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ECONOMY TESTING & RESEARCH

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

ECONOMY TESTING & RESEARCH


LABORATORY(ETRL)
E5/71,5th pusta KH.No.175,Street
No.12/2,Sonia Vihar Delhi-110094, Mobile
No.,8920039595
Email:info.etrl2016@gmail.com
All copyright of this manual reserved with ©.
ECONOMY
TESTING & RESEARCH LABORATORY(ETRL).

This manual, or parts thereof cannot be reproduced, stored in a retrieval system, or


transmitted in any form or by any means, electronic , photocopying , recording or otherwise
without the prior written permission from the copyright owner

Copy No. : Controlled / Uncontrolled


Issue No. : 01 Date: 01.02.2021
Holder Name : Section: A
Issued By : Quality Manager Level:
I Page No.: 01
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

This Quality Manual is released under the authority


of Mr. G.P.Jaiswal, CEO
And is the property of

ECONOMY TESTING & RESEARCH


LABORATORY
E5/71,5th pusta KH.No.175,Street
No.12/2,Sonia Vihar Delhi-110094, Mobile
No.,8920039595
Email:info.etrl2016@gmail.com

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: B Section: Release Authorization
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.: 00 Amend Date: 00 Page: 2
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical/Quality Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

AMENDMENT RECORD
Amendments are recorded in the amendment record sheet as below.

S. no Pg. no Section/ Clause/ Para/ Date of Amendment Reasons of Sign. of person


line (as applicable) Amendment made Amendment authorizing
Amendment

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: C Section: Amendment Record
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.: 00 Amend Date: 00 Page: 3
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: D Section: Foreword
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.: 00 Amend Date:00 Page: 4
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: E Section: Contents
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.: 00 Amend Date:00 Page: 5
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

Section Contents Pages

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

7.1 Review of requests, tenders and contracts 32


7.2 Selection, verification and validation of methods 33-34
Sampling 35
7.3
7.4 Handling of test or calibration items 36
7.5 Technical records 37
7.6 Evaluation of measurement uncertainty 38
7.7 Ensuring the validity of results 39
7.8 Reporting of results 40-42
Complaints 43
7.9
Nonconforming work 44
7.10
7.11 Control of data–Information management 45

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: E Section: Contents
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.:00 Amend Date: Page: 6
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

8. Management system requirements 46

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

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: E Section: Contents
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.: 00 Amend Date:00 Page: 7
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

DISTRIBUTION LIST

The following are the authorized holders of controlled copy of Quality Manual: -

Controlled Designation of the holder of controlled copy


Copy No.

1 Chief Executive Officer

2 Quality Manager (Master Copy)

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.

2. Master copy of Quality Manual is preserved and maintained by Quality Manager.

Doc. No.: ETRL/QM /01 Doc. Name: QUALITY MANUAL

Section No.: F Section: Distribution list

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.: 00 Amend Date: 00 Page: 8

Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal

Technical Manager CEO Quality Manager


ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

ABBREVIATIONS

Abbreviation = Expanded Form


NABL = National Accreditation Board for Testing & Calibration Laboratories
ISO = International Organization for Standardization
IEC = International Electro-technical Commission
ETRL = Economy Testing & Research Laboratory
CEO = Chief Executive Officer
QM = Quality Manager / Quality Manual
TM = Technical Manager
NC = Non-Conformity
MU = Measurement Uncertainty
MRM = Management Review Meeting
Doc. = Document
QC = Quality Control
ILC = Inter-Laboratory Comparison
PT = Proficiency Testing
QP = Quality Procedure Manual
F = Format
R = Records / Register
P = Procedure
IS = Indian Standard
SOP = Standard Operating Procedure
STP = Standard Test Procedure
BIS = Bureau of Indian Standards
EQ = Equipment
GEN = General
LB = Log Book
Dept. = Department

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL

Section No.: G Section: Abbreviations

Issue No.: 01 Issue Date:01.02.2021 Amend. No.: 00 Amend Date:00 Page: 9


Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal

Technical Manager CEO Quality Manager


ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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.

At present the Company is engaged in the Chemical services

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: H Section: Introduction
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.: 00 Amend Date: 00 Page: 10
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

QUALITY POLICY AND OBJECTIVES


The laboratory is committed to provide customer satisfaction through effective, efficient, reliable and accurate test
results by implementing the management system as per ISO / IEC 17025:2017 and conforming to national and
international standards to achieve customer satisfaction.

