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Table of contents
ISO 9001:2008
Clause
Manual
Clause
Title
Page
Front cover
Table of Contents
Organizational Profile
4.2.3
1.0
Revision history
4.2.2
2.0
Purpose
1.0
3.0
Scope
2.0
4.0
References
3.0
5.0
12.5
6.0
Responsibility
10.0
7.0
Records
4.1
8.0
4.2.1
9.0
Documentation requirements
4.2.3
10.0
Control of documents
4.2.4
11.0
Control of records
10
12.0
Management responsibility
10
13.0
Resource management
16
14.0
Product realization
18
15.0
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Organizational Profile
Describe your organization briefly for the benefit of readers of this manual, in terms of:
a.
History
b.
Products
c.
Milestone achievements
d.
e.
Etc.
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DAF #
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00
Revision description
Initial issue
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This manual describes the elements and processes of the quality management
system which is implemented as per the requirements of the ISO 9001:2008
international standard.
Relevant documents are referenced in the manual in order to provide users with
further guidance on the quality management system.
3.0 Scope and application
The quality management system demonstrates the organizations ability to
consistently provide products that meet customer and applicable statutory and
regulatory requirements and to enhance customer satisfaction through the
effective application of the quality management system. .
The following clauses of the ISO 9001:2008 standard are excluded from the
quality management system due to their non-relevance to the organizations
operations:
a.
State and justify which clauses of the ISO 9001:2008 that do not apply to your
quality management system. Exclusions are limited to sections within Clause 7
only.
Delete the sections of the manual that are excluded from the quality
management system.
products, Clause 7.3 is not applicable. Therefore, delete Clause 7.3 from the
manual.
The scope of the quality management system applies to the following products
of the organization:
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a.
b.
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4.0 References
These standards serve as references for the quality management system:
a.
b.
c.
d.
ISO 9004:2000
performance improvements
[Note: You need to buy original versions of these documents at
http://www.iso.org/iso/store.htm]
5.0 Terms and definitions
For the purposes of this quality management system, the standard terms and
definitions given in the current version of the ISO 9000 standard apply.
Throughout the text of this manual, wherever the term "product" occurs, it
represents either the physical goods or intangible services of the organization.
Where appropriate, the specific product is expressly mentioned in order to
convey the actual intent of a particular requirement.
6.0 Responsibility
The Management Representative is responsible for the operation of the quality
management system and review of this document (see Clause 12.5.2)
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7.0 Records
Related records are maintained as per Clause 9.2.4.
8.0 Quality Management System
The organization documents, implements and maintains a quality management
system and continually improves upon its effectiveness in accordance with the
requirements of ISO 9001:2008, which is an international standard for quality
management systems published by the International Organization for
Standardization.
The organization ensures that
a.
the criteria and methods needed to ensure that both the operation
and control of all processes within the quality management system
are effective;
b.
c.
d.
b.
c.
d.
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b.
c.
d.
e.
f.
g.
h.
i.
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All records that are maintained within the quality management system are
recorded in the Registry of Records.
10.0
Control of documents
A Control of Documents procedure has been established to define the controls
needed to
a.
b.
c.
ensure that the changes and the current revision status of documents are identified,
d.
ensure that relevant versions of applicable documents are available at points of use,
e.
ensure that documents of external origin are identified and their distribution controlled,
and
f.
prevent the unintended use of obsolete documents, and to apply suitable identification to
them if they are retained for any purpose.
The Document Controller is responsible for the implementation of this process.
The following records are maintained for this process:
a.
Registry of Documents
11.0
b.
c.
d.
Control of records
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Registry of Records
b.
12.1
Management responsibility
Management commitment
The top management of the organization is committed to continually improve
the quality management system and this is demonstrated by
a.
b.
c.
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d.
e.
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Customer focus
Top management is focused towards the fulfillment of customer requirements
and the enhancement of customer satisfaction.
