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QUALITY MANUAL
Of

XXXX Lab Name

ADDRESS.

Tel:
Mobile:

Issue No. : 01

Issue Date :

Copy No. :

Holder’s Name :

LAB PHOTO
 RELEASE AUTHORISATION

This Quality Manual is released under the authority of MD/CEO Name

and is the property of LAB NAME AND ADDRESS

Signature

Name of the MD/CEO

MD/CEO
Designation

AMENDMENT RECORD
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 SI. Section/ Date of Amendment Reasons of
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TABLE CONTENTS
Page
Section ISO/IEC Contents
17025:2017 No
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 Clause
Number
0.1 - Title page 1
0.2 - Release authorization 2
0.3 - Amendment sheet 3
0.4 - Table contents 4
0.5 - Distribution list 6
0.6 - Abbreviation 7
0.7 Quality Policy & Quality Objectives 8
0.8 - Introduction 9
0.9 - Laboratory Process Flow 11
1.0 - Scope & Exclusion 12
2.0 - Normative Reference 13
3.0 - Terms and Definitions 15
4 4 General requirements 16
4.1 4.1 Impartiality 17
4.2 4.2 Confidentiality 18
5 5 Structural requirements 22
6 6 Resource requirements 23
6.1 6.1 General 23
6.2 6.2 Personnel 24
6.3 6.3 Facilities and environmental conditions 25
6.4 6.4 Equipment 28
6.5 6.5 Metrological traceability 29
6.6 6.6 Externally provided products and services 30
7 7 Process requirements 31
7.1 7.1 Review of requests, tenders and contracts 32
7.2 7.2 Selection, verification and validation of methods 34
7.3 7.3 Sampling 35
7.4 7.4 Handling of test item 36
7.5 7.5 Technical records 36
7.6 7.6 Evaluation of measurement uncertainty 37
7.7 7.7 Ensuring the validity of results 38
7.8 7.8 Reporting of results 42
7.9 7.9 Complaints 43
7.10 7.10 Nonconforming work 44
7.11 7.11 Control of data and information management 46
8 8 Management system requirements 47
8.1 8.1 Options 47
8.2 8.2 Management system documentation 47
8.3 8.3 Control of management system documents 48
8.4 8.4 Control of records 50
8.5 8.5 Actions to address risks and opportunities 50
8.6 8.6 Improvement 51
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 8.7 8.7 Corrective action 52
8.8 8.8 Internal audits 53
8.9 8.9 Management review 54

ANNEXURE
1 1 List of Quality System Procedures 56
2 2 List of Standard Operating Procedures 57
3 3 List of External Origin Documents 59
4 4 List of Documents 62
5 5 List of Records 63
6 6 Organisation Chart 65
7 7 Duties and Responsibilities and Authority 66
8 8 Risk Assessment 71

a. Testing 72

b. Impartiality 75

DISTRIBUTION LIST

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 The following are the authorized holders of the controlled copy of this Quality
Manual.

Controlled Copy No Controlled Copy Holder

1 Quality Manager & all staff of the

Lab

* Uncontrolled: Any other copy other than the above list is uncontrolled copy.

ABBREVIATIONS
XXXX Lab Name
CEO Chief Executive Officer
MD Managing Director
AMC Annual Maintenance Contract

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 CAPA Corrective and Preventive Action
FIFO First in First Out
GLP Good Laboratory Practices
ID Identity
IEC International Electro Technical Committee
ILC Inter Laboratory Comparison
ISO International Organization for Standardization
IT Income Tax
IQA Internal Quality Audit
LMS Laboratory Management System
MRM Management Review Meeting
MSDS Material Safety Data Sheet
NABL National Accreditation Board for Testing & Calibration Laboratories
NCR Non - Conformity Report
PPE Personnel Protective Equipment
QC Quality Control
QM Quality Manager / Quality Manual
QMS Quality Management System
QSP Quality System Procedure
SI International System of Units
SOP Standard Operating Procedure
UCM Uncertainty Measurement
UPS Uninterrupted Power Supply
WI Work Instruction
PAR Preventive action report
CAR Corrective action report
QSP Quality System Procedure
No Number
Rev No. Revision Number

QUALITY POLICY

We are committed to good professional practices and to provide the highest

quality of testing services to our Customers by:

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  Carrying out the testing services in accordance with stated method
and Customer’s requirements.
 Timely delivery of services to meet our Customer’s requirements.
 Continual improvement of our processes and the effectiveness of
Quality Management System.
 Meeting the requirements of ISO/IEC 17025:2017 standard.
 Ensuring that all personnel concerned with testing activities familiarize
themselves with the quality documentation and implement policies and
procedure in their work.

Quality Objectives
 Enhance Customer satisfaction
 Enhance accuracy of test results by way of quality assurance efforts
like. ILC, PT etc.
 Focus on continual improvements
 Reduction of errors in sample collection
 Improving of results
 Knowledge Upgradation
 Timely Calibration of Instruments / Validation of measuring devices
 Reducing Downtime
 Reducing Complaints

Introduction

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 LABORATORY PROCESS FLOW

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 1.0 SCOPE & EXCLUSION
XXXX operates testing and applies the international standard ISO/IEC 17025:2017
accordingly. XXXX performs the testing in the following sections:

Group of Test Method /

Sl. products, Specific tests or Standard/ Range of
No materials or types of tests Technique against Testing/
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 items tested performed which tests are Limits of
performed Detection
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Exclusion:

SL.NO CLAUSE NO. JUSTIFICATION FOR EXCLUSION

1. 6.3.5 XXXX do not perform any activities at sites or facilities outside
our permanent control.
2. 6.4.2 XXXX do not perform any activities at sites or facilities outside
our permanent control.
3. 6.5.3 The metrological traceability to SI unit is possible.
4. 7.1.1 (c) XXXX do not use any external provider for testing
5. 7.2.2 XXXX do not use any non-standard methods.
6. 7.3 XXXX do not perform sampling activities.
The sampling is in the scope of the customer.
7. 7.8.1.1 (p) XXXX do not use any external provider for testing.
8. 7.8.4 The scope of accreditation covers only testing activities.
9. 7.8.5 XXXX do not perform sampling activities.
The sampling is in the scope of the customer.
10. 8.1.3 XXXX established management system as per option A

TERMS AND DEFINITIONS

3.1 Impartiality
Presence of objectivity

3.2 Complaint

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 Expression of dissatisfaction by any person or organization to laboratory,
relating to the activities or results of that laboratory, where a response is
expected.

3.3 Interlaboratory Comparison

Organization, performance and evaluation of measurements or tests on the
same or similar items by two or more laboratories in accordance with
predetermined conditions.

3.4 Interlaboratory Comparison

Organization, performance and evaluation of measurements or tests on the
same or similar items, within the same laboratory (3.6), in accordance with
predetermined conditions.

3.5 Proficiency testing

Evaluation of participant performance against pre-established criteria by
means of interlaboratory comparisons.

3.6 Laboratory
Body that performs one or more of the following activities:

 Testing
 Calibration
 Sampling, associated with subsequent testing

3.7 Decision rule

Rule that describes how measurement uncertainty is accounted for when
stating conformity with a specified requirement.

3.8 Verification
Provision of objective evidence that a given item fulfils specified requirements.

3.9 Validation
Verification, where the specified requirements are adequate for an intended
use.

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 4 GENERAL REQUIREMENTS

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 4.1 Impartiality
4.1.1 XXXX activities are undertaken impartially and structured so as to
safeguard impartiality: the organizational structure is such that there is no
conflict of interest with other activities, defining the responsibilities:..
Ref Annexure 8: Organization Chart

4.1.2 XXXX management is committed to impartiality.

4.1.3 XXXX responsible for the impartiality of its laboratory activities does not
allow commercial, financial or other pressures to compromise impartiality.
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 XXXX established procedure for risk assessment to identify various risks wrt
impartiality and the mitigation plan. For being impartial, XXXX conduct its
activities without any bias. Results of the laboratory is not compromised due to
being influenced by any relationships of the laboratory’s personnel involved in
the activities of the XXXX, with its customer. Risks to impartiality may also
arise within XXXX itself by means of creating undue pressure on the analysts/
technicians to skip the test procedural steps for faster results delivery or to
overlook the adverse results which will distress a customer. Further undue
pressure may also include offering monetary incentives to the employees for
the number of tests conducted or the results of test. (Ref: XXXX/QSP/001 –
Quality Procedure for Risk Assessment). Annexure 10 – Risk
Assessment.

