Professional Documents
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LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094
Quality Manual
(ISO/IEC 17025:2017) (ETRL/QM/01)
Of
AMENDMENT RECORD
Amendments are recorded in the amendment record sheet as below.
FOREWORD
The Economy Testing & Research Laboratory. Quality Manual is the procedure by which it operates a
laboratory quality management system, which is competent, and capable of performing testing activities as
per the guidelines of the National Accreditation board for Testing and Calibration laboratory (NABL). Any
local documents, procedures and policies associated with ISO/IEC 17025:2017 compliance for Testing
laboratories must comply with this document.
The Laboratory Quality Manual outline the company policy, management approach for ensuring the quality
work as per globally accepted testing practices as per reference standard document ISO/IEC
17025:2017. The Quality Manual will be the basis by which NABL (accreditation bodies) recognize the
quality management system, competence of calibration methodologies by which to form the basis for their
accreditation.
This manual has been prepared to define the quality system, establish responsibilities of the personnel
affected by the system, and to provide general procedure and policy statements for all activities comprising
the quality system. In addition this manual is used for the purpose of informing our customer of the quality
system and what specific process controls are effectively implemented to assure service quality.
This is the initial issue of the quality manual and is the sole property, internal and controlled document of
Economy Testing & Research Laboratory
CONTENTS
Section No. Contents Page No.
A Cover page 1
B Release Authorization 2
C Amendment Record 3
D Forward 4
E Contents 5-6
F Distribution List 7
G Abbreviations 8
H Introduction 9
I Quality Policy and Objectives 10
1. Scope 11
2. Normative references 12
3. Term and Definition 13-14
4. General requirements 15
4.1 Impartiality 16
4.2 Confidentiality 17
5. Structural requirements 18-20
6. Resource requirements 21
6.1 General 22
6.2 Personnel 23-24
6.3 Facilities and environmental conditions 25-26
6.4 Equipment 27-28
6.5 Metrological traceability 29
6.6 Externally provided products and services 30
7. Process requirements 31
8.1 Options 47
8.2 Management system documentation (Option A) 48-50
8.3 Control of(Option A) management system documents 51
8.4 Control of records (Option A) 52
8.5 Actions to (Option A) address risks and opportunities 53
8.6 Improvement (Option A) 54
8.7 Corrective action (Option A) 55
8.8 Internal audits (Option A) 56
8.9 Management reviews (Option A) 57
* Organization Chart 58
* Roles And Responsibility of Staff 59-60
DISTRIBUTION LIST
The following are the authorized holders of controlled copy of Quality Manual: -
3 Manager Technical
4 Auditor's Copy
Note:
1 Copy(s) issued to NABL / BIS is uncontrolled copy and it is latest available copy at the time of issue.
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.: 00 Amend Date: 00 Page: 8
ABBREVIATIONS
INTRODUCTION
ECONOMY TESTING & RESEARCH LABORATORY is situated E5/71,5th pusta KH.No.175,Street
No.12/2,Sonia Vihar Delhi-110094 , is a proprietary firm established on 9th May 2016, having PAN
No.AGDPJ5998B
Mr. G.P.Jaiswal
The ETRL lab has following approvals ISO 9001:2015, The lab is looked after by professionally
qualified personnel and managed by a team of highly experienced technical staff.
QUALITY POLICY
To provide Analytical services of precision and accuracy in concurrence with NABL/INTERNATIONAL
STANDARDS and comply with designed management system in line and thrive for continual
improvement as per ISO/IEC/17025:2017.
Respond to Customer complaints within two working days, Deliver error free test reports
to Customers.
The management of the laboratory communicate the personnel their duties,
responsibilities and authorities.
To provide quality reliable & timely services every time & all the time to its customers
.
To continually upgrade analytical facilities w.r.t. equipment & instruments.
To achieve the above by efforts & involvement of dedicated personnel at all levels.
When agreed with the customer, the results may be reported in a simplified way .
QUALITY OBJECTIVES
Focusing on customer needs & requirements by providing precision and accurate analytical services.
To remain alert & informed of quality improvements in analytical capabilities.
To abide by statutory requirements of regulatory authorities & remain conscious for safety health &
environment.
