Quality Manual

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LABORATORY QUALITY MANUAL
FOR
TÜV SÜD SOUTH ASIA PRIVATE LIMITED
This Manual is issued under the Authority of Sr. Vice President
ISSUE NO.: 06
ISSUE DATE: 22-05-2019
Prepared By: Arun George Approved By: N Ezhilan Issued By: Krishna Deori
Document No: LAB_QM_01 Issue No.:06 Issued on: 22/05/2019 Revision No.:11 Revision Date:22/02/2024 Page 1 of 40
AMENDMENT SHEET
Sr. Revision Revision Page Reason for Issued by Approved by

Amendments Made
No. No. Date No. Amendments (Designation) (Designation)
1 01 03.09.2019 10 To address the Added below under clause 5.3- Manager- Sr. Vice
clause 5.3 of The scope and activities of Central QA President
ISO/IEC laboratory of each location is
17025:2017 maintained by specific
laboratory in annexure-7.
42 To address the Annexure 7 added for Lab Manager- Sr. Vice
clause 5.3 of scope and activity. Central QA President
ISO/IEC
17025:2017
2. 02 26.12.2019 21 To provide the Added below under clause Manager- Sr. Vice
reference of SOP 7.8.1.2 – Central QA President
to address IECEE For IECEE CB Scheme detailed
CB scheme. in LAB_P(EE)_SOP_29
31 Changes in South Annexure 1 – Added Sathish Manager- Sr. Vice
Asia Organization Kumar as Head of Bangladesh. Central QA President
Chart
3. 03 01/05/2021 7 NABL 165 is Removed the reference of Sr. Manager- Sr. Vice
withdrawn by NABL 165 from Normative Central QA President
NABL reference.
4. 10 To address clause Rephrased the clause 5.3 Sr. Manager- Sr. Vice
5.3 of ISO/IEC paragraph and added Central QA President
17025:2017 “It excludes externally provided
laboratory activities on an
ongoing basis”
5. 21 To address the Four year PT/ILC plan has been Sr. Manager- Sr. Vice
new changes as replaced with two year plan Central QA President
per NABL 163 under Clause 7.7.2.
Issue 9 and BAB Added three year PT/ILC plan to
requirement. meet the BAB requirement
6. 04 29/06/2021 06 The Softline Clause 1.5 - Replaced Mumbai Sr. Manager- Sr. Vice
section is closed. – Softline to Mumbai – Hardline Central QA President
Testing (House hold care)
7. 26 Periodic review Reference of roXtra added Sr. Manager- Sr. Vice
under clause 8.3.1 Central QA President
8. 31 Periodic review Annexure 1 – Updated South Sr. Manager- Sr. Vice
Asia Organization Chart Central QA President
9. 33,34 Periodic review Annexure 2 – Details of Sr. Manager- Sr. Vice
,35 Regional Manager removed. Central QA President
Some changes done in the job
description.
1 05 26/07/2021 23 Amendment Clause 7.8.8.1 – Rephrased the Sr. Manager- Sr. Vice
0 review mechanism entire clause on Amendment to Central QA President
added Reports including review
mechanism.
1 Issue 05/02/2022 --- Internal review Removed the details of Greater Sr. Manager- Sr. Vice
1 No.6 Noida laboratory from clause Central QA President
Rev. 06 1.5
7,8 Added few more abbreviations.
9 Added the refresher training on
code of conduct training and
reference of LAB_F_334 in
clause 4.1.4. Replaced the
reference of
LAB_P(e)_SOP_187 to
LAB_P_SOP_478 in clause
4.2.1
Sr. Revision Revision Page Reason for Issued by Approved by

Amendments Made
No. No. Date No. Amendments (Designation) (Designation)
11 Issue 05/02/2022 10 Internal review Reference of IOPEPC and TEC Sr. Manager- Sr. Vice
No.6 added under clause 5.4 Central QA President
Rev. 06 18 Internal review Added the reference of IOPEPC
sampling SOP under clause
7.3.1
19 Internal review Added the SOP reference of
additional regulatory
requirement of sample in clause
7.4.1 and removed from 7.4.2.
30 Observation-QM Annexure 1- Revised to bring
adequacy the clarity of place of lab in
Parent org chart.
38 Internal review Added LAB_P_QAP_27 detail in
Annexure 4.
-- Internal review Removed Annexure 7-
Laboratory scope and activity
12 Issue 13/07/2022 10,12 Internal review Revised the clause 5.4, 6.3.5, Sr. Manager- Sr. Vice
No.6 & 38 7.4.1 and Annexure 4 to add Central QA President
Rev. 07 reference of LAB_P_QAP_28
12, Audit finding Revised the clauses 6.2.6, 6.3.5,
14, 6.5.2, 6.5.3, 7.2.1.6, 7.2.2.1,
17, 7.3.1, 7.8.3.1 & 7.8.7.1 to
18, specify the activities related to
21 & respective clauses for ENE lab
22
13 Issue 06/09/2022 05 Internal review Added more details to Sr. Manager- Sr. Vice
No.6 Introduction - TÜV SÜD Central QA President
Rev. 08 GROUP. And updated the no.
of locations worldwide and
staff.
14 06 To address the Removed the details of old Sr. Manager- Sr. Vice
new location address of Visakhapatnam food Central QA President
Visakhapatnam testing Laboratory
Food testing
laboratory new
premises Details.
15 20 To address the IAS Clause 7.7.2 – Added the Sr. Manager- Sr. Vice
requirement of reference of four-year Central QA President
PT/ILC mandatory plan to meet the
requirement of IAS accreditation.
16 30 To address the Annexure 1 – Updated South Sr. Manager- Sr. Vice
new change in Asia Parent Organization Central QA President
Bangladesh Structure.
Management
structure.
17 Issue 21/03/2023 9 Internal review Revised Clause 4.1.4 Manager QA Sr. Vice
No.6 President
18 Rev. 09 17 Observation-QM 7.2.2 to give more clarity on Manager QA Sr. Vice
adequacy relevant process. President
19 20 Internal review 7.7 to give more clarity on Manager QA Sr. Vice
relevant process. President
S. Pag
Revisio Revision Reason for Issued by Approved by
N e Amendments Made
n No. Date Amendments (Designation) (Designation)
o. No.
20 Issue 09/01/2024 8 Internal review To address the new location of Sr. Manager- Sr. Vice
No.6 BANGALORE – Electrical & Central QA President
Rev. 10 Electronics Testing laboratory (Product Service (Product
new premises Details. Division) Service
21 8-9 Added Abbreviation of CB, Division)
IECEE and TL under clause 3.2
22 12 Added the reference of
and LAB_P_QAP_29 Requirement
20 of IECEE CBTL and
LAB_P_QAP_30 Requirement
of Telecommunication
Engineering Center under
clause 5.4 and 7.4.1.
23 22 Clause 7.8.1.2-Corrected the
SOP ID as
LAB_P(EE)_SOP_291
24 Issue 22/02/2024 10 Internal review Clause 4.1.3- Reference of Sr. Manager- Sr. Vice
No.6 TSA_09_05 added Central QA President
Rev. 11 (Product Service (Product
25 31 Internal review Updated the parent organization
Division) Service
structure
Division)
26 39 Internal review Updated the List of Level 2
Procedures
TABLE OF CONTENT
Sr. ISO/IEC Section/

Description Page No.
No. 17025- 2017 Clause No.
1 Introduction 6
2 Scope & field of application & Normative Reference 1&2 1&2 6 to 8
3 Terms and Definitions -- 3.1 8
4 Abbreviations -- 3.2 9
5 General Requirements 4 4 10
6 Impartiality 4.1 4.1 10
7 Confidentiality 4.2 4.2 11
8 Structural Requirements 5 5 11-12
9 Resource Requirements 6 6 13
10 General 6.1 6.1 13
11 Personnel 6.2 6.2 13
12 Facilities and Environmental Conditions 6.3 6.3 13-14
13 Equipment 6.4 6.4 14-15
14 Metrological Traceability 6.5 6.5 15-16
15 Externally provided Products and Services 6.6 6.6 16-17
16 Process Requirements 7 7 17
17 Review of Request, Tenders & Contracts 7.1 7.1 17-18
18 Selection, Verification and Validation of Methods 7.2 7.2 18-19
19 Sampling 7.3 7.3 19-20
20 Handling of Test and Calibration Items 7.4 7.4 20
21 Technical Records 7.5 7.5 20-21
22 Evaluation of Measurement Uncertainty 7.6 7.6 21
23 Ensuring the Validity of Test 7.7 7.7 21-22
24 Reporting of Results 7.8 7.8 22
25 General 7.8.1 7.8.1 22
Common Requirements for reports (Test, Calibration or
26 7.8,2 7.8.2 22
Sampling)
27 Specific requirements for Test Reports 7.8.3 7.8.3 23
28 Specific requirements for calibration certificates 7.8.4 7.8.4 23
29 Reporting Sampling- Specific Requirements 7.8.5 7.8.5 23
30 Reporting Statement of Conformity 7.8.6 7.8.6 23-24
31 Reporting opinions and Interpretations 7.8.7 7.8.7 24
32 Amendments to Reports 7.8.8 7.8.8 24
33 Complaints 7.9 7.9 24-25
34 Non- Conforming Work 7.10 7.10 25
35 Control of Data and Information Management 7.11 7.11 25-26
36 Management System Requirement 8 8 26
37 Options 8.1 8.1 26
38 Management System Documentation 8.2 8.2 26-27
39 Control of Management System Documents 8.3 8.3 27
40 Control of Records 8.4 8.4 28
41 Actions to address risks and opportunities 8.5 8.5 28
42 Improvement 8.6 8.6 28-29
43 Corrective actions 8.7 8.7 29
44 Internal Audit 8.8 8.8 29-30
45 Management Reviews 8.9 8.9 30
46 Parent Organization Chart-South Asia -- Annexure 1 31
47 Job description, Authorities and Responsibilities -- Annexure 2 32-36
48 Organization Chart of Individual Testing Laboratory -- Annexure 3 37
49 List of Level 2 Procedures -- Annexure 4 38
50 Layout of Individual Testing Laboratory -- Annexure 5 39
51 Quality Policy -- Annexure 6 40
INTRODUCTION - TÜV SÜD GROUP
TÜV SÜD Group is the largest technical inspectorate in Germany. We have developed from a highly respected
German Testing and Certification organization into one of the world's leading providers of services related to
technical safety.
Established in 1866, as a steam boiler Inspection association, we are now a globally active future-oriented
company. We have transformed from a technical inspectorate, committed to the minimization of technical risks,
to a service provider today.
With our headquarters in Munich, Germany, we are represented internationally in more than 1000 locations
worldwide and employ more than 25,000 highly qualified engineers and professionals with extensive technical
knowledge.
More than 150 years on, sustainability and safety continue to be the backbone of our mission and services.
Our aim is to trust in technology, enabling progress by managing technology-related risks and facilitating
change. This commitment is embodied in our claim “Add value. Inspire trust.” We work progressively towards
being the trusted partner of choice for safety, security and sustainability solutions, adding tangible value to our
clients globally. As we look towards the future, we believe that sustainability and digitalization will continue to
shape the narrative of commerce and society.
Being a neutral and independent institution with activities in 70 different fields, we have become an
internationally competent source for solutions in the field of engineering, safety, environment, and quality.
Globally we have certified over 20,000 companies worldwide to quality management systems.
Today we are one of the world's leading organizations in the field of Auditing & System Certification, Inspection,
Knowledge Services, Testing, Training and Certification during development and manufacture of products, with
regard to Performance, Safety, Legality, Usability and overall Quality.
We have certified over 100000 products from varied fields.
1.0 Scope and Field of Application
1.1 TÜV SÜD South Asia has established the Quality Systems as per ‘ISO/IEC 17025: 2017 - General requirements
for the competence of testing and calibration laboratories’ to carry out tests, including sampling. It covers testing
performed using standard methods, non-standard methods and laboratory developed methods.
1.2 ISO/IEC 17025:2017 standard is applicable to all the laboratories under the TÜV SÜD group operating in South
Asia. TÜV SÜD South Asia provides Testing, Inspection and Auditing & System Certification services to its
customers.
1.3 The Quality Manual outlining the quality systems in TÜV SÜD South Asia is based on the international standard
ISO/ IEC 17025:2017 and relevant NABL documents and used as a guideline for developing Quality
Management systems, administrative and technical operations, based on customer, regulatory authorities and
accreditation bodies requirements.
1.4 TÜV SÜD South Asia has developed procedures to cover safety requirements on the operation of laboratories.
1.5 This manual is applicable to the TÜV SÜD South Asia’s operations in India, Sri Lanka, Bangladesh, covering
the laboratories at India--Bangalore, Gurugram, Walajapet, Mumbai, Tirupur, Prayagraj, Ambur,
Visakhapatnam (Vizag) & Bangladesh - Dhaka in the fields of Biological, Chemical, Mechanical, Electrical and
Electronics. The tests are applicable to products testing in Softlines (Textile and textile products), Food &
Agricultural products, Water/Waste water, Cosmetics & Chemicals, Leather and Footwear, Hardlines, Toys,
Civil testing, Pollution and Environment, Electrical and Electronic products.
This Quality Manual applies to all the laboratories under the control of TÜV SÜD South Asia. At present the
locations are as under –
AMBUR – Leather & Footwear Testing

