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REGIONAL WATER TESTING LABORATORY,

GROUNDWATER SURVEYS & DEVELOPMENT AGENCY, KONKAN REGION


Doc. No :QM/01 QUALITY MANUAL
Issue No : 4.0 Issue date : 01.03.2023 Amend No : 00 Amend Date:- - Pg No: 1 of 43

QUALITY MANUAL

REGIONAL WATER TESTING LABORATORY,


GROUNDWATER SURVEYS & DEVELOPMENT AGENCY
KONKAN REGION, NAVI MUMBAI
MAHARASHTRA STATE

Copy No - _____
REGIONAL WATER TESTING LABORATORY,
GROUNDWATER SURVEYS & DEVELOPMENT AGENCY, KONKAN REGION
Doc. No :QM/01 QUALITY MANUAL
Issue No : 4.0 Issue date : 01.03.2023 Amend No : 00 Amend Date:- - Pg No: 2 of 43

AMENDMENT RECORD

Section / Signature of
Sr. Page page / clause / Date of Amendment Reasons of person
No. No. line ( as amendment Made Amendment authorizing
applicable ) amendment

3
REGIONAL WATER TESTING LABORATORY,
GROUNDWATER SURVEYS & DEVELOPMENT AGENCY, KONKAN REGION
Doc. No :QM/01 QUALITY MANUAL
Issue No : 4.0 Issue date : 01.03.2023 Amend No : 00 Amend Date:- - Pg No: 3 of 43

TABLE OF CONTENTS

Section Contents Page

I Amendment record 2
…………………………………………………………………………….
II Table of contents 3
………………………………………………………………………………...
III Release 4
Authorization………………………………………………………………………….
Scope
1.0 5
………………………………………………………………………………………………….
Normative Reference
2.0 5
…………………………………………………………………………..
Statement - Quality Policy, Authorization, Controls & Distribution
3.0 5
………..
4.0 General Requirements
Impartiality
4.1 10
………………………………………………………………………………………...
Confidentiality
4.2 10
…………………………………………………………………………………….
Structural Requirements
5.0 12
………………………………………………………………..
6.0 Resource requirements
General
6.1 18
……………………………………………………………………………………………….
Personnel
6.2 18
……………………………………………………………………………………………
Facilities and environmental conditions
6.3 19
……………………………………………….
Equipment
6.4 20
………………………………………………………………………………………….
Metrological traceability
6.5 22
……………………………………………………………………...
External Provided Products And Services
6.6 24
…………………………………………….
7.0 Process Requirements
Review of Requests, Tenders & Contracts
7.1 26
……………………………………………..
Selection, Verification And Validation Of Methods
7.2 27
………………………………...
Sampling
7.3 29
…………………………………………………………………………………………….
Handling Of Test And Calibration Items
7.4 29
………………………………………………..
Technical Records
7.5 30
……………………………………………………………………………….
Evaluation Of Measurement Uncertainty
7.6 30
……………………………………………..
REGIONAL WATER TESTING LABORATORY,
GROUNDWATER SURVEYS & DEVELOPMENT AGENCY, KONKAN REGION
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Ensuring The Validity Of Results


7.7 31
………………………………………………………….
Reporting Of Results
7.8 32
……………………………………………………………………………
Complaints
7.9 34
………………………………………………………………………………………….
Nonconforming Work
7.10 34
………………………………………………………………………….
Control Of Data And Information Management
7.11 35
……………………………………..
8.0 Management System Requirements
Options
8.1 36
……………………………………………………………………………………………….
Management System Documentation
8.2 36
…………………………………………………...
Control Of Management System Documents
8.3 37
…………………………………………
Control Of Records
8.4 39
………………………………………………………………………………
Action To Address Risks And Opportunities
8.5 40
…………………………………………
Improvement
8.6 40
……………………………………………………………………………………...
Corrective Actions
8.7 41
……………………………………………………………………………….
Internal Audits
8.8 42
……………………………………………………………………………………
Management Review
8.9 43
…………………………………………………………………………...
Annexure 1 – Laboratory layout
Annexure 2 – Organizational Chart
Annexure 3 - Management structure chart
Annexure 4 - Standard Operating Procedures
Annexure 5 - Range of Laboratory Activities –Scope

Release Authorization
This Quality Manual is released under the authority of Deputy Director, G.S.D.A,
Konkan region, Navi mumbai

And is the property of

REGIONAL WATER TESTING LABORATORY,


GROUNDWATER SURVEYS & DEVELOPMENT AGENCY
REGIONAL WATER TESTING LABORATORY,
GROUNDWATER SURVEYS & DEVELOPMENT AGENCY, KONKAN REGION
Doc. No :QM/01 QUALITY MANUAL
Issue No : 4.0 Issue date : 01.03.2023 Amend No : 00 Amend Date:- - Pg No: 5 of 43

ROOM NO. 313, 3RD FLOOR, KONKAN BHAVAN


C.B.D. BELAPUR, NAVI MUMBAI-400614
MAHARASHTRA STATE

E-mail : [email protected], [email protected]

Quality Manual approval signature

Prepared by : Mr. Milind Gajanan Wagare, Jr.Chemist


G.S.D.A, Konkan region.

Checked , : Dr. Shailesh Babanrao Kanade, Asst.Chemist


Verified & G.S.D.A, Konkan region.
Issued by

Approved & : Dr. Pramod Pandurang Reddy, Deputy Director


Authorized by G.S.D.A, Konkan region.

1.0 Scope
Quality Manual is prepared by Regional Water Testing Laboratory, GSDA, Konkan
(RWTL,KR), to comply with the requirements of ISO / IEC 17025: 2017 for accreditation
of laboratory. Quality Manual being the apex Management System Document provides
the basis of defining and maintaining the overall management system at RWTL, KR
relevant to Testing of water service being offered to customers. The term ‘Management
System’ applies to quality, technical and Administrative systems that govern the
operation of the Laboratory.
REGIONAL WATER TESTING LABORATORY,
GROUNDWATER SURVEYS & DEVELOPMENT AGENCY, KONKAN REGION
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Issue No : 4.0 Issue date : 01.03.2023 Amend No : 00 Amend Date:- - Pg No: 6 of 43

The Quality Manual to be read in conjunction with relevant procedures established &
implemented to achieve the reliable test data by the Laboratory.

2.0 Normative References

 ISO/IEC 17025:2017: General Requirements for the Competence of Testing and


Calibration laboratories.

 ISO/IEC Guide 99, International vocabulary of metrology – Basic and general


concepts and associated terms.

 ISO/IEC 17000, Conformity assessment – vocabulary and general principles

 NABL Documents

3.0 Quality Policy Statement

RWTL,KR is committed to laboratory accreditation according to the requirements of


ISO/IEC 17025 and requirements of National Accreditation Body for Testing and
Calibration Laboratories (NABL). This commitment is evidenced by the approval
signatures for this manual.
The quality policy statement of RWTL,KR is as follows,

Quality Policy
Regional Water Testing Laboratory, G.S.D.A, Konkan Region is committed to achieve total
customer satisfaction for the testing service that we offer. RWTL,KR will achieve this by:
a) Establishing good professional practices and providing quality services to customers,
b) Maintaining accuracy, precision & reliability of testing services through maintaining
Standards,
c) Maintaining competence, impartiality & consistent operation of laboratory activities,
d) Adoption and maintenance of a laboratory management system for our laboratory
testing activities in accordance with ISO/IEC 17025,
REGIONAL WATER TESTING LABORATORY,
GROUNDWATER SURVEYS & DEVELOPMENT AGENCY, KONKAN REGION
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e.) Encouraging and welcoming customer feedback to proactively improve performance


and quality of services,
f.) Familiarizing all employees with relevant documents,
g.) Complying with ISO/IEC 17025:2017 and continually improving the effectiveness
of the Management system through regular review.

Quality Objectives
Regional Water Testing Laboratory, G.S.D.A, Konkan Region is committed to provide
accurate, precise, reliable Testing & Analytical services for Water Test results to
customer on time as per The Uniform Drinking Water Quality Monitoring Protocol, there
under along with implementation of Quality management system ISO/IEC 17025: 2017
norms.
a. Testing Services for Water.
b. To ensure accurate testing facilities which will give competency to personnel, results
of high degree of precision.
c. To obtain precise & accurate results consistently providing quality service using latest
national and international standards.
d. To maintain transparency in the implementation of the Quality management system of
Laboratory and also provide satisfactory service with impartiality & dignity to
customers.
e. Achieve customer satisfaction above 80 percent.

( Dr. Pramod Pandurang Reddy)


Deputy Director,
Groundwater Survey’s & Development Agency,
Konkan Region, Maharashtra State.

3.1 Authorization Statement

Regional Water Testing Laboratory, G.S.D.A, Konkan Region is committed to the


establishment and maintenance of management system given in this manual and
implemented by the RWTL,KR, to meet the requirements of ISO/IEC 17025:2017.

