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QUALITY MANUAL Date: 27-04-2009

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QUALITY MANUAL

Date of
Rev № Description of Revision Originator Approved
Revision

Aydin Farid
0 27-04-09 Initial release
Hajiverdiyev Madatli
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REVISION HISTORY
Rev. № Description of Change Author Effective Date
Aydin
0 Initial release 27-09-2009
Hajiverdiyev
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TABLE OF CONTENTS

1. General.....................................................................................................................................................................5
1.1 PURPOSE AND SCOPE...................................................................................................................................5
1.2 APPLICATION..................................................................................................................................................5
2. NORMATIVE REFERENCE................................................................................................................................5
3 TERMS AND DEFINITIONS.................................................................................................................................6
4 QUALITY MANAGEMENT SYSTEM..................................................................................................................6
4.1. GENERAL REQUIREMENTS.......................................................................................................................6
4.2. DOCUMENTATION REQUREMENTS.......................................................................................................7
4.2.1. GENERAL...........................................................................................................................................7
4.2.2. QUALITY MANUAL..........................................................................................................................7
4.2.3. CONTROL OF DOCUMENTS..........................................................................................................7
4.2.4. CONTROL OF RECORDS.................................................................................................................8
5 MANAGEMENT RESPONSIBILITY..............................................................................................................8
5.1. MANAGEMENT COMMITMENT................................................................................................................8
5.2 CUSTOMER FOCUS.................................................................................................................................8
5.3 QUALITY POLICY....................................................................................................................................8
5.4 PLANNING..................................................................................................................................................9
5.4.1 QUALITY OBJECTIVES...........................................................................................................................9
5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING................................................................................9
5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION.........................................................10
5.5.1 RESPONSIBILITY AND AUTHORITY.................................................................................................10
5.5.2 MANAGEMENT REPRESENTATIVE.....................................................................................................11
5.5.3 INTERNAL COMMUNICATION.............................................................................................................11
5.6 MANAGEMENT REVIEW.............................................................................................................................11
5.6.1 GENERAL..............................................................................................................................................11
5.6.2 REVIEW INPUT....................................................................................................................................12
5.6.3 REVIEW OUTPUT.................................................................................................................................12
6 RESOURCE MANAGEMENT................................................................................................................................12
6.1 PROVISION OF RESOURCES........................................................................................................................12
6.2 HUMAN RESOURCES..............................................................................................................................12
6.2.1 GENERAL..............................................................................................................................................12
6.2.2 COMPETENCE, AWARENESS AND TRAINING................................................................................12
6.3 INFRASTRUCTURE.................................................................................................................................13
6.4 WORK ENVIRONMENT..........................................................................................................................13
7 SERVICE REALIZATION.......................................................................................................................................13
7.1 PLANNING OF SERVICE REALIZATION.................................................................................................13
7.2 CUSTOMER-RELATED PROCESSES....................................................................................................14
7.2.1 DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT AND SERVICE...............14
7.2.2 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT AND SERVICE..........................14
7.2.3 CUSTOMER COMMUNICATION.........................................................................................................14
7.3 DESIGN AND DEVELOPMENT..................................................................................................................15
7.3.1 DESIGN AND DEVELOPMENT PLANNING......................................................................................15
7.3.2 DESIGN AND DEVELOPMENT INPUTS............................................................................................15
7.3.3 DESIGN AND DEVELOPMENT OUTPUTS.........................................................................................15
7.3.4 DESIGN AND DEVELOPMENT REVIEW...........................................................................................16
7.3.5 DESIGN AND DEVELOPMENT VERIFICATION..............................................................................16
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7.3.6 DESIGN AND DEVELOPMENT VALIDATION..................................................................................16