4.1.4 XXXX identifies risks to its impartiality on an on-going basis (Refer

Annexure 10 – Risk assessment - Impartiality). This includes those risks
that arise from its activities, or from its relationships, or from the relationships
of its personnel. However, such relationships do not necessarily present a
laboratory with a risk to impartiality. A relationship that threatens the
impartiality of XXXX can based on ownership, governance, management,
personnel, shared resources, finances, contracts, marketing (including
branding), and payment of a sales commission or other inducement for the
referral of new customers, etc.

For example:

Business relationships between the laboratory and the customer;

Family or personal relationships between persons of the laboratory who is

involved in laboratory activities and in case of test witness by external person,
the technical manager explain the producer of testing activities & ensure the
impartiality.

4.1.5 If a risk to impartiality is identified, XXXX able to demonstrate how it

eliminates or minimizes such risk.

4.2 Confidentiality
4.2.1 XXXX established Quality System procedure for handling
confidentiality. (Ref: XXXX/QSP/002- Handling Customer’s Confidential
Information). XXXX responsible, through legally enforceable commitments,
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 for the management of all information obtained or created during the
performance of laboratory activities. XXXX inform the customer in advance, of
the information it intends to place in the public domain. Except for information
that the customer makes publicly available, or when agreed between XXXX
and the customer (e.g. for the purpose of responding to complaints), all other
information is considered proprietary information and regarded as confidential.
Technical Manager ensure that customer related data accessible to his/her
only & do not share to other customer. All data in hard-copy should be locked
& safe. The soft copies are password protected.

4.2.2 When XXXX is required by law or authorized by contractual

arrangements to release confidential information, the customer or individual
concerned, unless prohibited by law, notified of the information provided.

4.2.3 Information about the customer obtained from sources other than the
customer (e.g. complainant, regulators) confidential between the customer and
the laboratory. The provider (source) of this information is confidential to
XXXX and do not share with the customer, unless agreed by the source.

4.2.4 Personnel, including any committee members, contractors, personnel

of external bodies, or individuals acting on the laboratory’s behalf, keep
confidential all information obtained or created during the performance of
laboratory activities, except as required by law. XXXX signs non-disclosure
agreement with all stakeholders (Form No: XXXX/LQMS/0020- Non
Disclosure agreement). QM/TM should explain the above rule & regulations
to all stakeholders.

5 STRUCTURAL REQUIREMENTS

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 5.1 XXXX is a registered legal entity with Government of India, and is legally
responsible for its laboratory activities.

Legal Entity

XXXX is a legal entity. XXXX comply with the legal status requirement of
clause 5. Quality Manager periodically review these documents for updation,
annual filing and renewal as applicable.

5.2 _______________ is the TECHNICAL MANAGER who has overall

responsibility for the laboratory.

5.3 XXXX defines and document the range of laboratory activities for which it
conforms with this document. Refer:-1.0 Scope of Accreditation. XXXX

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 claim conformity with this document for this range of laboratory activities,
which excludes externally, provided laboratory activities on an ongoing basis.

5.4 Laboratory activities carried out in such a way as to meet the

requirements of ISO/IEC 17025:2017, the laboratory’s customers, regulatory
authorities. This includes laboratory activities performed in all its permanent
facility at (LAB ADDRESS).

5.5 a) XXXX defined Organization chart with technical operations and

support services (Annexure 8 - Organization Chart);

b) Specified the responsibility, authority and interrelationship of all

personnel who manage, perform or verify work affecting the results
of laboratory activities (Annexure 9 - Duties, Responsibility and
Authority);

c) Documented its procedures to the extent necessary to ensure the

consistent application of its laboratory activities and the validity of
the results.

5.6 XXXX appointed Mr. _______________ as Quality Manager, who,

irrespective of other responsibilities, have the authority and resources
needed to carry out their duties, including:

a) Implementation, maintenance and improvement of the management

system;
b) Identification of deviations from the management system or from the
procedures for performing laboratory activities;
c) Initiation of actions to prevent or minimize such deviations;
d) Reporting to laboratory management on the performance of the
management system and any need for improvement;
e) Ensuring the effectiveness of laboratory activities.

5.7 Laboratory management ensures that:

a) Communication takes place regarding the effectiveness of the
management system and the importance of meeting customer’s and
other requirements;

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 b) The integrity of the management system is maintained when changes to
the management system are planned and implemented.

Communication Plan

S. Trigger – When What to Sender of Receiver of Method of

No to Communicate Communicate Communication Communication Communication
1. Enquiry Timing, Fee Receptionist Customer Phone/Enquiry
Form
Sample Collection Sample Sample Collector
2. Collection details Customer Phone
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 3. Lab testing Lab Testing Sample Collector Lab Technician Test Request
Requirement
4. Test Reporting Test Values Lab Technician Report-Executive Test Value
5. Readiness of Readiness of Receptionist Customer Phone
Report Report
Any Information
Internal from
6. Communication Management to Management Staff Circular / Notice
Staff Board
Internal Audit Internal Audit
7. Internal Audit Schedule Quality Manager All Staff Schedule in
Notice Board
8. Management Date & Timing Quality Manager Members of MR Verbal
Review Meeting
E-Mail/Direct
9. Complete Report Test Report Receptionist Customer Communication/
Courier
Material / Material /
10. Consumable Consumable Quality Manager Vendor Email/Purchase
Requirement Requirements Order
To get the Customer
11. Customer Satisfaction Quality Manager Customer Customer
satisfaction report Feedback
12. Complaints Details of Customer Quality Manager Verbal / Letter /
Complaints Email
6 RESOURCE REQUIREMENTS

INSERT RECEPTION PHOTO

INSERT EQUIPMENT PHOTO

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 INSERT FACILITIES LIKE COMPUTER INSERT LABORATORY PEOPLE PHOTO

PHOTO

6.1 General
XXXX has adequate personnel, facilities, equipment, systems and support
services necessary to manage and perform its laboratory activities.

6.2 Personnel
6.2.1 All personnel of the laboratory, both internal and external, act
impartially, are competent and work in accordance with the laboratory’s
management system.

6.2.2 XXXX document the competence requirements for each function

influencing the results of laboratory activities, including requirements for
education, qualification, training, technical knowledge, skills and experience.
(Form No: XXXX /LQMS/0050: Competency standard).

6.2.3 XXXX ensures that the personnel have the competence to perform
laboratory activities for which they are responsible and to evaluate the
significance of deviations.

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 6.2.4 The management of XXXX communicates to personnel their duties,
responsibilities and authorities. Refer: Annexure 9, Duties Responsibility
and authorities.

6.2.5 XXXX has procedure (Ref: XXXX/QSP/003: Competency

Management) and retains records for

a) Determining the competency requirements;

b) Selection of personnel;
c) Training of personnel;
d) Supervision of personnel;
e) Authorization of personnel;
f) Monitoring of competency of personnel.

6.2.6 XXXX authorizes personnel to perform specific laboratory activities,

including but not limited to, the following: (Form No: XXXX/LQMS/0060-
Masterlist of Authorized Statutory).

a) Development, modification, verification and validation of methods;

b) Analysis of results, including statements of conformity or opinions and

interpretations;

c) Report, review and authorization of results.

6.3 Facilities and environmental conditions

6.3.1 XXXX established quality system procedure (Ref: XXXX/QSP/004:
Facilities and Environmental conditions) to manage facilities and
environmental conditions. The facilities and environmental conditions are
suitable for XXXX activities and adversely affect the validity of results.
Influence that can adversely affect the validity of results such as:-

a. Microbial contamination dust

b. Electromagnetic disturbances

c. Radiation

d. Humidity

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 e. Electrical supply

f. Temperature

g. Sound and vibration

as required by relevant test SOP.