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.

(Chief Executive Officer)

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL

Section No.: I Section: Quality Policy and Objectives


Issue No.: 01 Issue Date: 01.02.2021 Amend. No.: 00 Amend Date: 00 Page: 11
Prepared By: Approved By: Issued
By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CE Quality Manager
O
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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.

S. No FIELD OF TESTING PRODUCT GROUP/PARAMETER

1. Chemical i) Food and Agricultural Products , etc .

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 1.0 Section: Scope
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.: 00 Amend Date: 00 Page: 12
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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.

ISO/IEC Guide 99, International vocabulary of metrology (VIM)

ISO/IEC 17000, Conformity assessment

NABL Documents and guidelines

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 2.0 Section: Normative References
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.: 00 Amend Date: 00 Page: 13
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

SECTION- 3

TERMS AND DEFINITIONS

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL

Section No.: 3.0 Section: Terms and Definitions

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 14

Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P.Jaiswal


G.P. Jaiswal
Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

3. Terms and Definitions

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.

3.2 Complaint: Expression of dissatisfaction by any person or organization to a laboratory. Relating to


the activities or results of that lab, where a response is expected.

3.3 Interlaboratory: comparison: Organization, performance and evaluation of measurements or tests


on the same or similar items by two or more laboratories in accordance with predetermined
conditions.

3.4 Intralaboratory comparison: Organization, performance and evaluation of measurements or tests


on the same or similar items within the same laboratories in accordance with predetermined
conditions.

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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 3.0 Section: Terms and Definitions

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 15

Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal

Technical Manager CEO Quality Manager


ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

SECTION- 4

GENERAL REQUIREMENTS

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 4.0 Section: General Requirements
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 16
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 4.1 Section: Impartiality
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 17
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 4.2 Section: Confidentiality
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 18
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

SECTION- 5

STRUCTURAL REQUIREMENTS

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL

Section No.: 5.0 Section: Structural Requirements

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 19

Prepared By: Approved By: Issued By:

G.P. Jaiswal
G.P. Jaiswal G.P.Jaiswal

Technical Manager CEO Quality Manager


ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

5.1 Structural Requirements

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

Established on 9th May 2016


UAN No. DL05D0000491
Pan No. AGDPJ5998B
GSTIN 07AGDPJ5998B1ZA
Type of Firm Proprietary Firm
5.3 CEO is responsible for overall management and provision of resources needed to ensure the required
quality of the laboratory. CEO appoints a Technical management which has overall responsibility
for the technical operations.

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.

5.6 The Laboratory has:

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);

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 5.0 Section: Structural Requirements
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 20
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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;

e. Quality Manager ensures the effectiveness of laboratory activities.

5.8 Laboratory management ensures that:

a. Proper communication is maintained regarding effectiveness of management system through regular


meetings and Management review. Lab management communicates the importance of meeting
customers and other requirements.

b.The integrity of the management system is maintained when changes to the management system are planned
and implemented through timely recruitment process.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL

Section No.: 5.0 Section: Structural Requirements

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 21

Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal

Technical Manager CEO Quality Manager


ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

SECTION- 6

RESOURCE REQUIREMENTS

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL

Section No.: 6.0 Section: Resource Requirements

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 22

Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal

Technical Manager CEO Quality Manager


ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL

Section No.: 6.1 Section: General

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 23

Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal

Technical Manager CEO Quality Manager


ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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

Section No.: 6.2 Section: Personnel

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 24

Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal

Technical Manager CEO Quality Manager


ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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

a. Development, modification, verification and validation of methods

b. Analysis of results, including statements of conformity or opinions and interpretations

c. Report, review and authorization of results.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 6.2 Section: Personnel
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 25
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CE Quality Manager
O
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

6.3 Facilities and Environment Condition

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)

S. NO. SECTION/ ROOM ENVIRONMENTAL CONDITIONS


Temp. (OC) Humidity (%)
1. Chemical Lab 27  2 40 5

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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL

Section No.: 6.3 Section: Facilities and Environmental Condition

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 26

Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal

Technical Manager CEO Quality Manager


ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL

Section No.: 6.3 Section: Facilities and Environmental Condition

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 27

Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P.Jaiswal

Technical Manager CEO Quality Manager


ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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.