The members of the RWTL, KR, strictly adhere to the various quality procedures and
work instructions /standard operating procedures, as supported by the policies outlined
in this manual.
REGIONAL WATER TESTING LABORATORY,
GROUNDWATER SURVEYS & DEVELOPMENT AGENCY, KONKAN REGION
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Issue No : 4.0 Issue date : 01.03.2023 Amend No : 00 Amend Date:- - Pg No: 8 of 43

Dr. Shailesh Babanrao Kanade has been appointed as Quality Manager and
Mr. Milind Gajanan Wagare has been appointed as Technical Manager of RWTL,KR,.
The Quality Manager is responsible for ensuring compliance with the quality
requirements stipulated in this manual. Quality Manager is authorized to ensure that the
management system is established, implemented, and maintained by the RWTL, KR,
CEO, Technical Manager, and RWTL, KR employees give full support and co–operation to
Quality Manager. Technical Manager assumes responsibility of Quality Manager and
Quality Manager assumes the responsibility of Technical Manager in their absence.
Technical Manager is responsible for ensuring compliance with the technical
requirements in the testing activities.

( Dr. Pramod Pandurang Reddy)


Deputy Director,
Groundwater Survey’s & Development Agency,
Konkan Region, Maharashtra State.

3.2 Controls and Distribution

3.2.1 Structure Of Quality Manual

This manual is prepared according to the table of contents. Cover page begins with page
no. 1 and the numbering continues throughout the manual.
The manual is supported by documented management system covering Quality Standard
operating Procedures (SOP).
The manual is issued in loose paper sheets and is accessible to the staff and customers.
The implementation of this manual and related quality procedure is mandatory. Any
REGIONAL WATER TESTING LABORATORY,
GROUNDWATER SURVEYS & DEVELOPMENT AGENCY, KONKAN REGION
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changes made in this manual shall be effected through the document control procedures
and must be approved by the CEO.

3.2.2 Responsibility

CEO approves the Quality Manual. The control and maintenance of this manual is the
responsibility of Quality Manager, who is maintaining master list of documents for
quality manual.

3.2.3 Reference

ISO/IEC 17025:2017 - General requirements for the competence of Testing and


Calibration Laboratories

3.2.4 Distribution

Quality Manual is distributed on a "controlled" basis. Controlled copies are the one,
which are subject to incorporation of "revisions".
"Controlled" copies of the quality manual are stamped “Controlled Copy” on all pages.
Distribution list of Quality Manual is given on the next page.
Quality Manager, through a “change note” issues amendments and revised pages of
quality manual to holders of controlled copies of the manual. Upon receipt of such
revisions, the recipient will replace the pages by the revised ones.
"Uncontrolled" copies may be issued by the Quality Manager to the customers on
request of the Technical Manager, or Functional Head to all employees but the recipient
shall not be issued the amendments / revisions.
Quality Manager is responsible to fill–up amendment sheet in line with any amendment.
All the information regarding revisions is distributed to Copy Holders. If any
amendment due to change in page number is done then the table of contents is amended
accordingly.

3.2.5 Distribution list of Quality Manual

Copy No. Type of document Distributed to


1 Controlled Copy Deputy Director, GSDA, Konkan/ CEO
2 Master Copy Assistant Chemist/ Quality Manager
3 Controlled Copy Junior Chemist/ Technical Manager
--- Uncontrolled copy Accreditation body

3.2.6 Numbering and document control for Quality Manual


REGIONAL WATER TESTING LABORATORY,
GROUNDWATER SURVEYS & DEVELOPMENT AGENCY, KONKAN REGION
Doc. No :QM/01 QUALITY MANUAL
Issue No : 4.0 Issue date : 01.03.2023 Amend No : 00 Amend Date:- - Pg No: 10 of 43

(1.) The number for Quality Manual is given as QM/01, where QM stands for Quality
Manual and 01 stands for 1st level document.

(2.) When any amendment becomes necessary, it is the affected page that is replaced
and not the whole chapter. The revised page is given amendment no. and amendment
date as well as in the amendment record sheet.

(3.) Revised pages of the Quality Manual are subject to the same approvals and controls
as per the original one. In case of amendments to the particular page the amendment no.
and amendment date for the particular page is identified on the footer of the amended
page.

(4) After more amendments the whole issue number of Quality Manual is revised with
new issue number with amendment no. as 00.

4.0 GENERAL REQUIREMENTS

4.1 Impartiality :

4.1.1 RWTL,KR is structured and managed to ensure that the activities are conducted
impartially. Service rules, code of conduct rules and guidelines issued by Government of
Maharashtra are implemented so as to safeguard impartiality, confidentiality, judgement
or operational integrity.
REGIONAL WATER TESTING LABORATORY,
GROUNDWATER SURVEYS & DEVELOPMENT AGENCY, KONKAN REGION
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4.1.2 RWTL,KR ensure that the management is committed to impartiality, to avoid


conflicts of interest, pressures, and influences, laboratory employees are familiar with
and observe the Maharashtra Civil service (Conduct) Rules 1979. The rule states thirty
general principles that broadly define the obligations of public service. Two core
concepts are embodied in these principles: (a) Employees shall not use public office for
private gain, (b) and employees shall act impartially and not give preferential treatment
to any private organization or individual.

4.1.3 Personnel of RWTL,KR are free from any undue internal, external, commercial,
financial or any other pressures/ influences that may adversely affect their quality of
work. Laboratory does not have activities other than testing. Key personnel of the
Laboratory are not involved in any such activity that may cause potential conflict of
interest.

4.1.4 RWTL,KR identifies risks to impartiality on an on-going basis through meetings,


discussions and management reviews.

4.1.5 If a risk to impartiality is identified, appropriate steps are taken to eliminate and
minimize such a risk.

4.2 Confidentiality :

4.2.1 Regional Water Testing Laboratory, GSDA, Konkan (RWTL,KR) is under the
administrative control of Director, GSDA, Pune and Water Supply & Sanitation
Department (WSSD), Government of Maharashtra, is responsible for the management of
all information obtained or created during the performance of laboratory activities. If
there is a requirement to place customer information in public domain, the customer is
informed in advance. All information other than the above [or when agreed between the
laboratory and the customer] is considered as proprietary and is regarded as
confidential.

4.2.2 When required by law or authorized by contractual arrangement, the customer or


individual concerned is notified of the information provided [unless prohibited by law]

4.2.3 Information about the customer obtained from sources other than the customer is
kept confidential between the customer and the laboratory. Unless agreed by the source,
this information is kept confidential to the laboratory and is not shared with the
customer.
REGIONAL WATER TESTING LABORATORY,
GROUNDWATER SURVEYS & DEVELOPMENT AGENCY, KONKAN REGION
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4.2.4 except as required by law information obtained or created during the performance
of laboratory activities is kept confidential by its personnel including any committee
members, contractors, personnel of external bodies, or individuals acting on the
laboratory’s behalf.

Reference documents
SOP/4.0 SOP for Maintaining Impartiality, Confidentiality & Integrity .

5.0 STRUCTURAL REQUIREMENTS

5.1 Regional water Testing Laboratory [ RWTL,KR ], is a testing laboratory which is a


part of the Office of Deputy Director, GSDA, Konkan which comes under Department of
Water Supply & Sanitation [WSSD], Government of Maharashtra.
On November 15, 1972, independent Directorate of ‘Groundwater Surveys &
Development Agency’ was established by Government Resolution of Govt. of
Maharashtra for envisaging inter-alia construction of wells, tube wells, improvement
REGIONAL WATER TESTING LABORATORY,
GROUNDWATER SURVEYS & DEVELOPMENT AGENCY, KONKAN REGION
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and energization of existing wells, to carry out surveys and supply of potable drinking
water to the rural population. (RWTL/QR/5.1)

5.2 RWTL, KR is headed by Regional Deputy Director (CEO) who has overall
responsibility for Laboratory activities and implementation of Quality Management
system & provides the required necessary imputes to the laboratory for its effective
implementation.

5.3 RWTL, KR has defined and documented the range of Laboratory activities: The
range of Laboratory activities (Scope of Accreditation) is documented, enclosed as
Annexure 05. All activities carried–out comply with the requirements given in ISO/IEC
17025 (this document). RWTL, KR claims conformity only for the defined scope of
accreditation.

5.4 Laboratory activities are carried–out in such a way as to meet the requirements of
ISO/IEC 17025, relevant test standards, customer requirements, regulatory authorities
and organizations providing recognition/ accreditation, such as Accreditation Body. This
includes Laboratory activities performed at permanent location & address, Room No. 313,
3rd floor, Konkan Bhavan, C.B.D Belapur, Navi Mumbai and the Deputy Director office is
located on 709/710/719, 7th floor, Konkan Bhavan, C.B.D Belapur, Navi Mumbai.
The Layout plan of the laboratory is attached as per Annexure 01. The approximate
built up area is about 3000 square feet. The building is maintained by P.W.D.,
Maharashtra State with fire safety measures, stabilized power supply, continuous water
supply and UPS has been provided to the sophisticated instruments and computer
systems to protect them from sudden breakdown of electricity. A library with good
collection of books is located at Deputy Director’s office. However, those books/Manuals
and test standard which are used regularly are kept within Laboratory. The laboratory
has maintained accommodation and environment in accordance with requirement of
standard test method.