6.3.2 The requirements for facilities and environmental conditions necessary

for the performance of XXXX activities are documented in the relevant test
SOP. (Refer: Annexure: 3 – List of Standard Operating Procedure).

6.3.3 XXXX monitor, control and record environmental conditions in

accordance with relevant specifications, methods or procedures or where they
influence the validity of the results. (Form No: XXXX/LQMS/0070:
Environmental Conditions Monitoring Form)

6.3.4 Measures to control facilities implemented, monitored and periodically

reviewed and include, but not are limited to:

a) Only the lab staffs and Authorized person area allowed to enter in the
lab. On particular circumstances, like witnessing by the customer,
house-keeping person etc, the access to lab is extended with
permission.
b) Prevention of contamination, interference or adverse influences on
laboratory activities;
c) There are proper separation of work areas in the laboratory are
maintain by TM.

6.3.5 When XXXX performs laboratory activities at sites or facilities outside

its permanent control, it ensures that the requirements related to facilities and
environmental conditions of this document are met or XXXX have only
permanent facilities.

or

XXXX do not perform any activities at sites or facilities outside our permanent
control.

6.4 Equipment
6.4.1 XXXX has established Quality System Procedure
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 (Ref: XXXX/QSP/005- Equipment Maintenance). XXXX have access to
equipment including, but not limited to, measuring instruments, software,
measurement standards, reference data, reagents, consumables or auxiliary
apparatus which is required for the correct performance of laboratory activities
and which can influence the result. XXXX have access to the equipment for
its dedicated use only either by ownership or by long term contract / lease.
Such contract shall be of minimum of 02 years. The control of such equipment
shall lie with the laboratory under the contractual agreement.

6.4.2 When XXXX uses equipment outside its permanent control, it ensures
that the requirements for equipment of this document are met or XXXX uses
equipment only in its permanent facility.

Or

XXXX do not perform any activities at sites or facilities outside our permanent
control.

6.4.3 XXXX have a procedure for handling, transport, storage, use and
planned maintenance of equipment in order to ensure proper functioning and
to prevent contamination or deterioration. Refer: XXXX/QSP/005 –
Equipment Maintenance.

6.4.4 XXXX verifies that equipment conforms to specified requirements

before being placed or returned into service (Form No: XXXX/LQMS/0080:
Installation Testing Report).

6.4.5 The equipment used for measurement is capable of achieving the

measurement accuracy or measurement uncertainty required to provide a
valid result.

6.4.6 Measuring equipments are calibrated when:

 The measurement accuracy or measurement uncertainty affects the

validity of the reported results, or
 Calibration of the equipment is required to establish the metrological
traceability of the reported result.

6.4.7 XXXX established calibration programme (Ref: XXXX/QSP/006 -

Calibration of Equipment), which are reviewed and adjusted as necessary in
order to maintain confidence in the status of calibration.

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 6.4.8 All equipment requiring calibration or which has a defined period of
validity are labeled, coded or otherwise identified to allow the user of the
equipment to readily identify the status of calibration or period of validity.

6.4.9 Equipment that has been subjected to overloading or mishandling,

gives questionable results, or has been shown to be defective or outside
specified requirement is taken out of service. It isolated to prevent its use or
clearly labeled or marked as being out of service until it has been verified to
perform correctly. XXXX examines the effect of the defect or deviation from
specified requirements and initiate the management of nonconforming work
procedure (Refer: XXXX/QSP/020 – Control of nonconforming Testing).

6.4.10 The intermediate checks are necessary to maintain confidence in the

performance of the equipment, these checks carried out according to a
procedure (Ref: XXXX/QSP/008- Procedure for Intermediate Check) and
records the details of the intermediate checks in the (Form No
XXXX/LQMS/090: Intermediate Checks).

6.4.11 The calibration and reference material data include reference values
or correction factors, XXXX ensure the reference values and correction factors
are updated and implemented, as appropriate, to meet specified requirements.
(Form No: XXXX/LQMS/0100- Calibration Record)

6.4.12 XXXX takes practicable measures to prevent unintended adjustments

of equipment from invalidating results.

6.4.13 Records are retained for equipment (Form No: XXXX/LQMS/0110-

Equipment Record).which can influence laboratory activities. The records
include the following, where applicable:

a) The identity 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;

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 g) The maintenance plan and maintenance carried out to date, where
relevant to the performance of the equipment (Ref: XXXX/QSP/008-
Intermediate Checks). (Form NO: XXXX/LQMS/0120 – Preventive
Maintenance Checklist; Form No: XXXX/LQMS/0130 – Preventive
Maintenance Schedule; Form No: XXXX/LQMS/140 - Breakdown
Maintenance record).
h) Details of any damage, malfunction, modification to, or repair of, the
equipment.

6.5 Metrological traceability

6.5.1 XXXX has a procedure (Ref: XXXX/QSP/009-Identification and

Traceability). XXXX establish and maintain metrological traceability of its
measurement results by means of a document unbroken chain of calibrations,
each contributing to the measurement uncertainty, linking them to an
appropriate reference.

6.5.2 XXXX ensures that measurement results are traceable to the

International System of Units (SI) through:

a) Calibration provided by a competent laboratory; or

b) Certified values of certified reference materials provided by a competent
producer with stated metrological traceability to the SI; or

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 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,

XXXX demonstrate metrological traceability to an appropriate reference, e.g.

a) Certified values of certified reference materials provided by a competent

producer;
b) Results of reference measurement procedures, specified methods or
consensus standards that are clearly described and accepted as
providing measurement results fit for their intended use and ensured by
suitable comparison.

6.6 Externally provided products and services

6.6.1 XXXX established Quality System procedure (Ref: XXXX/QSP/010-
Purchase, Receipt and Storage of Consumables). XXXX ensures that only
suitably externally provided products and services that affect laboratory
activities are used, when such products and services:

a) Are intended for incorporation into the laboratory’s own activities;

b) Are provided, in part or in full, directly to the customer by the laboratory,
by the laboratory, as received from the external provider;
c) Are used to support the operation of the laboratory. The laboratory take
external service only if it is useful & to its own activities & not affect to it
quality policy.

6.6.2 XXXX has a procedure and retains records for:

a) Defining, reviewing and approving the laboratory’s requirements for
externally provided products and services;
b) Defining the criteria for evaluation, selection, monitoring of performance
and re-evaluation of the external providers; (Form No:
XXXX/LQMS/0160: Supplier Evaluation form)
c) Ensuring that externally provided products and services conform to the
laboratory’s established requirements, or when applicable, to the
relevant requirements of this documents, before they are used or

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 directly provided to the customer; (Form No: XXXX/LQMS/0170:
Incoming Material inspection record)
d) Taking any actions arising from evaluations, monitoring of performance
and re-evaluations of the external providers. (Form No:
XXXX/LQMS/0180: Supplier Monitoring Form)

6.6.3 XXXX communicates its requirements to external providers through

(Form No: XXXX/LQMS/0200-Purchase Order) for:

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 its customer, intends to perform at the
external provider’s premises.

7 PROCESS REQUIREMENTS

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7.1 Review of requests, tenders and contracts

7.1.1 XXXX has a procedure for the (Ref: XXXX/QSP/011-Review of
Requests, Tenders and Contracts). The procedure ensures that:

a) The requirements are adequately defined, documented and understood;

b) XXXX has the capability and resources to meet the requirements;
c) XXXX do not subcontract any of its testing service.
d) The appropriate methods or procedures are selected and are capable
of meeting the customer’s requirements.

For internal or routine customers, reviews of requests, tenders and contracts

are performed in a simplified way.

7.1.2 XXXX informs the customer when the method requested by the
customer is considered to be inappropriate or out of date.

7.1.3 When the customer requests a statement of conformity to a

specification or standard for the test or calibration (e.g. pass/fail,
in-tolerance/out-of-tolerance) the specification or standard, and the decision
rule clearly defined. Unless inherent in the requested specification or
standard, the decision rule is selected communicated to, and agreed with, the
customer:

7.1.4 Any differences between the requests or tender and the contract are
resolved before laboratory activities commence. Each contract is acceptable
both to XXXX and the customer: Deviations requested by the customer impact
the integrity of XXXX or the validity of the results.

