Project Planning involves a number of tasks: defining project objectives, selecting a
development process and customizing it, identifying hardware and software platform/
components and tools to be used, defining project organization regarding team structure and
work breakdown structure, estimating effort, planning risks and mitigation, creating project
schedule and so on.
Project Planning finishes when the project plan has been completed, reviewed and
approved.
Project Execution
Project execution is to execute the project plan and perform adjustments to keep the
project on track as set out in the project plan. This stage proceeds in tight collaboration with
Quality Assurance and Configuration Management processes. Project execution primarily
involves the following:
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These are done on the documents to ensure that they are as per the requirements.
QA Audits
These are the inspections conducted on the other items like Code, User Interface,
Prototypes, Test Results and Final Product to be delivered to ensure the conformity
of the item. E.g. Code Review, Inspecting Prototypes and Internal User Acceptance.
Accepted
The product will be accepted at each stage of the development process, if it has
completed all the inspections and tests required in that phase and has all the approvals
required (by report or mail). Accepted inspection and test reports will be maintained
as an evidence of successfully completing the particular inspection and test.
Not Accepted
The product will not be accepted if it has not completed successfully any one of the
inspections and tests required or if has not got any one of the approvals required. The
product will be held until it is accepted.
Related Procedures
c. Configuration Management
Configuration Management provides a mechanism for uniquely identifying and tracing
all the software items, during the whole development process, to prevent the use of an
inappropriate item in the final product.
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This also includes the unique identification of each delivered product and all the related
software items specified in the contract.
Configuration Management Plan
Configuration Management is an important supporting process for the software
development process and after the development process. This needs to be well planned. The plan
should specify the CM activities, organizational elements involved, their respective
responsibilities and tools and techniques that need to be used for the CM process. Once the plan
is prepared, before implementation it is reviewed and approved by the concerned people. The
configuration management plan can be separate or part of the Software Project Plan.
Configuration Management Activities
Mainly there are three activities involved in the CM process. They are:
Configuration Identification
There has to be a process for identifying all the software items and the related
items during all the phases, starting from specification through development and
delivery. This is also applicable after delivery of the product to identify uniquely all
the items in the product.
An item, which is controlled under configuration management, is called a
Configuration Item (CI). This can be a software item or a related item like a
document.
In ABC, there are two types of Configuration Items, i.e. Source Code and
Documents.
Depending on the requirement, both the types (as specified above) of
configuration items that need to be controlled, will be identified. The naming and
numbering conventions for all the Configuration Items will be specified depending on
the identification required. The software tools that need to be used for Configuration
Management will be identified and specified.
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Related Procedures
4.1.6.
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Security Operations
There are strict security procedures to be followed in ABC to protect the system from
internal and external attacks.
Related Procedures
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Timeframe for maintaining any particular quality record will be decided and mentioned
in the List of Records.
The person responsible for controlling the quality records will be responsible for
disposition of the records.
Related Procedures
5. Management Responsibility
5.1.
Management Commitment
Customer Focus
A customer is any organization or individual entering a formal agreement with ABC for
delivery of ABC products or services. ABC ensures that customer requirements are determined
and fulfilled with the objective of enhancing customer satisfaction. Customer agreements, both
oral and written, are reviewed prior to acceptance to ensure that the specified requirements can
be met. These reviews ensure that the requirements are well defined and documented and that
differences between parties are resolved. Results of these reviews are maintained as Quality
Records.
Responsibilities
The Approving Official for each customer agreement shall ensure that appropriate
reviews of these agreements take place and that amendments are made according to documented
procedures. The Responsible Manager shall ensure that effective communication is established
with the customer, that all requirements are clearly stated and understood, and that ABC has the
ability to meet those requirements.
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5.3.
Quality Policy
See 3.1.
5.4.