The Laboratory is involved with following activities to extend the testing of water
samples:
1. Receipt of Samples
2. Handling, Physical coding and storage of Sample
3. Analysis of Sample
4. Reporting of Sample
5. Storage, Preservation & Destruction of Sample
6. Maintenance and calibration of instruments/equipment’s.
7. Procurement of chemicals, glassware & other lab articles.
8. Procurement of Instruments/Equipment’s
REGIONAL WATER TESTING LABORATORY,
GROUNDWATER SURVEYS & DEVELOPMENT AGENCY, KONKAN REGION
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9. Other associated work.

5.5 RWTL, KR has:

a) Defined the organization and management structure of RWTL, KR, and the
relationships between management, technical operations and support services. The
organization Chart and Management structure is enclosed as Annexure 02 &
Annexure 03 respectively.

b) Specified the responsibility, authority and interrelationship of all personnel who


manage, perform or verify work affecting the results of Laboratory activities. The
responsibilities and authorities of key personnel are given at the end of clause no. 5.0.

c) The laboratory documented its procedures as identified in successive clauses, to the


extent necessary, to assure the consistent application of its Laboratory activities and the
validity of the results.

5.6 RWTL, KR have personnel (Quality Manager and Technical Manager) who,
irrespective of other responsibilities, have the authority and resources needed to carry–
out their duties, including:
a) Implementation, maintenance and improvement of the management system as per
ISO/IEC 17025;

b) Identification of deviations from the management system or from the procedures for
performing Laboratory activities;

c) Initiation of actions to prevent or minimize such deviations;

d) Reporting to RWTL, KR management on the performance of the management system


and any need for improvement;

e) Ensuring the effectiveness of Laboratory activities..

5.7 RWTL, KR management ensures that:

a) Communication takes place regarding the effectiveness of the management system


and the importance of meeting customers' and other requirements. Method of
communication is effectively implemented related to management system within the
laboratory. In majority of the cases, the communication is done through routine records
for effective implementation and e–mail to the concerned.

b) The integrity of the management system is maintained when changes to the


management system are planned and implemented. Also it is ensured that the integrity
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GROUNDWATER SURVEYS & DEVELOPMENT AGENCY, KONKAN REGION
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Issue No : 4.0 Issue date : 01.03.2023 Amend No : 00 Amend Date:- - Pg No: 15 of 43

of management system is maintained, when changes are planned and implemented in


the system. In key position, the deputies are nominated to take care of the person related
issues.

Responsibility and authority of key personnel

Responsibility and authority of the Top Management (Deputy Director/ CEO)

Responsibility

 To provide resource for effective implementation of the system.


 To conduct the management review meeting periodically, and to ensure that the
system is effectively implemented within the laboratory.
 To nominate Quality Manager and Technical Manager as per the requirements of
the system.
 To prepare and review Quality Policy periodically, and to ensure that the same is
in line with the present circumstances.
 To provide evidence of commitment to the development and implementation of
management system and continual improvement and its effectiveness.
 To communicate the importance of meeting customer as well as statutory and
regulatory requirements within the organization.
 To ensure that the integrity of the management system is maintained during
changes to the management system as planned and implemented.

Authority

 To stop the activity, if found any non–conformity related to testing,


accommodation and environment

Responsibility and authority of Assistant Chemist/ Quality Manager

Responsibility

 To review and approve the management system documents.


 To ensure that a management system is established implemented and maintained
in accordance with the ISO/IEC 17025 management system standards.
 To ensure that the continual improvement is going on after implementing the
system.
 To liaise with Accreditation Body for all the matters related to accreditation.
REGIONAL WATER TESTING LABORATORY,
GROUNDWATER SURVEYS & DEVELOPMENT AGENCY, KONKAN REGION
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 To record the minutes during the management review meeting.


 Overall responsible for the document control.
 To establish control over document and data, including documents of external
origin (such as Indian Standards / International Standard, etc.).
 To schedule and arrange internal audits on the basis of status and importance of
the functions.
 To establish control system on quality and technical records.
 To identify causes of non–conformities and take necessary corrective actions to
remove the cause.
 To identify training needs of employees for the management system.
 Overall responsible for maintaining of training records in consultation with
Technical Manager.
 To prepare records of technical training of the employees.
 To identify the corrective action based on the analysis of complaints.
 To do data analysis and identify fruitful results for the further improvement.
 To conduct the analysis of customer feedback and to identify the customer
satisfaction level.
 Overall responsible for establishing and maintaining of system based on ISO/IEC
17025.
 To review and authorize daily records of the laboratory.

Authority

 To stop the activity, if found any non–conformity related to testing,


accommodation and environment.
 To review all the non–conformities raised during the audit and issue report to the
auditee for taking actions.
 To approve the actions taken by the auditee as a basis to resolve non–
conformities.
 To suggest corrective actions related to the system improvement.
 To monitor whole documented system and suggest preventive actions, if anything
goes wrong
 To review and authorize the Test Report before it is issued to the customer.

Responsibility and authority of Junior Chemist / Technical Manager

Responsibility

 To ensure that the documented test methods / reference standards are followed
during the testing.
 To prepare plan and to follow the requirements for ensuring the validity of
results.
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GROUNDWATER SURVEYS & DEVELOPMENT AGENCY, KONKAN REGION
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 To ensure that proper accommodation and environment is maintained in the


testing area as per the requirements of the relevant test standards.
 To initiate corrective actions based on the feedback of the testing activities.
 To ensure periodic monitoring of the environment to maintain records as per the
documented procedure.
 To ensure that all the available literatures, including manufacturers manual, are
maintained.
 To prepare preventive maintenance schedule and intermediate checks schedule
for all the instruments and to ensure that the employees follow the same.
 To verify and review test records.
 To ensure that calibration of all the equipments are traceable to the national /
international standards and having valid relationship & to re–calibrate the
equipment’s used in the testing before the validity expires.
 To ensure optimum use of available resources.
 To ensure that the proper records are maintained at all stages of testing and
quality control.
 To review and authorize daily records of the laboratory.
 To ensure safe and proper handling of the samples/materials in the laboratory.
 To provide technical training to the testing personnel, as identified.
 To ensure that uncertainty of measurement is calculated periodically for each test
parameter.
 To identify or receive the requirements for consumable purchase from the
concerned employees and to procure the same.
 To handle all the complaint and analyse the same.

Authority
 To review and authorize the routine records of the laboratory.
 To review and authorize the Test Report before it is issued to the customer.
 To review and approve records of employees’ competence, skills, etc.
 To review Calibration Certificates of equipments, received from the outside
calibration agency.
 To stop the testing activities, if proper environment condition is not maintained
and achieved.
 To take corrective actions identified based on analysis, related to the complaint
or results of testing.

Responsibility and authority of Chemist/testing personnel

Responsibility

 To check the physical condition of samples received for testing.


 To make sample ready for testing as per the defined test method.
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 To do testing of samples as per the documented test method given in the related
Standards.
 To use equipments for testing as referred in the related Standards.
 To ensure that the test methods / Standards for testing are available where
testing activities are performed.
 To conduct the uncertainty of measurement of the samples as per the defined
periodicity for the identified parameters.
 To ensure that all required information related to test conducted is adequately
available in the print–out or on the display of computer for High Volume
Instrument. Also to ensure that the test data related to water testing is available
in raw data sheet.
 To ensure that raw data sheet are reviewed by Quality or Technical Manager.
 To ensure that the equipment used for testing is having valid calibration.
 To conduct preventive maintenance of the equipments.
 To initiate proficienct testing/inter–laboratory comparison and to evaluate the
results.
 To handle breakdown maintenance of the equipment, as soon as possible.
 To place the remaining samples retained for the re–test in the sample
preservation area and ensure that the sample is preserved for specified retention
period. However, it may be stored for longer period, if required.
 To ensure proper disposal of the sample after retention period as well as after
testing, after receipt of approval from the Technical Manager.
 To ensure that the proper records are maintained at all stages of testing and
ensuring the validity of results.
 To monitor the environment condition regularly and record the same periodically
during the testing activities are carried–out.
 To handle the samples throughout the testing and preservation in such a way that
it does not create any problem in testing.
 To ensure stringent follow–up of the ISO/IEC 17025 system in the lab.
 To analyse the complaint by reviewing the related records as per the complaint
given by the Technical Manager.
 To report to the Technical Manager on day–to–day functioning / activities.

Authority

 To stop the testing activities, if proper environment condition is not maintained /


achieved

6.0 RESOURCE REQUIREMENTS

6.1 General
RWTL, KR has qualified and competent personnel, facilities, equipment, systems and
support services necessary to manage and perform laboratory activities.
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6.2 Personnel

6.2.1 Management ensures the competency of all the personnel of the Laboratory
performing analysis, writing test report, operating equipment and performing technical
and administrative review. All personnel of the laboratory act impartially and are
competent and work in accordance with the laboratory’s management system.

6.2.2 Laboratory personnel performing testing is science graduate in Chemistry with


more than 3 year’s relevant experience in relevant field of testing. Authorized signatory
is post graduate in science [relevant branch] with more than 1 year of relevant
experience. Assistant Chemist is an in charge of Laboratory holding post-graduation
degree in Chemistry with 19 year’s experience in testing work of the laboratory. He/she
is assisted by Junior Chemist rank officers, post graduate in Chemistry with 18 years of
experience in relevant field of testing, one Laboratory Assistant, science graduate with
14 years of experience and one Lab Attendant. The Directorate, G.S.D.A appoints Junior
Chemist as per the Recruitment Rules only after conforming appropriate education,
experience and skills. Chemists have education, training and experience commensurate
with their duties for positions in which specific requirements have been established by
governing body. In addition Contract/Outsource staff are also working in RWTL,KR.