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 7.1.5 The customer has to be informed of any deviation from the contract.

7.1.6 If a contract is amended after work has commenced, the contract

review repeated and any amendments communicated to all affected
personnel.

7.1.7 XXXX cooperates with customers or their representatives in clarifying

the customer’s request and in monitoring the laboratory’s performance in
relation to the work performed.

Such cooperation includes:

a) Providing reasonable access to relevant areas of XXXX to witness

customer-specific laboratory activities;
b) Preparation, packaging, and dispatch of items needed by the customer
for verification purposes.

7.1.8 Records of reviews, including any significant changes are retained

(Form No: XXXX/LQMS/0210-Contract Review Checklist). Records also
are retained or pertinent discussions with a customer relating to the customer’s
requirements or the results of XXXX activities.

7.2 Selection, verification and validation of methods

7.2.1 Selection and verification of methods

7.2.1.1 XXXX appropriate methods and procedures for all laboratory activities
and, where appropriate, for evaluation of the measurement uncertainty as well
as statistical techniques for analysis of data.

7.2.1.2 All methods, procedures and supporting documentation, such as

instructions, standards, manuals and reference data relevant to XXXX
activities, kept up to date and made readily available to personnel.

7.2.1.3 XXXX ensure that is uses the latest valid version of a method unless it
is not appropriate or possible to do so. Application of the method
supplemented with additional details to ensure consistent application.

7.2.1.4 When the customer does not specify the method to be used, XXXX
selects an appropriate method and informs the customer for the method
chosen. Methods published either in international, regional or national

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 standards, or by reputable technical organizations, or in relevant scientific
texts or journals, or as specified by the manufacturer of the equipment, are
recommended. Laboratory-developed or modified methods can also used.
These can be retained only if the lab adopts all these methods and in the
scope of accreditation also.

7.2.1.5 XXXX verifies that it can properly perform methods before introducing
them by ensuring that it can achieve the required performance. Records of the
verification are retained. If the method is revised by the issuing body,
verification is repeated to the extent necessary.

7.2.1.6 When method development is required, this planned activity and is

assigned to competent personnel equipped with adequate resource. As
method development proceeds, periodic review carried out to confirm that the
needs of the customer are still being fulfilled. Any modifications to the
development plan approved and authorized.

7.2.1.7 Deviations from methods for all laboratory activities occur only if the
deviation has been documented, technically justified, authorized, and accepted
by the customer:

7.2.2 Validation of methods

7.2.2.1 XXXX conducts its tests as per nationally and internationally approved
test methods. For example IS AAAA, IS BBBB, etc. In case, such test methods
are not available, XXXX develop non-standard methods. XXXX established
Quality System procedure for (Ref: XXXX /QSP/012-Test Methods and
Methods Validation). XXXX validates non-standard methods, laboratory-
developed methods and standard methods used outside their intended scope
or otherwise modified. The validation as extensive as in necessary to meet
the needs of the given application or field of application.

7.2.2.2 When changes are made to a validated method, the influence of such
changes determined and where they are found to affect the original validation,
a new method validation performed.

7.2.2.3 The performance characteristics of validated methods as assessed

for the intended use, relevant to the customers’ needs and consistent with
specified requirements.

7.2.2.4 XXXX retains the following records of validation (Form No: XXXX
/LQMS/0220 - Statement of Method Validation).

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 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 XXXX established Quality System procedure (Ref: XXXX/QSP/013-
Sampling). XXXX have a sampling plan and method when it carries out
sampling of substances, materials or products for subsequent calibration. The
sampling method addresses the factors to be controlled to ensure the validity
of subsequent calibration results. The sampling plan and method are available
at the site where sampling is undertaken. Sampling plans whenever
reasonable based on appropriate statistical methods.

7.3.2 The sampling method describes:

a) The selection of samples or sites;

b) The sampling plan;
c) Preparation and treatment of sample(s) from a substance, material or
product to yield the required item for subsequent calibration.

7.3.3 XXXX retains sample (Form No: XXXX/LQMS/0230- Sampling

Collection Record) of sampling data that forms part of the calibration that is
undertaken. These records include, where relevant:
a) Reference to the sampling methods 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) Environment or transport conditions;
g) Diagrams or other equivalent means to identify the sampling location
when appropriate;

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 h) Deviations, additions to or exclusions from the sampling method and
sampling plan.

7.4 Handling of test item

7.4.1 XXXX have a procedure (Ref: XXXX/QSP/014- Handling and
Identification of Test Items) for the transportation, receipt, handling,
protection, storage, retention, and disposal or return of test item, including all
provisions necessary to protect the integrity of the test item, and to protect the
interests of XXXX and the customer: Precautions taken to avoid deterioration,
contamination, loss or damage to the item during handling, transporting,
storing/waiting, and preparation for, testing. Handling instructions provided
with the item followed. XXXX ensure any anomalies and deficiencies are
recorded, upon receipt of the sample. These anomalies and deficiencies may
vary from:

i. Damaged sample,

ii. Insufficient sample for testing &

iii. Deficiencies to sampling, etc.

If the sample deficiencies may affect the validity of the result, the customer
shall be informed in advance.

7.4.2 XXXX has a system for the unambiguous identification of test item. The
identification retained while the item is under the responsibility of the
laboratory. The systems ensure that items will not be confused physically or
when referred to in records or other documents. The system, if appropriate,
accommodates a sub-division of an item or groups of items and the transfer of
items.

7.4.3 Upon receipt of the test item, deviations from specified conditions
recorded. When there is doubt about the suitability of an item for test, or when
an item does not conform to the description provided, XXXX consult the
customer for further instructions before proceeding and record the results of
this consultation. When the customer requires the item to be tested
acknowledging a deviation from specified conditions, XXXX includes a
disclaimer in the report indicating which results may is affected by the
deviation.

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 7.4.4 The items need to be stored or conditioned under specified
environment conditions these conditions are maintained, monitored and
recorded.

7.5 Technical records

7.5.1 XXXX ensure that technical records for each laboratory activity contain
the results, report and sufficient information to facilitate, if possible,
identification of factors affecting the measurement result and its associated
measurement uncertainty and enable the repetition of XXXX activity under
conditions as close as possible to the original. The technical records include
the date and the identity of personnel responsible for each laboratory activity
and for checking data and results. Original observations, data and
calculations recorded at the time they are made and identifiable with the
specific task.

7.5.2 XXXX ensures that amendments to technical records can be tracked to

previous versions or to original observations. Both the original and amended
data and files kept, including the date of alteration, an indication of the altered
aspects and the personnel responsible for the alterations.

7.6 Evaluation of measurement uncertainty

7.6.1 XXXX established Quality System Procedure (XXXX/QSP/015-
Evaluation of Measurement Uncertainty). When evaluating measurement
uncertainty, all contributions which are of significance, including those arising
from sampling, taken into account using appropriate methods of analysis.

7.6.2 XXXX evaluates measurement uncertainty (Form No: XXXX

/LQMS/0240-Measurement Uncertainty) Where the test method precludes
rigorous evaluation of measurement uncertainty, an estimation made based on
an understanding of the theoretical principles or practical experience of the
performance of the method.

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 7.7 Ensuring the validity of results
7.7.1 XXXX has a procedure for monitoring the validity of results. The
resulting data recorded in such a way that trends are detectable and, where
practicable, statistical techniques applied to review the results. This
monitoring are planned and reviewed and includes:

a) Use of reference materials or quality control materials;

b) Use of alternative instrumentation that has been calibrated to provide
traceable results;
c) Functional checks of measuring and testing equipment;
d) Use of check or working standards with control charts, where
applicable;
e) Intermediate checks on measuring equipment; (Refer: XXXX/QSP/008)
f) Replicate tests or calibrations using the same or different methods;
g) Retesting using the same or different methods;
h) Correlation of results for different characteristics of an item;
i) Review of reported results;
j) Inter laboratory comparisons; (Refer: XXXX/QSP/007)
k) Testing of blind sample(s).

