Standard : ISO 9001: 2008

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1.

SCOPE

1.1. General
This Quality Manual applies to all products and process at the companies that affect the quality of goods
provided to our customers. Carlisle India has an office at Olympia Tech Park, warehouse and Manufacturing facility
at senkadu, sriperumbudur.This warehouse facility is utilized for raw material storage, finished goods storage and
shipping parts to customer.
This Quality Manual specifies requirements for a Quality management system;
a)

Need to demonstrate the ability to consistently provide product that meets customer and applicable

b)

regulatory requirements
aim to enhance customer satisfaction through the effective application of the system, including processes
for continual improvement of the system

Note: In this Quality Manual, the term product applies only to the
a) product intended for, or required by , a customer.
b) any intended output resulting from the product realization processes.
It is intended that all requirements of this Quality Manual be applied. However, certain requirements may be
excluded in particular sections (see 1.2)

1.2 Application
All the requirements in this quality manual are generic and are intended to be applicable to the

Standard : ISO 9001: 2008

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organization, regardless of type, size and product provided.
Where any requirement(s) of this quality manual cannot be applied due to the nature of an organization and
its product, exclusion may be considered.
Where exclusions are made, claims of conformity of this Quality Manual are not acceptable unless these
exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability ,
or responsibility , to provide product that meets customer and applicable statutory and regulatory requirements.

2.

Normative References
The following referenced documents are indispensable for the application of this document. For dated

references, only the edition citied applies. For undated references, the latest edition of the referenced document

Standard : ISO 9001: 2008

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(including any amendments) applies
ISO 9000:2005, Quality Management Systems Fundamentals and vocabulary
This quality system is compliance with the guidelines of ISO 9001:2008, Quality Management Systems
requirements. The Quality system is defined in this Quality Manual. The detailed policies and procedures that
comprise the Quality System are found in the documents referenced at the end of each section of this manual.
References:
ISO 9000:2005 Quality Management Systems Fundamentals and vocabulary
ISO 9000:2005 Quality Management Systems Requirements

3.

Terms and Definitions

For the purpose of this document, the terms and definitions given in ISO 9000:2005 apply.
The following terms used in this Quality Manual to describe the supply chain are as follows;

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Supplier

Organization

Customer

The term organization is used to mean the company to which this Quality Manual applies. The term
supplier is used to describe sub-contractor.
References:
ISO 9000:2005 Quality Management System Fundamentals and Vocabulary

4.

Quality Management System

4.1 General Requirements

CBF has established documented, implemented and maintained a quality management system and
continually improves its effectiveness in accordance with the requirements of this Quality Manual.

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The organization has;

a) identified the processes needed for the QMS and their application throughout the organization
(see 1.2),
CBF identified the process, associated procedures and work instructions help to
implement the system.
b) determined the sequence and interaction of these processes,
Sequence and interaction of these processes are determined in Annexure - I.
c)

determined the criteria and methods needed to ensure that both the operation and control of these
processes are effective,
Criteria and methods are defined in the respective Quality systems procedures and other
documents viz., Control plan, Standard Operating procedure , Inspection Standard , Final
inspection etc.

d) Ensure the availability of resources and information necessary to support the operation and
monitoring of these processes,
Requirements for resources are reviewed and the necessary resources are provided by the
management. The need of resources is discussed in Management review meeting / any
other meetings based on the orders, production schedules and customer demand.
Outsourced processes are controlled as per the established procedure Supplier
Identification, Evaluation, selection and re-evaluation (QSP-XXXX)
e)

monitor, measure where applicable , and analyze these processes , and

Companywide data is collected and analyzed and the information is reviewed and
evaluated by the management for continuing effectiveness.
Monitoring and measurement of the product is carried out as per the procedure for
monitoring and measurement of products (QSP XXXX)

f)

implement the actions necessary to achieve planned results and continual improvement of those
processes,
Identified problems may be inputs to the corrective / preventive action process thereby
promoting continual improvement.

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4.2 Documentation Requirements

4.2.1.
General
The Quality management system documents includes
a) documented statements of a quality policy and quality objectives,
The Quality policy is defined in the section 5.3 and the quality objectives statements are
documented in section 5.4.1 of this manual.
b) a quality manual,
Documented Quality manual developed in accordance with ISO 9001:2008
c) documented procedures and records required by this quality manual ,
CBF has prepared documented procedures consistent with the requirements of ISO 9001:2008
d) documents , including records , determined by the organization to be necessary to ensure the
effective planning , operation and control of its processes ,
CBF has developed and documented for effective planning, operation and controls
(Eg.Production order, Control plan, SOP and Inspection plan)
e) records required by this quality manual ,
Records maintained as per the procedure of Control of Records (QSP_XXXX)
Note 1 : Where the term documented procedure appears within this manual , this means that the
procedure is established , documented, implemented and maintained. A single document may address
the requirements for one or more procedures. A requirement for the documented procedure may be
covered by more than one document.
Note 2 : The extent of the quality management system documentation can differ from one company to
another due to
a) the size of company and type of activities,
b) the complexity of processes and their interactions , and
c) the competence of personnel
Note 3 : The documentation can be in any form or type of medium.
4.2.2.