Laboratory send its technical staff for training program organized by G.S.D.A or other
organizations to ensure that individuals have the knowledge, skill, and ability needed to
perform various tests. Appropriate supervision is provided by Deputy
Director/Assistant Chemist for employees undergoing training or contract chemist.

6.2.3 The Management ensures that the personnel have the competency to perform
laboratory activities for which they are responsible and to evaluate the significance of
deviations by deploying personnel who have qualification and experience in the relevant
area as mentioned in 6.2.2 above.

6.2.4 The management of the laboratory communicates to personnel their duties,


responsibilities and authorities in the job descriptions and specifications.

6.2.5 RWTL, KR has procedure for the personnel and training and retains records for:
a. Determining the competence requirements, considering the requirements of relevant
test parameters covered under the scope of accreditation;
b. Selection of personnel for all activities carried–out by laboratory;
c. Training of personnel considering the skill and competence requirements;
d. Supervision of personnel;
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e. Authorization of personnel based on the skill and competence;


f. Monitoring of competence of personnel.

6.2.6 RWTL, KR has authorized specific personnel to perform specific laboratory


activities, including but not limited to, the following:.
a. Verification of methods,
b. Analysis of results,
c. Specific personnel are authorized for report, review and authorize results, signing of
report.

Reference documents
SOP/6.2 SOP for Personnel skill improvement through training.

6.3 Facilities and environmental conditions


6.3.1 RWTL, KR has provided the required facilitates and environmental conditions
suitable for the testing laboratory activities, considering the tests carried–out, and it is
ensured that it does not adversely affect the validity of results. The following parameters
are controlled considering the validity of test results, such as dust, humidity, electrical
supply, temperature. The following conditions are maintained in the laboratory.
S.N. Parameter Limits
1 Temperature in °C 25 °C ± 3 °C
2 Humidity in % RH 55 % RH ± 15 % RH

6.3.2 The requirements for facilities and environmental conditions (as above) necessary
for the performance of the laboratory activities are documented.
6.3.3 RWTL, KR monitors, controls and records environmental conditions in
accordance with relevant specifications, methods or procedure or where they influence
the validity of the results. The records of environmental condition monitoring are
maintained
6.3.4 RWTL, KR Measures to control facilities are implemented, monitored and
reviewed at every month and these include, but not limited to:
a) Access to and use of areas affecting mobile laboratory activities;
b) Prevention of contamination, interference or adverse influences on mobile laboratory
activities;
c) Effective separation between areas with incompatible mobile laboratory activities.
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6.3.5 Site testing is not done by RWTL, KR and hence requirement of site testing is not
applicable. The facilities provided at laboratory are already documented in 6.3.1 to 6.3.4.

Reference documents
SOP/6.3 SOP for Housekeeping, safety & environmental control.

6.4 Equipment

6.4.1 RWTL, KR has access to equipment including, but not limited to, measuring
instruments, measurement standards, reference materials, reference data, reagents,
consumables or auxiliary apparatus, which is required for the correct performance of
laboratory activities and which can influence the result. Reference materials from
producers meeting the requirements of ISO 17034 come with a product information
sheet / certificate that specifies, amongst other characteristics, homogeneity and
stability for specified properties and, for certified reference materials, specified
properties with certified values, their associated measurement uncertainty and
metrological traceability.

6.4.2 No equipment is used outside the permanent control of mobile laboratory and
hence a requirement of this clause is not applicable.

6.4.3 RWTL, KR follows prescribed procedures for handling, transport, storage, use
and maintenance of equipment to ensure proper functioning and in order to prevent
contamination or deterioration. It is strictly followed by all persons, during routine
activities. (SOP/6.4).

6.4.4 RWTL, KR verifies that equipment conforms to specified requirements before


being placed or returned into service. The details of checks conducted are recorded in
the equipment history card. Equipment history cards are maintained for all the
equipments used in the testing.

6.4.5 The equipment used for measurement is capable of achieving the measurement
accuracy and/or measurement uncertainty required to provide a valid result.

6.4.6 Laboratory equipment’s are calibrated to ensure the measurement accuracy


and/or measurement uncertainty required to provide a valid result. Calibrated
equipment establishes the metrological traceability of the reported results. On each
equipment, the calibration status is indicated.
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6.4.7 The Laboratory has calibration program which is been reviewed and adjusted as
necessary in order to maintain confidence in the status of calibration.

6.4.8 Equipment that requires calibration is labelled to indicate the status of its
calibration whenever practical. Calibration Status displays:
a) Name and make of the equipment
b) Calibrated on
c) Calibrated by
d) Due date of next calibration

6.4.9 Equipment that has been subjected to overloading or mishandling, gives suspected
results, or has been to be defective or outside specified limits, is taken out of service, and
clearly marked until it has been repaired and demonstrated to perform correctly. The
effect of the defect or departure from the specified limits on previous tests examination
is evaluated and the laboratory initiates the control of nonconforming work policy and
procedure if it is determined that the equipment defect or departure could have
adversely affected the result of analysis.

6.4.10 when intermediate checks and/or performance verification are needed to


maintain confidence in the status of equipment these checks are carried out in
accordance with the related quality procedure and the appropriate analytical method.
Records of such intermediate checks are maintained

6.4.11 When calibration and reference material data include reference values or
correction factors, RWTL, KR ensures the reference values and correction factors are
updated and implemented, as appropriate, to meet specified requirements.

6.4.12 RWTL, KR takes practicable measures to prevent unintended adjustments of


equipment from invalidating results

6.4.13 Records are retained for equipment that can influence laboratory activities in
the equipment history card, preventive maintenance schedule and calibration status of
equipments. The records include the following, where applicable:

a) The identity of equipment (name of equipment), including software and firmware


version;
b) The manufacturer's name, type identification, and serial number or other unique
identification;

c) Evidence of verification that equipment conforms with specified requirements;


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d) The current location;

e) Calibration dates, results of calibrations, adjustments, acceptance criteria, and the due
date of the next calibration or the calibration interval;

f) Documentation of reference materials, results, acceptance criteria, relevant dates and


the period of validity;

g) The maintenance plan and maintenance carried–out to date, where relevant to the
performance of the equipment;

h) Details of any damage, malfunction, modification to, or repair of, the equipment.

Reference documents
SOP/6.4 Procurement, Handling and Maintenance of Equipment
SOP/7.6 SOP for Measurement Uncertainty.

6.5 Metrological traceability

6.5.1 RWTL, KR has established and maintained metrological traceability of its


measurement results by means of a documented unbroken chain of calibrations, each
contributing to the measurement uncertainty, linking them to an appropriate reference.
All equipment used for testing, including equipment for subsidiary measurements (e.g.
for environmental conditions), having a significant effect on the accuracy or validity of
the results, are calibrated before being put into service. RWTL, KR has an established
program and procedure for the calibration of equipment, procedure is established and
implemented. The procedure covers details like selection, use, calibration, checking,
controlling, and maintenance of measurement standards, and reference standards for
measuring equipment..

Laboratory uses External calibration services that are NABL accredited to calibrate the
designated measuring equipment meet the requirement of traceability. Calibrations
certificates issued by calibrated laboratory contain measuring results, including the
measurement uncertainty and/or a statement of compliance with an identified
metrological specification.

6.5.2 RWTL, KR ensures that measurement results are traceable to the International
System of Units (SI) through ensuring the followings:
a) Calibration provided by a competent laboratory (ISO/IEC 17025 accredited
calibration laboratory);
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b) Certified values of certified reference materials provided by a competent producer


(ISO 17034 accredited CRM producer or by committee) with stated metrological
traceability to the SI;
c) Direct realization of the SI units ensured by comparison, directly or indirectly, with
national or international standards..
The Laboratory uses the certified reference material (CRMs) as reference standard
traceable to National Institute of Standards and Technology (NIST). These CRMs are
used only for calibration of testing Equipment used in laboratory and is sure enough to
use these CRMs up to the date of its shelf life as fixed by suppliers. The CRMs are
accompanied by certificate of analysis which authenticates these reference standards.

6.5.3 A reference material is a homogenous and well characterized substance used for
standardization of equipment used in the testing process. Reference materials are
traceable to national or international standard reference materials (SRMs), such as
National Institute of Standards and Technology (NIST), or certified reference materials
(CRMs) from competent suppliers of reference materials.
When metrological traceability to the SI Units is not technically possible, the laboratory
demonstrates metrological traceability to an appropriate reference
a] certified values of certified reference material provided by a competent producer.
b] results of reference measurement procedures, specified methods or consensus
standards that are clearly described and accepted as providing measurement results fit
for their intended use and ensured by suitable comparison
Intermediate checks:
Intermediate checks are carried out to maintain the confidence in the calibration status
of reference standard and reference material in accordance with the defined procedure.
The material received as CRM/SRM is identified by qualitative test.

Reference documents
SOP/6.5 SOP for Calibration & traceability.