This is achieved by ensuring that customer requirements are determined (see
Clause 14.2.1) and customer satisfaction levels are monitored and measured
(see Clause 15.2.1).
12.3
Quality Policy
Top management has established a Quality Policy to direct the quality
management system.
The Quality Policy is appropriate to the purpose of the organization and
includes a commitment to comply with requirements and continually improve
the effectiveness of the quality management system, and provides a framework
for establishing and reviewing quality objectives.
Top management ensures that the quality policy is communicated and
understood within the organization, and is reviewed during management
reviews for continuing suitability.
12.4
Planning
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b.
c.
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Management review
12.6.1 General
Top management reviews the quality management system at planned intervals
in order to ensure its continuing suitability, adequacy and effectiveness.
This review includes assessing opportunities for improvement and the need for
changes to the quality management system, including the quality policy and
quality objectives.
The management reviews are chaired by the [CEO/Managing Director] and
attended by the Management Representative, Document Controller and
members of the Quality Management System Committee.
12.6.2 Review input
The Management Representative provides the following inputs for the
management review:
a.
Results of audit;
b.
Customer feedback;
c.
d.
e.
f.
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b.
c.
resource needs.
Resource management
13.1
Provision of resources
Resources are determined and made available in order to ensure the effective
operation, maintenance and continual improvement of the quality management
system and enhance customer satisfaction.
Resource requirements are determined and planned during management
reviews.
13.2
Human resources
The Human Resources Department ensures that all personnel performing work
within the quality management system are competent on the basis of
appropriate education, training, skills and experience.
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All Department Managers are required to conduct induction sessions for all
new employees and transfer personnel.
b.
c.
a.
b.
c.
d.
Infrastructure
The organization determines, provides and maintains infrastructures that are
necessary to support the processes of the quality management system and
ensure conformity to product requirements.
Describe your infrastructures here, such as:
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[Buildings/Work Areas]
b.
[Process equipments]
c.
[Transportation Vehicles]
d.
[MIS/Software]
e.
Etc.
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Work environment
The organization determines and manages its work environment under which
work is performed, in accordance with its product quality requirements.
Describe your work environment and controls that your organization
implements, such as the physical environment and other environmental aspects
like such as noise, temperature, humidity, lighting and weather, where
applicable.
Note 1: List any control records.
14.0
Product realization
14.1
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The organization plans and implements effective processes needed for the
creation of its products in order to meet customer requirements and enhance
customer satisfaction.
Product realization planning involves the considerations of:
a.
Product requirements;
b.
Quality objectives;
c.
d.
e.
Required documentation;
f.
Required
verification,
validation,
monitoring,
measurement,
inspection and test activities specific to the product and the criteria for product acceptance;
and
g.
Customer-related processes
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b.
c.
d.
any
additional
requirements
considered
necessary
by
the
organization.
Details of product requirements are documented in the following documents:
a.
b.
b.
c.
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14.3
a.
[Record title 1]
b.
[Record title 2]
c.
Quotations
d.
Customer Complaints
e.
f.
Official Correspondences
Design and development [Note: If your organization does not design its
products, delete this section].
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c.
b.
c.
d.
b.
c.
d.
These inputs are reviewed for adequacy to ensure that they are complete,
unambiguous and not in conflict with each other.
The following records are maintained:
a.
b.
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purchasing requirements,
b.
c.
d.
a.
b.
c.
d.
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The following records of the results of the reviews and necessary actions are
maintained:
a.
b.
c.
b.
c.
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The following records of the results of validations and necessary actions are
maintained:
a.
b.
c.
14.4
a.
b.
Purchasing
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b.
c.
b.
c.
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Production and service operations [You may modify this title to suit your products]
14.5.1 General
The [Production Department] implements production and service provisions
under controlled conditions. Controlled conditions include
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b.
c.
d.
e.
f.
The following documents support and control the production and service
processes:
a.
b.