TÜV SÜD South Asia Pvt. Ltd
2nd Floor , Ambur Trade Centre,
M. C Road,
Ambur – 635802, Tamil Nadu,
BANGALORE – Food Testing

TÜV SÜD South Asia Pvt. Ltd.
A-151, 2C Main Road, Peenya Industrial Estate, IInd Stage,
Bangalore – 560058
BANGALORE – Electrical & Electronics Testing

Kushal Garden Arcade, ‘B’ Block, 2nd Floor,
1A, Peenya Industrial Area, 2nd Phase,
Bangalore – 560058
GURUGRAM – Softline, Food Testing; Hardgoods & Toy Testing

373, Udyog Vihar, Phase-II
Haryana – 122016
MUMBAI – Hardline Testing (Household care)

Off Saki Vihar Road, Saki Naka, Chandivli
Andheri(E),
Mumbai – 400072
PRAYAGRAJ – Civil Testing

C/O Vijay Singh Yadav,
255C/321, Kanhaipur Dhoomanganj,
Prayagraj,
Uttar Pradesh- 211011
TIRUPUR – Softline
284/1 B2, Door No. 106/2A, Nehru Street, Valluvanthottam
15th Valampalayam,
Tirupur – 641652
VISHAKAPATNAM – Food Testing

Plot No.19/1 IDA BLOCK – B,
Auto Nagar, Mindi Village,
GAJUWAKA Mandal,
Visakhapatnam District, AP, INDIA
Pincode: 530012
WALAJAPET – Leather, Footwear, Toys, Wastewater and its Product Testing

S. F No. 139/1B, Ammananthangal 7efinit
Chennai – Bangalore road (NH-46)
Walajapet – 632513, Vellore District
Tamil Nadu, India
BANGLADESH – Softline; Leather & Footwear; Air & Environment

TÜV SÜD Bangladesh (Pvt.) Ltd.
Level 7 & 8, Update Towers,
01, Shajalal Avenue, Sector 6,
Uttara Model Town,
Dhaka – 1230,
Bangladesh
BANGALORE – Electrical & Electronics Testing

TÜV SÜD South Asia
Plot No. 3-P1-B, Hitech Defence & Aerospace Park,
KIADB Industrial Area, BK Palya, Bengaluru,
Bengaluru North Taluk | Pin code – 562149
India
2.0 Normative References:
a. ISO/IEC 17025: 2017- General Requirement for competency of testing and calibration laboratories.
b. NABL 142 – Policy on Traceability of Measurement Results
c. NABL 160 – Guide for preparing Quality Manual.
d. NABL 161 – Guide for Internal Audit and Management Review for Conformity Assessment Bodies
e. NABL 163 – Policy for Participating in Proficiency Testing Activity
f. IAS/TL-CL/031- IAS Policy on Proficiency Testing
3.0 Terms & Definitions and Abbreviations
3.1 Terms and Definitions:

a. Impartiality – Presence of objectivity.
b. Complaint – Expression of dissatisfaction by any person or organization to a laboratory, relating to the

activities or results of that laboratory, where a response is expected.
c. 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.
d. Intralaboratory comparison – Organization, performance and evaluation of measurements or tests on the

same or similar items within the same laboratory in accordance with predetermined conditions.
e. Proficiency testing- Evaluation of participant performance against pre-established criteria by means of

interlaboratory comparisons.
f. Laboratory – body that performs one or more of the following activities:
— testing;
— calibration;
— sampling, associated with subsequent testing or calibration.
g. Decision rule – Rule that describes how measurement uncertainty is accounted for when stating
conformity with a specified requirement.
h. Verification- Provision of objective evidence that a given item fulfils specified requirements.
i. Validation – Verification, where the specified requirements are adequate for an intended use.
3.2 Abbreviations –
AB Accreditation Body
AC Academy
AVP: Assistant Vice President
ASMEA: ASEAN, South Asia, Middle East and Africa
AGMARK: Agricultural Marketing
APEDA: Agricultural and Processed Food Products Export Development Authority
BU Business Unit
BA Business Assurance
BIS Bureau of Indian Standards
BAB Bangladesh Accreditation Board
CB Certification Bodies
CS Cyber Security
CAP Calibration Procedures

CEO Chief Executive Officer
CFO Chief Finance Officer
CPS Consumer Product Service
CQA Central Quality Assurance
CRM Certified Reference Material
CSE Customer Service Executive
COM Communication
CAPA Corrective actions Preventive action
DM Deputy Manager
DGM Deputy General Manager
ENE Electrical and Electronics
EIC Export Inspection Council
EIA Export Inspection Agency
FHB Food, Health and Beauty
FSSAI Food Safety and Standards Authority of India
GM General Manager
HR Human Resource
IS Industrial Services
IT Information Technology
IAS International Accreditation Service
IEC International Electrotechnical Commission
IECEE IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and
Components
ILC Inter Laboratory Comparison
ISO International Organization for Standardization
IOPEPC Indian Oilseeds and Produce Export Promotion Council
LOD Limit of Detection
LOQ Limit of Quantification
LMS Laboratory Management System
MS Management Services
MU Measurement Uncertainty
MHS Medical Health Services
NABL National Accreditation Board for Testing & Calibration Laboratories
P&L Profit and Loss
PS Product Service
PT Proficiency Testing
PV Photovoltaics
QA Quality Assurance
QM Quality Manual
QAE Quality Assurance Executive
QAM Quality Assurance Manager
QAP Quality Assurance Procedures
QMS Quality Management System
RE Real Estate
RH Relative Humidity
RI Rail Infrastructure
RoHS Restriction of Hazardous Substances
SBU Strategic business unit
SOP Standard Operating Procedure
TL Testing Laboratories
TEC Telecommunication Engineering Center
TAT Turn Around Time
TSA TÜV SÜD South Asia
UPS Uninterruptible Power Supply
ULR Unique Laboratory number
VP Vice President
SI International System of Units
SVP Senior Vice President
4.0 General Requirements
4.1 Impartiality
4.1.1 TÜV SÜD South Asia’s top management has empowered their employees to take impartial decision under their
scope of work and activity. Laboratory organization is structured and managed in such a way to safeguard
impartiality. The organization is a third-party Testing, Inspection & System Certification Agency. The testing
activity is independent of all other activities of the group like Inspection, System Certification etc. to review no
influence whatsoever is brought in by other activities on the testing activity.
This is further ensured by having different reporting pattern with different individuals where functions do not
overlap (for e.g., Sales team, Operations team and Quality team are independent of each other in their
responsibilities handled by different personnel). The responsibilities of management personnel where the final
reporting of all functions is adequately defined and have no influence in day to day operations.
4.1.2 The management of TÜV SÜD South Asia including laboratory management is committed to maintain
impartiality and has included an impartiality statement in the quality policy (Refer Annexure 6).
4.1.3 The management gives utmost importance to impartiality and integrity in all its activities. TÜV SÜD South Asia
ensures that its management and personnel are free from any undue internal and external commercial, financial
and other pressures and influences that may adversely affect the quality of their work by providing sufficient
resources to carry out testing activities and by creating different verticals and reporting structure. No monetary
benefits are provided to the laboratory personnel based on either the no. of tests conducted, or no. of reports
released. Employee’s performances are measured through Performance Management Program. The main
objective of the program is to ensure that employees’ performance measures are aligned to TÜV SÜD’s South
Asia’s strategies and objectives as well as to inculcate the right performance culture in the organization (Refer
TSA_09_05).
4.1.4 TÜV SÜD South Asia ensures to identify risks to its impartiality on an ongoing basis that may arise from
different activities or from its relationships or from the relationships of its personnel. The following possibilities
of risk are duly considered
a. Family or personal relationships between persons of the laboratory who is involved in laboratory activities
– Employee are required to sign the conflict of interest - Employee (TSA-09_03_01) form during joining
and periodically.
b. Business relationship between the laboratory and the customer or vendor –All employees are required to
sign the conflict of interest - Vendor TSA-09_03_02. All vendors are also signed a declaration before the
creation of vendor code as approved vendor.
TÜV SÜD South Asia make sure that the employees are involved only in specified and authorized activities
based on their core competency, technical skills with utmost confidentiality to ensure that this does not diminish
their confidence in competence, impartiality, judgment, or operational integrity (Refer TSA-09-03-03 – SOP on
Conflict of Interest, Confidentiality, Impartiality and Integrity). Each of the employees is required to sign the
employment contract where employee agrees to the policies and procedure of organization to maintain
confidentiality on the company’s information including customer’s data and information. All signed contracts
are maintained with company’s Human Resource Department. The procedure is detailed in the HR Manual
TSA-09. All the employees undergo “Code of Conduct training “on their joining which details and emphasize
on organization objective to work in an impartial manner, maintain technical skill and operational integrity.
Additionally, all the employees are required to complete the e-COE awareness training on-line (https://ap.tuev-
sued.com/sa/hr/eCOC/Pages/default.aspx) and sign off. Without this, employee do not get any access to HR
portal. Thus, no influence can be exercised by persons or organization extraneous to the TÜV SÜD South Asia
laboratories.
Refresher online training on “Code of Conduct” is also initiated every year by HR and the same is mandatory
to complete by all the employees. Certificate of participation is issued upon successful completion. Additionally,
Lab Manager of individual laboratories ensures to get the signatures in LAB_F_334 (Declaration-Conflict of
Interest, Impartiality, Integrity and Confidentiality) from their staff every year.
TÜV SÜD South Asia has also identified the risks in other activities in addition to the testing and has clearly
defined the segregation of the other activities in its organization which are risks to impartiality. The same is
maintained at respective location in LAB_F_329 – Risk and Opportunities.
4.1.5 TÜV SÜD South Asia has identified the risk to its impartiality and action described in clause 4.1.4 is taken to
minimize the risk to impartiality on and on going basis. Adequate controls and checks like sample barcoding,
limited access rights to LMS according to role and responsibility are included in the system to ensure that there
are no external factors affecting the testing results. TÜV SÜD South Asia has a defined policy and mandatory
training programs on ‘Code of Conduct’ that establishes its commitment towards Impartiality and Integrity.
4.2 Confidentiality
4.2.1 The ‘Code of Conduct’ training also covers the aspect of Confidentiality. Laboratory have taken adequate
measures such as no use of mobile phone inside the lab, access controls, individual ID and password, firewalls,
lockable drawers etc are implemented to ensure the security of all the information or records created during
the performance of laboratory activities. Laboratory also ensures the confidentiality of the customer’s
information obtained during site testing. All the related staff from sample receipt to report dispatching maintains
confidentiality of information of customer. Any suspicious enquiry for data or test results are diverted to
assigned Laboratory Manager for suitable actions who ensures that confidentiality of information is maintained
(Refer LAB_ P_SOP_478). TÜV SÜD South Asia do not put any customer information in the public domain. It
informs the customer in advance in case it intends to do so, except for the information which are publicly
available.
4.2.2 When TÜV SÜD South Asia is required to release confidential information as required by law or authorized by
contractual commitments arrangements, unless prohibited by law, it is ensured that the customer or individual
concerned is notified.
4.2.3 All the information of customers is treated as confidential. TÜV SÜD South Asia is committed to ensure that
information about the customer obtained from sources other than the customer (e.g. complainant, regulators)
is treated as confidential and is not disclosed to the concerned customer. The provider (source) of this
information is confidential to the laboratory and is never shared with the customer, unless agreed by the source.
4.2.4 TÜV SÜD South Asia ensures that personnel including any committee members, contractors, personnel of
external bodies, or individuals acting on the laboratory's behalf signs a confidential declaration (LAB_F_330)
to ensure that all information obtained or created during the performance of laboratory activities is kept
confidential, except as required by law. Additionally, confidentially condition is defined in TÜV SÜD standard
terms and conditions (TSSA_Lgl_01) and the same is shared with a quotation with all the customers before
finalizing any contract.
5.0 Structural Requirements
5.1 Laboratory is a part of TÜV SÜD South Asia (Registered Office) which is a registered company in Mumbai
under section 21/22 (1)(a) / 22(1)(b) of the Companies Act 1956. The registration number of the same is 11-
121330. Under the registered office all laboratories are working having its own registration, complying with local
legal requirements. The details are maintained and available at specific location.
5.2 TÜV SÜD South Asia has adequate managerial and technical personnel who are provided with the authority
and resources needed to carry out their duties including the implementation, maintenance and improvement of
management system and to identify the occurrence of departures from the management system (detailed in
Annexure 2. The respective personnel also ensure that the testing operations are conducted appropriately and
during departures in performance of tests adequate actions by assessing root cause are initiated to prevent or
minimize such departures.
5.3 The scope and range of testing activities of laboratory are compliant with the International standard ISO/IEC
17025:2017, and regulatory requirement as applicable which excludes externally provided laboratory activities
on an ongoing basis. Each location maintains their activities in the form LAB_F_335. Layout of Individual
laboratory is available at the specific laboratory and the reference of the same is mentioned in Annexure-5.
5.4 This laboratory management system covers the activities carried out in the laboratory’s permanent facilities
located at the address given under clause 1.5 as well as conducted at customer’s premises (site) by the
laboratory (wherever applicable). TÜV SÜD South Asia does not have any mobile testing facility. The
Laboratory Management is committed to carry out the testing activities so as to meet the requirements of
ISO/IEC 17025:2017, applicable specific criteria of accreditation body, based on the requirements of the
regulatory and statutory bodies like FSSAI, EIC, NABL, BAB, IAS, APEDA, BIS, AGMARK, IOPEPC, TEC,
buyers and customers. To comply with the same the activity reports of laboratory is being submitted to
accreditation body, approved scheme owner, regulatory bodies like EIC/EIA, APEDA, BIS at defined time
interval when required The additional requirement of Regulatory Bodies are detailed in following Level 2
documents
 LAB_P_QAP_22: Additional requirement for EIC test samples