6.6 Externally provided products and services

6.6.1 RWTL, KR ensures that only suitable externally provided supplies, reagents and
consumable materials and services that affect the quality of tests are used. Government
of Maharashtra/ Departmental policies/guidelines pertaining to purchases are adhered
to in the selection and purchasing of services and supplies, reception, storage of critical
consumables relevant for services.
The laboratory ensures that purchase documents for items affecting quality of output
contains data describing the services and supplies ordered and the purchase documents
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are reviewed and approved for technical content prior to release as per departmental
policies/guidelines.
The laboratory maintains a uniform unbiased procedure as per rules of Govt. of
Maharashtra regarding purchasing equipment’s, chemicals, reagent and supplies, of
appropriate design, quality and grade to maintain quality in analysis. Purchase and
procurement of instruments/chemicals/glassware/stationeries and maintenance of the
same are done.
Laboratory requires following types of supplies
1. Chemicals/ Certified & Secondary Reference Material, Glassware and Accessories.
2. Equipment’s including major, semi-major, minor and ancillary equipment’s.
Laboratory requires following types of services
1. facility and equipment maintenance services;
2. Calibration services;
3. Training of personnel by outside institutes.
4. Testing services/ Proficiency testing services
5. Assessment and auditing services.
Purchasing process is governed by Government of Maharashtra guidelines. The
procedure for purchase is described in the (SOP/6.6). All the purchase of supplies and
services which are required for the functioning of Laboratory are done as per Industries,
Energy and Labor Department government resolution Dated 01/12/2016 and Dated
24/08/2017.

Laboratory has provision for externally provided services, which is given to only other
laboratories under groundwater surveys and development agency, which are accredited
as per ISO/IEC 17025: 2017 and having the specific parameters under their NABL scope.
The consent of the customer will be taken prior to subcontracting of test work either in
writing or telephonically. The above procedure also describes sub-contracting of
test/work.

Laboratory subcontracts Testing work to NABL accredited laboratories,


a) When work load is too high in Laboratory;
b) Sudden break down of equipment;
c) Lack of manpower; etc.;
d) CRM/SRM not available in ready stock;
e) Any unforeseen reason beyond appearance.

6.6.2 The laboratory has implemented procedure for:

a) Defining, reviewing and approving the laboratory’s requirements for externally


provided products and services, reagent and consumable materials.
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a) Defining the criteria for evaluation of suppliers of critical consumables, supplies


and services which affect the quality of test.
b) Ensuring that purchased supplies and reagents and consumables materials that
affect the quality of tests are not used until they have been inspected, their
performance monitored or otherwise verified complying the defined requirements,
before they are used or provided to the customer;
c) Taking any actions arising from evaluations, monitoring of performance and re–
evaluations of the external providers.

6.6.3 The laboratory communicates its requirements to external providers for:

a) Products and services to be provided;


a) Acceptance criteria;
b) Competence, including any required qualification of personnel;
c) Activities that the laboratory, or its customer, intends to perform at the external
provider's premises.
All the above details are incorporated in the Purchase Order and then the purchase
order is approved by Deputy Director before its issue to Approved External Provider.

Reference documents
SOP/6.6 SOP for Management of externally provided Products & Services.

7.0 PROCESS REQUIREMENTS

7.1 Review of requests, tenders and contracts

7.1.1 Procedure has been implemented for review of requests, tenders and contracts
and for feasibility of delivering service in conformity to customer requirements. Quality
Head is authorized to review requests, tenders and contracts. The procedure leads to a
contract for Testing and ensure that:
a) Requirements, methods are adequately defined, documented and understood;
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a) The laboratory has the capability and resources to meet the requirements;

b) When sample is sub-contracted to external providers, Laboratory ensures the


following,

 Work to be placed with competent external provider who complies with


ISO/IEC/17025:2017 requirements.

 The customer is adequately informed /advised about the lab activities that
will be performed by the external provider.

 Take approval of the customer in writing.

 Maintain record of all external providers used for test works and record of
the evidence of compliance.

c) The appropriate methods or procedures are selected and are capable of meeting
the customers' requirements.
7.1.2 Appropriate test methods are selected to meet the customer‘s requirements. When
the method requested by the customer is considered to be inappropriate or out of date
the customer is immediately informed by RWTL, KR.

7.1.3 The decision rule and a statement of conformity.is not given by RWTL, KR.

7.1.4 The Laboratory ensures that the contract is acceptable to customer and the
Laboratory. Deviations are normally not allowed, if they impact integrity of the
Laboratory or the validity of test results.

7.1.5 RWTL, KR informs customer of any deviation from the contract.

7.1.6 If a contract is amended after work has commenced, the contract review is
repeated and if any amendments is done it is communicated to all affected personnel.

7.1.7 The laboratory personnel are technically competent in providing necessary


guidance, which include providing clarification to customer quires on service needs.
Whenever required additional information/Clarifications are sought by Laboratory.
Customer is also given access to relevant lab areas to witness execution of their job on
need-to-basis.

7.1.8 Records of reviews, including any significant discussions with customer relating
to his requirements are maintained by RWTL, KR .

Reference documents
SOP/7.1 Procedure for Review of requests, tenders and contracts
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7.2 Selection, verification and validation of methods

7.2.1 Selection and verification of methods

7.2.1.1 RWTL, KR uses appropriate methods and procedures for all laboratory activities
(testing work carried–out for the parameter’s covered under the scope of accreditation)
and, where appropriate, for evaluation of the measurement uncertainty as well as
statistical techniques for analysis of data. These also include handling, transport, storage,
and preparation of items to be tested..

7.2.1.2 All methods, procedures and supporting documentation, such as instructions,


standards, manuals and reference data relevant to the laboratory activities, are kept up–
to–date and are made readily available to personnel, where the laboratory activities are
carried–out.

7.2.1.3 It is ensured that, the latest valid version of a method is used during the
laboratory activities, unless it is not appropriate or possible to do so. When necessary,
the application of the method is supplemented with additional details to ensure
consistent application. RWTL, KR uses Indian Standards/ International Standards or
other recognized specifications that contain sufficient and concise information on how to
perform laboratory activities. The copies of those standards are being issued to
laboratory personnel for conducting the laboratory activities. For smooth operation,
additional documentation for optional steps in the method or additional details are
provided considering the equipment to be used for the laboratory activities for
maintaining accuracy in the laboratory activities. Method prepared, documented and
issued for implementation are having following
information as minimum:
a) Identification No.,
b) Scope of activity,
c) Description of item to be tested,
d) Parameters etc.,
e) Equipment requirements, including technical performance requirements,
f) Reference of standards / materials on which basis the method is prepared,
g) Sample preservation methods / condition,
h) Description of Test Method, including
i. Checks to be done before commencement of testing
ii. Method for recording observation / print–out from the equipment
iii. Safety precautions to be taken before and during testing
i) Criteria for “Conformance / Compliance or Non–conformance / Non–compliance” are
provided based on acceptance norms as agreed with customer.
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j) Test Report preparation method.

7.2.1.4 When the customer does not specify the method to be used, the laboratory
selects an appropriate method (considering the samples under the test and its test
parameters) from the scope of accreditation and informs the customer of the method
chosen. The details of method selected for the test is clearly identified. Methods
published either in Indian Standards / International Standard, or by reputable technical
organizations, or in relevant scientific texts or journals, or as specified by the
manufacturer of the equipment is recommended. Laboratory–developed or modified
methods are not used in the laboratory activities performed by RWTL, KR.
All analytical methods are documented and available to the laboratory personnel. The
chemists of RWTL, KR can exercise discretion in selecting the analytical method most
appropriate to the sample being examined.

7.2.1.5 The laboratory verify that it can properly perform methods before introducing
them by ensuring that it can achieve the required performance. Records of the
verification are retained. If the method is revised by the issuing body, verification is
repeated considering its impact on the accuracy of the test results.

7.2.1.6 RWTL, KR uses only Standard Valid Methods.

7.2.1.7 Deviations from test methods are documented, technically justified, authorized,
and where circumstances call for it, accepted by the customer.

7.2.2 Validation of methods

7.2.2.1 The Laboratory use only valid Indian Standards / International Standard (APHA
Methods) considering the samples under the test and its test parameters. The valid
Method used is verified and the record of Verification of Method is maintained by the
Laboratory.

7.2.2.2 No changes are made to validated methods,


7.2.2.3 RWTL, KR is not involved in Method Validation.
7.2.2.4 This clause is not applicable

7.3Sampling

RWTL, KR is not doing sampling of samples. Samples are received from customer at our
regional water testing laboratory and hence a requirement of this clause is not
applicable.
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7.4 Handling of test or calibration items

7.4.1 RWTL,KR have procedure (SOP/7.4), describes the receipt, processing (handling),
protection, storage, retention and disposal of samples. This procedure addresses the
laboratory activities conducted to protect sample integrity and to protect the interests of
the laboratory and the customer. Precautions is taken to avoid deterioration,
contamination, loss or damage to the sample during handling, storing/waiting, and
preparation for testing

7.4.2 RWTL,KR has a system for uniquely identifying samples. The sample number is
used to track its progress from the time the sample is received until the analysis is
completed and the sample is disposed. The sample number is also used to provide
traceability between the sample and the data.