7.7.2 XXXX monitors its performance by comparison with results of other

laboratories. This monitoring is planned and reviewed and includes, but not
limited to, either or both of the following:

a) Participation in proficiency testing; (Ref: XXXX/QSP/016- Proficiency

Testing)
b) Participation in inter laboratory comparisons other than proficiency
testing. (Form No: XXXX/LQMS/0260 – Inter Lab Comparison)

7.7.3 Data from monitoring activities analyzed, used to control and, if

applicable, improve the laboratory’s activities. If the results of the analysis of

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 data from monitoring activities are found to outside pre-defined criteria,
appropriate action taken to prevent incorrect results from being reported.

7.8 Reporting of results

7.8.1 General

7.8.1.1 The results are reviewed and authorized prior to release.

XXXX established Quality System procedure (Ref: XXXX/QSP/017-

Reporting of Results). The results provided accurately, clearly,
unambiguously and objectively, usually in a report and include all the
information agreed with the customer and necessary for the interpretation of
the results and all information required by the method used. All issued reports
retained as technical records.

7.8.1.2 When agreed with the customer, the results may report in a simplified
way. Any information listed in 7.8.2 to 7.8.7 that is not reported to the
customer readily available.

7.8.2 Common requirements for reports

7.8.2.1 Each report includes at least the following information, unless XXXX
has valid reasons for not doing so, thereby minimizing any possibility of
misunderstanding or misuse: (Annexure 11 – Sample Test Report)

a) A title;
b) The name and address of the laboratory;
c) The location of performance of XXXX activities, including when
performed at a customer facility at sites from the laboratory’s permanent
facilities;
d) Unique identification that all its components are recognized as a portion
of a complete report and a clear identification of the end;
e) The name and contact information of the customer;
f) Identification of the method used;

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 g) A description, unambiguous identification, and, when necessary, the
condition of the item;
h) The date of receipt of the test item, and the date of sampling, where this
is critical to the validity and application of the results;
i) The date(s) of performance of XXXX activity;
j) The date of issue of the report;
k) Reference to the sampling plan and sampling method used by XXXX or
other bodies where these are relevant to the validity or application of
the results;
l) A statement to the affect that the results relate only to the items tested,
calibrated or sampled;
m) The results with, where appropriate, the units of measurement;
n) Additions to, deviations, or exclusions from the method;
o) Identification of the person(s) authorizing the report;
p) Clear identification when results are from external providers

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

Or

XXXX do not have responsibility of sampling.

7.8.4 The scope of accreditation covers only testing activities

7.8.5 Reporting sampling – specific requirements

Where XXXX is responsible for the sampling activity, in addition to the
requirements listed in 7.8.2, reports include the following, where necessary for
the interpretation of results:

a) The date of sampling;

b) Unique identification of the item or material sampled (including the
name of the manufacturer, the model or type of designation and serial
numbers as appropriate);
c) The location of sampling, including any diagrams, sketches or
photographs;
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 d) A reference to the sampling plan and sampling method;
e) Details of any environmental conditions during sampling that affect the
interpretation of the test results;
f) Information required evaluating measurement uncertainty for
subsequent testing.
Or
All accredited XXXX measurement facilities perform calibrations and
issue calibration certificates. Thus section 7.8.5 of ISO/IEC 17025
dealing with Sampling Report is not applicable.

7.8.6 Reporting statements of conformity

7.8.6.1 When a statement of conformity to a specification or standard is
provided, XXXX document 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.

7.8.6.2 XXXX report on the statement of conformity, such that the statement
clearly identifies:

a) To which 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 opinions and interpretation are expressed, XXXX ensures that
only personnel authorized for the expression of opinions and interpretations
release the respective statement. XXXX documents the basis upon which the
opinions and interpretations have been made.

7.8.7.2 The opinions and interpretations expressed in reports are based on

the results obtained from the tested item and is clearly identified as such.

7.8.7.3 When opinions and interpretations are directly communicated by

dialogue with the customer, a record of the dialogue retained.

7.8.8 Amendments to reports

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 7.8.8.1 When an issued report needs to be changed, amended or re-issued,
any change of information clearly identified and, where appropriate, the reason
for the change included in the report.

7.8.8.2 Amendments to a report after issue are made only in the form of a
further document, or data transfer, which includes the statement “Amendment
to Report, serial number… [Or an otherwise identified]”, or an equivalent form
of wording.

Such amendments meet all the requirements of this document.

Amended number should identified on report with date. This should be

corresponds to original report. This is responsibility of TM that amended
report fulfill the requirement of this documents.

7.8.8.3 When it is necessary to issue a complete new report, this will contain
an new report number and contain number of old report to the original that it
replaces.

7.9 Complaints
7.9.1 XXXX has a documented process (XXXX/QSP/018-Complaint
Handling) to receive, evaluate and make decisions on complaints.

7.9.2 A description of the handling process for complaints available to any

interested party on request. Upon receipt of a complaint, XXXX confirms
whether the complaint relates to laboratory activities that it is responsible for
and, if so, deals with it. XXXX responsible for all decisions at all levels of the
handling process for complaints.

7.9.3 The process for handling complaints includes at least the

following elements and methods:

a) Description of the process for receiving, validating, investigating the

complaint, and deciding what actions are to 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 XXXX receiving the complaint is responsible for gathering and verifying
all necessary information to validate the complaint.
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 7.9.5 Whenever possible, XXXX acknowledges receipt of the complaint, and
provides the complainant with progress reports and the outcome.

7.9.6 The outcomes to communicate to the complainant made by, or

reviewed and approved by, individual(s) not involved in the original laboratory
activities in question.

7.9.7 Whenever possible, XXXX gives formal notice of the end of the
complaint handling to the complainant. (Form No: XXXX/LQMS/0270 –
Customer Complaint Register).

7.10 Nonconforming work

7.10.1 XXXX has a procedure (Ref: XXXX/QSP/019-Control Non
Conforming Testing) that is implemented when any aspect of its laboratory
activities or results of this work do not conform to its own procedures or the
agreed requirements of the customer (e.g. equipment or environmental
conditions are out of specified limits, results of monitoring fail to meet specified
criteria). The 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 XXXX retains records of nonconforming work and actions as specified

in 7.10.1, bullets b to f). (Form No: XXXX/LQMS/0300-Non-Conformance
Report)

7.10.3 Where the evaluation indicates that the nonconforming work could
recur or that there is doubt about the conformity of the laboratory’s operations
with its own management system, XXXX implement corrective action.

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 7.11 Control of data and information management

7.11.1 XXXX has access to the data and information needed to perform
laboratory activities.

7.11.2 XXXX information management system(s) used for the collection,

processing, recording, reporting, storage or retrieval of data are validated for
functionality, including the proper functioning of interfaces within XXXX
information management system(s) by XXXX before introduction. Whenever
there are any changes, including laboratory software configuration or
modifications to commercial off-the-shelf software, they authorized,
documented and validated before implementation.

7.11.3 XXXX information management system(s):

a) Be protected from unauthorized access;

b) Be safeguarded against tampering and loss;
c) Be operated in an environment that complies with supplier or laboratory
specifications or, in the case of non-computerized systems, provides
conditions which safeguard the accuracy of manual recording and
transcription;
d) Be maintained in a manner that ensures the integrity of the data and
information;
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 e) Include recording system failures and the appropriate immediate and
corrective actions.

All files (hard or soft) kept in proper manner that it can be protected with
password or locked, backup is taken periodically, easy retrieval.

7.11.4 When a laboratory information management system is managed and

maintained off-site, XXXX ensure that the operator of the systems complies
with all applicable requirements of this document.

Or

XXXX do not maintain information management system through an external

provider

7.11.5 XXXX ensures that instructions, manuals and reference data relevant
to XXXX information management system is made readily available to
personnel.

7.11.6 Calculations and data transfer are checked in an appropriate and

systematic manner.

