}What
is QMS?
}Quality
means
different things to different people and in different situations,
no one
definition
can be
all-inclusive.
“The totality
of features and characteristics of a product or service that
bear on
its ability to satisfy stated or implied needs”.
}Management:
is
the use of the available resources to achieve the maximum desired results.
}System:
Is a
set of interrelated and interconnected processes and operations by which you
can convert inputs into outputs with value added.
}What
is ISO 9001
}It is
a member of ISO 9000 family
}ISO
9000: fundamentals and Vocabularies
}ISO
9001: the requirements of QMS
}ISO
9002, ISO 9003, are replaced with ISO 9001
}ISO
9004: Guidance for continual Improvement of QMS.
}Why
QMS
}Organization
need to deploy QMS When
1.The
Organization need to demonstrate its
ability for meeting the requirements of the customer.
2.To
enhance the customer satisfaction
3.ISO
9000 was born out of the need for
customers to have a common standard to control their suppliers and to reduce
multiple assessment.
}When
QMS
}The
deployment of ISO 9001 is a strategic decision taken by the top management, and
whenever management realized the need for QMS it can start the implementation.
}“Quality
management system on papers is not a quality management system”.
}Where
to implement QMS
}Quality
management system can be implemented in any kind of organizations.
}The
design and implementation of QMS depends on:
1.Needs
of the organization
2.The
main objective of the organization
3.The
products of the organization
4.The
applied processes
5.Size
and structure of the organization
}Who
implement QMS
}QMS
is implementing by each single employee
}As
you perform one process or more and since this/these process forms a piece of
the system chain, this means you are involved in QMS implementation.
}QMS
is not a separate system overrides the existing system
}How
to Implement QMS
}There
is 8 steps to implement QMS
1.Prepare
your organization
2.Gap
analysis
3.Project
plan
4.Training
5.Documentation
6.Use
and improve QMS
7.Internal
audit
8.ISO
certification
}ISO
9001 little in details
}When
you start your new organization or if you want to perform re-engineering
approach to your established organization you will start establish the OS
(organizational structure or chart)
}General
requirement on process management
}Customer
focus
}Quality
objectives
}Quality
management
system planning
}Internal
communication
}Infrastructure
}Work environment
}Determination
of
requirement relating to product
}Customer
communication
}Customer
satisfaction
}Monitoring
and
measurement of processes
}Analysis
of
data
}Continual
improvement
}ISO
9001 little in details
} Setting
goals
that serve the interested parties;
} Developing
processes
to achieve these goals;
} Operating
and
maintaining the processes as designed;
} Measuring
achievement
of the process goals;
} Improving
efficiency
by finding better ways of doing things and;
} Improving
effectiveness
by validating the goals and changing them if they
are no
longer relevant to the needs and expectations of the interested
parties.
}4
- Establishing a quality management system
}What does this mean?
}To establish
means to set up on a permanent basis,
install, or
create and therefore in establishing a
management system,
it has to be designed, constructed,
resourced,
installed and integrated into the organization signifying
that a management system
on paper
is not a management system.
}Why is this necessary?
}ISO
9001 contains a series of requirements which if met will provide the management
system with the capability of supplying products and services that satisfy the
organization’s customers.
}How is this implemented?
}The
terms ‘establish’, ‘document’, ‘implement’, ‘maintain’ and ‘improve’ are used
in the standard as though this is a sequence of activities when in reality, in
order to establish a system it has to be put in place and putting a system in
place requires two separate actions:
1.Design
the system using a process that transforms the system requirements into
specific characteristics
2.Construct
the system using a process that documents, installs, commissions and integrates
the processes to deliver the required business outputs.
}4-1
General Requirements
}The
organization shall establish, document, implement and maintain a quality
management system and continually improve its effectiveness in accordance with
the requirements of this International Standard.
The
organization shall
a)
determine the processes needed for the quality management system and their
application throughout the organization (see 1.2),
b)
determine the sequence and interaction of these processes,
c)
determine criteria and methods needed to ensure that both the operation and
control of these processes are effective,
d)
ensure the availability of resources and information necessary to support the
operation and monitoring of these processes,
e)
monitor, measure where applicable, and analyse these processes, and
f)
implement actions necessary to achieve planned results and continual
improvement of these processes.