7.3.7 CONTROL OF DESIGN AND DEVELOPMENT CHANGES.............................................................16
7.4 PURCHASING.................................................................................................................................................17
7.4.1 PURCHASING PROCESS.......................................................................................................................17
7.4.2 PURCHASING INFORMATION............................................................................................................17
7.4.3. VERIFICATION OF PURCHASED PRODUCT..................................................................................17
7.5 PRODUCTION AND SERVICE PROVISION............................................................................................17
7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION.....................................................17
7.5.2 VALIDATION OF PROCESSES FOR SERVICE PROVISION...................................................18
7.5.3 IDENTIFICATION AND TRACEABILITY...................................................................................18
7.5.4 CUSTOMER PROPERTY........................................................................................................................18
7.5.5 PRESERVATION OF PRODUCT AND SERVICE.......................................................................18
7.6 CONTROL OF MONITORING AND MEASURING DEVICES..............................................................18
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT...................................................................................19
8.1 GENREAL........................................................................................................................................................19
8.2 MONITORING AND MEASUREMENT.....................................................................................................19
8.2.1 CUSTOMER SATISFACTION........................................................................................................19
8.2.2 INTERNAL AUDIT..........................................................................................................................20
8.2.3 MONITORING AND MEASUREMENT OF PROCESSES..........................................................20
8.2.4 MONITORING AND MEASUREMENT OF SERVICE...............................................................20
8.3 CONTROL OF NONCONFORMING PRODUCT OR SERVICE............................................................21
8.4 ANALYSIS OF DATA.....................................................................................................................................21
8.5 IMPROVEMENT............................................................................................................................................22
8.5.1 CONTINUAL IMPROVEMENT.....................................................................................................22
8.5.2 CORRECTIVE ACTION..................................................................................................................22
8.5.3 PREVENTIVE ACTION.................................................................................................................22
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1. GENERAL

1.1 PURPOSE AND SCOPE

This Quality Manual documents our quality system to demonstrate «Rovshan


Oguz Group» LLC's ability to consistently provide product that meet customer
and regulatory requirements and establishes compliance with ISO 9001: 2008.

1.2 APPLICATION

Where any requirement of ISO 9001: 2008 can not be applied due to the nature of
our organisation and its activities, they will be considered for exclusion.

Any exclusion taken is documented in this section of the Quality Manual. The
excluded requirements are precisely identified with reference to specific clauses
and/or statements in the standard. There is also a brief justification why the
exclusion is taken and why it is appropriate.

2. NORMATIVE REFERENCE

This quality manual defines the policies and principles applied against requirements of
ISO 9001: 2008 and relates to all activities carried out in the organisation that determine
quality, and lays down guidelines within which the organisation can operate.

Uncontrolled Manuals

Uncontrolled manuals are up-to-date at issue and are only issued to outside organisations,
customers, etc.
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3 TERMS AND DEFINITIONS

Our Quality Management System uses the same internationally recognized terms,
vocabulary and definitions given in ISO 9001:2008.

Additional definitions apply for items not covered by the documents:

ORGANISATION “ROVSHAN OGUZ GROUP” LLC

SUPPLIER means the party to whom an order has been placed by the
organisation for the purchase of supplies, or the execution
of a specific part of a particular order.

CUSTOMER means firm or person having a contractual agreement with,


or the recipient of a service from the organisation.

SERVICE means the result of a process, which is the combination of


some of the four generic product categories, hardware,
software, services and processed materials.

SITE any location, other than the “Rovshan Oguz Group” LLC’s
established premises, where work is undertaken as part of a
formal contract

4 QUALITY MANAGEMENT SYSTEM

4.1. GENERAL REQUIREMENTS

«Rovshan Oguz Group» LLC has established, documented, implemented and maintains a
Quality Management System in accordance with the requirements of ISO 9001:2008.

«Rovshan Oguz Group» LLC continually improves the effectiveness of its QMS.

«Rovshan Oguz Group» LLC's Quality Management System:


- identifies the processes needed for its operations and their application throughout the
organisation
- determines the sequence and interaction of these primary processes
- determines criteria and methods needed to ensure that both the operation and
management of these processes are effective
- ensures the availability of resources and information necessary to support the operation
and monitoring of these processes
- ensures monitoring, measurement and analyses of these processes and
- ensures implementation of actions necessary to achieve planned results and continual
improvement of these processes.
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«Rovshan Oguz Group» LLC manages these processes in accordance with the
requirements of ISO 9001: 2008.

4.2. DOCUMENTATION REQUREMENTS


4.2.1. GENERAL
The quality management system documentation includes:
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures required by the ISO 9001 International
Standard,
d) documents needed by the organisation to ensure the effective
planning, operation and control of its processes, and
e) records required by the ISO 9001 International Standard.