 LAB_P_QAP_23: Additional requirement for BIS test samples
 LAB_P_QAP_24: Additional requirement for APEDA test samples
 LAB_P_QAP_27: Additional requirement for IOPEPC test samples
 LAB_P_QAP_28 Additional requirement for AGMARK approval
 LAB_P_QAP_29 Requirement of IECEE CBTL
 LAB_P_QAP_30 Requirement of Telecommunication Engineering Center (TEC)
5.5 TÜV SÜD South Asia Laboratories:
a. Has defined the organization structure, its place in the parent organization and relationship between Quality
management, Technical operations and Support services (Annexure- 1, Parent Organization Chart-South
Asia and Annexure 3, Individual Laboratory Organization Chart). The organization chart of each location is
detailed in the LAB_P_QAP_18. The company’s Headquarters is in Pune. The company is headed by the
Chief Executive Officer.
b. The responsibilities and authorities of all personnel who manage, perform, or verify work that affects the
quality of the test services are defined in Annexure 2, Job Description and Responsibilities and Authorities.
c. Has documented its procedures to ensure the consistent application of its laboratory activities and the
validity of the results are maintained in Level 2 documents.
5.6 TÜV SÜD South Asia have adequate managerial and technical personnel who are provided with authority and
resources needed to carry out their duties including the implementation, maintenance and improvement of
management system and to identify the occurrence of departures from the management system. The
respective personnel also ensures that the testing operations are conducted appropriately and during
departures in performance of tests, adequate actions by assessing root cause are initiated to prevent or
minimize such departures (Refer clause 7.9 to 7.10, 8.5 to 8.7).
Each location has nominated QA personnel who are responsible for implementation of Quality Management
system. Responsibilities with respect to the following activities are determined and documented as defined in
Annexure 2, Job Description, and Authorities.
a. Implementation, maintenance and improvement of the management system
- This is ensured by Central QA with the support of all location QA. Central QA has direct access to Senior
management i.e. Sr. Vice President.
b. Identification of deviations from the management system or from the procedures for performing laboratory
activities
- This is done by Managers of different sections of laboratory or by respective location QA.
c. Initiation of actions to prevent or minimize such deviations
- This is also done by Managers of different sections of laboratory or by respective location QA.
d. Reporting to laboratory management on the performance of the management system and any need for
Improvement
- This is done during the annual management review by the respective location managers, CQA in
coordination with location QA
e. Ensuring the effectiveness of laboratory activities
- This is ensured by respective location Managers of TÜV SÜD South Asia. Approved deputies are
available to ensure efficiency in the event of the absence of the key personnel.
5.7 TÜV SÜD South Asia management ensures that the :
a. Establishment and implementation of necessary communication process within the laboratory to meet -
customer and other requirements. As and when any development occurs while implementing Quality
Management System as per ISO/IEC 17025:2017, the same are duly communicated to all concerned staff;
the laboratory personnel are made aware of the objectives of the management system through various
mode like awareness programs, training program arranged within the organization and outside the
organization etc.
b. Integrity of the management system is maintained when changes to the management system are planned
and implemented. Whenever any changes are made to the Management system including in the Quality
Management System documents, corresponding changes are made to all other relevant documents that
are affected and these are approved preferably by same functions.
Laboratory personnel are informed about the changes in management system through group meetings or
via e-mail etc. Quality Manager ensures that the integrity of the documented QMS is maintained at all times
in the laboratory when changes are planned/ implemented.
6.0 Resource Requirements:
6.1 General
TÜV SÜD South Asia management ensures provision of resources needed for establishment, implementation,
maintenance and continual improvement of laboratory activities which include human resources, facilities,
equipment, systems and support services necessary to manage and perform laboratory activities.
6.2 Personnel
6.2.1 The laboratory personnel (either permanent or contract basis) are bound to adhere to code of conduct and
code of ethics of laboratory to ensure impartiality. All personnel are selected based on their technical skills and
core competency for the related activity (including those designated for site testing activities) and act
impartiality. Staff chosen in testing has scientific background (with Science/ Engineering as one of the subjects)
and sufficient technical knowledge in the work allocated to them. It may be related to the equipment operation,
performing the tests (includes site testing), evaluating the test results, etc. This is verified technically during the
recruitment process. The process of recruitment and selection is done as per HR manual TSA-09.
6.2.2 The management ensures that each function influencing the results of laboratory activities like operation of
specific equipments, carrying out particular tests, evaluation & authorization of staff, interpretation of results,
issuance and signing test reports as authorized signatory are suitable for the task assigned on the basis of
education, qualification, experience, skill and training. Basic educational qualification and experience etc.,
required for various categories of posts is documented in the Competency Matrix, LAB_F_062.
6.2.3 All personnel who operate specific equipment, does sampling, perform tests (in-house and/or on-site), and sign
test reports after review, evaluates the significance of deviations are trained to discharge their respective duties.
All trainees/new joinee perform the tests under the supervision of a senior staff. Training and evaluation
methods are documented in LAB_P_QAP_01 – Personnel – Training and Competency and PR_MAN_01-
Evaluation Procedure. The training records of the staff are maintained by the Laboratory Manager/Technical
Manager. The on-site testing authorization is given only to trained laboratory personnel after successful
evaluation as per the laid down procedure.
6.2.4 Job responsibilities of each personnel are determined, documented, communicated, and acknowledged by all
the staff who are involved in laboratory operations. The record of same is maintained by Laboratory Manager
and the same is specified in Annexure 2. Job responsibility for each personnel is being provided within one
week of joining period.
6.2.5 TÜV SÜD South Asia has documented a procedure to define the competency requirements, personnel
selection as per HR Manual TSA- 09 and Competency Matrix defined in LAB_F_062, training, supervision,
authorization & monitoring competence of personnel as per LAB_P_QAP_01. Records pertaining to following
points are retained with concerned Laboratory Manager/Technical Manager of each location:
a. Competence requirements
b. Selection of personnel
c. Training of personnel
d. Supervision of personnel
e. Authorization record of personnel
f. Monitoring competence of personnel
6.2.6 TÜV SÜD South Asia authorizes the staff for various functions in the laboratory as per the applicability of
respective labs including
a. Development, modification, verification, and validation of methods
b. Analysis of results, including statements of conformity or opinions and interpretations
c. Test report review and authorization of Test results
The authorization is done based on the educational and professional qualification, competence, training and
subsequent evaluation and they meet the requirements stipulated by NABL or other accreditation bodies.
Records of authorization are maintained.
6.3 Facilities and Environmental Conditions
6.3.1 TÜV SÜD South Asia ensures that the facilities and environmental conditions available are suitable for the
laboratory activities and the validity of results are not adversely affected. Laboratories are designed to ensure
that:
a. Adequate space to carry out sample receipt, testing, storage of sample, report preparation to maintain
sample integrity
b. Adequately ventilated to avoid fumes in Chemical and Biological testing by using fume hoods and making
dust free environment.
c. Effective segregation of incompatible activities based on the testing parameter in different divisions
d. UPS facilities for equipment’s, standby power generators.
e. Good security system to reduce the risk of theft, release of important documents from lab and sabotage of
chemical or high value equipment etc.
6.3.2 The requirements of facilities and environmental conditions necessary for the laboratory activities are
documented in the procedure ‘LAB_P_QAP_12 – Facilities and Environmental Condition’.
6.3.3 Respective laboratories of TÜV SÜD South Asia monitors, controls and records environmental conditions
required as per specification, methods or procedures. When the environmental conditions affect the instrument
& test results, the same are identified and recorded. In such condition, testing for related tests is stopped and
appropriate action is taken prior to resumption of tests.
6.3.4 Measures to control facilities by different sections of respective laboratories are implemented, monitored and
periodically reviewed includes the following
a. Access to and use of areas affecting laboratory activities is controlled.
b. Prevention of contamination, interference or adverse influences on laboratory activities
c. Effective separation between areas with incompatible laboratory activities
6.3.5 When laboratory performs the activities outside its permanent site, care is taken for maintaining the conditions
as per laid down test procedure for meeting the applicable requirements. The procedure is documented in
LAB_P_QAP_ 21 – Sampling and LAB_P_QAP_12 Facilities and Environmental Condition
6.4 Equipment
6.4.1 Each laboratory of TÜV SÜD South Asia is furnished with adequate laboratory equipment like
a. Measuring instruments,
b. Software,
c. Measurement standards,
d. Reference materials,
e. reference data,
f. Reagents,
g. Consumables or
h. Auxiliary apparatus.
All equipment’s and reference materials and consumables are maintained to ensure that the accuracy required
is achieved. Reference materials, certified reference materials, standard reference materials, quality control
materials and calibrated reference standards for intermediate check which can influence the test results are
required to meet the standard requirement of ISO 17034.
Laboratory uses reference materials which are traceable to National Standards or Certified reference material
wherever applicable. In case of absence of reference materials, appropriate materials with Certificate of
Analysis are utilized and preferably checked at frequent time intervals.
6.4.2 In case where the laboratory needs to use equipment outside its permanent control, it ensures that the
requirements of ISO/IEC 17025:2017 are met. While performing an offsite activity, only the equipment owned
by TÜV SÜD laboratory are used. Whenever, laboratory is using equipment for site testing, the same is being
verified before taking it out of the permanent facility using a reference standard or an artifact kept dedicatedly
for this purpose or using self-check/verification facility integrated with the equipment. Records of verification
are maintained.
6.4.3 TÜV SÜD South Asia ensures that all equipments are handled safely. Laboratory ensures safe handling,
transportation, storage, use, and planned maintenance of measuring equipment/ reference standard to ensure
proper functioning and in order to prevent contamination or deterioration used inside or outside the permanent
laboratory for tests or sampling. The same is detailed in LAB_P_QAP_02. The respective laboratories have
maintenance plan for the equipments and Laboratory Manager ensures the implementation of the plan. Any
equipment (including those used for on-site testing) giving suspect results or found to be defective is identified
with the sign “Do not operate”.
6.4.4 TÜV SÜD South Asia ensures that equipments used for different testing conforms to specified requirements
before being placed into service or returned into service only after equipment is calibrated/verified by means of
appropriate methods.
6.4.5 TÜV SÜD South Asia ensures that all equipment and software used for sampling/testing are capable to achieve
the accuracy required and comply to the specifications of tests concerned. Calibration and MU records are
maintained against each equipment to provide a valid result.
6.4.6 TÜV SÜD South Asia ensures the calibration of measuring equipment under following conditions:
a. Measurement accuracy & measurement uncertainty affects the validity of the tested & reported results.
b. Calibration of the equipment is required to establish the metrological traceability of the reported
results.
6.4.7 Respective laboratories of TÜV SÜD South Asia has identified the requirement of calibration/verification and
maintenance of all equipments. Calibrations/verification and maintenance programs for all relevant equipment
based on their properties (where applicable) are maintained. The procedure for the same is detailed in
LAB_P_QAP_02 – Handling of Equipment.
6.4.8 All equipment available in the laboratory have their calibration status identified by proper labels having date of
calibration, due date of calibration, calibration done by and unique ID of the equipment.
6.4.9 Any equipment which has been subjected to overloading or mishandling or gives erroneous results or the
calibration/verification of which is not satisfactory is taken out of service immediately with clear identification
“Do not operate/Out of service”. It is repaired and reviewed for its satisfactory performance by verification or
calibration before putting into regular use. All previous results of such equipment are examined and verified for
their reliability by Technical Manager or Lab Manager. Any deviation in this regard is notified to the Customer
after reporting as Non-conforming work and initiating adequate corrective action. The procedure to control non-
conforming work is detailed in LAB_P_QAP_08 – Control of Nonconforming work.
6.4.10 When intermediate checks are needed to maintain confidence in the performance status of the equipment, they
are carried out according to the procedure defined for various equipments as per applicability.
6.4.11 When calibration and reference material data includes correction factors/reference values, the respective
laboratories of TÜV SÜD South Asia ensures that the correction factors/reference values are updated and
implemented, as appropriate, to meet specified requirements.
6.4.12 TÜV SÜD South Asia ensures that only trained and authorized staff operates the equipments/reference
standard in order to protect it from unintended adjustments which would invalidate the test results. Further,
controlled access of the laboratories is also ensured.
6.4.13 TÜV SÜD South Asia retains records of all equipment which can influence laboratory activities. These records
includes the following:
a. Unique Identification of equipment, including software and firmware version;
b. The manufacturer's name, type identification, and serial number or other unique identification;
c. Evidence of verification that equipment conforms with specified requirements.
d. The current location;
e. Calibration dates, results of calibrations, adjustments, acceptance criteria, and the due date of the next
calibration or the calibration interval;
f. Documentation of reference materials, results, acceptance criteria, relevant dates and the period of
validity;
g. The maintenance plan and maintenance carried out to date, where relevant to the performance of the
equipment;
h. Details of any damage, malfunction, modification to, or repair of the equipment.
6.5 Metrological Traceability
6.5.1 TÜV SÜD South Asia has established and maintained metrological traceability of its measurement results by
means of a documented unbroken chain of calibrations, each contributing to the measurement uncertainty,
linking them to an appropriate reference. TÜV SÜD South Asia complies with the policy document of
Accreditation Body. All equipment used for testing and sampling are calibrated as per the schedule and the
records of calibration are maintained. Laboratory has a procedure to internally calibrate its equipment as per
defined procedures for various equipment and the estimation of measurement of uncertainty is detailed in
LAB_P_QAP_17. All the equipments are externally calibrated by an ISO/IEC 17025:2017 accredited laboratory
to assure the competence, measurement capability and traceability. These equipment calibrations include
parameters which have significant results in tests and where it is practical to do so. In absence of external
calibrations, critical points are identified and subsequent verification of the same is done. Calibration/verification
procedures are detailed in the Level 3 documents.
6.5.2 TÜV SÜD South Asia ensures that the measurement results are traceable to the International System
of Units (SI) through any one or more of the following wherever applicable:
a. Calibration by an ISO/IEC 17025:2017 accredited laboratory
b. Certified values of certified reference materials provided by a competent producer (comply with the
requirements of ISO/IEC 17034) with stated metrological traceability to the SI. This is not applicable
for ENE lab as they do not use any certified reference material.
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, TÜV SÜD South Asia demonstrates
metrological traceability to an appropriate reference, wherever applicable. e.g.:
a. Certified values of certified reference materials provided by a competent producer (comply with the
requirements of ISO/IEC 17034).
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 like participation in inter-laboratory program, where possible.
Note: ENE and Hardline laboratories do not use any reference material.
Calibrations of the equipment are done using certified reference material having traceability to the National
Standards as per procedure wherever applicable. In case the same is not available, suitable materials with
assigned values and acceptable criteria are used as reference material. Internal verifications are conducted
using master equipments in case of unavailability of external calibration facility.
6.6 Externally Provided Products and Services
6.6.1 TÜV SÜD South Asia ensures that only suitable externally provided products and services that affect laboratory
activities are used. All purchase in the laboratory including consumables, standard reference materials,
equipments, reference standards and services are done from reputed and TÜV SÜD approved vendors only.
In this regard TÜV SÜD South Asia ensures the following:
a. The product and services intended for incorporation into the laboratory’s own activities.
b. The product and services are provided, in part or in full, directly to the customer by the laboratory, as
received from the external provider;
c. The product and services are used to support the operation of the laboratory.
The externally provided products include measurement standards and equipment, auxiliary equipment,
consumable materials and reference materials etc. Services can include calibration services, sampling
services, testing services, facility and equipment maintenance services, proficiency testing services and
assessment and auditing services etc.
6.6.2 TÜV SÜD South Asia has defined procedures for externally provided products and services. These procedure
includes following -
a. Lab Manager/Technical Manager of the respective laboratories defines, reviews and approves the
laboratory’s requirements in coordination with CIM Incharge and Instrumentation Incharge for externally
provided products and services; Calibration of equipment is availed from ISO/IEC 17025 accredited
calibration laboratory only; Subcontracting is also done with ISO/IEC 17025 accredited testing laboratory.
Maintenance services are availed from competent service provider or from manufacturer’s trained service
engineers. Purchase of CRMS and critical consumables are also procured from reputed companies.
b. TÜV SÜD South Asia selects suppliers and service providers on the basis of evaluation, selection and
monitoring of its past experience and re-evaluation of all providers. It has defined the criteria in
LAB_P_QAP_03 - Purchasing, Products and Services and LAB_P_QAP_04 – External Service Provider –
Subcontracting.
c. TÜV SÜD South Asia ensures that externally provided products and services conforms with all the
requirements before they are used. Critical consumables identified by the laboratory are verified before
putting them for regular use and store. Records of quality check is maintained. Incase of subcontracting of
tests, laboratory subcontracts the testing to other laboratories which compliance with the requirement of
ISO/IEC 17025:2017 and the same is communicated to the customer in advance. Respective laboratories
maintain the list of subcontracting laboratory and record of the evidences of compliance.
d. Laboratory retains records of taking any actions arising from evaluations, monitoring of performance and re-
evaluations of the external providers.
6.6.3 TÜV SÜD South Asia communicates its specific requirement to external providers for the following:
a. The products and services to be provided;
b. The acceptance criteria;
c. Competence, including any required qualification of personnel;
d. Activities that the laboratory, or its customer, intends to perform at the external provider's premises.
7.0 Process Requirements
7.1 Review of Requests, tenders and contracts
7.1.1 TÜV SÜD South Asia has a defined procedure for reviewing of requests, tenders and contracts before
accepting any type of testing. The documented procedure LAB_P_QAP_05 ‘Review of requests, tender and
contracts’ defines and ensures that: -
a. Requirements are adequately defined, documented and understood.

