SP
has established, documented, implemented and
maintained a Quality Management System ( QMS
) for smooth and efficient working for the organization.
The QMS covers all laboratory functions and
their interactions to ensure delivery of quality
diagnostic investigation services to comply
with patient requirements and expectation and
continually improve its effectiveness in accordance
with the requirements of ISO 9001:2000 standards.
The organization ensures
a)
Identification of the processes
that are important and needed for the quality
management system and their application
throughout the organization. These processes
are described in order to facilitate the
understanding of responsibility lines and
work flow.
b)
Determination of the sequence and interaction
of these processes for better understanding
of work flow and understand the complexity
& importance of the interactions involved
in work performance.
c)
Determination of criteria and methods
needed to ensure that both the operation
and control of these processes are effective,
dynamic and designed to accommodate the
changing needs. The review is done during
Management Review Meetings, Internal Audit
and departmental meetings.
d)
The availability of information and resources
necessary to support the operation and monitoring
of these processes to ensure that they are
adhered to and complied with the system
requirements.
e)
A well defined system of monitoring and
measuring of these processes as deemed necessary
to maintain the quality of the medical and
healthcare services. The laboratory gives
due importance to the recording of information
and data, since analysis of these data is
important for control and improvement in
the quality of service.
f)
Implementation of actions necessary to
achieve planned results and continual improvement
of these processes
The laboratory undertakes
outsourcing of patient samples for testing /
investigations activities to other competent
laboratories as given. The laboratory ensures
suitable control over such processes by sub
contracting the activities to competent, experienced
and certified laboratories under controlled
conditions including proper sample collection,
sample transportation and timely report pick
up to ensure total patient satisfaction. The
laboratory management plans occasional visits
to these laboratories premises to verify the
quality of work and processes undertaken by
them.
Documentation Requirements - General
SP
has established, documented, implemented and
maintained 4 levels of Quality Management Systems
documents within the organization’s quality
management structure. The four levels are outlined
as follows.
a)
Quality System Manual ( LEVEL
1 ) which is a controlled document and includes
the elements and scope of the Quality Management
System, the statement of quality policy,
quality objectives set by the organization,
laboratory organizational structure and
the designations / responsibilities of key
personnel. These are dynamic in nature and
are reviewed during MRM.
b)
Quality System Procedures ( LEVEL 2 )
All documented procedures as specified by
this international standards and those,
which are necessary for smooth and effective
working of the organization are addressed
in Quality System Procedures. These procedures
describe the implementation of the requirements
of quality management system in the Laboratory.
These are hard copy controlled documents
and are not meant for outside agencies /
patients except in special cases or if required
by contract.
c)
Laboratory Plans / Work Procedures / Instructions
/ Forms ( LEVEL 3 ) All documents such as
work procedure/ instructions, quality plan,
flow charts, formats etc that are needed
by the organization to ensure the effective
planning, operation and control of its processes
are specified in the respective processes
/ procedures. These are hard copy documents
located by department. Procedures are drafted
where the absence of such procedures would
adversely affect healthcare service quality
and delivery.
d)
Quality Records ( LEVEL 4 ) All quality
records as mentioned in quality procedures
and required by ISO 9001:2000 standard are
documented and maintained at the respective
area of operation to achieve continuous
quality improvement . These records describe
details of practice and control specific
activities.
Quality Manual
The
organization has established and maintained
a quality manual which includes:
a)
The scope of the quality
management system, including details and
justification for any exclusion as applicable.
b)
The documented procedures established
for the quality management system and reference
to them as per the requirement of this standard
and for effective working of the organization.
c)
Description of interactions between processes
of the quality management system.
d)
The Laboratory’s organizational
structure and the responsibilities of key
personnel.
e)
Control and issue of Quality Manual
The C E O approves the Quality Manual
as well as subsequent amendments, issue
and/or revisions.
Q M R issues the amendments and ensures
that superceded pages are withdrawn
from all holders of controlled copies.
Q M R maintains a master copy of the
Quality Manual and record of all issues.
All copies issued are stamped controlled
or uncontrolled. Only controlled copies
are maintained up to date.
f)
Quality policy is displayed at all prominent
places within the organizations premises.
g)
A copy of authorized Hindi version of
quality policy has been circulated among
employees who ask for it.
h)
The employees are trained to understand
their role to achieve the objectives as
expressed in the policy.
Control Of Documents
All
internal and external data and documents relating
to the quality system, including this manual
and which require monitoring for revision and
distribution are termed ‘CONTROLLED’
as described by documented procedure. The quality
policy and quality objectives are documented
and controlled.
a)
All quality system documents
are reviewed for adequacy and approved by
authorized person prior to issue and use.
They are reviewed, updated, recalled and
re-approved as necessary under the control
of Quality Management Representative.
b)
To ensure that the changes and the current
revision status of documents are identified.
c)
All documents are controlled to ensure
that current versions of applicable documents
are available at point of use or in the
department. One signed and / or initialed
hard copy of documents is maintained by
QMR. This copy contains the official signed
and / or initialed up-to-date version for
state regulatory purposes.
d)
To ensure that documents remain legible,
readily identifiable and retrievable.
e)
To ensure that documents of external
origin are identified and their distribution
controlled to ensure that most current
documents are used.
Master lists (or similar) are established
and maintained as hard copy in identified
cabinets of each departments to identify
current issue / revision status of all
documents and to prevent the unintended
use of non applicable, obsolete documents.
When retained, these documents are clearly
identified and placed in specified file
cabinet to prevent unintended use. A procedure
is established, documented, implemented
and maintained to define the controls
needed.
f)
To apply suitable identification / numbering
of documents for unique identification of
documents of current status or obsolete
documents.
g)
The backup of the data is taken on a regular
basis. This is done to prevent the loss
of information in case of a system failure.
The system is also regularly scanned for
viruses and bugs.
h)
The Laboratory follows a well defined
system for preservation of obsolete documents
Quality Policy
The
Quality Policy as given on page 3 of this manual
is approved by the C E O and is a statement
appropriate to the nature of services provided
by the organization. It meets the organizational
aim of providing and meeting the needs and expectations
of its patients to provide quality medical diagnostic
service.
The C E O has the responsibility
to ensure that SP’s Quality Policy
a)
Is relevant to the nature
of services provided by SP and to the needs
and expectations of patients.
b)
Underscores the organization’s commitment
to comply with applicable requirement and
standards and continual quality improvement.
c)
Provides a framework for establishing
and reviewing the organization quality goals
and objectives.
d)
Is communicated, understood and implemented
at all levels of the organization. This
is done personally by the top management
during staff meetings, training opportunities
and other appropriate forums.
e)
Is reviewed on regular basis for continuing
suitability.
f)
Quality policy is displayed at all prominent
places within the organizations premises.
g)
A copy of authorized Hindi version of
quality policy has been circulated among
employees who ask for it.
h)
The employees are trained to understand
their role to achieve the objectives as
expressed in the policy.
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2006-2007 Scientific Pathology. All Rights Reserved.