6.4.2 Equipment are used at the permanent premises.

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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 6.4 Section: Equipment
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 28
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 6.4 Section: Equipment
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 29
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 6.4 Section: Equipment
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 30
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

6.5 Metrological traceability

6.5.1 ETRL establishes and maintains metrological traceability to ensure comparability of


its measurement results both nationally and internationally by documented unbroken
chain of calibrations and each contributing to uncertainty, linking to an appropriate
reference.

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

a. calibration provided by a competent laboratory;

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.:

a. certified values of certified reference materials (CRM) 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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 6.5 Section: Metrological traceability
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 31
Prepared By: Approved By: Issued By:

G.P. Jaiswal
G.P. Jaiswal G.P.Jaiswal

Technical Manager CEO Quality Manager


ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

6.6.1 Externally provided products and services

6.6.1 At present, the lab does not sub-contract any work in the field of testing services.

6.6.2 The laboratory maintains a procedure and retain records for:


Reference: ETRL/ QP-6.6/P-01

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.

6.6.3 The lab communicate its requirements to external providers for;

a. The products and services required


b. the acceptance criteria
c. competence, including any required qualification of personnel.
d. Activities that the lab or its customer, intends to perform at the external provider’s premises.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL

Section No.: 6.6 Section: Externally provided products and services

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 32

Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal

Technical Manager CEO Quality Manager


ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

SECTION- 7

PROCESS REQUIREMENTS

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 7.0
Section: Process Requirements

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 33

Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal

Technical Manager CEO Quality Manager


ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

7.1 Review of Requests, tenders and contracts

7.1.1 The lab has a procedure for review of requests, tenders and contracts which defines :

a. The requirements are defined adequately, are understood and documented.

b. The Laboratory has capability and resources to meet the requirements.

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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 7.1 Section: Review of Requests, tenders and contracts

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 34
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

7.1.5 The lab informs customer for any deviation in contract.

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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 7.1 Section: Review of Requests, tenders and contracts

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 35
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

7.2 Selection, verification and validation of methods

7.2.1 Selection and verification of methods

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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 7.2 Section: Selection, verification and validation of methods

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 36

Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal

Technical Manager CEO Quality Manager


ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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.

Currently ETRL is not using any Laboratory Developed Methods.

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.

Validation method should include one or combination of following techniques:

A) Calibration or evaluation of bias and precision using reference standard


B) Systematic assessment of the factors influencing the result.
C) Testing method robustness through variation of controlled parameters.
D) Comparison of results achieved with other validated methods
E) Inter laboratory comparison
F) Evaluation of uncertainty of the results based on understanding of theoretical principles of method
and practical experience of performance of sampling and test method.
7.2.2.2 When changes are made in validated method, if affect the original validation then new validation
is to be done
Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL
Section No.: 7.2 Section: Selection, verification and validation of methods

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 37
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 7.2 Section: Selection, verification and validation of methods

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 38
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

7.3 Sampling

At present ETRL does not undertake any sampling work.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 7.3 Section: Sampling

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 39

Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal

Technical Manager CEO Quality Manager


ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

7.4 Handling of test or Calibration items

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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 7.4 Section: Handling of test or Calibration items

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 40
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

7.5 Technical records (Raw Data Sheet)


7.5.1 The lab has to ensure that the technical records for each activities should have results, report and
sufficient information to facilitate and with identification of factors affecting measurement results
and associated measurement uncertainty, so that lab can repeat the activity under condition or close
to original results.

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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 7.5 Section: Technical Records

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 41
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

7.6 Evaluation of measurement uncertainty

7.6.1 Lab identifies all contributions, when evaluating measurement uncertainty which are
significant, including sampling and method of analysis.

7.6.2 Measurement of uncertainty is evaluated for calibration of its equipment.

7.6.3 Evaluation of measurement of uncertainty is done. In case test method precludes


rigorous evaluation of MU, lab estimates MU based on understanding of theoretical principles
and practical experience of performance of the method.

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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 7.6 Section: Evaluation of measurement uncertainty

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 42
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

7.7 Ensuring the validity of results

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.