Quality Planning
ABC ensures that quality is an integral part of the design and development of its products
and services. It emphasizes the use of problem prevention and problem correction in order to
supply quality products and services to its customers. The activities governed by the Quality
System are identified and documented. These documented procedures are controlled and
effectively implemented to ensure that ABC products meet customer requirements. Quality
planning is embedded in the procedures as well as the related documents. Quality planning
includes, as appropriate:
Preparation of quality plans,
Identification and acquisition of controls, processes, equipment, resources and skills
needed to achieve the required quality,
Ensuring the compatibility of the design, the development process, installation,
servicing, inspection, test procedures and applicable documentation,
Updating as necessary quality control, inspection and testing techniques, including
the development of new instrumentation,
Timely identification of the capability to be developed and any requirement involving
capability that exceeds the known state of the art,
Identification of suitable verification at appropriate stages in the products life cycle,
Clarification of standards of acceptability for all features and requirements, including
those which contain a subjective element, and
Identification and preparation of Quality Records.
Documents referenced in the Quality Manual, procedures, and program and project plans
are applicable only to the extent specified therein.
Responsibilities
The Responsible Manager shall identify activities governed by the Quality System and
ensure that they are documented. He/ she shall perform quality planning to relate specific
customer requirements to the Quality System and to ensure that quality documentation and
records are properly identified, maintained and controlled.
5.5.
The primary responsibility for implementing the Quality System resides with the
Responsible Managers/ Project Managers/ Project Leaders in the various departments (like
Technical, Marketing, HR and Finance). They shall ensure that documented procedures define
the specific responsibilities, authorities, and relationships of personnel who manage, perform, or
verify work that affects quality. The ABC Organization Chart is provided as an appendix
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(Appendix A). The department heads are responsible for updating their department
responsibilities, as the organizational structure of the company changes.
5.5.1.
President
The President of ABC has ultimate responsibility to establish quality policy, and where
necessary, to approve or reject recommendations from the employees or concerned groups.
5.5.2.
QMG
The President has established a Quality Management Group (QMG), which provides
technical expertise to support Responsible Managers in managing and maintaining the Quality
System. This includes training, developing documented procedures, and performing audits. The
QMG is responsible for defining the document and data control system, the corrective and
preventive action system, the nonconformance reporting system and the internal audit program.
In the case of the Technical Department, this role is handled by two member groups of the QMG,
namely the SEPG and the SQA (see 5.5.4 and 5.5.5). The mission of the QMG is to:
5.5.3.
The CEO .. has appointed ., who is the Senior Manager (.), as the
Management Representative (MR). Irrespective of his other responsibilities, he has authority for:
Ensuring that a quality system is established, implemented and maintained in
accordance with ISO 9001: 2000.
Coordinate and chair the Management Review meetings to determine whether the
performance of the Quality System is effective in meeting the objectives and goals of
ABC.
Reporting on the performance of the quality system to the companys management for
review and as a basis for improvement of the quality system.
Act as the interface with external customer and third-party organizations interested in
the operation of the Quality System.
Coordinate improvements of the Quality System to achieve strategic objectives.
Management Review meetings shall be held according to the procedure for Management
Reviews or as decided by the top management. Management Review meeting agenda shall
include the following:
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The MR ensures that minutes of the Management Review meetings are prepared and
distributed, and that the status of assigned action items is tracked. Management Review meeting
minutes are to be controlled in accordance with the section on Quality Records in this document.
The MR heads the QMG and coordinates the ISO activities of ABC. The responsibility of
the MR includes liaison with external parties on matters relating to the companys quality
system. The MR can and may delegate specific responsibilities as appropriate.
The President, assisted by the MR, reviews the Quality System yearly (at a minimum) to
ensure its continuing suitability and effectiveness in satisfying the companys stated quality
objectives and the requirements of ISO 9001: 2000. Records of these reviews are maintained.
5.5.4.
SEPG
The SEPG reviews company software standards and guidelines to recommend changes and to
identify software process procedures that need to be prepared.
Process Change Management
Proposed improvements to existing software process procedures should be encouraged
and may be submitted by any organizational employee. The SEPG reviews the proposed change,
acting as a change review board. The role of the SEPG in this process evolves as the organization
matures. It may begin by merely approving or disapproving proposed improvements made by
process owners. As the organization matures and significant process data is available, the SEPG
can use this data to predict change impacts and thereby manage change more effectively.
Technology Insertion
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Training
The SEPG has overall responsibility to train software personnel. (The term "software
personnel" encompasses software practitioners, software support personnel and software
management, e.g., software quality assurance.) This process includes preparing a training plan,
maintaining training records, and preparing training materials when necessary.