}4-2
Documentation
4-2-1
General
The
quality management system documentation shall include
a)
documented statements of a quality policy and quality objectives,
b) a
quality manual,
c)
documented procedures and records required by this International Standard, and
d)
documents, including records, determined by the organization to be necessary to
ensure the effective planning, operation and control of its processes
4-2-2
Quality
Manual
}4-2
Documentation
4-2-3
Document
control
A
documented procedure shall be 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 that 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 determined by the organization to be
necessary for the planning and operation of the quality management system 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.
}4-2
Documentation
4-2-4
Records
Control
}Records
shall be established and maintained to provide evidence of conformity to
requirements and of the effective operation of the QMS. Records shall remain
legible, readily identifiable and retrievable.
}A
documented procedure shall be 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 shall provide evidence of its commitment to the development and
implementation of the QMS and continually improving its effectiveness by:
a)
communicating to the organization the importance of meeting customer as well as
statutory and regulatory requirements,
b)
establishing the quality policy,
c)
ensuring that quality objectives are established,
d)
conducting management reviews, and
e)
ensuring the availability of resources.
}5
Management responsibility
5-2
Customer
focus
Top
management shall ensure that customer requirements are determined and are met
with the aim of enhancing customer satisfaction
5-3
Quality policy
Top
management shall ensure 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 QMS,
c)
provides a framework for establishing and reviewing quality objectives,
d) is
communicated and understood within the organization, and
e) is
reviewed for continuing suitability.
}5
Management responsibility
5.4
Planning
5.4.1
Quality objectives
}Top
management shall ensure that quality objectives, including those needed to meet
requirements for product [see 7.1 a)], are established at relevant functions
and levels within the organization. The quality objectives shall be measurable
and consistent with the quality policy.
5.4.2
Quality management system planning
}Top
management shall ensure 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.
}5
Management responsibility
5-5
Responsibility, authority and communication
5-5-1
Responsibility
and authority
}Top
management shall ensure that responsibilities and authorities are defined and
communicated within the organization.
5-5-2
Management
representative
}Top
management shall appoint a member of management who, irrespective of other
responsibilities, shall have 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
organization.
}NOTE
The responsibility of a management representative can include liaison with
external parties on matters relating to the quality management system.
}5
Management responsibility
5.5.3
Internal communication
}Top
management shall ensure that appropriate communication processes are
established within the organization and that communication takes place
regarding the effectiveness of the quality management system.
5.6
Management review
5.6.1
General
}Top
management shall review the organization's quality management system, at
planned intervals, to ensure its continuing suitability, adequacy and
effectiveness. This review shall include 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 shall be maintained (see 4.2.4).
}5
Management responsibility
5.6.2
Review input
}The
input to management review shall include 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 shall include 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, and
c)
resource needs.
}6
- Resource management
6-1
Provision of resources
}The
organization shall determine and provide 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 shall be competent on the basis of
appropriate education, training, skills and experience.
6-2-2
Competence, awareness and training
}The
organization shall
a)
determine the necessary competence for personnel performing work affecting
product quality,
}6
- Resource management
b)
provide training or take other actions to satisfy these needs,
c)
evaluate the effectiveness of the actions taken,
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, and
e)
maintain appropriate records of education, training, skills and experience (see
4.2.4).
6-3
Infrastructure
}The
organization shall determine, provide and maintain the infrastructure needed to
achieve conformity to product requirements. Infrastructure includes, as
applicable
}a)
buildings, workspace and associated utilities,
}b)
process equipment (both hardware and software), and
}c)
supporting services (such as transport or communication).
6.4
Work environment
}The
organization shall determine and manage the work environment needed to achieve
conformity to product requirements.
}7-
Product realization
7-1
Planning of product realization
}The
organization shall plan and develop the processes needed for product
realization. Planning of product realization shall be consistent with the
requirements of the other processes of the quality management system (see 4.1).
}In
planning product realization, the organization shall determine the following,
as appropriate:
a)
quality objectives and requirements for the product;
b)
the need to establish processes, documents, and provide resources specific to
the product;
c)
required verification, validation, monitoring, inspection and test activities
specific to the product and the criteria for product acceptance;
d)
records needed to provide evidence that the realization processes and resulting
product meet requirements (see 4.2.4).