The monitoring is planned and reviewed and includes:


a. Use of reference material or quality control material
b. Use of alternative instrumentation which is calibrated to provide traceable results.
c. Functional check(s) of measuring and testing equipment.
d. Use of check or working standards with control charts
e. Intermediate checks on measuring equipment
f. Replicate tests using same or different methods
g. Retesting of retain samples
h. Correlation of results for different characteristics of test item
i. Review of reported results
j. Inter laboratory comparisons
k. Testing of blind samples
Reference: ETRL/QP-7.7/P-01
Result will be acceptance limit ±MU
7.7.2 The lab should monitors its performance by comparison with results of other labs as under :

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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 7.7 Section: Ensuring the validity of results

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 43
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

7.8 Reporting of results


7.8.1 General
7.8.1.1 The results are reviewed and authorized prior to release.
7.8.1.2 The results are provided accurately, clearly, unambiguously and objectively in form of test
report or test certificate and report of sampling. The report should include all information agreed
with customers and all information required by method used which is necessary for interpretation
of results.

All issued reports are retained as technical records.

7.8.1.3 General Requirement:


1. Reporting Result
2.Formate
3.Data provided by the
customer, 4.Test Report
requirement
5. Test Method
6. Calculation Sheet in clause 7.5
As per 7.8.2 to 7.8.3.2
7.8.2 Common requirements for reports ( test and sampling)
7.8.2.1 Each report includes at least the following information;
a. A title ( test report or report of sampling)
b. The name and address of the lab
c. The location of activity performed
d. Unique identification report and identification of end
e. The name and address of customer
f. Identification of method used
g. Description, unambiguous identification and condition of item
h. The date of receipt, sampling
i. The date of activity performed
j. Date of issue of report
k. Reference to sampling plan and sampling method
l. A statement to the effect that the results related only to the item tested or sampled. A statement
specifying that the report should not be reproduced except in full without approval of the lab.
m. The unit of measurement
n. Addition, deviation or exclusions from test method
o. Identification of person authorizing the report
p. Clear identification when results are from external service providers
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: 44
Prepared By: Approved By: Issued
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

By:

G.P. Jaiswal G.P.Jaiswal


Technical Manager CE Quality Manager
O
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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 Specific requirement for test report

7.8.3.1 In additional to above requirement, where necessary for interpretation of test results, reports
include;

a. Information on specific test condition such as environmental conditions


b. Where relevant a statement of conformity with requirement or specifications
c. Where applicable the MU, when
i) It is relevant to validity or application of test results
ii) Customers requirement
iii) If MU affects conformity to specification limit
d. Where appropriate, opinion and interpretation
e. Any information required by specific methods, authorities, customers.

7.8.3.2 Where lab is n o t performing sampling activities.

7.8.4 Specific requirements for calibration


certificates Not Applicable

7.8.5 Reporting sampling – specific requirements


At present ETRL laboratory does not undertake sampling work.

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: 45
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

7.8.6 Reporting of conformity statement

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 Reporting of opinions and interpretations

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

Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

Technical Manager CEO Quality Manager


ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 7.9 Section: Complaints

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 47

Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal

Technical Manager CEO Quality Manager


ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

7.10 Nonconforming work

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

The procedure ensures ;


a. Responsibility and authority for management of nonconforming work are defined.
b. Action for halting, repeating of work and withholding of reports are based upon the risk levels
established.
c. An evaluation is made of the significance of the nonconforming work, including an impact analysis
on previous results.

d. Decision taken on the acceptability of non-conforming work.


e. If necessary customer is notified and work is recalled.

f. The responsibility for authorizing the resumption of work to be defined.

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

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 7.10 Section: Nonconforming work

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 48
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

7.11 Control of data and information management

7.11.1 The lab has access to the data and information needed to perform lab activities.

7.11.2 At present ETRL does not maintain records in electronic media.

7.11.3 The lab information management system(s) is:


a. protected from unauthorized access.
b. safeguarded against tampering and loss.
c. operated in controlled environment complies with provider or lab specifications and in non-
computerized systems, provided conditions which safeguard the accuracy of manual recording and
transcription.
d. maintained in such manner that ensures the integrity of the data and information.
e. includes recording system failures, immediate and corrective actions.
7.11.4 Lab does not maintain its records off site or through external service providers.

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

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 7.11 Section: Control of data and information management

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 49
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

SECTION- 8

MANAGEMENT SYSYTEM REQUIREMENTS

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 8.0 Section: Management System Requirements

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 50
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

8 Management system requirements


8.1 Options

8.1.1 General

The Economy Testing & Research Laboratory is providing high quality Testing facilities to its
Lab customers. The

maintains a quality system in accordance to ISO/IEC 17025-2017 guidelines. Policies, systems,


programmes, procedures and instructions which encompass this Quality to ensure the quality of
testing results.