Process Improvement Support
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The SEPG has established and maintains a set of software process assets for use by
organizational projects to define and improve software processes. These software process assets
are available in the intranet site.
Assessment
The SEPG is responsible for preparations necessary to support assessments. These may
include internal self- assessments (which the SEPG may also perform) and formal assessments
such as ISO assessments, CMM-Based Assessment for Internal Process Improvement and
Software Capability Evaluations. If the preparation activities are significant, this effort shall be
managed as a project. Once the assessment is complete, the SEPG follows up by preparing and
implementing action plans developed for each finding.
5.5.5.
SQA
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procedures are being followed, that required documentation is maintained, and that the
developer's status reports accurately reflect the status of the activity. The SQA
product is an audit report to management consisting of findings and recommendations to bring
the development into conformance with standards and/or procedures.
SQA Relationships to Other Assurance Activities
SQA assures that Software Configuration Management (SCM) activities are performed in
accordance with the CM plans, standards, and procedures. SQA reviews the CM plans for
compliance with software CM policies and requirements and provides follow-up for
nonconformances. SQA audits the CM functions for adherence to standards and procedures and
prepares reports of its findings.
SQA assures Verification and Validation (V&V) activities by monitoring technical
reviews, inspections, and walkthroughs. The SQA role in reviews, inspections, and
walkthroughs is to observe, participate as needed, and verify that they were properly conducted
and documented. SQA also ensures that any actions required are assigned,
documented, scheduled, and updated.
SQA assures that formal software testing, such as acceptance testing, is done in
accordance with plans and procedures. SQA reviews testing documentation for completeness and
adherence to standards. The documentation review includes
test plans, test cases and defect logs. SQA monitors testing and provides follow-up on
nonconformances. By test monitoring, SQA assures software completeness and readiness for
delivery.
5.5.6.
Internal Communications
President
Management
Representative
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Responsible Managers/
Project Managers/ Project
Leaders
All personnel
organization.
Ensure that the Quality System is established,
documented, implemented and maintained.
Regularly review the suitability and effectiveness of the
Quality System
Coordinate improvements to the Quality System.
Liaison with external parties on matters related to the
quality management system.
Coordinate the management review meeting and
actions arising out of the meeting.
Implement the Quality Management System.
Obtain and communicate customer requirements to the
appropriate personnel or functional organization.
Ensure that qualified, skilled and trained personnel and
other resources are available to implement the Quality
System.
Ensure that products and services satisfy customer
requirements including quality, safety, cost, schedule,
performance, reliability, durability, accuracy and
maintainability
Ensure that personnel comply with applicable
standards, regulations, specifications and documented
procedures.
Ensure the quality of their work.
Understand and implement the Quality Policy and
Quality Objectives in their respective areas of work.
Operate in conformance with the requirements of the
Quality System.
Stop work in progress or make appropriate notifications
when unsafe conditions exist or requirements are not
being met.
Note: The detailed Roles and Responsibilities in ABC are given as an appendix (Appendix B).
5.6.
Management Reviews
The MR is responsible for ensuring that meetings of the ABC Management Review
Committee take place, and the performance of the QMS, reports of audit observations and
feedback from customers are reviewed. The Committee conducts these reviews on at least a
quarterly basis to ensure continuing suitability, adequacy and effectiveness of the system. The
Technical Manager will give a consolidated report of the projects to the MR, in the Monthly
Status Report on Deliveries and Defects template each month. There should be no Fatal/ Major
defects in deliveries. Schedules should not slip by more than 12 % unless due to changes or
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enhancements required by the customer, or if the delay is caused by the customer in providing
information or delaying acceptance testing. Issues connected with this will be discussed by the
MR in the Management Review Meetings, and corrective and preventive action taken. The
Management Reviews also includes assessing opportunities for improvement and the need for
changes to the QMS, including the quality policy, objectives and goals. Records of management
reviews are maintained as per the Records Control Procedure.
6. Resource Management
6.1.
Provision of Resources
ABC management determines and provides the required resources (such as manpower
resources, hardware, software and infrastructure facilities) for the operation of the company and
to implement, maintain and continually improve the effectiveness of the QMS with the aim of
enhancing customer satisfaction by meeting customer requirements.