Quality Manual
The organization has established and maintains this quality manual that includes
a) the scope of the quality management system , including details of and justification for any exclusions
(see 1.2)
CBF has established and maintain a Quality Manual which includes
1. Scope of QMS ( see 1.1)
2. Quality Policy and objectives
3. Organization structure
4. Exclusions of clauses and justification
b) the documented procedures established for the quality management system, or reference to them, and
CBF has established, documented, implemented and maintained a procedure which is applicable to
the processes that carried out within this company.
c) a description of the interaction between the processes of the quality management system.
CBF has identified the process and their interactions between the processes( see Annexure I)

Standard : ISO 9001: 2008

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References:

4.2.3.

Control of documents
Documents required by the quality management system are controlled. Records are a special type of
document and are controlled according to the requirements given in 4.2.4
A documented procedure has been established to define the controls needed
a) to approve documents for adequacy prior to use,
All the documents are reviewed and signed before releasing.
b) to review and update as necessary and re-approve documents,
Document change request form initiates proposed changes and its retain by document control.
Document control carried out as per the procedure QSP XXXXX
c) to ensure that changes and current revision status of documents are identified,
Revision status is identified on the document, and a master list of documents is maintained
d) to ensure that relevant versions of applicable documents are available at the point of use ,
CBF has established documented procedure for control of documents ( QSP _XXX)
e) to ensure that documents remain legible and readily identifiable
Control of documents procedure established (QSP _XXX)
f) to ensure that documents of external origin are identified and their distribution controlled
Documents of external origin are identified , controlled, and list of these documents are
maintained.
g) to prevent the unintended use of obsolete documents ,and to apply identification to them if they
are they retained for any purpose
Control of documents procedure established (QSP _XXX)

References :

4.2.4.

Control of documents
Records are established and maintained to provide evidence of conformity to requirements and of the
effective operation of the quality management system.Records remains legible, readily identifiable
and retrievable.A documented procedure has been established to define the controls needed for the
identification, storage , protection, retrieval, retention and disposition of records
References:

5.

Management Responsibility
5.1 Management Commitment
CBF provides evidence of its commitment to the development and implementation of the QMS and continually
improving its effectiveness by

Standard : ISO 9001: 2008

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a) Communicating to the organization the importance of meeting customer as well as statutory and regulatory
requirements,
CBF communicates through a variety of methods, including company newsletter, employee meetings,
Management review meeting, Annual Sales meeting and posting performance charts.
b) Establishing the quality policy
The Quality Policy has been developed by the team and its documented in this manual and displayed
throughout the facilities.
c) ensuring the quality objectives are established ,
Quality objectives have been developed and documented in the Strategic Quality plan.
d) Conducting management reviews ,
Quarterly MRM are conducted at CBF, unscheduled meetings are conducted when necessary.
e) Ensuring the availability of resource s,
Management ensures required resources and provides the same.
5.2 Customer focus
CBF ensures that customer requirements are determined and are met with the aim of enhancing customer
satisfaction (see 7.2.1 and 8.2.1)
Customer requirements are reviewed in the contract review process and documented. Customer satisfaction is
monitored through Customer satisfaction survey once in a year.
5.3 Quality Policy
CBF has defined and documented its policy for quality, including objectives and its commitment to quality

CBF ensures that the quality policy

a) is appropriate to the purpose of the organization
b) includes a commitment to comply with requirements and continually improve the effectiveness of the
quality management system
See the Quality Policy and the management commitment
c) provides the framework for establishing and reviewing quality policies
the framework for establishing quality objectives is defined in company strategic quality plan and reviwed
in MRM
d) is communicated and understood within the organization ,
Quality policy is posted at conspicuous locations throughout the company. The Quality policy is printed
and communicated to the employee
e) is reviewed for continuing suitability
Quality policy and objectives are reviewed in MRM for suitability.
5.4 Planning
CBF has ensured that quality objectives , including those needed to meet the requirements for product (see
7.1 a), are established at the relevant functions and levels within the organization. The quality objectives
are measurable and consistent with the quality policy.

Standard : ISO 9001: 2008

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Quality objectives are established at all the relevant functions and levels as defined in the strategic
Quality plan.
Refreneces :
5.4.2 Quality Management system Planning
CBF ensures that :
a) the planning of the QMS is carriedout in order to meet the requirements given in 4.1, as well as the
quality objectives,
Quality Management system planning carried out as per this manual.
b) The integrity of quality management system is maintained when changes to the quality management
system are planned and implemented,
Any changes in this manual will be carried out as per the procedure for control of documents(QSPXXX)
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
CBF ensures that responsibilities and authorities are defined and communicated within the organization. CBF has
defined and documented the responsibility , authority , and the interrelation of all employees who manage, perform ,
and verify work affecting quality in this manual and the procedure and work instructions that support the quality
system.Refer
Annexure I - organization chart
Annexure II process responsibility matrix
Annexure III responsibilities and authority
Refrences :
5.5.2 Management Representative
CBF has appointed a member(s) of the organizations management who, irrespective of other
responsibilities , have responsibility and authority that includes,
a) Ensuring that processes needed for the quality management system are established , implemented and
maintained ,
The implementation and maintenance of necessary processes is ensured by performing intenal audits.
b) Reporting to top management on the performance of the quality management system and any need for
improvement ,
Performance of QMS is reported at Management review meetings and documentd
c) Ensuring the promotion of awareness of customer reuirments throughout the organization,
The company display process performance level charts and communicate performance at employee
meetings conducted by management.
Note : The responsibility of a management representative can include liaison with external parties on
matters relating to the quality management system
Refrences :
5.5.3 Internal Communication
CBF ensures that appropriate communication process are established within the organization and that
communication takes place regarding the effectiveness of the QMS.
Examples of internal communication may include
a) Team briefing / meeting
b) Performance Indicators
c) In-house News letter
d) Manufacturing / scheduling meetings
e) Employee meetings conducted by the management
f) Management reviews
g) Monthly / annual sales meetings