The laboratory implements a management system in accordance with Option A.

8.1.2 Option A

The management system of the lab addresses the followings;

a. Management system documentation

b. Control of management system documents


c. Control of records

d. Actions to address risks and opportunities


e. Improvement

f. Corrective actions

g. Internal audits
h. Management reviews

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 8.1 Section: Management System Requirements

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 51
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

8.2 Management system documentation (Option A)

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.

2. Procedure Manual (ETRL/QP/01) (Level II):


Procedure Manual is the secondary level of document. The laboratory manual consists of the
procedures to be followed to implement the policies framed in quality manual. The laboratory
manual indicates the tertiary level of document like standard test method, SOP and work
instructions

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 8.2 Section: Management System Documentation

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 52
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

3. Standard Operating Procedures/Work Instructions/STP’s (Level III):

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.

ETRL/SOP/SEC/ XXX(Serial No)


ETRL/SOP/GEN-XXX(Serial no);ETRL/STP/Sec/-XXX(Serial No)
This is the third level document, which consists of Operating Procedures pertaining to laboratory.

4. Forms & Formats (ETRL/Clause No./F-01) (Level IV):


This is the fourth level document, which consists of record formats, list etc pertaining to laboratory
management system.
Note:- Equipment Logbook format Numbering: ETRL/6.4/F-06/XXX
(XXX Denotes Equipment ID No)

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 8.2 Section: Management System Documentation

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 53
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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.

Level I: Quality Manual

Level II: Quality Procedures

Level III: Standard Operating Procedures/Work Instructions/STP’s

Level IV: Forms & Formats

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 8.2 Section: Management System Documentation

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 54
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 8.2 Section: Management System Documentation

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 55
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

8.3 Control of Management system documents (Option A)


8.3.1 Lab controls the documents ( internal & external) those required for fulfilment of this
ISO/IEC 17025:2017 document. Documents includes policy statements, procedures,
specifications, manufacturer’s instructions, calibration certificates, charts, text books, posters,
notices, memoranda, drawings, plan etc. which are stored in hard copy or digital.

8.3.2 Lab should ensure that :


a. Documents are approved for adequacy prior to issue by authorized Personnel.

S. Document Name Preparation Review Approval Issued by


No.
1. Quality Manual TM QM CEO QM
2. Procedure Manual TM QM CEO QM

3. Standard Operating Procedure/Work TM/ TM/ CEO QM


Section In Section In
Instructions/STP’s
Charge Charge

4. Forms & Formats TM / QM TM / QM CEO QM

b. Documents to be reviewed and updated once a year before management review.

c. Changes and current revision status of documents are identified

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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 8.3 Section: Control of Management system documents

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 56
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

8.4 Control of Records (Option A)

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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 8.4 Section: Control of Records

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 57
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

8.5 Actions to address risks and opportunities (Option A)

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.

b. Enhance opportunities to achieve the purpose and objectives.

c. Prevent or reduce, undesired impacts and potential failures in lab activities.


d. Achieves improvement.
8.5.2 The lab should plan actions to address these risks and opportunities and to integrate and implement
these actions into management system and evaluate the effectiveness of these actions.
8.5.3 The action to be taken to address risks should include identifying and avoiding threats, taking risks
in order to pursue an opportunity, eliminating the risk source, changing the likelihood or
consequences, sharing the risk or retaining risk by information decision and opportunities
including expanding the scope of lab activities, addressing new customers, using new technology
and other possibilities to address customer needs and action taken should be proportional to the
potential impact on validity of lab results.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 8.5 Section: Actions to address risks and opportunities

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 58
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

8.6 Improvements (Option A)


8.6.1 The lab identifies and select opportunities for improvement and implement necessary
actions.

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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 8.6 Section: Improvements

Issue No.: 01 Issue Date:01.02.2021 Amend. No.00 Amend Date: -00 Page: 59
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

8.7 Corrective actions (Option A)

8.7.1 When non conformity occurs, the lab:


a. Reacts to the NC as applicable, take action to control and correct it and address the consequences.
b. Evaluate the need for action to eliminate the cause(s) of NC, in order that it does not recur or
occur elsewhere by reviewing and analyzing, determining the cause of NC and also determining
if similar NC exist or could potentially occur.

c. Implement any action needed.


d. Review the effectiveness of any corrective action.

e. Update risks and opportunities determining during planning.


f. Make changes to the management system if required.