6.2.
Human Resources
6.2.1.
General
ABC management ensures that personnel performing work that affects the quality of the
product are competent on the basis of appropriate education, training, skills and experience.
6.2.2.
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Training Records
Records of training are maintained as Quality Records. When the employees complete a
training programme, the HR Department will update the skill database accordingly.
Related Procedures
6.3.
Infrastructure
6.4.
Work Environment
ABC has determined and manages the work environment needed to achieve conformity
to the requirements of projects/ products.
7. Product Realization
7.1.
ABC plans and develops the processes needed for the product/ project realization as per
design, development and maintenance of software. Planning of product realization is consistent
with the requirements of the other processes of the QMS as per element 4.1 of this Quality
Manual. In planning product / project realization, ABC determines the following, as appropriate:
Quality objectives and requirements for the product,
The need to establish processes, documents, and provide resources specific to the
product,
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7.2.
Customer-related processes
7.2.1.
7.2.2.
7.2.3.
Customer Communication
ABC has determined and implemented effective arrangements for communication with
customers through weekly reports, teleconferencing, issue escalation, feedbacks and
satisfaction survey in relation to:
Product information,
Inquires, contracts or order handling, including amendments, and
Customer feedback, including customer complaints.
Responsibilities
The responsible manager ensures that the customers requirements are properly
considered at the various stages of the processes in the projects. The Management Review
Committee reviews the feedback and suggestions received from the customers.
7.3.
7.4.
Purchasing
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ABC has established and maintains a documented procedure to ensure that all purchased
goods/ software/ tools/ services, related to the operation of the company, are purchased in
conformity to specified requirements.
7.4.1.
Evaluation of Suppliers
Suppliers are selected on the basis of their ability to meet requirements. The selection
shall be dependent on the type of the product and on the history of the suppliers previously
demonstrated capability and performance. New suppliers will be selected with clearly specified
approval/ disapproval criteria. A preferred vendor list is maintained by ABC.
7.4.2.
Purchasing Information
While purchasing an item, the item type, class and specification are clearly specified in
the purchase order. Before purchasing the item, the purchase order needs to be approved by the
concerned people.
7.4.3.
Reviews are conducted to ensure that purchased products are in compliance with
company requirements. ABC does not subcontract work presently. If this is done in future,
reviews will be conducted to ensure that subcontractors perform quality assurance activities
during the development of products.
7.4.4.
Related Procedures
7.5.
7.5.1.
ABC plans and carries out execution of projects and service under managed conditions. It
identifies and plans processes that directly affect quality. This includes product creation,
installation, servicing processes such as software design and development, and program and
project management. These core processes shall be carried out under controlled conditions,
including:
Use of written procedures that define the manner of process operation, where their
absence would compromise quality.
Use of suitable equipment, tools, and working environments.
Compliance with applicable codes, standards, plans, specifications and documented
procedures.
Monitoring and control of suitable process parameters and product characteristics.
Approval of processes and equipment, whenever appropriate.
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ABC validates any processes for production and service where the resulting output
cannot be verified by subsequent monitoring or measurement. This includes any processes where
deficiencies become apparent only after the product is in use or the service has been delivered.
Validation demonstrates the ability of these processes to achieve planned results. ABC has
established arrangements for these processes, including as applicable:
a) Defined criteria for review and approval of the processes.
b) Approval of equipment and qualification of personnel.
c) Use of specific methods and procedures.
d) Requirements for records as per the Records Control Procedure.
e) Revalidation.
Responsibilities
The Responsible Manager shall ensure that ABC processes are appropriately planned,
documented, monitored and controlled.
7.5.3.
ABC uniquely identifies materials and products in order to prevent the inadvertent use of
an inappropriate item in a final product. Documented procedures, when required by customer
agreements, ensure that product identification and traceability is performed in accordance with
the configuration management system. This includes the unique identification of each delivered
product, component, assembly, module and part as specified by customer agreement.
At ABC, we have a system of identifying the status of inspections/ tests/ reviews carried
out. Identification is by segregated areas and accompanying reports.
Responsibilities
The Responsible Manager shall ensure that appropriate product identification and
traceability activities are performed throughout the products life cycle in accordance with
documented procedures.