7.4.3 Upon receipt of the sample, abnormalities or departures from normal or specified
conditions are recorded. When samples received do not meet established acceptance
criteria, laboratory personnel consult the customer for further instructions before
proceeding. Register is maintained When the customer requires the sample to be
acknowledging a deviation from specified conditions, the laboratory include a disclaimer
in the report indicating which results may be affected by the deviation.

7.4.4 RWTL,KR has appropriate facilities and quality procedures for avoiding
deterioration, loss or damage of sample during storage, handling and preparation for
analysis. Submitted samples are stored in a designated area until taken for analysis.
Handling instructions for water samples will be followed. Lab implements quality procedures for storage
and security of samples that protect the integrity of sample in its control.
Reference documents
SOP/7.4 SOP for Handling of Test sample

7.5 Technical records


7.5.1 RWTL,KR retains original records of observation, calculations, derived data,
information to establish an audit trail, and the original or copy of each test report. If
possible, the records for each examination contain significant information to facilitate
identification of factors affecting the uncertainty and to enable examinations to be
repeated under conditions as close as possible to the original. These records include
identification of personnel responsible for sampling, performing each examination/test
and checking results. Observation, data and calculations are recorded at the time they are
made and are identifiable to a specific test. If original observations are handwritten, it is
acceptable to translate the handwritten observations to an electronic form, but the
original handwritten observations must also be maintained as part of the test record.
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7.5.2 RWTL,KR ensures that amendments to technical records can be tracked to


previous versions or to original observations. Both the original and amended data and
files are kept, including the date of alteration, an indication of the altered aspects and the
personnel responsible for the alterations. When mistakes occur in records, each mistake
is crossed–out and not erased, made illegible or deleted, and the correct value is entered
alongside. All such alterations to records are signed or initiated by the person making
the correction. In the case of records stored electronically, possible care is taken to
prevent loss or change in the original data.

7.6 Evaluation of measurement uncertainty

7.6.1 Laboratory is committed to measure and report the uncertainty of measurement as


per the requirement of the certification body.
7.6.2 Being a testing laboratory, the requirements of this clause is not applicable.
7.6.3 Laboratory has created and implements a quality procedure to estimate
uncertainties of measurement for quantitative analysis results which appear in the
examination reports except when the analytical methods precludes such rigorous
calculations (SOP/7.6). In certain cases, a valid estimation of uncertainty of
measurement is not possible. In these cases, Laboratory attempts to identify all the
components of uncertainty and make the best possible estimation, and ensure that the
form of reporting does not give an exaggerated impression of accuracy. Rescannable
estimation is based on knowledge of the performance of the analytical method and on
the measurement scope and makes use of previous experience and validation data.
Eurachem guide is used as the guide for measurement of uncertainty for tests.
Reference documents
SOP/7.6 SOP for Evaluation of measurement uncertainty

7.7 Ensuring the validity of results

7.7.1 The laboratory implements quality procedures that are utilized to monitor the
reliability, validity of testing results. The resulting data is recorded and maintained so
that trends are detectable overtime. Analytical testing is monitored using quality
controls appropriate to the examinations. The range of quality control activities
employed by RWTL, KR includes, but is not necessarily limited to the following:

a) Use of reference materials or quality control materials;


a) Use of alternative instrumentation that has been calibrated to provide traceable
results;
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b) Functional check(s) of measuring and testing equipment;


c) Use of check or working standards with control charts, where applicable;
d) Intermediate checks on measuring equipment;
e) Replicate tests or calibrations using the same or different methods;
f) Retesting or recalibration of retained items;
g) Correlation of results for different characteristics of an item;
h) Review of reported results;
i) Intra laboratory comparisons;
j) Testing of blind sample(s).

7.7.2 The laboratory monitor’s its performance by comparison with results of other
laboratories, where available and appropriate. This monitoring is planned, reviewed and
have included, but not be limited to, either or both of the following:
a) Participation in proficiency testing;
a) Participation in inter laboratory comparisons other than proficiency testing.

7.7.3 The laboratory has defined the criteria for quality control data and performs
analysis by such means as control charting. When data is found to be outside the
established criteria, action is taken in accordance with the laboratory’s control of non-
conforming work procedure.

Reference documents
SOP/7.7 SOP for Validity of Results / Quality Control

7.8 Reporting of results

7.8.1 General

7.8.1.1 The results obtained in testing of sample’s are reviewed and authorized prior to
release.

7.8.1.2 Each examination is reported clearly, accurately, objectively and unambiguously


as is possible within the constraints of scientific knowledge/ opinion and in accordance
with any specific instructions in the analytical method.

Results of examination are reported in a Laboratory Test Report. Reports include all
information necessary to interpret results along with other information’s that may be
required. Test reports are issued as hard copy.

7.8.1.3 Customers implicitly agree to Laboratory Test Report format and content when
they submit samples for testing. Laboratory chooses to include some information
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required by ISO/IEC 17025:2017 (E) in the report. Laboratory does not use simplified
reporting.

7.8.2 Common requirements for reports (test, calibration or sampling)


7.8.2.1 Laboratory test report include the following information,

a) a title (e.g. “Water Analysis Test Report”);


a) the name and address of the laboratory;
b) the location of performance of the laboratory activities,
c) unique identification that all its components are recognized as a portion of a
complete report and a clear identification of the end;
d) the name and contact information of the customer;
e) identification of the method used;
f) a description, the condition of the item;
g) the date of receipt of the test, and the date of sampling[provided by customer],
h) the date(s) of performance of the laboratory activity;
i) the date of issue of the report;
j) the results with, where appropriate, the units of measurement;
k) identification of the person(s) authorizing the report;
l) Clear identification when results are from external providers.

7.8.2.2 The laboratory takes responsibility for all the information provided in the
report, except when information is provided by the customer. Data provided by a
customer is clearly identified. In addition, a note is put on the report when the
information is supplied by the customer and can affect the validity of results. Where the
laboratory has not been responsible for the sampling stage (e.g. the sample has been
provided by the customer), it is state in the report that the results apply to the sample as
received.

7.8.3 Specific requirements for test reports


7.8.3.1 Laboratory maintain record of environmental conditions like temperature,
Humidity while analyzing the sample’s the measurement uncertainty is also recorded all
the information affects the conformity to a specification limit. While interpretation of the
test results the information is available with Laboratory.

7.8.3.2 As sampling is not done, hence requirement of this clause is not applicable
7.8.4 Specific requirements for calibration certificates

Being a testing laboratory the requirement of this clause & sub clauses from 7.8.4.1 to
7.8.4.3 are not applicable to RWTL, KR.
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7.8.5 Reporting sampling-specification requirements

As sampling is not done, hence requirement of this clause is not applicable .

7.8.6 Reporting statements of conformity

7.8.6.1 RWTL,KR does not provide any statement of conformity to a specification or


standard in its analysis report.

7.8.7 Reporting opinions and interpretations

Though RWTL, KR does not express opinions and interpretations, the requirement of this
clause & sub clauses from 7.8.7.1 to 7.8.7.3 are not applicable to RWTL, KR.

7.8.8 Amendments to reports


7.8.8.1 When Laboratory changes, amends or re-issues an issued report, the change of
information and the reason for change is included in the report.

7.8.8.2 Material amendments to analytical findings after issue are made only in the form
of an additional document. They are flagged “Corrigendum” and include the change of
information and the reason for change. Amendments are to meet the same reporting
criteria.

7.8.8.3 When it is necessary to issue a complete new report, it is uniquely identified and
contains reference to the original report that it replaces.

7.9 Complaints

7.9.1 The laboratory has a documented procedure to receive, evaluate and make
decisions on complaints.

7.9.2 Laboratory has complaint handling process and it is made available to any
interested party on request. Upon receipt of a complaint, the laboratory confirms
whether the complaint relates to laboratory activities that it is responsible for and, if so,
it deal with it. The laboratory is responsible for all decisions at all levels of the handling
process for complaints. The handling of complaints is described in detail. (SOP/7.9).
7.9.3 The process for handling complaints includes the following elements and methods:
a) Description of the process for receiving, validating, investigating the complaint,
and deciding what actions are to be taken in response to it;
a) Tracking and recording complaints, including actions undertaken to resolve
them;
b) Ensuring that any appropriate action is taken.
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7.9.4 RWTL, KR on receiving the complaint, is responsible for gathering and verifying all
necessary information to validate the complaint.
7.9.5 Laboratory acknowledges receipt of the complaint, and provides the complainant
with progress reports and the outcome.

7.9.6 The outcomes to be communicated to the complainant is reviewed and approved


by, Deputy Director [Office Head] GSDA, Konkan.

7.9.7 Laboratory give’s formal notice of the end of the complaint handling to the
complainant.
Reference documents
SOP/7.9 SOP for Complaints & Customer feedback.

7.10 Nonconforming work

7.10.1 The laboratory has implemented a procedure for Handling/managing non-


conforming work, Evaluation of the significance of the non-conforming work is made in
accordance with the procedure, followed by corrective action. The procedure ensures
that:

a) the responsibilities and authorities for the management of nonconforming work


are defined;
a) actions (including halting or repeating of work and withholding of reports, as
necessary) are based upon the risk levels established by the laboratory;
b) an evaluation is made of the significance of the nonconforming work, including
an impact analysis on previous results;
c) a decision is taken on the acceptability of the nonconforming work;
d) where necessary, the customer is notified and work is recalled;
e) the responsibility for authorizing the resumption of work is defined.