b. Laboratory verifies the feasibility of test requests and ensures the availability of resources and capabilities
to meet the customer requirements before accepting any customer request/tenders/contracts. In case of
non-availability of any resources, the same is intimated to the customers. All the communications are
recorded accordingly with the details wherever possible.
c. When external providers are used, laboratory informs to the customer about the specific activity performed
by the external providers and gains customer approval as well. All the requirements of clause 6.6 also need
to be met while using external providers.
d. Laboratory uses the appropriate methods or procedures and are capable of meeting the customer
requirements in case the same is not specify or inform by the customer. Customer care team informs
customer about the selection of appropriate test standard/method.
In case of regulatory requirements, the samples are accepted as per applicable schemes addressed in
respective Level 2 documents like for EIC approval scheme (LAB_P_QAP_22), APEDA recognition scheme
(LAB_P_QAP_24) and for BIS Lab approval scheme (LAB_P_QAP_23) are referred. When the parameters
requested for testing are not covered under regulatory/statutory bodies approved scope like FSSAI, EIC, BIS,
APEDA, AGMARK then that are treated as non-EIC/APEDA/FSSAI/BIS samples and separate report with
different format for such parameters is issued.
7.1.2 Whenever, the customer requests the testing of any parameter by inappropriate or out of date/obsolete test
method, customer is informed accordingly. And with his consent appropriate latest method is used by laboratory
for the testing.
7.1.3 When the customer requests a statement of conformity to a specification or standard for the test (e.g. pass/fail,
in- tolerance/ out- of – tolerance), TÜV SÜD South Asia ensures that the specification or standard or decision
rule is clearly defined. Unless there is no specific requirement in the requested specification or standard or from
customer, the decision rule selected is communicated to, and agreed with, the customer. TÜV SÜD South Asia
takes measurement of uncertainty also into account while giving statement of conformity. The procedure used
for considering decision rule and statement of conformity while reporting test results is described in
LAB_P_QAP_26.
7.1.4 Any differences between the request, tender and the contract is resolved before the laboratory activities
commences. Only written contract is acceptable to provide a customer with testing services. In case of internal
customers, verbal agreement is also acceptable. TÜV SÜD South Asia ensures that deviations requested by
the customer do not impact the integrity of the laboratory or the validity of the results.
7.1.5 Customers are duly informed in case of any deviations made by TÜV SÜD South Asia from the contract.
7.1.6 If the contract is amended after the work has already commenced, the same review process is repeated by
TÜV SÜD South Asia and all amendments are communicated to all the affected personnel.
7.1.7 TÜV SÜD South Asia cooperates with the customers or their representatives in clarifying the customer’s
request and also allows them to monitor the laboratory performance in relation to the work performed. This
cooperation includes following-
a. Providing the customer or the customer’s representative reasonable access to the relevant areas of the
laboratory to witness the tests performed for the customer.
b. Any preparation, packaging and dispatch of any test items needed by customer for verification purposes.
In all cases the integrity and confidentiality related to other customers are ensured by Laboratory
Manager/Technical Manager/Quality Manager.
7.1.8 TÜV SÜD South Asia retains record of reviews, including any significant changes, discussions with customer
and the results of all the lab activities.
7.2 Selection, Verification and Validation of Methods
7.2.1 Selection and Verification of Methods

7.2.1.1 Respective laboratory of TÜV SÜD South Asia uses appropriate methods and procedures for all the activities
including evaluation of measurement uncertainty. Statistical techniques are also used for analysis of data (e.g
calculation of z-score while organizing ILC). Only national or international test methods or validated in-house
methods are used by the laboratory.
7.2.1.2 All instructions, standards, manuals and reference data relevant to the work of the laboratory are kept up-to-
date and are made readily available to concerned personnel. All procedures such as Instrument operating
procedure, standard operating procedure, calibration procedure and in-house test procedure are available in
Level 3 documents online for easy review. Notification on newly revised test methods are regularly provided by
QA to respective location of Lab Manager or Technical Manager who verifies the revision status of test
methods. Latest editions are then downloaded from TÜV SÜD standard portal or procured and make it available
at the laboratory. Request to make the changes in LMS also made to reflect the latest edition in the test report.
7.2.1.3 TÜV SÜD South Asia ensures that its laboratory uses latest valid version of a test methods or test methods as
per customer’s test request form or the relevant buyer’s manual. The laboratory ensures that it uses the latest
applicable test methods where applicable. Whenever a customer requests testing with obsolete test method,
the customer is informed of the revision status. In case the buyer/customer insist to use it, the laboratory follows
the same and maintains the records. Respective laboratory of TÜV SÜD South Asia generally uses National
or International standards for the testing without any deviation. However, standard operating procedure for
some test methods are also prepared in a simplified manner so that technical staff can understand the same
clearly.
7.2.1.4 When the customer does not specify the test method, TÜV SÜD South Asia selects any of the following
appropriate test method and communicates the same to the customer.
a. National / International standard test methods;
b. Methods specified by reputable technical organizations such as AATCC;
c. Methods published in relevant scientific texts or journals;
d. Methods specified by reputed manufacturer of equipment; and,
e. Laboratory-developed or modified methods after necessary validation.
7.2.1.5 TÜV SÜD South Asia verifies the methods before introducing them by ensuring that it can achieve the required
performance. Records of verification are retained. If the method is revised by the issuing body, verification is
repeated to the extent necessary.
7.2.1.6 When method development is required (for e.g. in absence of national/international standard), TÜV SÜD South
Asia ensures that the same is done in a planned manner. The method development is assigned to competent
personnel equipped with adequate resources. As method development proceeds, periodic review is carried out
to confirm that the needs of the customer as well as specified requirements are fulfilled. Any modification to the
development plan is taken up only after the same is approved and authorized by concerned Technical Head.
This clause is not applicable for ENE Lab as lab uses only standard methods.
7.2.1.7 TÜV SÜD South Asia ensures that deviation from test methods occur only if that has been documented,
technically justified, authorized by concerned Technical Head/Technical Manager and accepted by customer.
And such customer acceptance can be agreed in advance in the contract.
7.2.2 Validation of Methods