}The
output of this planning shall be in a form suitable for the organization's
method of operations.
}7-
Product realization
7.2
Customer-related processes
7.2.1
Determination of requirements related to the product
}The
organization shall determine
a)
requirements specified by the customer, including the requirements for delivery
and post-delivery activities,
b)
requirements not stated by the customer but necessary for specified or intended
use, where known,
c)
statutory and regulatory requirements related to the product, and
d)
any additional requirements determined by the organization.
7.2.2
Review of requirements related to the product
}The
organization shall review the requirements related to the product. This review
shall be conducted prior to the
}organization's
commitment to supply a product to the customer (e.g. submission of tenders,
acceptance of contracts or orders, acceptance of changes to contracts or
orders) and shall ensure that
a)
product requirements are defined,
}7-
Product realization
b)
contract or order requirements differing from those previously expressed are
resolved, and
c)
the organization has the ability to meet the defined requirements.
}Records
of the results of the review and actions arising from the review shall be
maintained (see 4.2.4).
}Where
the customer provides no documented statement of requirement, the customer
requirements shall be confirmed by the organization before acceptance.
}Where
product requirements are changed, the organization shall ensure that relevant
documents are amended and that relevant personnel are made aware of the changed
requirements.
}NOTE
In some situations, such as internet sales, a formal review is impractical for
each order. Instead the review can cover relevant product information such as
catalogues or advertising material.
}7-
Product realization
7.2.3
Customer communication
}The
organization shall determine and implement effective arrangements for
communicating with customers in
}relation
to
a)
product information,
b)
enquiries, contracts or order handling, including amendments, and
c)
customer feedback, including customer complaints.
}7-
Product realization
7-3
Design and development
7.3.1
Design and development planning
}The
organization shall plan and control the design and development of product.
}During
the design and development planning, the organization shall determine
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 shall manage the interfaces between different groups involved in
design and development to ensure effective communication and clear assignment
of responsibility.
}Planning
output shall be updated, as appropriate, as the design and development
progresses.
}7-
Product realization
7.3.2
Design and development inputs
}Inputs
relating to product requirements shall be determined and records maintained
(see 4.2.4). These inputs shall 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 shall be reviewed for adequacy. Requirements shall be 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 shall be approved
prior to release.
}7-
Product realization
}Design
and development outputs shall
a)
meet the input requirements for design and development,
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 shall be
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 shall 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 shall be maintained (see 4.2.4).
}7-
Product realization
7.3.5
Design and development verification
Verification
shall be 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 shall be maintained (see 4.2.4).
7.3.6
Design and development validation
Design
and development validation shall be 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 shall be completed prior to the
delivery or implementation of the product. Records of the results of validation
and any necessary actions shall be maintained (see 4.2.4).
7.3.7
Control of design and development changes
Design
and development changes shall be identified and records maintained. The changes
shall be reviewed, verified and validated, as appropriate, and approved before
implementation. The review of design and development changes shall include
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 shall be
maintained (see 4.
}7-
Product realization
7.4
Purchasing
7.4.1
Purchasing process
The
organization shall ensure that purchased product conforms to specified purchase
requirements. The type and extent of control applied to the supplier and the
purchased product shall be dependent upon the effect of the purchased product
on subsequent product realization or the final product.
The
organization shall evaluate and select suppliers based on their ability to
supply product in accordance with the organization's requirements. Criteria for
selection, evaluation and re-evaluation shall be established. Records of the
results of evaluations and any necessary actions arising from the evaluation
shall be maintained (see 4.2.4).
7.4.2
Purchasing information
Purchasing
information shall describe the product to be purchased, including where
appropriate
a)
requirements for approval of product, procedures, processes and equipment,
}7-
Product realization
b)
requirements for qualification of personnel, and
c)
quality management system requirements.
}The
organization shall ensure the adequacy of specified purchase requirements prior
to their communication to the supplier.
7.4.3
Verification of purchased product
}The
organization shall establish and implement the inspection or other activities
necessary for ensuring that purchased product meets specified purchase
requirements.