7.10.2 The laboratory has retained records of nonconforming work and actions as
specified in 7.10.1, [b to f].

7.10.3 Where the evaluation indicates that the nonconforming work could recur or that
there is doubt about the conformity of the laboratory's operations with its own
management system, the laboratory implements corrective action against the
nonconforming work.
Reference documents
SOP/7.10 SOP for Control of Nonconformance, corrective action.
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7.11 Control of data and information management

7.11.1 The laboratory has access to the data and information needed to perform
laboratory activities through various electronic and paper records maintained according
to SOP/8.4, Record and data management.

7.11.2 When computers or automated equipment are used for the acquisition,
processing, recording, reporting, storage or retrieval of test or calibration data, the
laboratory ensures that computer software developed by the user is documented in
sufficient detail and is suitably validated as being adequate for use.
7.11.3 The Laboratory has process for the protection of data to include, but not limited
to data integrity, data confidentiality during entry, collection, storage, transmission and
processing. The processes also ensure safeguards are in place to prevent unauthorized
access to or amendment of records. The process is detailed in procedure.

7.11.4 The information management system is managed and maintained by Laboratory


itself.

7.11.5 The Laboratory ensures that instructions, manuals and reference data relevant to
the information system are available to laboratory personnel through the document
control process (see section 8.3).

7.11.6 Calculations and data transfers are reviewed before the data is reported. All
changes are identified and verified where they occur. This process is detailed in the
procedure for laboratory quality control identified in section 7.7, Ensuring the Validity
of Results.

8.0 MANAGEMENT SYSTEM REQUIREMENTS


8.1 Options

8.1.1 General
The laboratory management system is outlined in the following documents:

8.1.1.1 Quality manual,

8.1.1.2 Written procedures,

8.1.1.3 Document, Records, Reports, Formats, Forms etc.

This management system is established to address the requirements in ISO/IEC


17025:2017 and assuring the quality of laboratory results. In addition to meeting the
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requirements of clauses 4 to 7, RWTL, KR has implemented a management system in


accordance to option A.

8.1.2 Option A: The Laboratory follows the requirements for option A, outlined in
the following sections 8.2 to 8.9.

8.1.3 Option B RWTL,KR has implemented the requirements of Option A, and hence,
requirements of this clause are not applicable.

8.2 Management system documentation (Option A)

8.2.1 RWTL, KR has established, documented, and maintained policies and objectives
for the fulfillment of the purpose of ISO/IEC 17025 and ensures that the policies and
objectives are acknowledged and implemented at all levels of the laboratory
organization. The detailed Quality Policy is given as below.

8.2.2 The policies and objectives address the competence, impartiality and consistent
Operation of the laboratory.

8.2.3 The policies for operation of the laboratory management system are established to
address the requirements of ISO/IEC 17025:2017. Laboratory is committed to
laboratory accreditation as per the requirements of ISO/IEC 17025:2017. The
implementation of the quality policies is evidenced by the way work activities are
conducted. Implementation of the management system procedures is evidenced by the
generation of required records. The audit and management review activities are the
mechanisms that are used to monitor the implementation effort of the laboratory
management system.
Evidence of management’s commitment to the management system and its continual
improvement in effectiveness is demonstrated by but not limited to participation of
managers in the management reviews, performance of internal audits, proficiency
testing, and the analysis of quality control samples.

8.2.4 Management system documents, procedures, records supporting quality policies


related to the fulfillment of the requirements of ISO/IEC 17025:2017 are cited in related
section of this document and linked to the management system. The hierarchy of
documentation prepared, implemented and cross– referred in the lab are as under;

Tier Name of Document Cross–referred in


I Quality Manual ---
II Quality Procedure Standard Operating Procedure [SOP]
III Document, Records, Reports, Quality Manual, Quality Procedures and Work
Formats, Forms etc. Instructions/Test Methods
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8.2.5 All laboratory employees involved in laboratory activities have access to approved
and controlled consensus standards, instrument manufacturers’ manuals, and
procedures for reference ensuring consistent application and validity of activities that
contribute toward results reported.

8.3 Control of management system documents (Option A)

8.3.1 The Laboratory controls the documents, both internal and external, that relate to
the fulfillment of ISO/IEC 17025:2017. RWTL, KR has established and maintained
procedure (SOP/8.3) to control all documents that have formed part of the management
system, such as standards, normative reference, test methods, specifications,
instructions, manuals and other used as reference are covered in the document control
system.

Internal documents All documents prepared by the RWTL,KR to fulfill the requirements
of ISO/IEC17025 as well as other reference standards.
External documents Customer documents Indian Standard
Supplier documents International Standard
Manufacturer’s manual Testing guidelines

8.3.2 Laboratories Document control requirements:

a. All documents issued to personnel in the laboratory as part of the management system
are reviewed and approved for use by authorized personnel prior to issue as per the
details given below. A master list and distribution list of documents is maintained for all
tiers of documents, showing current revision status and distribution of documents.

Responsibility Matrix For Documents


Authority to
Prepare Review/ Approve/ Issue Maintaining
Verify Authorize Master list
and issuing as
per
distribution
1. Quality manual Technical Quality C.E.O Quality Quality
Manager Manager Manager Manager

2. Quality procedure Technical Quality C.E.O Quality Quality


Manager Manager Manager Manager

3. Applicable --- Quality --- --- Quality


reference standards Manager Manager
(external)
4. Formats, work Technical Quality C.E.O Quality Quality
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instructions Manager Manager Manager Manager


5. Exhibits, reference
documents and data
6. Customer --- Quality Quality --- Quality
specifications, and Manager Manager Manager
documents of
external origin

b. all documents are reviewed every year and, where necessary, are revised to ensure
continuing suitability and conformance with the management system and ISO/IEC
17025 requirements; documented information is retained for such periodic review of
documents;
c. changes/ amendments done in any documents are identified; the altered or new text is
identified by underlining the text and deletion is identified by striking of text. Current
version status of the document is identified in the document header the procedure for
change of documents is described in the SOP/8.3;
d. authorized management system documents and external documents are available at
locations where operations essential to the effective functioning of the laboratory are
performed. Distribution and locale of these documents is controlled.
e. documents are uniquely identified. Such identification includes the identification
number, revision status and inclusive pagination. The issuing authority is indicated by
the name of the approving official for each document;
f. Invalid or obsolete documents are promptly removed from all points of issue or use, or
marked as Uncontrolled to assure against unintended use. Obsolete documents retained
for either legal or knowledge preservation purposes are suitably marked such as
Obsolete.

All documents are identified by unique document numbering system as per the details
given below:
Numbering System for Documents
QM/X.X
A QM Quality Manual
XX Stands for continuous sl. no. of Manual
SOP/X.X
B SOP Standard Operation Procedure
XX Stands for continuous sl. no. of Clauses as per ISO 17025:2017
Documents
C QSD Documents
XX Stands for continuous sl. no. of Clauses as per ISO 17025:2017
Records
D QR Records
XX Stands for continuous sl. no. of Clauses as per ISO 17025:2017
Formats
E F Formats
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XX Stands for continuous sl. no. of Clauses as per ISO 17025:2017


Work Instructions
F WI Work Instructions

Reference documents
SOP/8.3 SOP for document control

8.4 Control of records (Option A)

8.4.1 All records are legible and retained in such a way that they are readily retrievable
in facilities that provide a suitable environment to prevent damage, deterioration and
loss. Retention time of records are established and followed. Quality records include
reports from internal audits, management reviews, corrective actions, and preventive
actions. Technical records include the original observations, derived data, calculations,
standard preparation, instrument printouts, and results.

8.4.2 The Laboratory has a control of records procedure (SOP/8.4) for identifying,
collecting, indexing, accessing, filing, storing, maintaining, and disposing of quality
and technical records. Retention time of records are established and followed.
Access to these records is consistent with the confidentiality commitments and
records are made readily available. All records maintained in computer are
safeguarded from virus, having password protection and back-up of all such data/
records are taken on monthly basis by users.
Reference documents
SOP/8.4 SOP for control of records
8.5 Actions to address risks and opportunities (Option A)

8.5.1 RWTL,KR has considered the risks and opportunities associated with the
laboratory activities in order to::
a. Assure the management system achieves its intended results;
b. Enhance opportunities to achieve the purpose and objectives of the laboratory;
c. Prevent, or reduce negative impacts and potential failures in laboratory
activities;
d. Achieve improvement.

8.5.2 RWTL,KR has planned:

a) actions to address these risks and opportunities;


b) how to:
 integrate and implement the actions into its management system;
 Evaluate the effectiveness of these actions.
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8.5.3 Actions are taken to address risks and opportunities. It is ensured that the same
are proportional to the potential impact on the validity of laboratory results. Risk and
opportunities related to laboratory activities are identified and are implemented in the
Risk assessment sheet. Procedure is prepared for the Risk assessment

Reference documents
SOP/8.5 SOP for Risk and opportunity management

8.6 Improvement (Option A)

8.6.1 RWTL,KR has identified and selected opportunities for improvement and
implemented necessary actions for the improvement in the laboratory activities.
Opportunities for improvement are identified through:
 review of the operational procedures,
 the use of the policies,
 overall objectives,
 audit results,
 corrective actions,
 management review,
 suggestions from personnel,
 risk assessment,
 analysis of data, and
 Proficiency testing results.
Improvement log is maintained as soon as it is identified.