4.2.2. QUALITY MANUAL


The organisation establishes and maintains a quality manual that includes:
a) the scope of the quality management system, including details
of and justification for any exclusions,
b) the documented procedures established for the quality
management system, or reference to them, and
c) a description of interaction between the processes of the quality
management system.

4.2.3. CONTROL OF DOCUMENTS


Documents required by the quality management system are controlled.
Records required by the quality management system are controlled
according to the requirements given in 4.2.4.

A documented procedure is established to define the controls needed:


a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of
documents are identified,
d) to ensure the relevant versions of applicable documents are
available at points of use,
e) to ensure that documents remain legible and readily
identifiable,
f) to ensure that documents of external origin are identified and
their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to
apply suitable identification to them if they are retained for any
purpose.
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4.2.4. CONTROL OF RECORDS


Records are established and maintained to provide evidence of conformity
to requirements and or the effective operation of the quality management
system. Records remain legible, readily identifiable and retrievable. A
documented procedure is established to define the controls needed for the
identification, storage, protection, retrieval, retention time and disposition
of records.

5 MANAGEMENT RESPONSIBILITY
5.1. MANAGEMENT COMMITMENT
Top management is committed to the development and implementation of the
quality management system and continually improves its effectiveness by:
a) communication to the organisation the importance of meeting customer
as well as statutory and regulatory requirements,
b) establishing a quality policy,
c) establishing quality objectives,
d) conducting management reviews, and
e) ensuring the availability of resources.

5.2 CUSTOMER FOCUS


Top management ensures that customer requirements are determined and are met
with the aim of enhancing customer satisfaction, (see 7.2.1 and 8.2.1)

5.3 QUALITY POLICY

Top management ensures that the quality policy:


a) is appropriate to the purpose of the quality policy,
b) includes a commitment to comply with requirements and continually
improve the effectiveness of the quality management system,
c) provides a framework for establishing and reviewing quality objectives,
d) is communicated and understood within the organisation, and
e) is reviewed for continuing suitability.

See attached quality policy for reference.


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5.4 PLANNING
5.4.1 QUALITY OBJECTIVES
Top management have ensured that quality objectives needed to meet
requirements for the service which are measurable and consistent with the
quality policy including the commitment to continual improvement have
been established and maintained at relevant functions and levels within the
organisation.

The quality management system is described in a series of procedures and


specifies the management objectives, policies and organisations that have
been developed to ensure compliance with ISO 9001:2008. When any
inconsistency exists between the requirements of a particular customer
specified in a contract/order and those called for in the above standard, the
higher standard will prevail.

The quality manual provides a general outline of the quality management


system with respect to the requirements of ISO 9001:2008. Detailed
responsibilities of management and organisation have been set out in this
manual. This manual is controlled and the current version is always
available for reference to all employees.

The quality system is detailed and targeted to achieve organisation quality


policy and objectives documented in this manual. The quality system is
maintained to provide assurance to our customers that the organisation has
the ability and resources to give constant service to a defined standard of
quality.

See attached quality objectives for reference.

5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING


Top management ensures that:
a) the planning of the quality management system is carried out in
order to meet the requirements given in 4.1, as well as the quality
objectives, and
b) the integrity of the quality management system is maintained when
changes to the quality management system are planned and implemented.
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5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION


5.5.1 RESPONSIBILITY AND AUTHORITY
The responsibilities, authority and the interrelation of all personnel who
manage, perform and verify work affecting quality are defined and
communicated in order to facilitate effective quality management

All people have been given authorities and responsibilities to enable them
to assist in the achievement of the quality objectives. This assignment of
authority and responsibility helps to establish involvement and
commitment of people throughout the organisation.

The responsibility of personnel is given. An individual may be appointed


with a dual role, in such cases he/she will be responsible for fulfilling the
tasks assigned to both roles.

Full written job descriptions are issue to all personnel and a full set of
same maintained with the training records.

DIRECTOR

The Director is responsible to «Rovshan Oguz Group» LLC for identifying


and providing all the necessary resources to meet the requirements of the
quality system and the organisations customers. These resources include
trained personnel for the management and performance of work, including
system audits and verification activities.