To optimize on cost of analysis for the benefit of society & humanity at large.
Exercising stringent control & supervision for quality procedures adopted for analytical accuracy.
SCOPE
The Economy Testing & Research Laboratory has chosen chemical testing for the preparation of
laboratory Accreditation.
The laboratory is to provide independent, impartial and quality testing results to our customers.
The accreditation follows the standard of ISO/IEC 17025:2017. The scope and field of applications of
the laboratory amongst others covers in terms of preparation and testing.
NORMATIVE REFERENCES
The following documents are referred to in text for some or all content constitutes requirements of this
Quality Manual.
The latest edition of the below listed documents are referenced documents.
SECTION- 3
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 14
For the purposes of this Quality Manual, the terms and definitions given in ISO/IEC Guide 99 &
ISO/IEC 17000 and ISO and IEC maintained terminological databases for use of standardization
applies.
3.1 Impartiality (presence of objectivity): Means that conflict of interest do not exist or are resolved
so that it does adversely influence subsequent activities of the lab.
The element of impartiality are freedom from conflict of interests, freedom from bias, lack of
prejudice, neutrality, fairness, open- mindedness, even-handedness, detachment etc.
3.5 Proficiency Testing: Evaluation of participant performance against pre-established criteria by means
of inter laboratory comparisons.
3.6 Laboratory: Body that performs one or more of the following activities. Activities are Testing and
sampling, associated with subsequent testing.
3.7. Decision rule: Rule that describes how measurement uncertainty is accounted for when stating
conformity with a specified requirement.
3.8. Verification: Provision of objective evidence that a given item fulfils specified requirements.
3.9. Validation: Where the specified requirements are adequate for an intended use but presently we have
not done validation.
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 15
SECTION- 4
GENERAL REQUIREMENTS
4.1 Impartiality
4.1.1 Lab activities are undertaken impartially and structured and managed such that the impartiality is
safeguarded.
Reference: ETRL/QP-4.1/P-01
4.1.2 The Laboratory management is committed to impartiality and lab activities and supervision are
kept independent of other activities.
4.1.3 Laboratory is responsible for impartiality of its activities and does not allow commercial, financial or
other pressures to compromise impartiality by employing permanent salaried paid employees.
Unauthorized personnel is restricted in laboratory.
4.1.4 The laboratory identifies risks to its impartiality on an on-going basis. This includes those
risks that arise from its activities, or from its relationships, or from the relationships of its
personnel. However, such relationships do not necessarily present a laboratory with a risk to
impartiality.
4.1.5 The risk to the impartiality are identified and lab takes action to eliminate or minimize such risks.
The relationship risk is eliminated or minimized based on the information available about the
relationship of different activities and personnel by defining responsibility of each individual
including supervisors and reporting authorities such that it does not affect impartiality in lab activity.
Reference: ETRL/QP-4.1/P-01
4.2 Confidentiality
4.2.1 The laboratory is responsible, through legally enforceable commitments, for the management of all
information obtained or created during the performance of laboratory activities. The laboratory
informs the customer in advance, of the information it intends to place in the public domain.
Except for information that the customer makes publicly available, or when agreed between the
laboratory and the customer (e.g. for the purpose of responding to complaints), all other
information is considered proprietary information and shall be regarded as confidential.
Reference: ETRL/4.2/F-01
4.2.2 When the laboratory is required by law or authorized by contractual arrangements to release
confidential information, the customer or individual concerned are, unless prohibited by law,
notified of the information provided.
4.2.3 Information about the customer obtained from sources other than the customer (e.g. complainant,
regulators) is confidential between the customer and the laboratory. The provider (source) of this
information is confidential to the laboratory and is not shared with the customer, unless agreed
by the source.
4.2.4 The Laboratory ensures personnel, including any committee members, contractors, personnel of
external bodies, or individuals acting on the laboratory's behalf, shall keep confidential all
information obtained or created during the performance of laboratory activities, except as required
by law.
