Msword&rendition 1
Msword&rendition 1
Msword&rendition 1
QUALITY MANUAL
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
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TABLE OF CONTENTS
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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Release Authorization
This Quality Manual is released under the authority of Deputy Director, G.S.D.A,
Konkan region, Navi mumbai
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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The Quality Manual to be read in conjunction with relevant procedures established &
implemented to achieve the reliable test data by the Laboratory.
NABL Documents
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,
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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.
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.
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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.
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
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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
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.
(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.
4.1 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.
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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.
4.1.5 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.
4.2.3 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,
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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 .
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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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.
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;
Responsibility
Authority
Responsibility
Authority
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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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
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
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.
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.
6.2.5 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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Reference documents
SOP/6.2 SOP for Personnel skill improvement through training.
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.
REGIONAL WATER TESTING LABORATORY,
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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).
6.4.5 The equipment used for measurement is capable of achieving the measurement
accuracy and/or measurement uncertainty required to provide a valid result.
6.4.7 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.
6.4.11 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.
6.4.13 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:
e) Calibration dates, results of calibrations, adjustments, acceptance criteria, and the due
date of the next calibration or the calibration interval;
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.
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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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.
6.6.1 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.
Reference documents
SOP/6.6 SOP for Management of externally provided Products & Services.
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;
The customer is adequately informed /advised about the lab activities that
will be performed by the external provider.
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.
7.1.6 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.
7.1.8 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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7.2.1.1 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..
7.2.1.3 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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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.
7.2.1.7 Deviations from test methods are documented, technically justified, authorized,
and where circumstances call for it, accepted by the customer.
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.
7.3Sampling
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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7.4.1 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
7.7.1 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:
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
7.8.1 General
7.8.1.1 The results obtained in testing of sample’s are reviewed and authorized prior to
release.
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.
7.8.2.2 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.
7.8.3.2 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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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.
7.8.8.2 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.
7.9.7 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.
7.10.2 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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7.11.1 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.
7.11.5 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.
8.1.1 General
The laboratory management system is outlined in the following documents:
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.
8.2.1 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.
8.2.5 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.
8.3.1 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
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.
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
REGIONAL WATER TESTING LABORATORY,
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Reference documents
SOP/8.3 SOP for document control
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.
8.5.3 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
8.6.1 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
8.7.1 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.
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.
8.8.1 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;
8.8.2 RWTL,KR :
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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
8.9.2 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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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
ANNEXURE- 04
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
12 CHEMICAL- WATER POTABLE WATER SULFATE APHA METHOD 4500 SO4 2-E