Standard : ISO 9001: 2008

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Refreneces :
5.6 Management Review
5.6.1 General
CBF reviews the organizations QMS ,at planned interval of once in 3 months to ensure its continuing
suitability ,adequacy, and effectiveness. This review includes assessing opportunities for improvement and
the need for changes to the QMS , including the quality policy and quality objectives
Records from management reviews are maintained as per procedure for Minutes of management review
meetings ( QSP _XXXX)
Referenes
5.6.2 Review input
The input to management review includes information on
a) Results of audits
The results from internal, customer, and third party audits are presented at management review
meetings
b) Customer feedback
Customer satisfaction report, which include customer complaint and customer surveys, are presented
at management reviews
c) Process performance and product conformance
Performance indicators for each process presented at management reviews
d) Status of preventive and corrective action
Preventive and corrective actions are reviewed in management review meeting for implementation,
follow up, and final closure
e) Follow up actions from previous management reviews
Action items from previous management reviews are reviewed for completion, effectiveness and / or
additional actions required
f) Changes that could affect the quality management system,
Sources of information that could affect the QMS are internal audits, document review and agenda
items to management review
g) Recommendations for improvement
Interested party, customer, supplier recommendations and suggestions by employees may be
considered and reviewed for appropriate action and implemented through the corrective / preventive
action process.
References:
5.6.3 Review output
The output from the management review includes any decisions and actions related to
a) Improvement of the effectiveness of the quality management system and its processes,
b) Improvement of product related to customer requirements
c) Resource needs
The outputs includes any decisions and action items related to corrective /preventive actions,
resources needed to implement evaluated actions, customer communications and / or revised
manufacturing processes , and other opportunities for improvement
References:
6.0 Resource Management
6.1 Provision of resorces
The organization has determined and provided the resources needed

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a)

to implement and maintain the quality management system and continually improve its
effectiveness,
The QMS is maintained and continually improved through internal quality audits, Corrective /
preventive action, customer requests and Management reviews.
b) To enhance customer satisfaction by meeting customer requirements
Customer satisfaction parameters are analyzed so that appropriate resources can be provided to
satisfy the customer needs.
References

Records

6.2 Human resources

6.2.1 General
Personnel performing work affecting conformity to product requirements are competent on the basis of
appropriate education, training, skills and experience.
Employee competence is documented in employee training records and personal files
Refereneces
6.2.2
Competence, training and awareness
CBF has
a) Determine the necessary competence for personnel performing work affecting conformity to
product requirements,
The required skills are defined in job descriptions, employee training record, and skill matrix
b) Provide training or take actions to achieve the necessary competence ,
Training needs identification done against the competence of personnel and training provided to
enhance the employee skill
c) Evaluated the effectiveness of the actions taken,
Training effectiveness is evaluated through end of training test
d) Ensure that its personnel are aware of the relevance and importance of their activities and how
they contribute to the achievement of the quality objectives,
Departmental objectives that relate directly to the company objectives are communicated to
employee through employee meeting, performance charts and management reviews
e) Maintain appropriate records of education, training, skills and experience (see 4.2.4)
Training records are maintained per applicable procedure and work instructions
References

6.3 Infrastructure
CBF determine, provide and maintain the infrastructure needed to achieve conformity to product
requirements. Infrastructure includes, as applicable
a) Buildings , workspace and associated utilities
Facilities and utilities are maintained to ensure that they continue to meet the operational
needs. The maintenance program considers the type and frequency of maintenance depends
upon the criticality and usage
b) Process equipment ( both hardware and software)
Hardware is evaluated at periodically for its performance and necessary revisions to software
are installed in timely manner.
c)

Supporting devices (such as transport, communication and information systems)

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Outside experts services are contracted whenever internal resources are limited or inadequate.
Refrences
6.4 Work Environment
The organization has determined and managed the work environment needed to achieve
conformity to product requirements

6.
7.

Safety rules and regulations are defined in work instructions. The term work environment relates
to conditions under which work is performed including physical, environmental and other factors
(such as noise, temperature, humidity, lighting, or weather)ss
Product Realization
Product Realization
7.1. Planning of product realization
The organization plan and develop the processes needed for product

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