SECTION- 5
STRUCTURAL REQUIREMENTS
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 19
G.P. Jaiswal
G.P. Jaiswal G.P.Jaiswal
5.2 The Legal identity: The ECONOMY TESTING & RESEARCH LABORATORY is having a legal
entity, which is as follows:
Name of the Laboratory Economy Testing & Research Laboratory
Address E5/71,5th pusta KH.No.175,Street No.12/2,
Sonia Vihar Delhi-110094
5.4 Laboratory carries out its testing activities in such a way as to meet the requirements of this
Hand book and to satisfy the needs of the customer. Laboratory meets the requirements of
NABL and other regulatory authorities or organizations providing recognition as per
ISO/IEC – 17025:2017.
5.5 Lab activities are be carried out to meet the requirement of ISO/IEC 17025:2017, customers,
regulatory authorities and NABL and as per our quality policy.
5.5. a Well defined the organization and management structure of the laboratory, and the relationships
between quality management, technical operations, and support services.
(Refer Organization Chart of this manual in Annexure-A),
5.5.b Specified the responsibility, authority and interrelationship of all personnel who manage, perform
and personnel who verify work affecting the results of lab activities.
(Refer Roles and Responsibility of staff to this manual in Annexure-B);
5.5.c Documented all the activities of the laboratory as per the Laboratory Quality Procedure instructions
to ensure the validity of the results.
5.7 The Laboratory has well qualified, trained and experienced managerial and technical personnel
who irrespective of other responsibilities, have the authority and resources needed to carry out their
duties.
a. Quality Manager is responsible for implementation, maintenance and improvement of the
management system;
b. Quality Manger is responsible for identification of deviations from the management system or from
the procedures for performing laboratory activities;
c. Quality Manager has authority for initiation of actions to prevent or minimize such deviations;
d. Quality Manager is responsible for reporting to laboratory management on the performance of the
management system and any need for improvement;
b.The integrity of the management system is maintained when changes to the management system are planned
and implemented through timely recruitment process.
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 21
SECTION- 6
RESOURCE REQUIREMENTS
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 22
6.1 General
The laboratory is having the availability of the personnel, facilities, equipment, systems and support
services which is necessary to manage and perform testing activities.
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 23
6.2 Personnel
6.2.1 Laboratory management ensures that it is the policy of Economy Testing & Research Laboratory to
employ only those personnel who are having necessary educational qualifications and experience
in the respective fields and competent to specific work. The management ensures that the training and
appropriate supervision is imparted to the persons (employees as fresh candidates) performing the
specific task.
Reference: ETRL/QP-6.2/P-01
6.2.2 Management has formulated goals, with respect to the education, training and skills of the
Laboratory personnel. Management identifies the need of training to be imparted to the
personnel. The training program is prepared, relevant to the anticipated tasks of the
laboratory. Training imparted is evaluated for its effectiveness.
6.2.3 The lab ensures that the personnel are competent to perform lab activity for which they are
responsible and evaluates the significance of deviations.
6.2.4 Laboratory maintains current job description for managerial, technical and key support
personnel involved in tests. Reference: ETRL/QP-6.2/P-02
The top Management has adopted a relatively flat organizational system to facilitate
the smooth internal communication.
The management decide the job and duties responsibility of the Personnel as per his
Work ability .
The responsibility with respect to performing of work and its ability as booking, testing, reporting .
The responsibility of testing related work is provided to Technical manager and their team
Team briefing
Management and Supervisory activities.
Receipt of incoming products,and their quality
Verbal/Written instructions
Display on notice board .
Job responsibility with respect to planning of tests and evaluation of results.
Job responsibility with respect to reporting opinion and interpretations.
Responsibility with respect to method modification, if applicable,
Expertise, experience, qualification and training program and managerial duties.
In case Quality/Technical Manager is not present the the responsibility of Technical Manager take
charge of him as vice versa.
Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 24
6.2.5
The laboratory maintains a procedure(s) (Refer Procedure ETRL/QP-6.2/P-01) and retain
records for:
a) determining the competence requirements;
b) selection of personnel;
c) training of personnel;
d) supervision of personnel;
e) authorization of personnel;
f) monitoring competence of personnel.
6.2.6
The lab authorizes individual to perform specific activities
6.3.1 Laboratory facilities for testing, including but not limited to energy sources, lighting and
environmental conditions, facilitate correct performance of the Testing.
