QUALITY MANUAL (ISO/IEC 17025 : 2008)
Document
ID
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XXX/QM/08
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Title
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Organization
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Issue
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Revision
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Revision
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Reference
ISO Clause
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4.1 Policy The laboratory ensures
protection of customer’s confidential information and proprietary rights. The
laboratory shall always avoid involving in any activity that shall jeopardize
its confidence in its competence, impartiality, judgment and operational integrity.
It lays down procedure for carrying out the activities.
4.1.1 Legal
Identity Organization (A Deemed
Public Limited Organization), which is registered under Indian companies act 1234, with registration No. 123 dated 00th Jan 1008 registered by
Register of companies, India. The laboratory is having its works at India,. It
is registered with Service Tax Industries vide Service Tax No. XXXX 1234 GST
000 dated 00/00/1008.
4.1.2 Responsibility
of the laboratory The Laboratory carries out testing and calibration
activity meeting the requirements of ISO/IEC 17025 : 2008 and satisfying the
needs of the customer, regulatory authorities and certification body.
4.1.3 Laboratory
facility The Laboratory is working independently. The Laboratory management
system covers work carries out in laboratory’s permanent facility only and
accepts test items for Water & waste water, pharmaceutical products, Chemical,
Biological and Analytical Research & Development , Forensic . Also carries
calibration in the field of mechanical, thermal, electrical and dimensional
trend.
4.1.4 Independent
organization The Laboratory is a part of India Limited and the
responsibilities of key personalities does not have any potential conflict of
interest.
4.1.5 (a) The
managerial and technical personnel who, irrespective of other responsibilities
have authority and resources needed to carry out duties, including the
implementation, maintenance and improvement of management system and to
identify the occurrence of departures from the management system or from the
procedures for performing tests and or calibrations, and to initiate actions to
prevent or minimize such departures.
(b)
Employees in testing section
are not permitted to come in contact with customers. Technical manager ensures
that there is neither commercial nor financial pressure on the employees. T.M.
ensures that employees maintain integrity and independence of judgment in
day-to-day work. It is ensured that remuneration of employees does not depend
on number of items tested / calibrated or on test result.
(c)
The policy of laboratory is to
protect customer’s confidential information and proprietary rights. Test /
calibration items of customers are given unique identification number. For
samples in Environment, the customer’s identity is not divulged to testing
personnel. Test result of one customer will not be divulged to other customer.
No employee is allowed to inform the test / calibration results other than
through official channel. Proprietary rights and confidential information of
customers are not divulged to others. Procedure ORG/QP/0000 is followed. An
undertaking from the testing personnel is being obtained that they maintain
integrity and independence of judgment in their day-to-day work.
(d)
The policy of the laboratory is
to avoid involvement in any activities that will diminish confidence in its
competence impartiality judgment and integrity. Procedure ORG/QP/0000 is
followed to avoid unwanted activities.
Document
ID
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XXX/QM/08
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Title
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Organization
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Issue
No.
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Issue
Date :
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Revision
No.
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:
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Revision
Date :
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Reference
ISO Clause
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Page :
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(b)
RESPONSIBILITIES & AUTHORITIES
The Organization Chart above illustrates the position of the persons
who manage, perform and verify the work affecting quality. The main
responsibilities of these functions are also identified in the pages that
follow. The Overall, Direct and Secondary responsibilities for implementing
sections 4.1 to 5.10 of ISO/IEC 17025: 2008 are presented in the Responsibility
Matrix
Further details of Responsibilities & Authorities are as
follows:
CHAIRMAN & MANAGING DIRECTOR (CMD)
CMD is
overall responsible for implementation and issuance of Quality Policy and
Objectives of the laboratory. CMD is coordinating activities of laboratory with
Head Office and is empowered to purchase new equipment, discard obsolete ones,
provide and use resources. CMD is chairing Management Review Committee meeting
and ensures compliance ISO/IEC 17025: 2008 in day-to-day activity of
Organization.
RESIDENT DIRECTOR / TECHNICAL MANAGER (RD/TM)
RD is
overall responsible for implementation of Management System of the laboratory
as Technical Manager. TM is authorized for amendment in Quality Manual. TM is
coordinating with customers for order execution, looking after complaints,
organizing training programme and verifying effectiveness. Technical Manager is
responsible for the technical operation and use resources provided to ensure
the required quality of laboratory operations. TM is authorized signatory of
test reports. The other responsibilities are a) Proficiency Testing, b)
Training of personnel & supervision, c) Arranging for annual service
contract of the equipment, d) Calibration of equipment, e) Ensuring compliance
of activities with ISO/IEC 17025: 2008. RD is reporting to CMD.
GENERAL
MANAGER / DEPUTY TECHNICAL MANAGER (GM/DTM)
DTM is
responsible for coordinating with customers for order execution, looking after
complaints, organizing training programme and verifying effectiveness. DTM is
responsible for the technical operation and use resources provided to ensure
the required quality of laboratory operations. The other responsibilities are
a) Arranging for annual service contract of the equipment, b) Calibration of
equipment. DTM is reporting to TM.
QUALITY ASSURANCE MANAGER (QAM)
QAM is
responsible for quality assurance functions, supervisions and assisting
different functions like receipt of test / calibration items, testing and
calibration. The other responsibilities are a) Upkeep and distribution of
Quality Manual, Quality Procedures and other Management system documents, b)
Processing amendments, c) Arranging and carrying out internal quality audits, d)
Quality assurance testing, e) Ensuring compliance of activities with ISO/IEC
17025 : 2008, f) Authorized signatory of Test Reports. QAM is reporting to TM
for day-to-day activity and to highest policy making bodies for Quality
Management System.