The clause 7.2.2 is completely not applicable for ENE lab as ENE lab uses only standard methods and thus
does not perform the validation of test method.
7.2.2.1 TÜV SÜD South Asia validates non-standard test method, laboratory developed methods and standard
methods used outside their intended scope prior to use as applicable. The procedure of validation is detailed
in LAB_P_QAP_20.The techniques used for method validation can be one of, or a combination of, the following:
a. Calibration or evaluation of bias and precision using reference standards or reference materials;
b. Systematic assessment of the factors influencing the result;
c. Testing method robustness through variation of controlled parameters, such as incubator temperature,
volume dispensed;
d. Comparison of results achieved with other validated methods;
e. Interlaboratory comparisons;
f. Evaluation of measurement uncertainty of the results based on an understanding of the theoretical
principles of the method and practical experience of the performance of the sampling or test method.
7.2.2.2 Whenever changes are made to a validated method, the influence of such changes is determined and when
they are found to affect the original validation, then a new validation is performed.
7.2.2.3 TÜV SÜD South Asia ensures that the performance characteristics of validated methods as assessed for the
intended use are relevant to the customers needs and consistent with specified requirements. The performance
characteristics includes
a. Measurement range
b. Accuracy
c. Measurement Uncertainty
d. Limit of detection
e. Limit of quantification
f. Selectivity
g. Linearity
h. Repeatability
i. Reproducibility
j. Robustness
7.2.2.4 TÜV SÜD South Asia ensures to retain the following validation records wherever applicable:
a. The validation procedure used
b. Specification of the requirements
c. Determination of the performance characteristics of the method
d. Results obtained
e. A statement on the validity of the method, detailing its fitness for the intended use.
7.3 Sampling
7.3.1 TÜV SÜD South Asia is normally not involved itself in drawing samples from the bulk or from the customer lot.
Samples provided by the customer, if appropriate to conduct the required test, is taken up of for the testing.
Laboratory takes out specimens from the submitted samples as per the procedure specified in the test methods
or the customer’s guidelines.
Whenever the Laboratory involves in the sampling activity, the sampling is done as per the documented
procedure and the reference of relevant procedures are mentioned in LAB_P_QAP_21 – Sampling.
ENE lab is not involved in any sampling activity and hence the clause 7.3 is not applicable for ENE lab.
The relevant sampling plan and method are made available at the location where the sampling is undertaken.
The sampling method addresses the factors to be controlled to ensure the validity of subsequent testing.
7.3.2 The sampling method mentioned above for different categories describes the following :
a. The selection of samples or sites;
b. The sampling plan;
c. The preparation and treatment of sample(s) from a substance, material or product to yield the required item
for subsequent testing .
Handling of test items when sample received into the laboratory is followed as per the procedure defined in
LAB_P_QAP_06.
7.3.3 TÜV SÜD South Asia retains records of sampling data that forms part of testing that is undertaken. These
records include, where relevant:
a. Reference to the sampling method used;
b. Date and time of sampling;
c. Data to identify and describe the sample (e.g. number, amount, name);
d. Identification of the personnel performing sampling;
e. Identification of the equipment used;
f. Environmental or transport conditions.
g. Diagrams or other equivalent means to identify the sampling location, when appropriate;
h. Deviations, additions to or exclusions from the sampling method and sampling plan.
7.4 Handling of Test Items
7.4.1 TÜV SÜD South Asia has a documented procedure for the transportation, receipt, handling, protection, storage,
retention and disposal of test items in LAB_P_QAP_06. Precautions are taken to avoid deterioration,
contamination, loss or damage to the item during handling, transporting, storing/waiting, and preparation for
testing or as per instruction if any. When the items are stored or conditioned under specified environmental
conditions; these conditions are maintained, monitored and recorded and samples are appropriately disposed
with records. Following procedures are followed to meet the additional requirement of regulatory sample-
For EIC samples- please refer LAB_P_QAP_22
For BIS samples – please refer LAB_P_QAP_23
For APEDA samples- please refer LAB_P_QAP_24
For IOPEPC samples – please refer LAB_P_QAP_27
For AGMARK samples – please refer LAB_P_QAP_28
For IECEE CBTL requirements – Pls refer LAB_P_QAP_29
For TEC requirements – Pls refer LAB_P_QAP_30
7.4.2 TÜV SÜD South Asia has a system of identification of all the test items received. The identification is retained
throughout the life of the item in the laboratory generated by LMS. This unique identification generated through
software represents the sample no. as well as report no for that particular test item. Sample number is written
on the sample or the label is affixed to the sample. The system also ensures that while conducting any testing
if any sub-division or groups of items and the transfer of items is required, TÜV SÜD South Asia ensures that
the test items are duly incorporate the sample identity in order to avoid any confusion of items physically or
when referred to in records.
7.4.3 Upon receipt of the test item, any abnormality or departure from normal specified condition are reviewed and
details recorded by the Customer care team. This includes any damage to the sample received or insufficient
quantity of the sample etc. When there is doubt about the suitability of an item for test or when it does not
conform to the description provided, or the test required is not specified in sufficient detail, the Customer care
team communicates to the customer for further instruction before proceeding for the test. These
communications are recorded. When the customer requires the sample to be tested acknowledging a deviation
from specified conditions, TÜV SÜD South Asia duly include a disclaimer in the report indicating which results
may be affected by the deviation.
7.4.4 When the items are stored or conditioned under specified environmental conditions; these conditions are
maintained, monitored and recorded and samples are appropriately disposed with records.
7.5 Technical Records
7.5.1 TÜV SÜD South Asia makes sure that the hard copies of all technical records contain the results, report and
sufficient information, if possible, identification of factors affecting the results and its associated measurement
uncertainty and enable the repetition of the laboratory activity under conditions as close as to the original.
All handwritten records are made legibly in pen only and initialed. All records are retained such that they can
be retrieved easily and avoid damage during storage. All observations, data and calculations are recorded
immediately on conducting the test. Sometimes the results are available as computer printout. In both the
cases, laboratory sample no. is incorporated in the records. The records include the date and the identity of
personnel responsible for each laboratory activity. Retention time of Records and documents has been
established in the procedure LAB_P_QAP_10 and LAB_P_QAP_09 respectively.
7.5.2 TÜV SÜD South Asia ensures that amendments to any technical records can be tracked to previous versions
or to original observations. Laboratory retains all the original records like testing records, staff related
information with appropriate identification in a manner to establish easy retrievability and audit trail. Both the
original and amended data and files are retained including the date of alteration, identification of changes and
personnel responsible for the alterations. Erasing of errors is not allowed by the system and when mistakes
are made while recording the test data, such mistakes are crossed out and the correct values entered
alongside. All such corrections are signed or initialed by the person making the changes.
7.6 Evaluation of Measurement Uncertainty
7.6.1 TÜV SÜD South Asia has identified all the components which are important in contributing to the measurement
uncertainty. When estimating measurement uncertainty, all contributions that are of significance are considered
using appropriate methods of analysis for both types [type A and B]. The detailed procedure is defined in
LAB_P_QAP_17.
7.6.2 All the equipment is externally calibrated by an ISO/IEC 17025:2017 accredited laboratory to assure the
competence, measurement capability and traceability. TÜV SÜD South Asia performs internal calibration of its
equipments, glassware and other accessories. Measurement uncertainty is evaluated for all such calibrations.
7.6.3 TÜV SÜD South Asia has a documented procedure in LAB_P_QAP_17 for calculations of uncertainty of
measurement for testing of parameters which are reported objectively. However, in case of testing where
results are determined in a subjective manner like colour fastness, measurement uncertainty is not calculated.
Measurement uncertainty calculations are done for each laboratory tests based on the procedure and records
are maintained. In case where the test method precludes rigorous evaluation of measurement uncertainty,
estimation is made based on the understanding of the theoretical principles or practical experience of the
performance of the method. For a particular method where the measurement uncertainty of the results has
been established and verified, measurement uncertainty is not evaluated for each result provided the identified
critical influencing factors that contribute to the uncertainty are under control.
7.7 Ensuring the Validity of Results
7.7.1 TÜV SÜD South Asia gives very high priority to the Quality of the test results. The procedure of monitoring the
validity of results is documented in LAB_P_QAP_07. Data is recorded in such a way that trends are detectable
and statistical techniques are applied wherever applicable/practicable. The annual plan for internal quality
control is prepared covering all the tests in the scope of accreditation by QA in coordination with Lab Manager
or Technical Manager and the results are reviewed. This monitoring includes the following wherever applicable
and feasible –
a. Use of reference materials or quality control materials

b. Use of alternative instruments that has been calibrated to provide traceable results.
c. Functional checks of measuring and testing equipments.
d. Use of check or working standards with control charts, wherever applicable
e. Intermediate checks on equipments
f. Replicate testing using the same or different methods conducted as per plan
g. Retesting of retained items
h. Correlation of results for different characteristics of an item
i. Review of reported results;
j. Intralaboratory comparisons.
k. Analysis of blind samples provided by QA personnel.
7.7.2 TÜV SÜD South Asia monitor its performance by comparison with results of other laboratories. This monitoring
is reviewed and includes, but not be limited to, either or both of the following:
a. Participation in proficiency testing conducted either by ASTM, AATCC, IIS, LGC, FAPAS and other
reputed PT Providers.
b. Participation in Inter-laboratory comparisons other than proficiency testing.
Two-year plan for Proficiency testing program or Inter-laboratory comparison participation covering all the tests
is prepared in accordance with the document NABL 163, three year plan to meet the requirement of BAB and
four year plan to meet the requirement of IAS accreditation, as applicable
7.7.3 The data obtained from the above findings is analyzed and evaluated using statistical technique, wherever
applicable to improve the laboratory activities. If the results of the analysis of data from monitoring activities are
found to be outside pre-defined criteria, an appropriate action is taken by the concerned Technical Manager or
Laboratory Manager to prevent incorrect results from being reported.
7.8 Reporting of Results
7.8.1 General
7.8.1.1 TÜV SÜD South Asia ensures that all the test results are released to the customers after the same are properly
reviewed and approved by authorized persons prior to release. Test reports are released only through software
and detailed process is outlined in LAB_P_QAP_11 on Work Flow Chart of Laboratory Process. Test report
carries the signature of the authorized signatory based on their authorization on respective discipline.
All test report carrying digital scanned signature are captured only through software or manually signed (based
on regulatory requirement).
7.8.1.2 The results of each test or series of tests carried out by the laboratory (including tests performed at site) are
reported accurately, clearly, unambiguously, and objectively in accordance with the customer requirements.
This includes all the information requested by the customer and necessary for the interpretation of the test
result. The results/data obtained on site is recorded & communicated to client only through reviewed and
approved report issued by the laboratory. The test results released to the customers are titled as “TEST
REPORT”. Test reports are issued as hard copies and by electronic means, and it is ensured that the
requirements of ISO/IEC 17025:2017 are met.
All issued reports are retained as technical records. Retention time of record is detailed in LAB_P_QAP_10.
TÜV SÜD South Asia has documented the requirements of accreditation/statutory/regulatory bodies for
issuance of test reports in the respective formats. These test reports of regulatory, statutory and other related
bodies are released in format prescribed from their end. For IECEE CB Scheme, it is detailed in
LAB_P(EE)_SOP_291. Laboratories accredited by NABL, when uses their symbol, LAB_P_QAP_16 needs to
be followed, whereas laboratory accredited by other AB follows their guidelines. Laboratory accredited by IAS,
when uses their symbol,
7.8.1.3 TÜV SÜD South Asia has made a provision for reporting the test results in a simplified way for internal customer
and written agreements in case of external customers. Any information listed in clause 7.8.2 to 7.8.7 which is
not reported to the customer is readily available in the laboratory.
7.8.2 Common Requirements for Reports

7.8.2.1 TÜV SÜD South Asia ensures that each report includes the following information, unless the laboratory has
valid reasons for not doing so, thereby minimizing any possibility of misunderstanding or misuse:
a. A title (e.g. Test Report )
b. Name and address of the laboratory.
c. The location of performance of the laboratory activities (testing) is not specifically incorporated as it is
always done at the permanent premises only.
d. Unique identification of all the components that all its components are recognized as a portion of a
complete report and a clear identification of the end;
e. Name and contact information of customer
f. Identification of the methods used.
g. Description, condition and the identification of the test item.
h. The date of receipt of the test item(s), where this is critical to the validity and application of the results;
i. Dates of performance of the testing
j. Date of issue of the report.
k. Reference to the sampling plan and sampling method used by the laboratory or other bodies where these
are relevant to the validity or appreciation of the results.
l. A statement to the effect that the results relate only to the items tested or sampled.
m. The test results with appropriate units of measurements where necessary.
n. Addition, deviations or exclusion from the method
o. Identification of the person(s) authorizing the report.
p. Clear identification when results are from external providers.
q. A statement specifying that the report is not to be reproduced except in full without approval of TÜV SÜD
South Asia
r. ULR number (applicable for NABL accredited laboratory only). To be used as per NABL instruction.
7.8.2.2 TÜV SÜD South Asia is responsible for all the information provided in the report, except for the data and
information provided by the customer. If any data either on site or offsite provided by the customer, it is clearly
identified in the test reports. TÜV SÜD South Asia ensures that a disclaimer is put on the report when the
information is provided by the customer and can affect the validity of results. In addition, a statement to the
effect that the ‘Submitted samples are not drawn by the Laboratory’ is also reported in case lab is not
responsible for sampling.
7.8.3 Specific Requirements for Test Reports

7.8.3.1 In addition to the requirements listed in clause 7.8.2, following details are included in the test reports wherever
necessary for the interpretation of the test results:
a. Information on specific test conditions (e.g, environmental conditions)
b. A statement of compliance / non-compliance with requirements or specifications.
c. where applicable, the measurement uncertainty presented in the same unit as that of the measurand or
in a term relative to the measurand (e.g. percent) when:
— it is relevant to the validity or application of the test results;
— a customer's instruction so requires, or
— the measurement uncertainty affects conformity to a specification limit;
d. Opinion and interpretation wherever required. Softline, Hardline and ENE laboratories of TÜV SÜD South
Asia do not provide any opinion and interpretation.
e. Any additional information required by customer or by specific methods or authorities.
7.8.3.2 In addition to the requirements listed in clause 7.8.5, TÜV SÜD South Asia ensures to provide following
information in the test report where necessary for the interpretation of test results when it is involved in sampling
activity
a. Date of Sampling
b. Location of the sampling
c. Identification of substance/sample includes the name of the manufacturer, model, serial number as
appropriate
d. Reference to the Sampling plan and method
e. Details of environmental condition details during sampling that affect the interpretation of results
f. Information required to evaluate measurement of uncertainty for subsequent testing.
7.8.4 Specific Requirements for Calibration Certificates

As TÜV SÜD South Asia is not responsible for the calibration activity for customers, this clause is not applicable.
7.8.4.1 Not Applicable
7.8.5 Reporting Sampling – Specific Requirements

Where the laboratory is responsible for the sampling activity, the requirements listed in clause 7.8.2 & 7.8.3.2
are included in the reports, where necessary for the interpretation of results.
7.8.6 Reporting Statements of Conformity

7.8.6.1 When a statement of conformity to a specification or standard is provided, TÜV SÜD South Asia documents
the decision rule employed, taking into account the level of risk (such as false accept and false reject and
statistical assumptions) associated with the decision rule employed, and apply the decision rule. However, if
the decision rule is prescribed by the customer, regulations or normative documents, a further consideration of
the level of risk is not done. The procedure for using decision rule, while reporting test results is described in
LAB_P_QAP - 26 – Providing Opinion, Interpretations, Statements of Conformity and Handling Test Results
Close to the Specification.
7.8.6.2 Whenever TÜV SÜD South Asia reports the statement of conformity, it is ensured that the statement clearly
identifies the following:
a. To which test results the statement of conformity applies;
b. Which specifications, standards or parts thereof are met or not met;
c. The decision rule applied (unless it is inherent in the requested specification or standard).
7.8.7 Reporting Opinions and Interpretations