The laboratory ensures that the environmental conditions do not invalidate the results or adversely
affect the required quality of any measurement.
6.3.2 The technical requirements for accommodation and environmental conditions that can affect the
results of testing are documented.
6.3.3 The environmental conditions for Testing Lab are maintained as given below as per
IS:196:1966(RA2001)
6.3.4 The laboratory controls monitors and records the relevant environmental conditions as required by
NABL standards. Due attention is paid, for example, to biological sterility, dust, electromagnetic
disturbances, radiation, humidity, electrical supply, temperature, and sound and vibration levels, as
appropriate to the technical activities concerned. testing are stopped when the environmental
conditions jeopardize the results of the testing.
Measures to control facilities is implemented, monitored and periodically reviewed and included,
but not limited to:
a. Access to laboratory area is to be restricted to unauthorized personnel only. Access to and uses
of areas affecting the quality of the testing are controlled. The laboratory has determined the
extent of control based on its particular circumstances.
b. Good and adequate housekeeping is maintained to ensure a safe, efficient and productive work
environment.
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c. There are effective separations between neighboring areas in which there are incompatible
activities. Measures are taken to prevent cross-contamination.
6.3.5 The laboratory ensures while performing laboratory activities at sites or facilities outside its
permanent control, that the requirements related to facilities and environmental conditions are met.
Reference: ETRL/QP-6.3/P-02
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6.4 Equipment
6.4.1 The lab is furnished with all equipments including measuring instruments, software, measurement
standards, reference materials, reference data, reagents, consumables and auxiliary apparatus that
are required for correct performance of lab activities and have proper access to these equipment that
can influence the results.
The reference material are purchased meeting the requirement of ISO 17034 and which are
provided with product information sheet/certificate which should specify homogeneity and
stability for sp. Properties. Certified reference materials with certified values, measurement
uncertainty and metrological traceability.
6.4.3 Laboratory has procedure for safe handling, transport, storage, use and planned maintenance of
measuring equipments to ensure proper functioning and in order to prevent its deterioration.
Reference: ETRL/QP-6.4/P-01
6.4.4 The equipment is verified and calibrated before placing for use or on placing after maintenance or
repair.
6.4.5 The equipment used for measurement are capable of achieving the measurement accuracy and
measurement uncertainty required to provide valid results.
6.4.6 Measuring equipment viz those used for direct measurement of measurand e.g balance, those used
to make correction to the measured value e.g temperature and those used to obtain a measurement
result calculated from multiple quantities are calibrated when:
a. Measurement accuracy or measurement uncertainty affects the validity of the reported results.
b. calibration is required for establishing the metrological traceability of the reported results.
6.4.7 Lab has calibration programme/plan which is reviewed and adjusted as necessary to maintain
confidence in the status of calibration.
6.4.8 All equipment are labelled defining the period of validity of calibration, so that the user can readily
identify the status of calibration.
6.4.9 The equipment which are found to give questionable results or found to be defective due to
overloading, mishandling or occurs of any technical problem are taken out of service. Such
equipment are isolated to prevent its use or clearly labelled out of service till it is rectified and
verified to perform correctly. The effect of defect or deviation from specified requirement are
examined by procedure of nonconforming work.
Reference: ETRL/QP-6.4/P-02
6.4.10 A procedure is in place about the handling and maintenance of laboratory equipment
describing the system of intermediate checks
Reference: ETRL/ QP-6.4/P-03
6.4.11 After calibration the reference values and correction factors are updated and implemented to
meet the specific requirement.
6.4.12 Lab takes practicable measures to prevent unintended adjustments of equipment which
invalidate the results.
6.4.13 Records are retained for equipment which can influence laboratory activities. These records
Include the following, where applicable:-
a. Identity of equipment, its software and accessories
b. The manufacturer’s name, type and serial no. or any other unique identity.
c. Evidence of verification that equipment conforms to specific requirements.
d. Current location
e. Calibration date, results of calibration, adjustment, acceptance criteria and due date of next
calibration.
f. Documentation of reference materials, results, acceptance criteria (traceability), relevant dates and
period of validity.
g. Lab to have maintenance plan relevant to the performance of equipment and record of date of
maintenance.
h. details of any damage, malfunction, modification, or repair of equipment.