The Director has responsibility for the overall performance and operation
of the organisation, developing the strategy in the medium and. His duties
include the future direction of the organisation, maintaining customer,
supplier and interested party liaison as required.

Regular meetings are held either individually or collectively to brief staff


on performance, customer requirements, any recurring problems and
obtaining feedback as necessary.

Is responsible for ensuring the organisation performance can adequately


measured to meet the requirements of its customers and has nominated a
Quality Representative with the authority and responsibility for ensuring
that the requirements of the latest issue of ISO 9001: 2008 are
implemented and maintained by internal quality audits.
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OTHER STAFF
The organisation chart reference and associated responsibilities are
available on request.

ORGANISATION CHART
See attached chart for reference.

5.5.2 MANAGEMENT REPRESENTATIVE

The Director has appointed a management representative who, irrespective of


other responsibilities, has the responsibility and authority that includes
a) ensuring that processes needed for the quality management
system are established, implemented and maintained,
b) reporting to top management on the performance of the quality
management system and any need for improvement, and
c) ensuring the promotion of awareness of customer requirements
throughout the organisation.

5.5.3 INTERNAL COMMUNICATION


Top management have defined and implemented processes for the
communication of quality requirements, objectives and accomplishments.
The providing of this information becomes a resource for improvement and
the involvement of people in achieving quality objectives including one to
one, and team briefings, in-house memos, information on notice boards,
audio-visual and electronic media as necessary.

5.6 MANAGEMENT REVIEW

5.6.1 GENERAL
Top management reviews the organisation's quality management system, at
intervals of at least once a year to ensure its continuing suitability, adequacy
and effectiveness. The review includes assessing opportunities for
improvement and the need for changes to the quality management system,
including the quality policy and quality objectives. Records from management
reviews are maintained (see 4.2.4).
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5.6.2 REVIEW INPUT


The input to management review includes information on:
a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and
g) recommendations for improvement.

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 service related to customer requirements, and
c) resource needs.

6 RESOURCE MANAGEMENT

6.1 PROVISION OF RESOURCES


The organisation determines and provides the resources needed
a) to implement and maintain the quality management system and
continually improve its effectiveness, and
b) to enhance customer satisfaction by meeting customer requirements

6.2 HUMAN RESOURCES

6.2.1 GENERAL
Personnel performing work affecting product quality are competent on the
basis of appropriate education, training, skills and experience.

6.2.2 COMPETENCE, AWARENESS AND TRAINING


It is policy to identify and determine competency needs for personnel
performing activities affecting quality, provide training to satisfy those needs,
and evaluate the effectiveness of the training provided.
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A procedure exists for the induction of new employees in mandatory and


quality system elements and for the training needs of existing staff in order to
achieve its objectives.

Employees are given job descriptions and made aware of the relevance and
importance of their activities and how they contribute to the achievement of
quality objectives,

Records are maintained of education, training and experience.

6.3 INFRASTRUCTURE
The Director has determined, provided and arranged maintenance for the infrastructure
needed to achieve the conformity of the service requirements, including buildings,
workspace and associated facilities, process equipment, computer hardware and
software, communication media, transport and supporting services.

A maintenance programme specifies the type and frequency of needed maintenance,


the methods for maintenance and the verification of its completion.

6.4 WORK ENVIRONMENT

It is ensured that the working environment in offices and site areas is suitable at
all times to achieve conformity to service requirements.

7 SERVICE REALIZATION
7.1 PLANNING OF SERVICE REALIZATION

Planning of service realisation is the sequence of processes and sub-processes


required to achieve the required end service. Planning of the realisation processes is
consistent with the other requirements of the organisation’s quality management
system. Documentation has been put in place to support and manage the processes
including:

a) Quality objectives and requirements for the service


b) Activities within the processes, including documents and the provision of
resources
c) Required verification, validation, monitoring, inspection and test activities
specific to the service and the criteria for acceptance of the service
d) Records are to provide evidence that the realisation processes and resulting
service meets requirements.
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7.2 CUSTOMER-RELATED PROCESSES

7.2.1 DETERMINATION OF REQUIREMENTS RELATED TO THE


PRODUCT AND SERVICE
Requirements, including service requirements specified by the customer, are
determined. Particular consideration is given to:
a) the extent to which customers have specified the requirements of
the service,
b) customer requirements, availability of labour, equipment and
support,
c) requirements not specified by the customer but necessary for fitness
and purpose,
d) obligations related to product, and service including statutory and
legal requirements,
e) any additional requirements determined by the organisation.