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 8 MANAGEMENT SYSTEM REQUIREMENTS

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 8.1 Options
8.1.1 General
XXXX establish, document, implement and maintain a management system
that is capable of supporting and demonstrating the consistent achievement of
the requirements of this document and assuring the quality of XXXX results.
In addition to meeting the requirements of Clauses 4 to 7, XXXX implements a
management system in accordance with Option A.

8.1.2 Option A
As a minimum, the management system of XXXX addresses the following:

 Management system documentation.

 Control of management system documents.
 Control of records.
 Actions to address risks and opportunities.
 Improvement.
 Corrective action.
 Internal audits.
 Management review.

8.1.3 XXXX adopt option A, This is Not Applicable

8.2 Management system documentation

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 8.2.1 Laboratory management establish, document, and maintain policies
and objectives for the fulfillment of the purpose of this document and ensure
that the policies and objectives are acknowledged and implemented at all
levels of XXXX organization.

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

8.2.3 Laboratory management provides evidence of commitment to the

development and implementation of the management system and to
continually improving its effectiveness.

8.2.4 All documentation, processes, systems, records, related to the

fulfillment of the requirements of this document included in, referenced from, or
linked to the management system. (Refer: Annexure:6 – Master list of
document, Annexure 7 – Master list of records).

8.2.5 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

8.3.1 XXXX established Quality System procedure (Ref: XXXX/QSP/020-
Document of Control). XXXX controls the documents (internal and external)
that relate to the fulfillment of this document.

8.3.2 XXXX ensures that:

a) Documents are approved for adequacy prior to issue by authorized
personnel;
b) Documents are periodically reviewed, and updated as necessary;
c) Changes and the current revision status of documents are identified;
d) Relevant versions of applicable documents are available at points of
use and, where necessary, their distribution is controlled;
e) Documents are uniquely identified;
f) The unintended use of obsolete documents is prevented, and suitable
identification is applied to them if they are retained for any purpose.

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 8.4 Control of records
8.4.1 XXXX established Quality System procedure (Ref: XXXX/QSP/021-
Control of Records). XXXX establishes and retains legible records to
demonstrate fulfillment of the requirements in this document.

8.4.2 XXXX implements the controls needed for the identification, storage,
protection, back-up, archive, retrieval, retention time, and disposal of its
records. XXXX retains records for a period consistent with its contractual
obligations. Access to these records consistent with the confidentiality
commitments and records readily available.

8.5 Actions to address risks and opportunities

8.5.1 XXXX established Quality System procedure (Ref: XXXX/QSP/022-
Risk and Opportunities). XXXX considers the risk and opportunities
associated with XXXX 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 failure in XXXX
activities;
d) Achieve improvement.

8.5.2 XXXX plan:

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 a) Actions to address these risks and opportunities;
b) How to:
 Integrate and implement the actions into its management
system;
 Evaluate the effectiveness of these actions.

XXXX establish Quality System procedure (XXXX/QSP/001 : Risk

Assessment)

XXXX conducts risk assessment (Ref: XXXX/LQMS/0010) and takes actions

to minimize risk. Annexure 10 – Risk Assessment

8.5.3 Actions taken address risks and opportunities proportional to the

potential impact on the validity of laboratory results. (Ref: Form:
XXXX/LQMS/0010).

8.6 Improvement

8.6.1 XXXX established Quality System procedure (Ref: XXXX/QSP/023-

Improvement). XXXX identifies and selects opportunities for improvement
and implements any necessary actions.

8.6.2 XXXX seeks feedback, both positive and negative, from its customers.
The feedback are analyzed and used to improve the management system,
laboratory activities and customer service. (Ref: Form No:
XXXX/LQMS/0280).

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 XXXX continually improve the suitability, adequacy and effectiveness of the
quality management system.

XXXX consider the results of analysis and evaluation, and the outputs from
management review, to determine if there are needs or opportunities that are
addressed as part of continual improvement.

8.7 Corrective action

8.7.1 XXXX established Quality System procedure (Ref: XXXX/QSP/024-
Corrective Action Report). When nonconformity and, as applicable:

a) React to the nonconformity and, as applicable:

 Take action to control and correct it;
 Address the consequences;
b) Evaluate the need for action to eliminate the cause(s) of the
nonconformity, in order that it does not recur or occur elsewhere, by:
 Reviewing and analyzing the nonconformity;
 Determining the causes of the nonconformity;
 Determining if similar nonconformities exist, or could potentially
occur;
c) Implement any action needed;
d) Review the effectiveness of any corrective action taken;
e) Update risks and opportunities determined during planning, if
necessary;
f) Make changes to the management system, if necessary.

8.7.2 Corrective actions are appropriate to the effects of the nonconformities

encountered.

8.7.3 XXXX retains records as evidence of: (Form No: XXXX/LQMS/0320-

Corrective Action Report)

a) The nature of the nonconformities, cause(s) and any subsequent

actions taken;
b) The results of any corrective action.

8.8 Internal audits

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 8.8.1 XXXX established Quality System procedure (Ref: XXXX/QSP/025-
Internal Audits). XXXX conduct internal audits at planned intervals to provide
information on whether the management system:

a) Conforms to:
 The laboratory’s own requirements for its management system,
including XXXX activities;
 The requirements of this document;
b) Is effectively implemented and maintained.

8.8.2 XXXX:
a) Plan, establish, implement and maintain an audit programme including
the frequency, methods, responsibilities, planning requirements and
reporting, which take into consideration the importance of XXXX
activities concerned, changes affecting the laboratory, and the results of
previous audits;
b) Define the audit criteria and scope for each audit;
c) Ensure that the results of the audits are reported to relevant
management;
d) Implement appropriate correction and corrective actions without undue
delay;
e) Retain records as evidence of the implementation of the audit
programme and the audit results.

8.9 Management reviews

8.9.1 XXXX established Quality System procedure (Ref: XXXX/QSP/026-
Management Review). XXXX management reviews its management system
at planned intervals, in order to ensure its continuing suitability, adequacy and
effectiveness, including the stated policies and objectives related to the
fulfillment of this document.

8.9.2 The inputs to management review recorded and include

information related to the following:

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 a) Changes in internal and external issues that are relevant to the
laboratory;
b) Fulfillment of objectives;
c) Suitability of policies and procedures;
d) Status of actions from previous management reviews;
e) Outcome of recent internal audits;
f) Corrective actions;
g) Assessments by external bodies;
h) Changes in the volume and type of the work or in the range of
laboratory activities;
i) Customer and personnel feedback;
j) Complaints;
k) Effectiveness of any implemented improvements;
l) Adequacy of resources;
m) Results of risk identification;
n) Outcomes of the assurance of the validity of results; and
o) Other relevant factors, such as monitoring activities and training.

8.9.3 The outputs from the management review record all decisions and
actions related to at least:

a) The effectiveness of the management system and its processes;

b) Improvement of XXXX activities related to the fulfillment of the
requirements of this document;
c) Provision of required resources;
d) Any need for change. (Form No: XXXX/LQMS/0380 – Minutes of
Management Review Report).

ANNEURE - 1

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 List of Quality System Procedures

S. No Title Doc. No

1. Risk Assessment XXXX /QSP/001

2. Handling Customer’s Confidential Information XXXX /QSP/002
3. Competency Management XXXX /QSP/003
4. Facilities and Environmental Conditions XXXX /QSP/004
5. Equipment Maintenance XXXX /QSP/005
6. Calibration of Equipment XXXX /QSP/006
7. Inter Laboratory Test Program XXXX /QSP/007
8. Intermediate Checks XXXX /QSP/008
9. Identification and Traceability XXXX /QSP/009
10. Purchase, Receipt and Storage of Consumables XXXX /QSP/010
11. Test Request XXXX /QSP/011
12. Test Methods and Methods Validation XXXX /QSP/012
13. Sampling XXXX /QSP/013
14. Handling and Identification of Test Items XXXX /QSP/014
15. Evaluation of Measurement Uncertainty XXXX /QSP/015
16. Proficiency Testing XXXX /QSP/016
17. Reporting of Results XXXX /QSP/017
18. Complaint Handling XXXX /QSP/018
19. Control Non Conforming Testing XXXX /QSP/019
20. Document of Control XXXX /QSP/020
21. Control of Records XXXX /QSP/021
22. Risk and Opportunities XXXX /QSP/022
23. Improvement XXXX /QSP/023
24. Corrective Action Report XXXX /QSP/024
25. Internal Audits XXXX /QSP/025
26. Management Review XXXX /QSP/026
27. Measurement of Uncertainty XXXX /QSP/027

ANNEXURE - 2

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 Standard Operating Procedures

S. No Title Doc. No
1

ANNEXURE – 3
Master List of Documents
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 S. Issu Rev. No. & Date
No. Ref. No. Title e No.