QUALITY ASSURANCE OFFICER (QAO)
QAO is
responsible for report checking, raw data signing, quality assurance testing
and carrying out internal quality audits. QAO reviews test / calibration
requirements of customers and report to QAM for further line of action.
RESEARCH OFFICER / JUNIOR RESEARCH OFFICER (RO/JRO)
RO/JRO
is carrying out test / calibration as per work instructions and relevant test
/calibration methods and prepare test / calibration reports and put up the test
/ calibration report to authorized signatory for signature. After testing /
calibration, arrangements are made for disposal of items as per procedure. JRO/RO
report to TM/DTM.
ADMINISTRATIVE OFFICER (ADO
ACCOUNTS OFFICER (ACO)
ACO is
responsible for Accounts function and is responsible for purchase, inventory
control and proper storage of chemicals and consumables, preparation of
purchase order, preparation of invoices and collection of test charges and for
sale of scrap. ACO reports to ADO/DTM/TM.
SYSTEM MANAGER (SYM)
SYM is
responsible for internal audit as an approved internal auditor. SYM also
responsible for computer system and laboratory system programme. SYM reports to
DTM/TM.
SAMPLE RECEIPT PERSONNEL (SRP)
SRP is
receiving the items, tallies with test request. SRP records the item number,
description, date of receipt and other details in register. SRP is responsible
for maintaining the records of receipt, handling over the items to different
section, disposal of items. When requisition is not received from the
customers, SRP prepares the test request and forward it to the section along
with the items. SRP is responsible for proper storage of items. SRP manage the
receipt of the samples, proper and timely distribution of reports. SRP reports
to DTM/TM.
(c)
Supervisory personnel of the
laboratory are familiar with test methods, procedures, purpose of each test and
/ or calibration and assessment of test or calibration result and provide
adequate supervision to testing staff including trainees. The members of
supervisory panel are RO, QAO, QAM, DTM and TM.
(d)
The laboratory has a technical
management of RO, QAO, QAM, DTM and TM which has overall responsibility for the
technical operations and provides the resources needed to ensure the required
quality of laboratory operations.
(e)
The laboratory has appointed a
member of the staff as Quality Assurance Manager who has responsibility and
authority for ensuring that management system is implemented and followed at
all times. He is having direct access to the highest level of management at
which decisions are made on laboratory policy and resources.
(f)
If TM is on tour or leave,
DTM/QAM assumes full responsibility of the functions of TM. Similarly, if DTM
or QAM is on leave or tour, TM shall assume full responsibility of the
functions of DTM & QAM.
(g)
TM ensures in the monthly
meeting with the laboratory personnel that they are aware of the relevance and
importance of their activities and that they would contribute to the
achievement of the objective of management system.
4.1.6 Internal
Communication The management ensures that appropriate communication is
established within the organization by using display boards / inter office memo
which will be updated as & when required.
Reference
Procedure(s)
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XXX/QP/000
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Procedure to protect confidentiality and
proprietary rights
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XXX/QP/000
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Procedure to prevent unusual activity.
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Reference
Format(s)
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XXX/QF/000
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Record of monthly meeting
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Reference
Work Instruction(s)
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Nil
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RESPONSIBILITY MATRIX OF KEY OFFICIALS
ISO Clause No.
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Responsibility Area
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CMD
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TM
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DTM
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QAM
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SRP
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SYM
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4.1
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Organization
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O
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D
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S
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S
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-
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-
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S
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4.2
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Management system
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O
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D
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D
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D
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S
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S
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S
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4.3
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Document control
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O
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O
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O
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D
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-
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-
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D
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4.4
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Review of requests, tenders and contracts
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O
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D
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D
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S
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S
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-
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-
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4.5
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Subcontracting of tests and calibrations
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-
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-
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-
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-
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-
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-
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-
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4.6
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Purchasing services and supplies
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O
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O
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O
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O
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D
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-
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-
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4.7
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Service to customer
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O
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O
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O
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D
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-
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-
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-
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4.8
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Complaints
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O
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O
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O
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D
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-
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-
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-
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4.9
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Control of nonconforming testing and/or
calibration work
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O
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O
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O
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D
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-
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-
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S
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4.10
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Improvement
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O
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O
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D
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D
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D
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D
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S
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4.11
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Corrective action
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O
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O
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D
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D
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D
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D
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-
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4.12
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Preventive action
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O
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O
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D
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D
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D
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D
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-
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4.13
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Control of records
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O
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S
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S
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D
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S
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S
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-
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4.14
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Internal audits
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O
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S
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S
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D
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-
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-
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O
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4.15
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Management reviews
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O
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O
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O
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D
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-
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-
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D
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5.2
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Personnel
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O
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O
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O
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D
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S
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-
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-
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5.3
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Accommodation and environmental
conditions
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O
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O
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O
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S
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D
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-
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-
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5.4
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Test and calibration methods and method
validation
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O
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O
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D
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D
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-
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-
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-
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5.5
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Equipment
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O
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D
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S
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S
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S
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-
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-
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5.6
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Measurement traceability
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O
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O
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O
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D
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-
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-
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-
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5.7
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Sampling
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-
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-
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-
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-
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-
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-
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-
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5.8
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Handling of test and calibration items
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O
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O
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S
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S
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D
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D
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-
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5.9
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Assuring the quality of test and
calibration results
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O
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O
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D
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D
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-
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-
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-
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5.10
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Reporting the results
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O
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O
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D
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D
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-
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-
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-
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O
– Overall Responsible
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D
– Direct Responsible
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S
– Secondary Responsible
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CMD – Chairman & Managing Director
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TM – Technical Manager
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ACO – Accounts Officer
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DTM – Deputy Technical Manager
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SRP – Sample Receipt Personnel
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QAM – Quality Assurance Manager
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SYM – System Manager
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