7.8.7.1 When opinion and interpretations are included, TÜV SÜD South Asia documents the basis upon which the
opinions and interpretations have been made. Also the same is done by only competent authorized person. A
detailed procedure is described in LAB_P_QAP_26. Softline, Hardline and ENE labs of TÜV SÜD South Asia
do not provide any opinion and interpretation
7.8.7.2 When the opinions and interpretation expressed in test reports it is based on the test results obtained pertaining
to test item.
7.8.7.3 In the case of transmission of opinion and interpretations by dialogue with the customer, a record is retained,
and care is taken that the requirements of ISO/IEC 17025:2017 are met.
7.8.8 Amendments to Reports

7.8.8.1 When an issued report needs to be changed, amended or re-issued, any change of information is identified.
The reason for the change is included in the amendment report issued by TÜV SÜD South Asia. A change
request received from the customer side is forwarded to the approval authority and QA. Location QA maintains
the approval authority for their respective location. The approval on the amendment to reports are based on
below but not limited to the following reasons -
a. Availability of the reason for the change
b. A thorough review of the change request.
c. Amendment request is not considered if the change request pertains to changes in the traceability of the
product
Change request received from customer side is forwarded to approval authority and location QA. Approval
authority scrutinizes the amendment request based on above and provides the approval to amend the report.
Amended test reports are then issued with adequate care to the customer.
7.8.8.2 If the test report is amended after issue, the same is made only in the form of a further document, or data
transfer, which includes the statement as specified above. TÜV SÜD South Asia ensures that such
amendments meet all the requirements of ISO/IEC 17025:2017. All amended test report are identified as ‘A1,
A2 etc’ and includes statement as
“The test report no. ____________dated DD/MM/YYYY has been superseded. The test report is amended in
terms of……. (reason of the amendment)”.
If additional tests are conducted on the same sample tested earlier, the test report is identified with the words
“ADDITIONAL” (As per BIS reporting format the Test Report is marked with Supplementary Report).
If the customer request for split of the test reports, the same is done with adequate care and the split reports
are identified as “1-2”, “2-2”.
7.8.8.3 When it is required to issue a completely new test report, the same is uniquely identified with reference to the
original that it replaces. For all amendment and split report, prior approval is taken from the authorized person
as per approval matrix of each location.
7.9 Complaints
7.9.1 TÜV SÜD South Asia has a a defined process to register, evaluate and make decisions on all complaints
(written / verbal) received from customer.
7.9.2 Entire process of complaint handling is detailed in LAB_P_QAP_13. A description of the handling process for
complaints is made available to any interested party on request. Laboratory acknowledges the complaint if it
relates to laboratory activities and deals with it until resolution. TÜV SÜD South Asia takes responsibility for all
decisions at all levels of the handling process for complaints.
7.9.3 The complaint handling procedure defined in LAB_P_QAP_13 has included following elements and methods:
a.Description of the process for receiving, validating, investigating the complaint, and deciding what actions
are to be taken in response to it;
b.Tracking and recording complaints, including actions undertaken to resolve them;
c. Ensuring that any appropriate action is taken.
7.9.4 TÜV SÜD South Asia takes responsibility to collect and verify all necessary information to validate the
complaint.
7.9.5 Complaints received are acknowledged and registered preferably within 24 hrs. The same are reviewed and
appropriate corrective actions are taken to resolve the same and subsequently responded.
7.9.6 TÜV SÜD South Asia ensures that the outcomes of complaint investigation to be communicated to the
complainant are made by, reviewed by and approved by individual not involved in the original laboratory
activities in question.
7.9.7 The investigation details and actions taken is communicated to complainant / appellant appropriately. In case
there is no response from client within 30 working days the complaint is treated as closed. BU quality
representative is responsible for closure of this complaint.
The summary of the Complaints/Appeals, actions taken are a part of Management Review Input.
7.10 Non-Conforming Work
7.10.1 TÜV SÜD South Asia has a documented procedure LAB_P_QAP_08, when any aspects of its laboratory
activities or results of this work do not conform to its own established procedures or the agreed requirements
of customers. Non-conforming work is evaluated once identified and suitable action is taken.This procedure
ensures that
a. The responsibilities and authorities for the management of nonconforming work are defined;
b. Actions (including halting or repeating of work and withholding of reports, as necessary) are based upon the
risk levels established by the laboratory;
c. An evaluation is made of the significance of the nonconforming work, including an impact analysis on
previous results;
d. A decision is taken on the acceptability of the nonconforming work;
e. Where necessary, the customer is notified, and work is recalled;
f. The responsibility for authorizing the resumption of work is defined.
7.10.2 TÜV SÜD South Asia retains records of nonconforming work and actions as specified in above clause 7.10.1
from b) to f). Any nonconforming work noticed at any stage is brought to the notice of the Laboratory Manager
or Technical Manager and location specific QA personnel / Quality Manager. Respective location QA is
responsible to retain the records.
7.10.3 Where the evaluation indicates that the nonconforming work could recur or there is doubt about the conformity
of the laboratory’s operations with its own management system, TÜV SÜD South Asia ensures the
implementation of corrective action after conducting root cause analysis.
7.11 Control of Data and Information Management
7.11.1 TÜV SÜD South Asia ensures that all its employees have access to the data and information needed to perform
laboratory testing activities.
7.11.2 TÜV SÜD South Asia uses the laboratory information management system (computerized and non-
computerized) used for the collection, processing, recording, reporting, storage or retrieval of data.
Computerized information management system (LMS) is validated for functionality before introduction.
Whenever there are any changes, including laboratory software configuration or modifications,TÜV SÜD South
Asia ensures that such changes are authorized by General Manager or Quality Manager or Technical Manager,
documented and validated before implementation.
All computers (related to equipment as well) are protected adequately from damage due to environment or
other sources. All data from the computers are taken in back-up drives/discs periodically. Virus control care is
ensured by installing firewalls, antivirus software and by running the scan on weekly basis, the records of which
are available with IT person of respective location (Ref. TSA-IT-P3, P5 and P7).
7.11.3 TÜV SÜD South Asia ensures while using the laboratory information management system(s), the LMS is:
a. Protected from unauthorized access by providing each user an unique ID and password.
b. Safeguarded against tampering and loss;
c. Operated in an environment that complies with provider or laboratory specifications or, in the case of non-
computerized systems, TÜV SÜD South Asia provides conditions which safeguard the accuracy of manual
recording and transcription;
d. Maintained in a manner that ensures the integrity of the data and information;
e. Include recording system failures and the appropriate immediate and corrective actions.
7.11.4 TÜV SÜD South Asia has developed and validate its own laboratory information management system (LMS)
which complies with all the applicable requirements of ISO/IEC 17025:2017.
7.11.5 TÜV SÜD South Asia ensures that all the instructions, manuals and reference data relevant to the laboratory
information management system(s) are made readily available to all concerned personnel.
7.11.6 After analysis, observed data are recorded very carefully in worksheets/logbooks or in the software (Laboratory
Management System - LMS) after thorough review of calculations by the concerned Lab in-charge/ Lab
Manager/Authorized and competent delegate.
8.0 Management System Requirement
8.1 Options
8.1.1 General
TÜV SÜD South Asia has established, documented, implemented and maintained a management system that
is capable of supporting and demonstrating the consistent achievement of the requirements of ISO/IEC
17025:2017 standard and assuring the quality of the laboratory results. In addition to meeting the requirements
of Clauses 4 to 7 of this Quality Manual, TÜV SÜD South Asia has implemented a management system in
accordance with Option A given in the standard ISO/IEC 17025:2017.
8.1.2 Option A
The Management System of the TÜV SÜD South Asia Laboratories address the clauses from 8.2 to 8.9.
8.1.3 Option B
Not Applicable
8.2 Management System Documentation (Option A)
8.2.1 The management of TÜV SÜD South Asia has established, documented, and maintained policies and
objectives for the fulfillment of the purposes of ISO/IEC 17025:2017 and has ensured that the policies and
objectives are acknowledged and implemented at all levels of the laboratory organization.
In addition, TÜV SÜD South Asia also focusses on following established core values
1. Integrity: To act in a professional and ethical manner, maintain confidentiality & be independent
in our work.
2. Honesty: To be committed to the absolute truth in all we work.
3. Passion: Be prepared to go extra mile to ensure customer satisfaction.
4. Respect: To treat everyone with courtesy, fairness and equality
(non-discriminatory)
5. Communication: To openly share any issue, thought or brief and in return, to openly accept
constructive criticism for the purpose of continuous improvement.
8.2.2 The Quality Policy of TÜV SÜD South Asia is addressed in Annexure 6. Based on the policy, the following
objectives have been established for the laboratories.
a. Value added services to its customers in competent manner (new product development).
b. Maximizing Customer satisfaction.
c. Continual Improvement
d. Complying with requirement of standard/ regulatory body/ authorities.
e. Familiarity, updates and complies with Quality Management System consistently and are performing
the testing activities impartially.
f. Provision of safe workplace and healthy Environment.
The policy and objectives includes the competence, impartiality and consistent operation of the different testing
activities of TÜV SÜD South Asia.
8.2.3 The management of TÜV SÜD South Asia provides evidence of commitment to the development and
implementation of the management system and to continually improving its effectiveness. This is done by the
active involvement of Sr. Vice President and Central QA/Location QA/Technical Heads/Laboratory
Manager/Technical Managers in the implementation of established quality management system as per ISO/IEC
17025:2017 and to continually improve the effectiveness of the Management System through monitoring the
objectives.
8.2.4 TÜV SÜD South Asia has an established, documented, implemented and maintained four tier documented
system appropriate to the scope of its testing activities. Laboratory made a reference to supporting procedures
including technical procedures in Quality Manual (such as QAP’s & SOP’s) in such a way that it outlines the
structure of documentation used in the management system and in line with ISO/IEC 17025:2017.
The documentation of the system is divided in the following four levels.
Level 1 - Quality Manual

Level 2 - Quality Assurance Procedures
Level 3 - Standard Operating Procedures for Tests, Instrument Operating Procedures and Calibration
procedures for equipments, In-house Testing Procedures
Level 4 - Forms & Formats, Records
The list of Level 2 documents is given in Annexure- 4 and system is designed to ensure that same assures the
quality of test results.
8.2.5 TÜV SÜD South Asia ensures that all personnel involved in laboratory activities, have access to the parts of
the management system documentation and related information that are applicable to their responsibilities.
8.3 Control of Management System Documents (Option A)
8.3.1 All Management system documents (e.g. internal and external documents) that relate to the fulfillment of
ISO/IEC 17025:2017 are controlled by designated quality functionaries. This includes the four tier
documentation structure described in clause 8.2.4 and external documents such as test methods. All the
documents are controlled using roXtra for all pertinent revisions after approval of designated personnel as
documented in LAB_P_QAP_09. The authority for final release and publishing of the document is with Central
QA. Respective location Quality Manager are printing and issuing the L1 to L3 documents to respective
sections, once it is suitably stamped as “CONTROLLED COPY” for intended use. Any printed document without
suitable mark is considered as uncontrolled copy. In case of conflict, the document available on roXtra prevail
over any other copy.
Provision is made for accessibility to Management System documents by the employees in the electronic
media. These documents are right protected to ensure that employees can not make any changes in the
documents.
8.3.2 All documents that form part of the Management System are controlled and TÜV SÜD South Asia ensures that
the following requirements are fulfilled:
a. Documents are approved for adequacy prior to issue by authorized personnel;

The different levels of documents are approved by functions detailed in the LAB_P_QAP_09 prior to issue
by authorized personnel. Senior Vice President is responsible for approval of the L1 and L2 documents.
Central QA is responsible to review L1 and l2 documents. In case of L3 and L4 documents designated
personnel with adequate background perform the review of these documents. All the documents are issued
by CQA.
b. Documents are periodically reviewed, and updated as necessary;
-All the internal documents related to management system are reviewed either once in 3 years or based
on the need like changes in functions, methods, operations, standards, regulations and where necessary
revised to ensure continuing suitability and compliance with applicable requirements.
c. changes and the current revision status of documents are identified;