[Production procedures]
c.
[Work instructions]
d.
[Flowcharts]
e.
[Drawings]
14.5.2 Validation of processes for production and service provision [If this section is not
applicable to your organization, delete it]
The organization validates processes for production and service provision
where the resulting output cannot be verified by subsequent monitoring or
measurement and, as a consequence, deficiencies become apparent only after
the product is use or the service has been delivered.
Validation demonstrates the ability of these processes to achieve planned
results. Where applicable, the validation process includes
a.
b.
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d.
e.
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b.
The following documents record the methods of validation and their results:
a.
b.
14.4.3 Identification and traceability [If this section is not applicable to your organization,
delete it]
Product status is identified throughout product realization with respect to
monitoring and measurement requirements.
This process is defined in the following document:
a.
b.
14.4.4 Customer property [If this section is not applicable to your organization, delete it]
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14.4.5 Preservation of product [If this section is not applicable to your organization, delete
it]
All products including their constituents are preserved during internal
processing and delivery to the intended destination in order to maintain
conformity to requirements.
Preservation activities include identification, handling, packaging, storage and
protection.
Storage requirements are defined in the following document:
a.
14.5 Control of monitoring and measuring equipment [If this section is not applicable to
your organization, delete it]
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b.
c.
d.
e.
Records of the previous measuring results are assessed to ensure validity when
the equipment is found not to conform to requirements and appropriate actions
shall be taken on the equipment and any product affected.
Individual records of calibration and verification of each equipment are
maintained:
a.
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15.0
15.1
General
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b.
c.
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a.
b.
c.
The Internal Audit procedure defines the responsibilities and requirements for
planning and conducting audits, establishing records and reporting of results.
The audit programme is planned accordingly, taking into consideration the
status and importance of the processes and areas to be audited, as well as the
results of previous audits.
The audit criteria, scope, frequency and methods are defined.
Auditors are ensured to be objective, impartial and independent of the area
being audited.
The Quality Representatives who are responsible for the area being audited
ensures that any necessary corrections and corrective are taken without undue
delay to eliminate detected nonconformities and their causes. Follow-up
activities include the verification of the actions taken and the reporting of
verification results.
15.2.3 Monitoring and measurement of processes
Suitable methods for monitoring and, where applicable, measurement of the
quality management system processes are applied in order to demonstrate the
ability of the processes to achieve planned results.
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When determining suitable methods, the organization considers the type and
extent of monitoring or measurement appropriate to each of the processes in
relation to their impact on the conformity to product requirements and on the
effectiveness of the quality management system.
Relevant processes are monitored and measured by the respective Quality
Representatives in terms of their
a.
b.
When planned results are not achieved, correction and corrective action are
taken, as appropriate.
Monitoring and measurement data which have been collected are analyzed for
continual improvements as per Section 15.4.
15.2.4 Monitoring and measurement of product
Product characteristics are monitored and measured in order to verify that
requirements have been met.
Products are monitored and measured at the following stages:
a.
b.
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The release of product and delivery of service to the customer does not proceed
until the planned arrangements for the product have been satisfactorily
completed, unless otherwise approved by a relevant authority and, where
applicable, by the customer.
The following records that indicate evidence of conformity with the acceptance
criteria and person(s) authorizing release of product are maintained:
a.
15.3
b.
c.
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Analysis of data
Types of data for monitoring and measurement activities are maintained in the
Data Analysis Register.
These data are analyzed by the Quality Management System Committee at
specified intervals.
The analysis of data is conducted to demonstrate the suitability and
effectiveness of the quality management system and evaluate where continual
improvement of the effectiveness of the quality management system can be
made. These data include data generated as a result of monitoring and
measurement and from other relevant sources, as applicable.
The analysis of data provides information relating to
a.
customer satisfaction,
b.
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d.
15.5
suppliers.
Improvement
b.
c.
d.
e.
f.
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b.
c.
d.
e.