7.2.2 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT


AND SERVICE
The organisation reviews the requirements related to the service. This
review is conducted prior to the organisations commitment to supply a
service to the customer (e.g. submission of tenders, acceptance of contracts
or orders, acceptance of changes to contracts or orders) and ensures that:
a) the requirements are adequately defined, documented and planned,
b) where the customer provides no written statement of requirement,
the order requirements are confirmed verbally before acceptance

c) the requirements comply with the enquiry and any differing


requirements are satisfactorily resolved
d) the organisation has the ability to meet the defined requirements.

The results of the review and subsequent follow-up actions are recorded.
Where product or service requirements are changed, and agreed with the
customer or their representative the documentation is amended, and all
relevant personnel made aware of the changed requirements.

7.2.3 CUSTOMER COMMUNICATION


The organisation determines and implements effective arrangements for
communicating with customers in relation to:
a) service information,
b) enquiries, contracts or order handling, including amendments, and
c) customer feedback, including customer complaints.
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7.3 DESIGN AND DEVELOPMENT

7.3.1 DESIGN AND DEVELOPMENT PLANNING

The organization plans and controls the design and development of


product.
During the design and development planning, the organization determines

a) the design and development stages,


b) the review, verification and validation that are appropriate to each
design and development stage, and
c) the responsibilities and authorities for design and development.

The organization manages the interfaces between different groups


involved in design and development to ensure effective communication
and clear assignment of responsibility.
Planning output is updated, as appropriate, as the design and development
progresses.

7.3.2 DESIGN AND DEVELOPMENT INPUTS

Inputs relating to product requirements are determined and records


maintained (see 4.2.4). These inputs include

a) functional and performance requirements,


b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar
designs, and
d) other requirements essential for design and development.

These inputs are reviewed for adequacy. Requirements are complete,


unambiguous and not in conflict with each other.

7.3.3 DESIGN AND DEVELOPMENT OUTPUTS

The outputs of design and development shall be provided in a form that


enables verification against the design and development input and are
approved prior to release.
Design and development outputs

a) meet the input requirements for design and development,


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b) provide appropriate information for purchasing, production and for


service provision,
c) contain or reference product acceptance criteria, and
d) specify the characteristics of the product that are essential for its
safe and proper use.

7.3.4 DESIGN AND DEVELOPMENT REVIEW

At suitable stages, systematic reviews of design and development are


performed in accordance with planned arrangements (see 7.3.1)

a) to evaluate the ability of the results of design and development to


meet requirements, and
b) to identify any problems and propose necessary actions.

Participants in such reviews include representatives of functions


concerned with the design and development stage(s) being reviewed.
Records of the results of the reviews and any necessary actions are
maintained (see 4.2.4).

7.3.5 DESIGN AND DEVELOPMENT VERIFICATION

Verification is performed in accordance with planned arrangements (see


7.3.1) to ensure that the design and development outputs have met the
design and development input requirements. Records of the results of the
verification and any necessary actions are maintained (see 4.2.4).

7.3.6 DESIGN AND DEVELOPMENT VALIDATION

Design and development validation is performed in accordance with


planned arrangements (see 7.3.1) to ensure that the resulting product is
capable of meeting the requirements for the specified application or
intended use, where known. Wherever practicable, validation is completed
prior to the delivery or implementation of the product. Records of the
results of validation and any necessary actions are maintained (see 4.2.4).

7.3.7 CONTROL OF DESIGN AND DEVELOPMENT CHANGES

Design and development changes are identified and records maintained.