}Where
the organization or its customer intends to perform verification at the
supplier's premises, the organization shall state 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
}The
organization shall plan and carry out production and service provision under
controlled conditions. Controlled conditions shall include, as applicable
}7-
Product realization
a)
the availability of information that describes the characteristics of the
product,
b)
the availability of work instructions, as necessary,
c)
the use of suitable equipment,
d)
the availability and use of monitoring and measuring devices,
e)
the implementation of monitoring and measurement, and
f)
the implementation of release, delivery and post-delivery activities.
7.5.2
Validation of processes for production and service provision
}The
organization shall validate any processes for production and service provision
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
shall demonstrate the ability of these processes to achieve planned results.
}The
organization shall establish arrangements for these processes including, as
applicable
}7-
Product realization
}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 (see 4.2.4), and
}e)
revalidation.
7.5.3
Identification and traceability
}Where
appropriate, the organization shall identify the product by suitable means
throughout product realization.
}The
organization shall identify the product status with respect to monitoring and
measurement requirements.
}Where
traceability is a requirement, the organization shall control and record the
unique identification of the product (see
4.2.4).
}NOTE
In some industry sectors, configuration management is a means by which
identification and traceability are maintained.
}7-
Product realization
7.5.4
Customer property
}The
organization shall exercise care with customer property while it is under the
organization's control or being used
by the
organization. The organization shall identify, verify, protect and safeguard
customer property provided for use or incorporation
into the product. If any customer property is lost, damaged or otherwise found
to be unsuitable for
use,
this shall be reported to the customer and records maintained (see 4.2.4).
}NOTE
Customer property can include intellectual property.
7.5.5
Preservation of product
}The
organization shall preserve the conformity of product during internal
processing and delivery to the intended destination.
This preservation shall include identification, handling, packaging, storage
and protection. Preservation
shall also
apply to the constituent parts of a product.
}7-
Product realization
7.6
Control of monitoring and measuring devices
}The
organization shall determine the monitoring and measurement to be undertaken
and the monitoring and
measuring devices
needed to provide evidence of conformity of product to determined requirements
(see 7.2.1).
}The
organization shall establish processes to ensure that monitoring and
measurement can be carried out and are
carried out
in a manner that is consistent with the monitoring and measurement
requirements.
}Where
necessary to ensure valid results, measuring equipment shall
a) be
calibrated or verified at specified intervals, or prior to use, against
measurement standards traceable to international or
national measurement standards; where no such standards exist, the basis used
for calibration or
verification shall
be recorded;
b) be
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) be
protected from damage and deterioration during handling, maintenance and
storage.
}7-
Product realization
}In
addition, the organization shall assess and record the validity of the previous
measuring results when the
equipment is found not to conform to requirements. The organization shall take
appropriate action on the equipment and any
product affected. Records of the results of calibration and verification shall
be maintained (see 4.2.4).
}When
used in the monitoring and measurement of specified requirements, the ability
of computer software to satisfy
the intended
application shall be confirmed. This shall be undertaken prior to initial use
and reconfirmed as
necessary.
}NOTE
See ISO 10012-1 and ISO 10012-2 for guidance.
}8-
Measurement, analysis and improvement
8.1
General
}The
organization shall plan and implement the monitoring, measurement, analysis and
improvement processes
needed
a) to
demonstrate conformity of the product,
b) to
ensure conformity of the quality management system, and
c) to
continually improve the effectiveness of the quality management system.
}This
shall include determination of applicable methods, including statistical
techniques, and the extent of their use.
8.2
Monitoring and measurement
8.2.1
Customer satisfaction
}As
one of the measurements of the performance of the quality management system,
the organization shall monitor
information relating
to customer perception as to whether the organization has met customer
requirements. The
methods for
obtaining and using this information shall be determined.
}8-
Measurement, analysis and improvement
8.2.2
Internal audit
}The
organization shall conduct internal audits at planned intervals to determine
whether the
QMS
a)
conforms to the planned arrangements (see 7.1), to the requirements of this
International Standard and to the QMS requirements
established by the organization, and
b) is
effectively implemented and maintained.
}An
audit program
shall
be planned, 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 shall be defined.