1 XXXX/QM/001 Quality Manual 01 00 & XX.XX.XXX

2 XXXX/QSP/001 Quality System 01 00 & XX.XX.XXX

Procedures

3 XXXX/SOP/001 Master List of Standard 01 00 & XX.XX.XXX

Operating Procedures

4 XXXX/MEOD/001 Master List of External 01 00 & XX.XX.XXX

Origin Documents

5 XXXX/MLR/001 Master List of Records 01 00 & XX.XX.XXX

ANNEXURE - 4

Master List of External Origin Documents

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 Current Date of
Name of Document Document Origin Revision Issue
No. Status
Quality management International Organization 2015 15/09/2015
systems -- Requirements ISO 9001 for Standardization
General requirements for
the competence of testing International Organization 2017 10/09/2017
and calibration ISO/IEC for Standardization
laboratories 17025
Guidelines for auditing ISO 19011 International Organization 2018 07/2018
management systems for Standardization

ANNEXURE – 5
Master List of Records ISO/IEC 17025:2017

S. FORM REV NAME OF THE RECORD RETENTION

No NO PERIOD
1 XXXX/LQMS/0010 R0 Risk Assessment Permanent
2 XXXX /LQMS/0020 R0 Nondisclosure Agreement Three Years
3 XXXX /LQMS/0030 R0 Organization Chart Three Years
4 XXXX /LQMS/0040 R0 Responsibility and Authority Permanent
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 5 XXXX /LQMS/0050 R0 Competency Standard Permanent
6 XXXX /LQMS/0060 R0 Master list of Authorized Statutory Permanent
7 XXXX /LQMS/0070 R0 Environmental Conditions Monitoring Form Permanent
8 XXXX /LQMS/0080 R0 Installation Testing Report Permanent
9 XXXX /LQMS/0090 R0 Intermediate Checks Three Years
10 XXXX /LQMS/0100 R0 Calibration Record Three Years
11 XXXX /LQMS/0110 R0 Equipment Record Permanent
12 XXXX /LQMS/0120 R0 Preventive Maintenance Checklist One Year
13 XXXX /LQMS/0130 R0 Preventive Maintenance Schedule One Year
14 XXXX /LQMS/0140 R0 Breakdown Register Three Years
15 XXXX /LQMS/0150 R0 Monthly Inventory Audit for Expiry Date Three Years
16 XXXX /LQMS/0160 R0 Supplier Evaluation Form Permanent
17 XXXX /LQMS/0170 R0 Incoming Material Inspection Record Permanent
18 XXXX /LQMS/0180 R0 Supplier Monitoring Form One Year
19 XXXX /LQMS/0190 R0 Master List Approved Suppliers One Year
20 XXXX /LQMS/0200 R0 Purchase Order Three Years
21 XXXX /LQMS/0210 R0 Test Review Checklist Three Years
22 XXXX /LQMS/0220 R0 Statement of Method Validation Three Years
23 XXXX /LQMS/0230 R0 Sample Collection Record Three Years
24 XXXX /LQMS/0240 R0 Measurement Uncertainty Study Three Years
25 XXXX /LQMS/0250 R0 Customer Feedback Three Years
26 XXXX /LQMS/0260 R0 ILC Work Sheet Three Years
27 XXXX /LQMS/0261 R0 ILC Annual Plan Three Years
28 XXXX /LQMS/0270 R0 Customer Complaint Register Three Years
29 XXXX /LQMS/0280 R0 Customer Feedback Analysis Three Years
30 XXXX /LQMS/0290 R0 Continual Improvement Report Three Years
31 XXXX /LQMS/0300 R0 Non Conformance Report Three Years
32 XXXX /LQMS/0310 R0 Training Record Cum Evaluation One Year
33 XXXX /LQMS/0320 R0 Corrective Action Report Three Years
34 XXXX /LQMS/0330 R0 Internal Audit Report Three Years
35 XXXX /LQMS/0340 R0 Internal Audit Plan Three Years
36 XXXX /LQMS/0350 R0 Internal Audit Schedule Three Years
37 XXXX /LQMS/0360 R0 Internal Audit Nonconformance Register Three Years
38 XXXX /LQMS/0370 R0 List of Approved Auditors Three Years
39 XXXX /LQMS/0380 R0 Minutes of Management Review Meeting Three Years
40 XXXX /LQMS/0390 R0 Proficiency Test Record Three Years
41 XXXX /LQMS/0400 R0 List of External Origin Document Three Years

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 ANNEXURE – 6
ORGANIZATION CHART

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 ANNEXURE – 7
Duties, Responsibilities and Authority
1. Managing Director/CEO:

 Overall responsibility of the laboratory.

 Manages and monitors all activities of the laboratory.
 Establish policies and legal guidelines.
 Ensure a positive work environment.
 Reward performance, prevent issues and resolve problems.

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  Analyze problematic situations and occurrences and provide
solutions to ensure laboratory survival and growth.
 Further develop and enhance laboratory culture.
 Develop and execute the laboratory strategies in order to attain
goals.
 Plan cost effective operations and market development activities.
 Authorized to approve various quality documents.
 Authorized to provide resources, budgets, etc for effective
operation.
 Support and provide resources for effective implementation of
ISO/IEC 17025:2017.
 Nominate Quality Manager and Technical Manager as per the
requirements of the system.
 Providing evidence of commitment to the development and
implementation of management system and continual
improvement and its effectiveness.
 Communicate the importance of meeting customer as well as
statutory and regulatory requirements within the organization.

2. Quality Manager:

 Maintains and implements ISO/IEC 17025:2017.

 Monitors and updates laboratory management system documents
and records.
 Understanding customer needs and requirements to develop
effective quality control processes.
 Keep accurate documentation and perform statistical analysis.
 Submit detailed reports to appropriate executives.
 Be on the lookout for opportunities for improvement and develop
new efficient procedures.
 Supervise inspectors, technicians and other staff and provide
guidance and feedback.
 Organizing internal audits, management reviews
 Coordination with consultants, trainers and Auditor.
 Organizing trainings related to effective implementation of
ISO/IEC 17025:2017.
 Promoting quality awareness and continual improvement.
 Maintaining all external origin documents. To visit the website
various standards publication bodies to any updates.

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  Identification of deviations from the management system or from
the procedures for performing laboratory activities;
 Record the minutes during the management review meeting.
 Overall responsible for the document control.
 Establish control system on quality and technical records.
 Identify the corrective action based on the analysis of
complaints.
 Identify training needs of employees for the management
system.
 Data analysis and identify fruitful results for the further
improvement.
 Approve the actions taken by the auditee as a basis to resolve
non-conformities.
 Participate the management review meeting periodically, and to
ensure that the system is effectively implemented within the
laboratory.
 Stop the activity, if found any non-conformity related to testing,
accommodation and environment.
 Visit standard meetings.

3. Technical Manager:

 Monitors Technical operations of the laboratory and maintains

relevant records.
 Authorized to sign test reports.
 Authorized to sign various logs.
 Authorized to deal with various agencies for PT/ILC.
 Authorized to prepare documentation wrt ISO/IEC 17025:2017.
 Handling customer complaints and analyze the same.
 Breakdown/ preventive maintenance of lab equipment.
 Prepare various SOP’s.
 Organizing measurement uncertainty study.
 Prepare four year plan and to follow the requirements for
ensuring the validity of results.
 Identify the training needs of the employees and provide the
same in consultation with the Quality Manager.
 Ensure that proper accommodation and environment is
maintained in the testing area as per the requirements of the
relevant test standards.
 Initiate corrective actions based on the feedback of the testing
activities.
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  Verify and review test records.
 Review and authorize daily records of the laboratory.
 Stop the testing activities, if proper environment condition is not
maintained and achieved.
 Review the print-out from the equipment of each testing after
completion of necessary testing work.
 Review and authorize the test report before it is issued to the
customer.
 Ensure optimum use of available resources.
 Review and approve records of employees competence, skills,
etc.