The systematic measurement error( bias) of the calibrated equipment is taken into account to
disseminate metrological traceability to measurement results.
Certified values of certified reference materials from reference material producers conforming to
ISO 17034 provide metrological traceability. Other ways to demonstrate conformity of metrological
traceability by national institutes and designated institutes,
6.5.2 The Lab ensures that the measurement results are traceable to international system( SI) of
units through
b. certified values of certified reference materials provided by a competent producer 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.
6.5.3 When metrological traceability to the SI units is not technically possible, the laboratory
demonstrates metrological traceability to an appropriate reference, e.g.:
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.
G.P. Jaiswal
G.P. Jaiswal G.P.Jaiswal
6.6.1 At present, the lab does not sub-contract any work in the field of testing services.
a. Defining, reviewing and approving the lab requirements for externally provided products and services
b. Defining the criteria for evaluation, selection, monitoring of performance and re-evaluation of
external providers
c. Ensuring the externally provided products and services applicable to relevant requirement before use.
d. Taking any action arising on evaluation, monitoring of performance and re-evaluation of the external
providers.
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 32
SECTION- 7
PROCESS REQUIREMENTS
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 33
7.1.1 The lab has a procedure for review of requests, tenders and contracts which defines :
c. When any activities required to be subcontracted due to unforeseen reasons due to inability to
undertake in part or full or lab does not have resources or competence to perform the activities.
The lab advises the customer for activity to be carried out by external service provider and to take
the customer’s approval.
d. The appropriate test method or procedures are selected which is capable of meeting customer’s
requirements.
For internal or routine customer’s review of requests, tenders and contracts can be performed in
simplified way.
7.1.2 The lab informs the customer in case the method requested by customer is inappropriate or out
dated.
7.1.3 When customer request for statement of conformity to specification or standard test method, the
decision rule to be clearly defined. If the specification or standard are not part of request the
decision rule selected are communicated to and agreed with the customers.
7.1.4 In case of any differences between the request or tender and the contract are to be resolved with
customer before start of lab activity. The contract should be acceptable to both. If any deviation
requested by customer should not impact the integrity of lab or validity of results.
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Prepared By: Approved By: Issued By:
7.1.6 If any amendment is required in contract after commencement of work, contract to be reviewed
again and amendments to be communicated to all affected personnel.
7.1.7 Lab has to cooperate customers or their representatives to clarify their request and in monitoring the
lab’s performance in relation to their work performed i.e providing reasonable access to relevant
areas of lab to witness his specified lab activity and handling of test item.
7.1.8 Records are to be retained for reviews, any significant changes, pertinent discussions and the
results.
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Prepared By: Approved By: Issued By:
7.2.1.1 Lab uses appropriate methods and procedures for all lab activities for evaluation of measurement
uncertainty and statistical techniques for analysis of data.
7.2.1.2 All methods, procedures and supporting documentation, such as instructions, standards, manuals
and reference data relevant to lab activities, are kept up to date and made readily available
to concerned personnel.
7.2.1.3 The Lab uses latest valid version of a method i.e international, regional or national standards or
other recognized specifications that contain sufficient and concise information to perform lab
activities. These methods arenot supplemented or rewritten as internal procedures.
Additional documentation is required for optional steps in the method or additional details.
7.2.1.4 In case customer does not specify the method, the lab can select an appropriate method and inform
to customer.
Methods published as international, regional, internal standards or by reputable technical
organizations or relevant scientific texts or journals or specified by the manufacturer of the
equipment are recommended.
Lab developed or modified methods can also be used.
7.2.1.5 The lab verifies that it can properly perform methods and ensure that it can achieve the
required performance and verification record are retained. Also if method is revised by issuing
authority then verification is done again.
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7.2.1.6 When method development is required, it is planned and assigned to competent personnel
and equipped with adequate resources. Developed methods are reviewed periodically. Any
modifications are approved and authorized.
7.2.1.7 Deviation from the method are documented, technically justified, authorized and accepted by
the customer.