8.7.2 Corrective actions should be appropriate to the effects of the NC encountered.

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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Section No.: 8.7 Section: Corrective actions

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.00 Amend Date: -00 Page: 60
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

8.8 Internal audits (Option A)


8.8.1 The lab should conduct internal audit at least once a year to confirm that the management system
Confirms to:

a. The lab’s own requirements including the lab activities, requirement of ISO/IEC 17025:2017

b. Effective implementation and maintenance.

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.

b. Lab should define criteria and scope for each audit.

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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Section No.: 8.8 Section: Internal Audits

Issue No.: 01 Issue Date:01.02.2021 Amend. No.00 Amend Date: -00 Page: 61
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

8.9 Management Reviews (Option A)

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.

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 8.9 Section: Management Reviews

Issue No.: 01 Issue Date:01.02.2021 Amend. No.00 Amend Date: -00 Page: 62
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

ANNEXURE-A

ORGANIZATION CHART

CHIEF EXECUTIVE OFFICER

TECHNICAL MANAGER / DY.QUALITY MANAGER QUALITY MANAGER / INCHARGE CUSTOMER SUPPORT (ICS) / HR
DY.QUALITY MANAGER

Sr. Analyst Sr. Analyst MARKETING EXECUTIVE RECEPTION / FIELD STAFFS

Analysts Analysts

OFFICE BOY/ LAB ATTANDENTS

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL


Section No.: 5.5 Section: Organization Chart
Issue No.: 01 Issue Date: 01.02.2021 Amend. No.: -00 Amend Date: 00 Page: 63
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal


Technical Manager CEO Quality Manager
ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

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-

1. Chief Executive Officer


He is the head of the laboratory and is responsible for providing adequate resources to enable
effective implementation of the management systems in the laboratory. He approves Quality
Manual and Procedure Manual. He has overall control of the laboratory and chairs
management review meetings.
2. Quality Manager/Deputy Quality Manager
- The major functions of Quality Manager are:
- Design, develop, and implement the Management system.
- Co-ordination with all departments
- Maintenance of Management system Documents and their distribution.
- Preparation and issue of Quality Manual and Quality Procedure Manual.
- Interaction with NABL.
- Arrangement of Internal/External Audit.
- Arrangement of Management Review.
- Training of Personnel.
- Resolution of the complaints of customers
- Initiation of Corrective and Preventive actions

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL

Section No.: 5.5 Section: Role and Responsibility of Staff

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.: 00 Amend Date: 00 Page: 64

Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal

Technical Manager CEO Quality Manager


ECONOMY TESTING & RESEARCH
LABORATORY (ETRL)
E5/71,5th pusta KH.No.175,Street No.12/2,Sonia
Vihar Delhi-110094

3. Technical Manager/ Section In-charge


- The major functions of Concerned Technical Manager are:
- Maintenance of Laboratory equipment’s.
- Periodic Calibration of Laboratory equipment’s.
- Request for training of personnel to Quality Manager.
- Implementation and Preparation of all the Technical procedures.
- Review of customer enquiries, orders, & Customer Test Request.
- Calculate MU and maintaining the record.
- Preparation & Review SOP’s and STP’s
- Approval of Test Results.
- Approval of Test Reports.
4. Sr. Analysts / Analyst
- Some of the major functions are:
- Reporting to Concerned Section in charge/Manager Technical.
- Testing of samples as per established procedures.
- Monitoring & recording of environmental conditions.
- Preparation of Test Results.
- Preparation SOP’s and STP’s
5. In charge Customer Support (ICS) /Executive Customer Relations & HR:
All the samples are received by Executive Customer Relations. Some of major functions
are:
- Reporting to CEO.
- Receipt of Test Samples from customers
- Receipt of enquires from customers.
- Interaction with customers.
- Receiving Customer feedback and complaints from customers and forward it to the Quality
Manager

Doc. No.: ETRL/QM/01 Doc. Name: QUALITY MANUAL

Section No.:5.5 Section: Role and Responsibility of Staff

Issue No.: 01 Issue Date: 01.02.2021 Amend. No.: 00 Amend Date: -00 Page: 65
Prepared By: Approved By: Issued By:

G.P. Jaiswal G.P. Jaiswal G.P.Jaiswal

Technical Manager CEO Quality Manager

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