Related Procedures
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7.5.4.
Customer Property
Customer-supplied products are verified to ensure that it does not compromise the quality
aspects of our product or services. The storage and maintenance of these products are controlled
so that any loss, damage or unsuitability for use of such products will be recorded within ABC
and reported to the customer.
Verification of Customer-supplied Products
All customer-supplied products (information, data, documents, software, hardware) must
be evaluated for the suitability to use in our products or services.
Reception of Customer-supplied Products
After verifying the products supplied by the customer, the acceptance will be recorded.
Storage
These products will be stored at a suitable location easily accessible to the concerned
employees of ABC and also to avoid loss or damage. For example, the Project Directory for data
and information (in electronic format), or Project Folder for documents in hard copy.
Control of lost and damaged products
Any loss or damage to the customer-supplied products will be recorded and reported to
the customer.
Return of customer-supplied products
After finishing the product, all customer-supplied products will be returned to the
customer and the delivery of the products will be recorded.
Related Procedures
7.5.5.
ABC minimizes the risk of damage to or deterioration of ABC materials and products
during handling, storing, packaging, preserving and delivering materials and products, by doing
it in accordance with a standard documented procedure, unless special requirements are
identified or specified.
Responsibilities
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The Responsible Manager shall identify and document special procedures for handling,
storage, packaging, preservation and delivery if required.
Related Procedures
7.5.6.
At ABC, we use testing tools like Winrunner. ABC ensures that test software and
comparative reference are checked and rechecked at prescribed intervals to prove that they are
capable of verifying acceptable product/ project if applicable. Records of such checks are
maintained as Quality Records.
Responsibilities
The Technical Manager shall ensure that test tools are identified and properly cared for,
and that they are evaluated before they are used. The records of these validations are maintained.
General
ABC plans and implements the monitoring, measurement, analysis and improvement
process, to demonstrate conformity of the product/ project, ensure conformity to the QMS and
continually improve the effectiveness of the QMS. This includes determination of applicable
methods including statistical techniques, and the extent of their use.
8.2.
8.2.1.
Customer Satisfaction
ABC has established, as one of the measurements of the performance of the QMS,
monitoring of information related to customer perception as to whether ABC has met customer
requirements. Customer appreciation letters/ commendation letters are considered to indicate the
satisfaction of the customer to the services rendered by ABC. The Responsible Manager shall
collect the customer feedback using the Customer Satisfaction Survey, analyze it and present it to
the Management Review Committee for review. An overall rating less than 7 is cause for
initiating corrective and preventive action.
8.2.2.
An Internal Quality Audit is once in three months to objectively evaluate the adequacy of
all aspects of the ABC Quality System, and to ensure that all quality activities comply with ISO
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9001 2000 requirements. Management responsible for the functions being audited shall review
and correct deficiencies revealed in the audit report. All actions taken to correct deficiencies shall
be verified for effectiveness.
Audit Plan
Audit plan is always prepared in advance and notification is sent to the auditee at least
three working days prior to the audit.
Audit Preparation
Audit Team
The Audit team is appointed by the MR. When selecting a team to audit the technical
department, members from the Software Quality Assurance (SQA) group shall be included. To
ensure impartial and effective audit, appropriately trained personnel who are not directly
responsible for the function being audited shall carry out audits.
Audit Schedule and Checklist
Before an audit, the Audit team based on the status and the importance of the activity
being audited will prepare audit schedule and checklist in advance. These will serve as guidelines
for the auditors during the audit.
Conducting Internal Audit
Before an audit, the Audit Team will hold a kickoff meeting with the Heads of the
Departments to be audited to brief them about the audit. During the audit, the checklist will be
followed to check for conformity or nonconformity in the departments activities.
Completing Audit
Any nonconformity will be recorded on the Corrective Action Report (CAR) and sent to
the concerned Department Head.
Corrective Action
The Department Head will take up corrective action in a timely manner, and the CAR
will be returned to the auditor for follow-up.
Follow-up Corrective Action
Corrective action will be verified to confirm whether it is effective or not. If it is
acceptable, CAR will be approved.
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8.2.3.