7.2.2 Validation of methods (Currently ETRL is not using any Laboratory Developed Methods.)
7.2.2.1 The Lab validates non standard methods, lab developed methods and standard methods if
used outside their intended scope or modified. The validation should be extensive as necessary to
meet the need of application. Validation to include sampling procedure, handling and
transportation of test items.
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7.2.2.3 The performance characteristics of validated methods are relevant to customer’s need and
consistent with specific requirements. The performance characteristics are measurement range,
accuracy, MU of results, limit of detection, limit of quantification, selectivity of method, linearity,
repeatability or reproducibility, robustness against external influences or cross sensitivity against
interference from matrix of sample and bias.
7.2.2.4 The lab retains record of validation such as the validation procedure used, specification of the
requirements, determination of performance characteristics of the method, results obtained and
statement on validity of the method, detailing its fitness for the intended use.
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7.3 Sampling
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7.4.1Laboratory has procedures for the transportation, receipt, handling, protection, storage,
retention and/or disposal of the test items. It is ensured to protect the integrity of the test items
and to protect the interests of the laboratory and the customer.
Reference: ETRL/QP-7.4/P-01
7.4.2 Laboratory has a system to identify the test items. The identification remains same throughout the
life of the item in the laboratory.
7.4.3 On receipt of the sample, any abnormalities or departures from the normal or specified test method
are recorded and the customer is consulted for its clarification before proceeding.
7.4.4 The laboratory ensures that the test item has no deterioration, loss or damage during storage,
handling and preparation.
When the item has to be stored or conditioned under specified environmental conditions, these
conditions are maintained, monitored, recorded.
The laboratory has arrangement for storage and security that protect the condition and
integrity of the secured items or portions concerned. The procedure is followed as per
laboratory manual.
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The technical records include the date and identity of person who has undertaken the
activities and who have checked data and results.
Original observations, data and calculations are recorded at the time they are made and
identified with specific task.
7.5.2 The Lab ensures that amendments to technical records can be tracked to previous versions or
original observations. Both original and amended data and files are retained including the
date of alteration, an indication of altered aspects and personnel responsible for the alterations.
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7.6.1 Lab identifies all contributions, when evaluating measurement uncertainty which are
significant, including sampling and method of analysis.
When a well recognized test method specifies limits to the values of major source of MU and
specifies the form of presentation of calculated results fulfils the requirement of MU by following
the test method and reporting instructions.
For methods where MU of the results are established and verified then evaluation of MU not
required.
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7.7.1 The lab has procedure for monitoring the validity of results. The monitoring data of validity of
results are recorded to detect the trends and statistical techniques applied to review the results.
a. Participation in proficiency testing ( the PT providers should meet the requirement of ISO/IEC
17043)
b. Participation in Inter laboratory comparison other than PT.
7.7.3 Data from monitoring activities is analyzed, used to control or improve the lab activities. If the
monitoring data found outside the pre-defined criteria, appropriate corrective actions are taken
to prevent incorrect results from being reported.
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By:
7.8.2.2 The Lab is responsible for all information provided in the report except when information is
provided by customer, which should be clearly identified. A disclaimer should be put on report
when information is supplied by customer and can affect the validity of results. When sample is
provided by customer, it is stated in report that the results apply to the sample received.
7.8.3.1 In additional to above requirement, where necessary for interpretation of test results, reports
include;
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7.8.6.1 When statement of conformity to specification or standard is provided in test report, Lab has to
document the decision rule employed and taking account of level of risk except where decision
rule is prescribed by customers, regulations and normative documents consideration of risk level is
not necessary.
7.8.6.2 In case lab provides statement of conformity it clearly identifies :
a. To which results conformity applies
b. Which specification, standard or parts are met or not met
c. The decision rule applied.
7.8.7.1 The opinion and interpretation are expressed by only authorized personnel. The lab documents the
basis upon which opinion and interpretation are made. The opinion and interpretations are
distinguished from statement of inspections, product specifications and from statement of
conformity.
7.8.7.2 The opinion and interpretations expressed in report are based on the results obtained from
tested item.
7.8.7.3 When opinion and interpretation can be directly communicated by dialogue to customer, a record
of the dialogue is retained.