8.6.2 After providing the testing services to the customer, the customer feedback form
is submitted to customer along with the test report for taking feedback, both positive
and negative, from customer related to service provided. Quality Manager follows–up
with the customer for the collection of filled customer feedback form in time. Upon
receipt of customer feedback form, the same is reviewed for the comments given by
customer. If the feedback given by customer is Average or poor, then customer is
communicated about such ranking and necessary actions are initiated by the Quality
Manager, based on customer’s comments. Also, actions initiated for the same are
informed to the customers. Every year, customer feedback is analyzed and percentage
satisfaction level of customer is identified.
Reference documents
SOP/7.9 SOP for complaint & feedback management
SOP/7.10 SOP for Control of Nonconformance, corrective action
SOP/8.5 SOP for Risk and opportunity management
SOP/8.8 SOP for Internal Audit
SOP/8.9 SOP for management review

8.7 Corrective action


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8.7.1 Procedure (SOP/7.10) is documented and implemented for the corrective action.
When a non-conformance is identified, the corrective action chosen addresses the
magnitude of the non-conformance and the risk attributed to the non-conformance.

a. Immediate action is implemented to correct a non -conformity and address the


consequences.
b. An evaluation is performed to determine the cause(s), a history of similar issue(s),
potential for recurrence, and the need for action to eliminate the problem to prevent
recurrence;
c. Corrective actions are determined and implemented based upon this evaluation.
d. A review of the effectiveness of corrective actions is performed.
e. If necessary, updates for risks and opportunities are determined during planning.
f. Essential changes discovered during the corrective action investigation are
implemented within the management system, where necessary.

8.7.2 Corrective actions are appropriate to the effects of the nonconformities


encountered.

8.7.3 Laboratory records corrective action to include the nature of the nonconformities,
cause(s) and subsequent actions taken, including the results of any corrective action.

Reference documents
SOP/7.10 SOP for Control of Nonconformance, Corrective action.

8.8 Internal Audit

8.8.1 RWTL, KR has documented and implemented procedure for internal audit. RWTL,
KR conducts internal audit at least once in year to provide information on whether the
management system:

a) Conforms to:
 the laboratory’s own requirements for its management system, including the
laboratory activities;
 the requirements of ISO/IEC 17025;

b) is effectively implemented and maintained within the laboratory.

8.8.2 RWTL,KR :
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a) Plans, establishes, implements and maintains an audit program, including the


frequency, methods, responsibilities, planning requirements and reporting, which takes
into consideration the importance of the laboratory activities concerned, changes
affecting the laboratory, and the results of previous audits;

b) Defines the audit criteria and scope for each audit, and addresses them in the audit
plan / schedule.

c) ensures that the results of the audits, in terms of audit findings and internal audit
non–conformity report , are reported to relevant management;

d) Implements appropriate correction and corrective actions without undue delay and
retains documented information in the form of internal audit non–conformity report;

e) Retains records as evidence of the implementation of the audit program and the audit
results.

Reference documents
SOP/8.8 SOP for Internal Audit
SOP/7.10 SOP for Corrective Action

8.9 Management reviews

8.9.1 A management review is conducted by the laboratory’s executive management at


least once in a year; This review is conducted to ensure continuing suitability, adequacy,
and effectiveness based upon information related to the inputs and outputs of laboratory
activities and operations and stated policies and objectives and fulfillment of ISO/IEC
17025:2017. Procedure (SOP/8.9) is documented and implemented for planning
conducting management review meeting.

8.9.2 The management review is planned and carried out taking into consideration:

a. Changes in external and internal issues that are relevant to the QMS;
b. Fulfillment of objectives;
c. Suitability of policies & procedures, analytical methods, work instructions & forms etc.
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d. The status of actions from previous Management Reviews;


e. Outcome of recent internal audits;
f. Nonconformities and corrective actions;
g. Assessments by external bodies;
h. Changes in the volume and type of work or in the range of laboratory activities;
i. Customer and personnel feedback;
j. Complaints;
k. Effectiveness of any implemented improvements;
l. Adequacy of resources;
m. Results of risk identification;
n. Outcome of the assurance of the validity of results; and
o. Other relevant factors such as monitoring activities and training.

8.9.3 The outputs of the management review include decisions and actions related to:
a. the effectiveness of the management system and its process’
b. improvements for the QMS and processes for the fulfillment of ISO/IEC 17025:2017;
c. resources need; and
d. any need for changes to the quality management system.
Laboratory retains documented information as evidence of the results of management
reviews.
Reference documents
SOP/8.9 SOP for management review meeting

--- END OF QUALITY MANUAL ---


REGIONAL WATER TESTING LABORATORY,
GROUNDWATER SURVEYS & DEVELOPMENT AGENCY,
KONKAN REGION

ANNEXURE- 01 Laboratory layout


REGIONAL WATER TESTING LABORATORY,
GROUNDWATER SURVEYS & DEVELOPMENT AGENCY,
KONKAN REGION

ANNEXURE- 02 Organization Chart


REGIONAL WATER TESTING LABORATORY,
GROUNDWATER SURVEYS & DEVELOPMENT AGENCY,
KONKAN REGION

ANNEXURE- 03 Management Structure Chart


REGIONAL WATER TESTING LABORATORY,
GROUNDWATER SURVEYS & DEVELOPMENT AGENCY,
KONKAN REGION

ANNEXURE- 04

TYPE OF DOCUMENT: STANDARD OPERATING PROCEDURE

Sr. Identification No.


Name of the Document
No. of Document
1 SOP/4.0 SOP for Maintaining Impartiality, Confidentiality & Integrity
SOP for Determining Competency, Selection & monitoring
2 SOP/6.2 Competency of Personnel & their skill improvement through
training
3 SOP/6.3 SOP for Housekeeping, safety & environmental control

4 SOP/6.4 SOP for Procurement, Handling & maintenance of Equipment

5 SOP/6.5 SOP for Calibration & traceability

6 SOP/6.6 SOP for Management of externally provided Products & Services

7 SOP/7.1 SOP for Review of requests, tenders & contracts

8 SOP/7.4 SOP for Handling of Test sample

9 SOP/7.6 SOP for Evaluation of measurement uncertainty

10 SOP/7.7 SOP for Validity of result Quality control

11 SOP/7.9 SOP for Complaints & feedback management

12 SOP/7.10 SOP for Control of nonconformance, corrective action

13 SOP/8.3 SOP for Document control & Document change

14 SOP/8.4 SOP for Control of records

15 SOP/8.5 SOP for Risk and opportunity management

16 SOP/8.8 SOP for Internal Audit

17 SOP/8.9 SOP for Management Review meeting

18 SOP/NABL133 SOP for Use of NABL Symbol claim of accreditation on test reports
REGIONAL WATER TESTING LABORATORY,
GROUNDWATER SURVEYS & DEVELOPMENT AGENCY,
KONKAN REGION

ANNEXURE- 05

RANGE OF LABORATORY ACTIVITIES - SCOPE


Component,
parameter or Test Method Specification
characteristic tested / against which tests are
Materials or
S.N. Discipline / Group Specific Test performed and / or the
Products tested
Performed / techniques / equipment
Tests or type of tests used
performed
Permanent Facility
APHA METHOD 2320 B /
1 CHEMICAL- WATER POTABLE WATER ALKALINITY
IS 3025 (PART 23) 2000
2 CHEMICAL- WATER POTABLE WATER CALCIUM APHA METHOD 3500 Ca B

3 CHEMICAL- WATER POTABLE WATER CHLORIDE APHA METHOD 4500 Cl- B

4 CHEMICAL- WATER POTABLE WATER COLOUR APHA METHOD 2120 - B


ELECTRICAL
5 CHEMICAL- WATER POTABLE WATER APHA METHOD 2510 B
CONDUCTIVITY
6 CHEMICAL- WATER POTABLE WATER FLUORIDE APHA METHOD 4500-F D

7 CHEMICAL- WATER POTABLE WATER IRON APHA METHOD 3500-Fe B

8 CHEMICAL- WATER POTABLE WATER MAGNESSIUM APHA METHOD 4500 Cl- B

9 CHEMICAL- WATER POTABLE WATER Nitrate as NO3 APHA METHOD 3500 Mg B

10 CHEMICAL- WATER POTABLE WATER ODOUR IS 3025 (PART 5) 2018

11 CHEMICAL- WATER POTABLE WATER pH APHA METHOD 4500-H+ B

12 CHEMICAL- WATER POTABLE WATER SULFATE APHA METHOD 4500 SO4 2-E

13 CHEMICAL- WATER POTABLE WATER TASTE IS 3025 (PART 8) 2017

14 CHEMICAL- WATER POTABLE WATER TURBIDITY APHA METHOD 2130 B


TOTAL DISSOLVED APHA METHOD 2540 C /
15 CHEMICAL- WATER POTABLE WATER
SOLIDS IS 3025 (PART 16)
16 CHEMICAL- WATER POTABLE WATER TOTAL HARDNESS APHA METHOD 2340 C

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