4. Test Engineer/ Team Lead/Test Supervisors:

 Conducts technical activities of the laboratory

 Maintain technical documents and records and allocates work for
subordinate.
 Analyze technical findings, perform appropriate calculations and
prepare data reports to manager.
 Provide direction to technical team in testing activities.
 Evaluate team performance and determine training needs to
meet performance objectives.
 Perform basic office administration tasks when needed.
 Plan and conduct technical exploration effectively.
 Authorized to sign various test logs.
 Check the physical condition of samples received for testing.
 Testing of samples as per the documented test method given in
the related standards.
 Conduct preventive maintenance of the equipments.
 Initiate inter-laboratory comparison and to evaluate the results of
inter-laboratory comparison.
 Handle breakdown maintenance of the equipment as soon as
possible.
 Reduce wastage of available resources.
 Ensure stringent follow up of the ISO/IEC 17025 system in the
lab.
 Analyze the complaint by reviewing the related records as per
the complaint given by the Technical Manager.
 Use available resources on optimum basis to achieve maximum
output during the testing.

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  Handle the samples throughout the testing and preservation in
such a way that it does not create any problem in testing.
 Conduct the uncertainty of measurement of the samples as per
the defined periodicity for the identified parameters.

5. Lab Assistant/Lab Technician:

 Performs testing and related technical activities

 Updates related records
 Receive and process samples to identify suitability
 Prepare samples for testing using various types of laboratory
equipment.
 Identify specimens samples accurately and distribute them to the
appropriate department.
 Clean and maintain work area and all lab equipment and
supplies
 Maintain good housekeeping and safety inside the laboratory.

6. Administration

 Answering incoming calls; taking messages and re-directing calls

as required.
 Dealing with email enquiries.
 Taking minutes.
 Data entry (sales figures, property listings etc.).
 General office management such as ordering stationary
 Organising travel and accommodation for staff and customers
 Preparation of reports and timely dispatch.
 Data and information security.
 Authorized to purchase of stationery items.

7. Analyst
 Maintains records of all quality activities as documented in SOPs
and test methods
 Handles samples and performing analyses according to SOPs
and test methods
 Writes SOPs and test methods
 Signs reports when designated with signing authority
 Maintains and calibrates equipment
 Reports deficiencies or malfunction to the supervisor
 Identifies and records nonconformities on Corrective Action *
Requests

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  Identifies and recording potential nonconformities on Preventive
Action Requests
 Corrects nonconformities and potential nonconformities
 Improves laboratory and/or quality activities on a continuous
basis

8. Sample Collector

 Following procedures to ensure all samples are accurately

identified and archived.
 Keeping various records of sample.

ANNEXURE – 8
RISK ASSESSMENT

Risk Index

Risk Matrix

Highly Likely
MED HIGH HIGH

Possible LOW MED HIGH

Unlikely
LOW LOW MED

Negligible Moderate Severe

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 Severity

HIGH Risk is very high. Action to be taken immediately. Action can

include, procedure, Instruction, alert,
performance measure, records, checklist, training, Control
chart etc.

MED Risk is Medium. Action to reduce risk can be taken in priority.

Action can include training, record, checklist etc.,

a. RISK ASSESSMENT FOR TESTING

LOW Risk is low. No action is required.

S. Process / Risk Effect (Impact on Action to Work

No Activity Product Conformity) address the Risk Product
Risk Index
Frequency

(Mitigation (Doc,
Severity

Plan) Record,
Training
etc.,)
1. Receipt of Mix of samples The report of are H L M Sample SOP for
samples sample may go to Identification Sample
another Collection
2. Sample Quality of Testing Cannot be H L M Quality to be SOP for
Collection sample completed standardized Sample
insufficient Collection
3. Sample Breakage/ Testing Cannot be H M H Closure, Box, SOP for
Transportatio Damage completed Fixture to be Sample
n provided Collection
4. Sample Inadequate Testing cannot be H M H Contract SOP for
receipt information completed review, Training Test
about testing for test request. review
such as test
method, No of
testings etc
5. Testing In Accuracy/ Test result will be in H L M Regular SOP for
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 Imprecision accurate and calibration Calibratio
impression n
6. Testing Customer may Inadequate test result H L M Disciplinary Impartialit
ask to change action y
the result declaratio
value. n
7. Testing Delay in M L L Inform the Communi
testing due to Customer, Shift cation to
work load. system the
Customer
s
8. Testing Finance Minimize Cash H L M Where petty Evidence
Management Transactions cash seen
procedures on
stated in lab financial
shall not be files
allowed, and
Laboratory to disbursem
make all ent
progress vouchers
payments to
contractors,
suppliers and
consultants –
firms,
individuals,
national and
international –
by check or
transfer to bank
accounts, and
retain evidence
for audit and
donor
supervision
missions
9. Reporting Error Test result will be H M H Report SOP for
different from actual / Verification, Reporting
Lack of Customer Regular training
confidence, confusion
10 Reporting Delay Customer M L H E-mail the E-mail
dissatisfaction report in case communic
of urgency. ation

10 Overall Confusion in Lab logo misuse H L H Display the Lab Training

management Lab scope / certificate / report
Non-Lab Training on Lab
scope scope.
11 Sharps A ‘sharp’ is any Disease – Hepatitis, HIV M M H Safety WBS

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 device having and other blood borne
corners, edges, diseases.
or projections Cuts/stabs.
capable of Needle Stick Injury
cutting or
piercing the
skin. When
working with
needles, glass
and other sharp
items there is a
risk of sharps
injury
12 General General Unsupervised Students M M H All persons WBS
Laboratory Laboratory Access. working in a
Safety Safety PPE - Chemical / laboratory must
Biological contamination. adhere to the
Fire. guidelines
Hygiene. detailed within
Storage and Disposal. laboratory Work
Handling of Microbial Practice Sheets
Cultures. Laboratory
Safety
Regulations.
Follow all written
and verbal
instructions
carefully. If you
do not
understand a
direction or part
of a procedure,
ASK YOUR
SUPERVISOR
BEFORE
PROCEEDING
WITH THE
ACTIVITY.
13 Fire Safety Fire Safety Fire. Display Fire Fire
Explosion. Extinguisher Extinguish
Serious bodily injury or er
fatality.
Damage to property.

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 ANNEXURE – 10
a. RISK ASSESSMENT FOR IMPARTIALITY

S. Area Risk Effect (Impact on Action to address the Risk Work

N Product (Mitigation Plan) Product
Risk Index
Frequency

o Conformity) (Doc,
Severity

Record,
Training
etc.,)
1. Governance Disclosure Possible conflicts H L M Executing agency to Internal
of interest among ensure all staff sign the audit
implementation disclosures report
staff
2. Finance Finance Minimize Cash H L M Where petty cash Evidence
Management Management Transactions procedures seen
stated in lab shall not be on
allowed, Laboratory to financial
make all progress files
payments to and
contractors, suppliers disbursem
and consultants – firms, ent
individuals, national and vouchers
international – by check
or transfer to bank
accounts, and retain
evidence for audit and
donor supervision
missions
3. Relationship Some times Misuse the Test H L M Client name shall not be Display
between may result value known to testing staff “No
client & inference the only with unique number Admission
testing staff testing to should be conducted. ” Board
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 change test Entry restricted for the
result value external persons inside
the laboratory
4. Sales Sales Inadequate Test H L M Cash transactions not Lab Policy
Commission Commission result value. allowed.
No proper Policies should include
training “Laboratory do not offer
regarding duties sales commission”.
and policies of There is no incentive.
laboratory

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