Selection of auditors and conduct of audits shall ensure objectivity and
impartiality of the audit process.
}Auditors
shall not audit their own work.
}The
responsibilities and requirements for planning and conducting audits, and for
reporting results and maintaining
records (see
4.2.4) shall be defined in a documented procedure.
}The
management responsible for the area being audited shall ensure that actions are
taken without undue delay to eliminate detected
nonconformities and their causes. Follow-up activities shall include the
verification of the actions
taken and
the reporting of verification results (see 8.5.2).
}NOTE
See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.
}8-
Measurement, analysis and improvement
8.2.3
Monitoring and measurement of processes
}The
organization shall apply suitable methods for monitoring and, where applicable,
measurement of the QMS
processes.
These methods shall demonstrate the ability of the processes to achieve planned
results.
When planned results are not achieved, correction and corrective action shall
be taken, as appropriate, to ensure conformity
of the product.
8.2.4
Monitoring and measurement of product
}The
organization shall monitor and measure the characteristics of the product to
verify that product requirements
have been
met. This shall be carried out at appropriate stages of the product realization
process in accordance with
the planned
arrangements (see 7.1).
}Evidence
of conformity with the acceptance criteria shall be maintained. Records shall
indicate the person(s) authorizing release of product (see 4.2.4).
}Product
release and service delivery shall not proceed until the planned arrangements
(see 7.1) have been satisfactorily completed, unless otherwise approved by a
relevant authority and, where applicable, by the customer
}8-
Measurement, analysis and improvement
8.3
Control of nonconforming product
}The
organization shall ensure that product which does not conform to product
requirements is identified and controlled to
prevent its unintended use or delivery. The controls and related
responsibilities and authorities for
dealing with
nonconforming product shall be defined in a documented procedure.
}The
organization shall deal with nonconforming product by one or more of the
following ways:
a) by
taking action to eliminate the detected nonconformity;
b) by
authorizing its use, release or acceptance under concession by a relevant
authority and, where applicable, by
the customer;
c) by
taking action to preclude its original intended use or application.
}Records
of the nature of nonconformities and any subsequent actions taken, including
concessions obtained, shall
be maintained
(see 4.2.4).
}When
nonconforming product is corrected it shall be subject to re-verification to
demonstrate conformity to the requirements.
}When
nonconforming product is detected after delivery or use has started, the
organization shall take action
appropriate to
the effects, or potential effects, of the nonconformity.
}8-
Measurement, analysis and improvement
8.4
Analysis of data
The
organization shall determine, collect and analyse appropriate data to
demonstrate 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 shall include data generated as a result of
monitoring and
measurement and
from other relevant sources.
The
analysis of data shall provide information relating to
a)
customer satisfaction (see 8.2.1),
b)
conformity to product requirements (see 7.2.1),
c)
characteristics and trends of processes and products including opportunities
for preventive action, and
d)
suppliers.
8.5
Improvement
8.5.1
Continual improvement
The
organization shall continually improve the effectiveness of the quality
management system through the use of the quality policy, quality objectives,
audit results, analysis of data, corrective and preventive actions and
management review.
}8-
Measurement, analysis and improvement
8.5.2
Corrective action
The
organization shall take action to eliminate the cause of nonconformities in
order to prevent recurrence.
Corrective
actions shall be appropriate to the effects of the nonconformities encountered.
A
documented procedure shall be established to define requirements for
a)
reviewing nonconformities (including customer complaints),
b)
determining the causes of nonconformities,
c)
evaluating the need for action to ensure that nonconformities do not recur,
d)
determining and implementing action needed,
e)
records of the results of action taken (see 4.2.4), and
f)
reviewing corrective action taken.
8.5.3
Preventive action
The
organization shall determine action to eliminate the causes of potential
nonconformities in order to prevent their occurrence. Preventive actions shall
be appropriate to the effects of the potential problems.
}8-
Measurement, analysis and improvement
}A
documented procedure shall be established to define requirements for
a)
determining potential nonconformities and their causes,
b)
evaluating the need for action to prevent occurrence of nonconformities,
c)
determining and implementing action needed,
d)
records of results of action taken (see 4.2.4), and
e)
reviewing preventive action taken.