7.8.8 Amendments to reports
7.8.8.1 When a issued report needs change, amendment or re-issue any change of information is
clearly identified and the reason for change is included in report.
7.8.8.2 Amendments to report to be made in form of further documents or data transfer, which
include the statement “A m e n d m e n t to report, serial no.” or an equivalent form of
wording.
7.8.8.3 When to issue complete new report, it is uniquely identified and contains the reference to the
original report amended.
Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL
Section No.: 7.8 Section: Reporting of results
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 46
7.9 Complaints
7.9.1 The laboratory has a complaint procedure describing the process for the receipt and recording of
complaints received from any party. Records of all complaints received are maintained according to the
procedure.
7.9.2 Lab provides description of handling process for complaints to interested party on request.
7.9.3 The process for handling of complaints have at least the following elements and methods :
a. description of process for receiving, validating, investigation of complain and deciding action to be
taken.
b. Tracking and recording complaints including actions undertaken to resolve.
c. Ensuring that appropriate action is taken.
7.9.4 The lab gathers and verify all necessary information to validate the complaint.
7.9.5 The lab acknowledges receipt of complaint and provide progress report and outcome to
complainant.
7.9.6 The outcome of complaints are communicated to complainant are reviewed and approved
by personnel who is not involved in the original lab activities in question.
7.9.7 The lab gives formal notice to complainant for satisfactory closer of complaint.
Reference ETRL/QP-7.9/P-01
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7.10.1 The lab has a procedure and implemented for any aspect of lab activities or results do not confirm
to its own procedures or agreed requirement of the customers e.g equipment or environmental
conditions, results of monitoring fail to meet specific criteria.
Reference: ETRL/QP-7.10/P-01
7.10.2 The Lab retains the records on nonconforming work and action taken.
7.10.3 When evaluation indicates that the nonconforming work can reoccur or there is doubt about the
conformity with lab’s management system, lab implements corrective action.
Reference: ETRL/QP-7.10/P-01
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7.11.1 The lab has access to the data and information needed to perform lab activities.
7.11.5 The relevant instructions, manuals and reference data are readily available to personnel.
7.11.6 Calculations and data transfers are checked in an appropriate and systematic manner.
Reference: ETRL/QP-7.11/P-01
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SECTION- 8
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8.1.1 General
The Economy Testing & Research Laboratory is providing high quality Testing facilities to its
Lab customers. The
8.1.2 Option A
f. Corrective actions
g. Internal audits
h. Management reviews
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8.2.1 Lab management establishes, documents and maintains policies and objectives for fulfilment of
purposes of this document and ensure that the policies and objectives are acknowledged and
implemented at all levels of lab organization.
The ETRL Documentation of the system is arranged in four levels as given below-
1. Quality Manual (ETRL/QM/01) (Level I):
The quality manual of the laboratory consists of the policies framed as per the guidelines of
ISO/IEC 17025: 2017. This is the primary level of document. The laboratory has made its policies
against each of the clauses of ISO/IEC 17025-2017. The policies are defined under various
section of the quality manual. The laboratory shall follow the policies as mentioned in the
manual. The lab may amend the policies as per the requirement after raising the issue in
management review meeting. The quality manual has relation with the procedure of the
procedure manual.
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STP: Standard Testing procedure is the test method prepared by taking any reference of the
standard test method, which is used in absence of reference standard test method.
Work Instruction: Work instructions are prepared based on the national and international
standards and are followed to perform the work in absence of the standard test methods, STP
and senior staff.
Operating Procedure are generally provided by the manufacturer / supplier of the equipment.
In case of non-availability of operating manual, either SOP or the Work Instruction is prepared
as per the guideline of the commissioning Engineer.
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8.2.2 The policies and objectives of ETRL addresses the following aspects:-
1) Competence as per Clause 6.2 of this Document.
2) Impartiality as per Clause 4.1 of this Document, and
3) Consistent operation of the lab as per Clause 7 of this Document.
8.2.3 Top management through regular interval audits, customer feedback and management review
meeting etc. tries to see the implementation of management system and sought the areas for
continual improvement for improving the effectiveness of the management system developed and
implemented. Records of these are used as an evidence for the top management commitment.