The changes are reviewed, verified and validated, as appropriate, and
approved before implementation. The review of design and development
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changes includes evaluation of the effect of the changes on constituent


parts and product already delivered.
Records of the results of the review of changes and any necessary actions
are maintained (see 4.2.4).
7.4 PURCHASING

7.4.1 PURCHASING PROCESS


The organisation ensures that purchased product conforms to specified
purchase requirements. The type and extent of control applied to the
supplier and the purchased product is dependent upon the effect of the
purchased product on subsequent product realization or the final product.
The organisation evaluates and selects suppliers based on their ability to
supply product in accordance with the organisations requirements. Criteria
for selection, evaluation and re-evaluation is established. Records of the
results of evaluations and any necessary actions arising from the
evaluation is maintained (see 4.2.4).

7.4.2 PURCHASING INFORMATION


Purchasing information describes the product to be purchased, including
where appropriate
a) requirements for approval of product, procedures, processes and
equipment,
b) requirements for qualification of personnel, and
c) quality management system requirements.

The organisation ensures the adequacy of specified purchase requirements


prior to their communication to the supplier.

7.4.3. VERIFICATION OF PURCHASED PRODUCT


The organisation establishes and implements the inspection or other
activities necessary for ensuring that purchased product meets specified
purchase requirements. Where the organisation or its customer intends to
perform verification at the supplier’s premises, the organisation states the
intended verification arrangements and method of product release in the
purchasing information.

7.5 PRODUCTION AND SERVICE PROVISION

7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION


There is no requirement for production but service provision activities are
an essential aspect of the business and are therefore included.
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Operations are controlled through:


a) The availability of information that specifies the characteristics of
the product or service
b) The provision of suitable working environments
c) The use of suitable equipment
d) Suitable methods for delivery, collection and on site activities

7.5.2 VALIDATION OF PROCESSES FOR SERVICE PROVISION

Any service process where the resulting output cannot be verified by


subsequent measuring or monitoring is validated. Validation demonstrates
the ability of the process to achieve planned results and is controlled
through:

a) review and approval of processes,


b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirements for records, and
e) revalidation

7.5.3 IDENTIFICATION AND TRACEABILITY

Where appropriate the organisation identifies the product or service by


suitable means throughout the service realisation. Where traceability is a
requirement, the organisation controls and records the identification of the
product or service.

7.5.4 CUSTOMER PROPERTY

The organisation exercises care with customer property while it is under


our control or being used by us. We identify, verify and protect, and
safeguard customer property provided for use by ourselves. The customer
is notified, and records maintained of any lost or damaged or unsuitable
customer property.

7.5.5 PRESERVATION OF PRODUCT AND SERVICE


Conformity of product and service with customer requirements is
preserved during collection, during internal processing and whilst in transit
to the intended destination. This includes identification, handling and
protection.
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7.6 CONTROL OF MONITORING AND MEASURING DEVICES

Monitoring and measurements to be made are identified and the monitoring and
measuring devices required to ensure conformity of product and service to
specified requirements.

Measuring and monitoring devices are used and controlled to ensure that
measurement capability is consistent with the monitoring and measurement
requirements.

Where applicable, measuring equipment is:


a) Calibrated and adjusted periodically or prior to use, against
measurement standards traceable to international or national
measurement standards. Where no such standards exist, the basis used
for calibration shall be recorded,
b) Adjusted or re-adjusted as necessary,
c) Be identified to enable the calibration status to be determined,
d) Be safeguarded from adjustments that would invalidate the
measurement result,
e) Protected from damage and deterioration during handling, maintenance
and storage,
f) Recorded with the results of their calibration,
g) Required to have the validity of previous results re-assessed if they are
subsequently found to be out of calibration.

When used in the monitoring and measurement of specified requirements, the


ability of computer software to satisfy the intended application is confirmed, prior
to initial use and reconfirmed as necessary.

8 MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1 GENREAL

The organisation plans and implements the monitoring, measurement, analysis


and improvement processes needed to:
a) demonstrate conformity of the product or service,
b) ensure conformity of the quality management system, and
c) continually improve the effectiveness of the quality management
system.

This includes determination of applicable methods, including statistical


techniques, and the extent of their use.
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8.2 MONITORING AND MEASUREMENT

8.2.1 CUSTOMER SATISFACTION

As one of the measurements of the performance of the quality management


system, information relating to customer perception as to whether the
organisation has met customer requirements is monitored. The methods for
obtaining and using this information are determined.