ABC applies suitable methods for monitoring, and where applicable measurement, of the
QMS processes. These methods demonstrate the ability of the processes to achieve planned
results. When planned results are not achieved, corrective action is taken as appropriate to ensure
conformity of the product. The responsible manager shall decide the control procedure while
preparing the project plan based on the customers requirements and size of the project.
8.2.4.
ABC monitors and measures the characteristics of the product to verify that product
requirements are met. This is carried out at appropriate stages of the product realization process
in accordance with the planned arrangements. Evidence of conformity with the acceptance
criteria is maintained as per the Records Control Procedure. Records indicate the person(s)
authorizing release of the product. Product release and service delivery does not proceed until the
planned arrangements have been satisfactorily completed. The project plan outlines the testing
procedure and delivery plan of the particular product. The Responsible manager/ Project
manager shall ensure that the documented procedure for testing is followed before delivery, at
the appropriate stages of processes, as per the quality manual and the specific project plan.
8.3.
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the customer for concession. If the customer accepts the non-conforming product, then
description of non-conformity accepted and actual specifications delivered are recorded.
Related Procedures
8.4.
Analysis of Data
ABC has established a process to determine, collect and analyze appropriate data to
determine the suitability and effectiveness of the QMS and evaluate areas where continuous
improvement of the effectiveness of the QMS can be made. This includes data generated by
monitoring and measurement and obtained from other relevant sources. This data is analyzed to
provide information related to:
a) Customer satisfaction,
b) Conformity to product requirements,
c) Characteristics and trends of process and products including opportunities for preventive
action, and
d) Suppliers.
Responsibilities
The MR is responsible for ensuring that data is collected and presented to the
Management Review Committee. The Management Review Committee will review and analyze
the data and ensure that corrective and preventive actions are taken. Data analysis shall be done
in accordance with the Procedure for Management Review (Procedure Id).
Related Procedures
8.5.
Improvement
8.5.1.
Continuous Improvement
ABC shall continually improve its QMS through the use of the following.
a)
b)
c)
d)
e)
Quality Policy
Quality Objectives,
Audit results as per the Internal Audit Procedure,
Analysis of Data
Corrective and Preventive actions as per the Corrective and Preventive Action Procedure,
and
f) Management Review and Data Analysis
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The ABC Quality System emphasizes the use of problem prevention or problem
correction to determine the potential cause or actual cause of nonconformance (including
customer complaints, and nonconforming processes) and prevent their occurrence or recurrence.
It investigates the causes of nonconformance relating to the Quality System, including Quality
System products and processes. The results of these investigations are maintained as Quality
Records. Investigations resulting in changes to documented procedures are processed in
accordance with the document and data control system or the configuration management control
system. Preventive and corrective action is taken to eliminate potential or existing
nonconformance to a degree appropriate to the magnitude of the problems and commensurate
with the risks encountered to eliminate or minimize the impact on safety, performance,
dependability, processing cost, quality-related cost, and customer satisfaction. The Responsible
Manager shall ensure that requirements contained in documented procedures that implement this
policy are communicated and followed by the individuals responsible for implementing the
process.
Corrective Action
All customer complaints and/or reports of nonconformities should be effectively handled,
so that the root cause can be identified. The corrective action recommended by the responsible
persons will be implemented, and controlled to ensure its effectiveness.
Preventive Action
Based on the root cause identified and investigated during Corrective Action and Internal
Audit, the Preventive Action should be initiated by implementing preventive plan approved by
the responsible persons. This should also be controlled to ensure its effectiveness.
Related Procedures
9. Appendices
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Appendix A
Organization Chart
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Appendix B
Organizational Roles and Responsibilities
Role
CEO
Manager (.) - MR
Manager (Technical)
Software Engineer
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Appendix C
List of QMS Procedures
Sl. No
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
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Doc Name
Document Management procedure
Records Control Procedure
Procedure for Management Review
Administration Procedure
Purchasing procedure
Internal Quality Audits procedure
Procedure for Control of Non-conforming Products
Procedure for Corrective and Preventive Action
Human Resources Administration and Recruitment
Procedure
Marketing Procedure
Software Development Procedure
Software Quality Assurance Procedure
Procedure for Configuration Management
Procedure for Document Reviews
Procedure for Code Reviews
Testing Procedure
System Administration procedure
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