8.2.4 The quality manual which specifies the policies of the organization, details of all the documented
procedures as specified by internal standard ISO/IEC 17025:2017 and those which are necessary
for smooth and effective working of the laboratory are addressed in this manual along with the
cross reference of the documents.
ETRL maintains the following document structure for smooth functioning of the laboratory.
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8.2.5 ETRL ensures that all the personnel involved in laboratory activities have access to the parts of the
management system documentation and related information that are applicable to their
responsibilities
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d. Relevant versions are to be available at points of use and their distribution is controlled.
e. Documents are uniquely identified
f. Unintended use of obsolete documents are prevented by stamping obsolete , when copy is retained
for any future reference.
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8.4.1 Lab maintains and retains legible records as per requirement of this document.
8.4.2 The lab has implemented the controls of records needed for identification, storage, protection,
backup, achieve, retrieval, retention time and disposal. The retention period is as per
contractual obligation and with confidentiality commitments and records are readily available.
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8.5.1 Lab considers the risks and opportunities associated with the lab activities in order to :
a. Give assurance that the management system achieves its intended results.
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Opportunities are identified through review of operational procedures, use of policies, objectives,
audit results, corrective actions, management review, suggestions from personnel, risk assessment,
analysis of data and PT results.
Reference: ETRL/QP-8.6/P-01
8.6.2 Lab seeks feedback both positive and negative from customers. Feedbacks are analyzed
and used to improve the management system, lab activities and customer service.
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8.7.3 Lab retains records of the nature of the NC, cause(s) and any subsequent actions taken and
results of any corrective action.
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a. The lab’s own requirements including the lab activities, requirement of ISO/IEC 17025:2017
8.8.2 It is the responsibility of the quality manager to plan and organize audits as required by the
schedule and requested by management. Such audits are carried out by personnel trained and
qualified for internal auditing to ISO/IEC: 17025:2017 and, wherever resources permit,
independent of the activity to be audited. The Lab has a procedure for internal Audit of all the
elements of the laboratory as per ISO/IEC: 17025:2017.
Reference: ETRL/QP-8.8/P-01
a. Lab should plan, establish, implement and maintain an audit programme as per frequency,
methods, responsibility, planning requirements and reporting, taking into consideration the
importance of lab activities concerned, changes affecting the lab and results of previous audits.
c. Lab shall ensure that the results of audits are reported to relevant management.
d. Lab should implement appropriate correction and corrective actions without undue delay.
e. Lab should retain records as evidence of implementation of the audit programme and audit
results.
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8.9.1 The CEO reviews its management system at least once year in order to ensure its
continuous stability, adequacy and effectiveness, including the stated policies and objectives.
8.9.2 The agenda for the management review is prepared and recorded, should include this
information
a. Changes in internal and external issues relevant to the lab.
b. Fulfilment of objectives
c. Suitability of policies and procedures
d. Status of actions from previous management reviews
e. Outcome of recent internal audits
f. Corrective actions
g. Assessments by external bodies
h. Changes in volume and type of work or in range of lab activities.
i. Customer and personnel feedback
j. Complaints
k. Effectiveness of any implemented improvements
l. Adequacy of resources
m. Results of risk identified
n. Outcome of assurance of validity of results
o. Other relevant factors, such as monitoring activities and training.
8.9.3 The outcome from management review should be recorded for decisions and actions related to at
least :
a. the effectiveness of the management system and its processes
b. improvement of lab activities for fulfilment of requirement of this document.
c. Provision of required resources
d. Any need for change.
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ANNEXURE-A
ORGANIZATION CHART
TECHNICAL MANAGER / DY.QUALITY MANAGER QUALITY MANAGER / INCHARGE CUSTOMER SUPPORT (ICS) / HR
DY.QUALITY MANAGER
Analysts Analysts
ANNEXURE -B
ROLES AND RESPONSIBILITY OF STAFF
The Economy Testing & Research Laboratory responsibility, authority, and interrelationship of all personnel
connected with the laboratory work affecting quality are given in the laboratory chart, job descriptions,
authorization record and relevant procedures and Job descriptions of key personnel are as given below-
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