8.2.2 INTERNAL AUDIT

An internal audit system is established for performing periodic internal


audits of the quality management system and related processes. The
purpose of the internal audit is to determine whether:
a) The quality management system conforms to the requirements of
this International Standard
b) The quality management system has been effectively implemented
and maintained.

A planned audit programme has been put in place taking into consideration
the status and importance of the activities and areas to be audited as well
as the results from previous audits. The audit scope, frequency and
methodologies are defined. Audits are conducted by personnel other than
those who perform the activity being audited.

The documented procedure includes the responsibilities and requirements


for conducting audits, ensuring their independence, recording results and
reporting to management

Management ensure that timely corrective action is taken on deficiencies


found during the audit. Follow up action includes the verification of the
implementation of corrective action, and the reporting of verification
results.

8.2.3 MONITORING AND MEASUREMENT OF PROCESSES

The organisation applies suitable methods for monitoring and, where


applicable, measurement of the quality management system processes to
demonstrate the ability of the processes to achieve planned results. When
planned results are not achieved, correction and corrective action is taken,
as appropriate, to ensure conformity of the service.
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8.2.4 MONITORING AND MEASUREMENT OF SERVICE

Documented procedures have been established and maintained to monitor


and measure the characteristics of the service to verify that requirements
for the service are met. This is carried out at appropriate stages of the
service realisation process in accordance with the planned arrangements.
Evidence of conformity with the accepted criteria is maintained and
records indicate the person(s) authorising release of the service. Release
and service delivery does not proceed until the planned arrangements have
been satisfactorily completed, unless otherwise approved by a relevant
authority and, where applicable, by the customer.

8.3 CONTROL OF NONCONFORMING PRODUCT OR SERVICE

A documented procedure is in place to ensure that product and service which does
not conform to requirements is identified and controlled to prevent its unintended
use or delivery.

Non-conforming product and service is dealt with in one of the following ways:
 by taking action to eliminate the detected nonconformity,
 by authorising its use, release or acceptance under concession by a
relevant authority and, where applicable, by the customer, and
 by taking action to preclude its original use or application.

Records of the nature of nonconformities and any subsequent actions taken,


including concessions obtained, are maintained.

When non-conforming product or service is corrected it is subject to re-


verification to demonstrate conformity to the requirements

When non-conforming product or service detected after collection, delivery, or


use has started, the organisation takes action appropriate to the effects, or
potential affects, of the nonconformity.

8.4 ANALYSIS OF DATA

All data is effectively collected and analysed to determine the suitability and
effectiveness of the quality management system and to evaluate where continual
improvement of the effectiveness of the quality management system can be made.
This includes data generated as a result of monitoring and measurement and from
other relevant sources.
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Data is analysed to provide information on customer satisfaction, conformance to


customer, product or service requirements, characteristics and trends of processes,
products and services including opportunities for preventive action, and suppliers.

8.5 IMPROVEMENT

8.5.1 CONTINUAL IMPROVEMENT

The process necessary for the continual improvement of the quality


management system is planned and organised.

Continual improvement of the quality management system is facilitated


through the use of the quality policy, quality objectives, audit results,
analysis of data, corrective and preventive actions and management
review.

1.5.2 CORRECTIVE ACTION

A corrective action programme is established and maintained to eliminate


the cause of nonconformities in order to prevent recurrence. Corrective
action appropriate to the impact of the problems encountered is
appropriated carried out.

The documented procedure for corrective action defines requirements for:


a) identifying and reviewing nonconformities including customer
complaints
b) determining the causes for nonconformities
c) evaluating the need for actions to ensure that nonconformities do
no recur
d) determining and implementing the corrective action needed
e) recording results of action taken
f) reviewing of corrective action taken.

8.5.3 PREVENTIVE ACTION

Documented procedures have been established and are maintained for


implementing preventive action to eliminate the causes of potential
nonconformities in order to prevent occurrence

The documented procedure for preventive action defines requirements for:


identifying potential non-conformities and their causes, evaluating the
need for action to prevent occurrence of non-conformities, determining
and ensuring the implementation of action needed, recording results of
action taken, and reviewing preventive action taken.

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