-Any changes in the document is highlighted for identification in the respective document. Hand written
amendments are not allowed in the documents. Any immediate changes required in the documents and/or
process is communicated through internal circulars through Technical manager and Quality Manager to all
concerned for effective implementation.
d. Relevant versions of applicable documents are available at points of use and where necessary, their
distribution is controlled;
-Authorized editions of appropriate documents are available at all locations with concerned functional staff
(including the site testing) where operations essential to the effective functioning of the laboratory (including
site testing) are performed. Location QA personnel are responsible for issuing the documents and details
of issued documents are also maintained by them.
e. Documents are uniquely identified;
-All the documents generated by laboratory is uniquely identified. This includes Issue No., Issued date,
Revision No., Revision date, total no of pages and approving/issuing authority.
f. Invalid and obsolete documents are promptly removed from all points of issue or use or otherwise assured
against unintended use and are appropriately marked as “Obsolete”. The management system documents
are retained by Central Quality Assurance
8.4 Control of Records (Option A)
8.4.1 TÜV SÜD South Asia has established and retain legible records to demonstrate the fulfilment of the ISO/ IEC
17025:2017.
8.4.2 TÜV SÜD South Asia has a defined procedure to implement the controls needed for identification, storage,
protection, back-up, archive, retrieval, retention time and disposal of its records. The laboratory’s procedure
for control of records is detailed in LAB_P_QAP_10. The retention period of records is established and
documented considering the requirements of the approval schemes of regulatory agencies (Like EIC, BIS,
APEDA etc.) and the own requirements of TÜV SÜD laboratories. TÜV SÜD South Asia ensures that access
to these records is consistent with the confidentiality commitments, and records are readily available as
specified in the abovementioned procedure.
The backup records stored electronically are prevented for unauthorized access by following the central IT
policy (Refer: TSA-IT-P3).
TÜV SÜD South Asia ensures that hard copies of all records are held secure and in confidence with
identification. All handwritten records are made legibly in pen only and initialed. All records are retained such
that they can be retrieved easily and avoid damage during storage. Retention time of Records and documents
has been established in the procedure LAB_P_QAP_10 and LAB_P_QAP_09 respectively.
Sampling In-charge ensures that the data/ records generated on site (during on site sampling or testing) is
maintained secured & confidential. This data is not disclosed to anybody on site before final review & approval
by authorized personnel.
The responsibility of controlling the records are defined as –
Lab Supervisors / Laboratory Manager – Technical Records
Location QA person /Quality Manager– System Records.
TÜV SÜD South Asia retains all the original records like testing records, staff related information with
appropriate identification in a manner to establish easy retrievability and audit trail. Erasing of errors is not
allowed by the system and identification of changes include crossing with initials.
8.5 Actions to Address Risks and Opportunities (Option A)
8.5.1 TÜV SÜD South Asia considers the risk and opportunities associated with laboratory activities, in order to:
a. Give assurance that the management system achieves its intended results;
b. Enhance opportunities to achieve the purpose and objectives of the laboratory;
c. Prevent, or reduce, undesired impacts and potential failures in the laboratory activities;
d. Achieve improvement
8.5.2 As mentioned in clause 8.5.1, TÜV SÜD South Asia plans

a. Actions to eliminate or mitigate risk and exploring opportunities (Refer LAB_F_329).
b. The actions taken or planned to be taken are duly incorporated in the management system for their effective
implementation. These actions are evaluated to check the effectiveness of these actions.
8.5.3 Actions taken to address risk and opportunities are proportionate to the potential impact on the validity of the
laboratory results.
8.6 Improvement (Option A)
8.6.1 TÜV SÜD South Asia identify and select opportunities for continual improvement and implement appropriate
action as defined in LAB_P_QAP_19. The opportunities for improvement can be identified through the review
of any of the following :
a. By review of operational procedures

b. Implementation of policies and objectives
c. Corrective actions on complaints, negative feedback
d. Analysis of audit results,
e. Results of the proficiency tests/inter laboratory tests.
f. Discussion and decisions taken in Management Review Meeting
g. Use of latest technology and best practices
h. Up gradation through training
8.6.2 TÜV SÜD South Asia has a a system of obtaining customer feedback, both positive and negative, through
various modes (Telephonic, by sending Customer Feedback Form) on regular basis. The same is detailed in
LAB_P_QAP_25. Feedbacks are analyzed and used to improve the management system, laboratory activities
and customer service after taking suitable follow-ups in case of negative feedback.
8.7 Corrective Action (Option A)
8.7.1 When non-conforming work is identified either through complaints, audits, participation in PT/ILC etc , TÜV
SÜD South Asia ensures the following
a. Takes an appropriate action to control and correct it after evaluating the significance of non-conforming
work
b. Evaluates the need of any action in order to prevent the recurrence of non-conforming work.
c. Implement appropriate correction and corrective action which eliminate, if not, minimize the cause of the
nonconformity;
d. Review to effectiveness of any corrective action taken;
e. Update the risks and opportunities during planning
f. Make necessary changes in the management system if required
8.7.2 TÜV SÜD South Asia ensures that corrective actions are appropriate to the effects of the nonconformities
encountered.
8.7.3 TÜV SÜD South Asia retain records while taking corrective action, as evidence of:
a. The nature of the nonconformities, cause(s) and any subsequent actions taken;
b. The results of any corrective action. Refer LAB_F_058
8.8 Internal Audits (Option A)
8.8.1 The laboratory conducts internal audits at least once in a year covering all locations and site testing activities
as applicable. The Internal Audit covers all the elements of ISO/IEC 17025:2017. Internal Audit is conducted
to provide information whether the management system conforms to:
a. The laboratory’s own requirements for its management system in 4 levels, including the laboratory activities;
b. The requirement of ISO/IEC 17025:2017.
c. And its effectively implemented and maintained.
8.8.2 TÜV SÜD South Asia ensures that:
a. The internal audit program is planned, established, implemented and maintained as described in
LAB_P_QAP_14. This includes frequency, methods, responsibilities, planning requirement and reporting.
Internal audits take into consideration the importance of the laboratory activities concerned, changes
affecting the laboratory, and the results of previous audits. Central QA Manager schedule Internal Audit in
such a manner that the entire Quality System is covered along with the requirements of regulatory or
statutory body wherever applicable.
b. Audit criteria and scope for each audit is defined; Internal audits are conducted as per ISO/IEC 17025:2017
by qualified personnel (who have successfully completed the course of ISO/IEC 17025:2005 and transition
course of ISO/ IEC 17025:2017 and independent of the activity to be audited. Internal audit plan also ensures
to cover the requirements of regulatory or statutory requirements and/or its applicable schemes.
c. The outcome of audits are reported to all concerned.
d. Based on the audit findings the Laboratory Manager /Technical Manager/ Quality Manager is responsible to
take the appropriate corrective action within two months. The same is further reviewed for its effectiveness.
Manager Quality Assurance / Location Quality assurance personnel is responsible for ensuring the follow
up and closure of all Non-conformance within timeline. No audit report is considered closed unless this cycle
is completed.
e. Audit findings, non-conformance closures and all the related records are retained as evidence of the
implementation of the audit programme and the outcomes of audit results.
8.9 Management Reviews (Option A)
8.9.1 TÜV SÜD management reviews its managements system at least once in a year, in order to ensure the
continuing suitability, adequacy and effectiveness, including the policies and objectives related to the fulfilment
of ISO/IEC 17025:2017. The review meeting is chaired by Sr. Vice President and following members also
attend the review meeting :
 Assistant Vice President
 Operation Heads of respective Business Units
 Central Quality Assurance
 Respective location QA personnel
 Technical Heads
 Laboratory Manager/Technical Manager
 Any other member of staff as decided by SVP/ AVP/ Operation Head/ CQA.
Central QA is responsible for planning in coordination with Management representative and convening the
Management Review meeting.
8.9.2 The inputs to management review is recorded and this includes –
a. Changes in internal and external issues that are relevant to the laboratory;
b. Fulfillment of Objectives
c. Suitability of policies & procedures
d. Status of action from previous management review
e. Outcomes of recent internal audits
f. Corrective actions
g. Assessments by external bodies
h. Changes in the volume and type of the work or in the range of the laboratory activities
i. Customer and personnel feedback
j. Complaints
k. Effectiveness of any implemented improvements
l. Adequacy of resources
m. Results of risk identification
n. Outcomes of the assurance of the validity of results
o. Other relevant factors, such as monitoring activities and training
8.9.3 The outputs from management review are recorded with respect to all the decisions taken and actions related
to at least:
a. The effectiveness of the management system and its processes;
b. Improvement of the laboratory activities related to the fulfilment of the requirements of this document;
c. Provision of required resources;
d. Any need for change.
The lab Quality Manager ensures that appropriate and timely actions are taken by the officials as per the
decisions of management review. The detailed procedure is documented in LAB_P_QAP_15.
ANNEXURE – 1
PARENT ORGANIZATION STRUCTURE – SOUTH ASIA
ANNEXURE – 2
JOB DESCRIPTION, AUTHORITIES & RESPONSIBILITIES
Senior Vice President

 Responsible for budgeting the SBU Sales and central costs.
 Responsible for meeting SBU Sales targets.
 Responsible for P&L performance for SBU dedicated operations (e.g. laboratory).
 Ensure SBU business development for all SBU products on a national basis.
 Approval of Pricing guidelines in discussion with Operation and Sales Head.
 Monitoring performance of SBU by Sales & Gross Profits & discussing results with Operation Heads.
 Overseeing the proper functioning of respective DM's & to support them to achieve SBU targets
 Approval of major expenses of SBU & capital goods e.g. Lab, test equipment, etc.
 Responsible for overall quality of services of TÜV SÜD South Asia laboratories.
 Addressing the unresolved Customer complaints.
 Responsible for providing the resources required.
 Responsible for achieving and maintaining all necessary Accreditations.
 Responsible for approval of Quality Manual and Quality Assurance Procedures.
 Responsible for Chairing the Management review meetings.
Vice President /Assistant Vice President

 Identify potential business opportunities for the Business Unit & create the environment for necessary
inflow of revenue.
 Create new services & products.
 Close coordination with Key accounts.
 Preparation of SBU presentation, Brochure material, marketing materials & updating the TÜV SÜD web-
site with coordination of Marketing team (as applicable).
 Prepare & provide support in making marketing & business plans.
 Prepare pricing guidelines, develop Sales budget.
 Analyze Sales & Gross profit statements (from Accounts) & discuss them with Sr. VP SBU.
 Contract review & Bid approval.
 Complaint analysis for all laboratories.
 Totally Responsible for Laboratory Operations including full P & L.
 Responsible to approve Level 2 documents (Quality Assurance Procedures-BU Specific).
 Identifying the training needs of Managerial staff and planning for execution.
Operation Head (Sr. General Manager/General Manager / Dy. General Manager)

 Overall Laboratory Operation management and to ensure it is in line with ISO/IEC 17025
 General administration of all laboratory services executed in the region.
 Approval of local purchase/supplies for purchases
 To advise lab manager in deciding appropriate corrective actions.
 Resource planning and management based on the volume of Business.
 Responsible for overall smooth operations, customer relationship & management & profitability in their region
 Ensure competences, quality & integrity in all activities.
 To carry the business promotional activities & presentations
 Create system for enquiry, quotes & order handling
 Responsible for approving withdrawal of test reports and all the amendments requested by the customer.
 Driving the projects of continual improvements in the laboratory..
 Attending new query and development of the capability.
 Optimizing the operational cost and meeting the profitability objectives
Central Quality Assurance

 Responsible for implementation of overall Quality Management System across the laboratories of South
Asia as per ISO/IEC 17025 and regulatory body or statutory body requirement.
 Responsible to maintain and periodically review of the documentation related to Quality Management system
as per ISO/IEC 17025 in coordination with location QA Personnel.
 Planning or scheduling internal audit across South Asia laboratories and depute Internal Auditors in
consultation with Sr. Vice President.
 Coordination with Global Team and across South Asia for harmonization of QMS.
 Ensuring implementation of different TÜV SÜD South Asia procedures in coordination with location Quality
Personnel
 Responsible to review and finalize the PT plan for all Business Unit.
 Responsible to review and plan actions to address risk and opportunity across South Asia on periodical
basis in coordination with location QA/Lab Manager.
 Planning Management Review Meeting in consultation with Sr. Vice President.
 Review and data compilation of customer complaints, customer feedback, PT/Outlier of PS division and
updating to Senior management.
 Maintenance of master list of system documents.
 Handling of Accreditation / regulatory Bodies and recognition (regulatory queries, follow up and compliance).
 Responsible for review of L1 management system documents and issuing of documents from L1 to L4 after
review.
Quality Assurance Personnel (Asst. Manager/ Dy. Manager/ Sr. Executive)

 Responsible for maintenance of Quality Management System of the laboratory.
 Responsible for planning of PT programs, execution of PT programme, co-relation activities within labs,
Internal Quality checks etc.
 Responsible for Internal audits, follow up actions, reviewing of corrective actions.
 Responsible to coordinate with Central Purchase for vendor evaluation.
 Monitoring if the lab is following the practices / procedures laid down.
 Customer complaints – to register the complaint received from customer and coordinate for the root cause
analysis and conclude on Corrective actions.
 To issue the controlled version of documents and to ensure that all stakeholders at Lab are using latest
version of each document.
 Ensuring about the calibration activity schedule is followed by respective lab.
 Responsible to review the risk and opportunity in the location.
 To monitor that the environmental conditions are maintained by lab.
 Monitoring the implementation of Management system and review departures from the same and report to
CQA.
 Ensuring implementation of safety requirements in coordination with Safety Manager
Deputy General Manager – Regulatory/Accreditation

 Responsible for updating on new changes in Regulatory requirement to all the Food laboratory.
 Responsible for development of feasibility according to new changes in coordination with Technical Heads.
 Responsible to impart training on new requirements as applicable.
 Responsible to deal with Regulatory bodies for any query.
Technical Head –
 Responsible for validation of new development based on customer need, regulatory requirement etc.
 Responsible to deal with Customer query.
 Responsible to provide technical support and address technical issues.
 Responsible to deal with Customer complaint.
 Provide Technical Training to teams wherever required.
 Responsible for planning of PT programs in coordination with respective location QA.
Senior Manager/Lab Manager/Deputy Manager/Assistant Lab Manager

 Responsible to implement Quality Management System in the laboratory.
 Reviewing of all documents and records in the lab.
 Responsible for corrective actions, root cause analysis wherever required and authorizing resumption of
work during any nonconformance
 Taking a pro-active action to identify opportunities for improvement.
 Reviewing of the control of the technical records as per requirement of accreditation body/regulatory
bod/statutory body.
 Review all the tests are performed as per the correct method.
 Review of the validation data and calibration of all instrument & plan schedule for calibration & validation.
 Responsible to implement any new test method and process.
 Responsible for review and approval of final test report, commercial invoice.
 To provide Technical support and address technical, operational issues

 Ensuring that confidentiality and integrity is maintained at all times in the laboratory.
 Co-ordinate and promote customer service activities
 Identify, Initiate & evaluate training activities for laboratory staff.
 Ensuring the implementation of Corrective Actions.
 Ensuring traceability of all reference materials and calibration of equipments.
 To ensure that technical staff follows latest version of test standards.
 Vendor evaluation for lab supplies and services
 Communicating to Quality Assurance personnel / Quality Manager in Quality related issues.
 Review and assessment of performance of the staff members.
 Follow up of pending payments from customers in conjunction with accounts.
 Review of calibration status when equipment goes outside permanent control.
 Optimizing operational cost and achieving the profitability goals
 Putting up the systems to implement the continual improvement projects
Technical Manager
 Responsible to implement Quality Management System in the laboratory.
 Reviewing of all documents and records in the lab.
 Responsible for corrective actions, root cause analysis wherever required and implementation of same.
 Responsible for Validation of tests methods.
 Reviewing of the control of the technical records as per the ISO/IEC 17025 requirements.
 Review all the tests are performed as per the correct method.
 Responsible to implement any new test method and process
 To provide Technical support and address technical issues.
 Provide Technical Training to staff.
 Ensuring traceability of all reference materials and calibration of equipment’s.
 To ensure that latest version of test standards are followed in the laboratory.
 Communicating to Quality Assurance personnel/Quality Manager in Quality related issues.
 Ensuring the all test procedures are implemented without any deviations.
 Monitoring the equipment break down in the laboratory and taking necessary actions.
Lab Supervisor/Executive/Team Leader/Sr. Executive

 Responsible to maintain Quality Management System.
 Ensuring all documents and records in the lab are properly maintained.
 To ensure the tests are performed as per the tests requested, with required standards.
 Responsible of subcontracting the sample and maintaining the documents.
 Execution of the preventive actions.
 Responsible for validation of methods and calibration of the instruments.
 Ensure calculation of raw data of analyst and data transfer is correct.
 Maintenance of housekeeping, Environmental conditions in the laboratory.
 Indenting reference standards, glassware and chemicals as required.
 Ensuring the purity and validity of standard solutions and CRM's.
 To maintain minimum stock levels of all Chemicals & Consumables in the laboratory
 Ensuring traceability of all reference materials and calibration of equipments.
 Identification of departures/ non-conformities in testing activities
 Monitoring TAT and reporting to lab managers
 Review of test request after receipt of samples.
 Implementing the all technology oriented projects to improve process efficiency.
Senior Technician/Senior Analyst/Senior Testing Officer

 To perform the testing as per the correct test standard.
 Responsible for training to new technician / analyst.
 Execution of the corrective and preventive actions.
 To maintain the technical records.
 Responsible for validation of methods and calibration of the instruments.
 To ensure initial observations, necessary data, and calculations are recorded at the time they are made.
 Inform to lab supervisor for any kind of equipment breakdown, fault or any kind of irrelevant test results.
 Timely disposal of samples.
 Preparation of standard solutions and maintaining records for the same. Checking validity and purity of
CRM.
 Calibration and Verification of equipment.
 Following the technology process (barcode etc) and using the data.
 Implementing the projects of continual improvement projects
Analyst/Technician/ Testing Officer

 Understanding and maintenance of Quality Management System.
 Performing the testing as per the correct test standard under supervision of Senior Analyst/Technician and
Supervisor.
 Instrument operation.
 Maintenance the technical records as per requirement.
 Recording Initial observations, necessary data, and calculations
 Inform to lab supervisor for any kind of equipment breakdown, fault or any kind of irrelevant test results
(Preventive maintenance).
 Schedule for timely disposal of samples.
 Preparation of standard solutions and maintaining records for the same.
 Following the technology process (barcode etc) and using the data.
EMC/Safety Engineer (R & R)

 Perform test and report as per EMC/Safety standards.
 Responsible to maintain Quality Management system
 Carry out routine test/setup verification to ensure quality
 Participate in IQC/ILC program as per Lab norms
 Develop new test as per business and customer requirements
 Implement good lab practice as per TUV SUD norms
 Comply to Lab quality objectives and hence meet TAT and Quality
 Participate in technical exchange program
 Maintain equipment in good order
 Ensure customer technical requirements are addressed in time
 Responsible for in house verification of equipments at different time intervals.
Manager - Customer Service / Project and Customer Handling

 Managing the customer service functions
 Ensuring customers are served as per the agreement
 Monitoring and ensuring TAT
 Analyzing customer feedback and taking necessary actions in customer service area
 Meeting with the customers and discussing their challenges and extending solutions
 Supporting sales for market information or sales leads
 Implementing the technology process (barcode etc.) and using the data.
Customer Service Executive/Senior Customer Service Executive

 Responsible for all required correspondence with clients
 Monitoring TAT and reporting to Lab Managers.
 Sub-contracting of samples
 Review of requests, tenders and contracts
 Maintaining confidentiality and integrity of the laboratory
 Follow-up of dispatch activities for test reports, invoice.
 Obtaining Customer feedback.
 Co-coordinating with Lab Managers for technical analysis of results.
 Updating Lab Managers on complaints.
 Implementing the technology process (barcode etc.) and using the data.
Microbiologist
 Microbiological analysis as per standard methods
 Maintaining the integrity of samples
 Maintaining log books, calibration records
 Calibration of equipment and glassware as per schedule
 Maintenance of housekeeping, Environmental conditions in the laboratory
 Timely disposal of samples
 Preparation of standard solutions and maintaining records for the same
 Checking validity and purity of Reference material
 Performing Sterility checks and air sterility monitoring as per schedule.
 Maintenance of standard reference cultures
 Maintenance of stock levels of all consumables required in the laboratory.
 Review of sampling process and samplers
Maintenance Manager
 To ensure electrical audits are conducted in all the locations as per scheduled plan.
 To Identify all requirements and ensure implementation to prevent any incidents due to electrical
installations
 Ensure location has a proper preventive maintenance checklist for electrical installations.
CIM Team
 Responsible to ensure that chemical store is audited and requirements maintained.
 Ensure all safety rules followed within chemical store.
 Ensure only good cylinders are brought inside.
 Ensure that vendors are communicated that they need to follow all Safety rules at time of lab equipment
installation/ implementation
 Ensure that the Store room has minimum stock list available for all PPE and chemical spill kit (Sorbent).
 Ensure risk assessment for New equipment completed at the time of raising PR (NERF form).
Sampling In charge
 Responsible for arranging onsite sampling.
 Ensuring that confidentiality and integrity of data / information generated on site until formal report is
issued by the lab.
 Ensure all documents and records related to sampling is properly maintained.
 Responsible for calibration, verification and maintenance of sampling instruments (wherever applicable)
 Responsible for supervision of sampling staff for sampling.
 Co-ordinate and promote customer service activities
 Identify the training activities for sampling staff in consultation with Technical and QA.
 Communicating to Quality Assurance Personnel/Quality Manager in Quality related issues.
 Responsible for Sampling, composite sampling / grouping of sample from product.
 Review of calibration status when equipment goes outside permanent control.
Note:
 The job responsibilities of personnel are defined for all locations (as applicable) above. However, based on
functions at the locations the same may have few changes. The same is documented in the individual Job
responsibility format (Form Number: Lab_F_069) and is available in the respective personal training file. In
addition, there could be changes in designations as well as broad categorisation of summaries has been
mentioned here. In addition, multiple responsibilities may also be performed by an individual like Safety
coordinator and Quality Manager.
 In case of changes in designation during annual review the new designations based on internal circular
would be applicable for Management system document
 Laboratory Manager/Senior Laboratory Manager would also perform the functions of Technical Manager
after due authorisation at respective location as applicable.
ANNEXURE - 3
ORGANIZATION CHART OF INDIVIDUAL TESTING LABORATORY
NOTE : Respective laboratory organization chart is defined in LAB_P_QAP_18.
ANNEXURE - 4
LIST OF LEVEL 2 PROCEDURES
QAP No. Title

LAB_P_QAP_01 Personnel – Training and Competency
LAB_P_QAP_02 Handling of Equipment
LAB_P_QAP_03 Purchasing, Services and Supplies
LAB_P_QAP_04 External Service Provider - Sub-Contracting
LAB_P_QAP_05 Review of requests, Tenders & Contracts
LAB_P_QAP_06 Handling of Test Items
LAB_P_QAP_07 Quality of test result
LAB_P_QAP_08 Control of Nonconforming Work
LAB_P_QAP_09 Document Control
LAB_P_QAP_10 Control of Records
LAB_P_QAP_11 Work Flow of Laboratory Process
LAB_P_QAP_12 Facilities and Environmental Condition
LAB_P_QAP_13 Complaint Handling
LAB_P_QAP_14 Internal Audit
LAB_P_QAP_15 Management Review
LAB_P_QAP_16 Control of NABL Symbol in Test Reports
LAB_P_QAP_17 Uncertainty of Measurement
LAB_P_QAP_18 Individual Laboratory Organization Chart
LAB_P_QAP_19 Improvement
LAB_P_QAP_20 Validation of Methods
LAB_P_QAP_21 Sampling
LAB_P_QAP_22 Additional requirements for EIC test samples
LAB_P_QAP_23 Additional Requirements for BIS test samples
LAB_P_QAP_24 Additional Requirements for APEDA test samples
LAB_P-QAP_25 Procedure on Service to Customer
Providing Opinion, Interpretation, Statement of Conformity and Handling of test
LAB_P_QAP_26
result close to the specification
LAB_P_QAP_27 Additional requirement of IOPEPC Test Sample
LAB_P_QAP_28 Additional requirements for AGMARK approval
LAB_P_QAP_29 Additional requirements for CBTL test samples
LAB_P_QAP_30 Requirements of TELECOMMUNICATION ENGINEERING CENTER(TEC)
ANNEXURE - 5
LAYOUT OF INDIVIDUAL TESTING LABORATORY
NOTE: Respective laboratory is responsible to maintain the updated layouts as mentioned in clause 5.3
ANNEXURE – 6
QUALITY POLICY

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LABORATORY QUALITY MANUAL

TÜV SÜD SOUTH ASIA PRIVATE LIMITED

This Manual is issued under the Authority of Sr. Vice President

ISSUE DATE: 22-05-2019

Sr. Revision Revision Page Reason for Issued by Approved by

Sr. Revision Revision Page Reason for Issued by Approved by

Sr. ISO/IEC Section/

INTRODUCTION - TÜV SÜD GROUP

1.0 Scope and Field of Application

AMBUR – Leather & Footwear Testing

BANGALORE – Food Testing

BANGALORE – Electrical & Electronics Testing

GURUGRAM – Softline, Food Testing; Hardgoods & Toy Testing

MUMBAI – Hardline Testing (Household care)

PRAYAGRAJ – Civil Testing

VISHAKAPATNAM – Food Testing

WALAJAPET – Leather, Footwear, Toys, Wastewater and its Product Testing

BANGLADESH – Softline; Leather & Footwear; Air & Environment

BANGALORE – Electrical & Electronics Testing

2.0 Normative References:

3.0 Terms & Definitions and Abbreviations

3.1 Terms and Definitions:

b. Complaint – Expression of dissatisfaction by any person or organization to a laboratory, relating to the

c. Interlaboratory comparison – Organization, performance and evaluation of measurements or tests on the

d. Intralaboratory comparison – Organization, performance and evaluation of measurements or tests on the

e. Proficiency testing- Evaluation of participant performance against pre-established criteria by means of

f. Laboratory – body that performs one or more of the following activities:

CAP Calibration Procedures

4.0 General Requirements

5.0 Structural Requirements

 LAB_P_QAP_22: Additional requirement for EIC test samples

5.5 TÜV SÜD South Asia Laboratories:

5.7 TÜV SÜD South Asia management ensures that the :

6.0 Resource Requirements:

6.3 Facilities and Environmental Conditions

6.5 Metrological Traceability

6.6 Externally Provided Products and Services

7.0 Process Requirements

7.1 Review of Requests, tenders and contracts

a. Requirements are adequately defined, documented and understood.

7.2 Selection, Verification and Validation of Methods

7.2.1 Selection and Verification of Methods

7.2.2 Validation of Methods

7.4 Handling of Test Items

7.5 Technical Records

7.6 Evaluation of Measurement Uncertainty

7.7 Ensuring the Validity of Results

a. Use of reference materials or quality control materials

7.8 Reporting of Results

7.8.2 Common Requirements for Reports

7.8.3 Specific Requirements for Test Reports

7.8.4 Specific Requirements for Calibration Certificates

7.8.4.1 Not Applicable

7.8.4.2 Not Applicable

7.8.4.3 Not Applicable

7.8.5 Reporting Sampling – Specific Requirements

7.8.6 Reporting Statements of Conformity

7.8.7 Reporting Opinions and Interpretations

7.8.8 Amendments to Reports

7.10 Non-Conforming Work

7.11 Control of Data and Information Management

8.0 Management System Requirement