17025 - 2017 Training Manual for the Laboratory

ISO/IEC 17025:2017 REQURIEMENT
Presented by:
DR SAMBHU CHAKRABORTY
Website: www.sambhuchakraborty.com

Course Delivered By
Institute of Applied Quality Management
386/1 D H Road, Kolkata 700063, India
Website: www.quality-pathshala.com
E.mail : director@iaqmconsultants.com
Phone: +919830051583/ +91-33-24976080

UNDERSTOOD/CLEAR/OKAY
Institute of Applied Quality Management 4

I HAVE NOT UNDERSTOOD/NOT CLEAR/NOT
OKAY

Participant Introduction

Code of conduct
• The participants are expected to be punctual
• The participants are expected to attend every
session
• The use of cell/mobile phone should be
avoided, it should be in silent/vibration mode
• A harmonious and cordial ambiance is
necessary for the program, the participants
are expected to show their team spirit

Important Announcement
• Every day training 9 am to 5.30 PM
• Please make yourself available at 8.50 am
• Tea Break for 15 minutes only
• Lunch for 45 minutes only
• 3.30 PM Group Photogrpah session
• Only 10th April Banquet will be changed, get
confirmation from our Staff

What is Quality in Laboratory
The characteristics of Laboratory services that
bear on its ability to satisfy stated or implied
needs of the user of laboratory services

Quality IS…
• Right specimen/sample/Item
• Right method
• Right Result
• Right time
• Right Delivery
• Right accuracy
• Employee safety
• Soft skill
• Acknowledging feedback
• Showing improvement……ALLLLL

Quality (contd)

Stages of Quality - Hierarchy
Quality control
Quality assurance
Quality system
Quality
management

Quality Control
• Operational techniques and activities used to
fulfill requirements for quality (ISO)
• Internal quality control (IQC) – set of
procedures for continuously assessing
laboratory work and the emergent results;
immediate effect, should actually control
release of results

Quality Assurance
• A Systematic process approach to ensure the
quality in every input and output area.
• LAB Quality : Right results, at the right time, on the
right specimen, from the right sample with the
result interpretation based on correct reference
data and at the right price

The Quality Assurance Cycle
•Data and Lab
Management
•Safety
•Customer
Service
Sample Collection
Sample Receipt
and Accessioning
Sample Transport
Quality Control
Record Keeping
Reporting
Personnel Competency
Test Evaluations
Testing

Quality system
Organizational structure, resources, processes
and procedures needed to implement quality
management (ISO, NCCLS)

What is accreditation in Laboratory
• Evaluation of Technical competency by a 3 rd
party based on established criteria or
standard
• Laboratory is Accredited means laboratory is
technically competent to carry out the test.
• Accreditation is given based on evaluation of
Man. Machine, Materials , Process Control
and Quality control in Test.

Accreditation and
Certification difference

Why laboratory Accreditation
laboratory Accreditation is the only tool to
convey internal and external customer that
laboratory is technically competent to carry out
the test

International Scenario
ILAC-International Laboratory Accreditation Co-operation
APLAC-Asia Pacific Laboratory
Accreditation co-operation
EAL-European
Accreditation for
laboratories
CAMS/NABL HKAS SAC-SINGLAS

National Scenario
Total 4 Accreditation Bodies are working in India
1) CAMS-Conformity Accreditation Management System
Website: www.camsglobal.org
2) Quality Accreditation Institute
Website : www.qai.org.in
3) National Accreditation Board for Testing and
Calibration Laboratories (NABL)
Website : www.nabl-india.org
4)ACCAB-Accreditation Commission For Conformity
Assessment Bodies
Website: www.accab.org

CONFORMITY ACCREDITATION
MANAGEMENT SYSTEM
Website : www.camsglobal.org

laboratory Global recognition
Accreditation
acceptance is done
globally through
membership of ILAC

International Organization for
Standardization (ISO)

About the Standard
• Scope : This document specifies the general
requirements for the competence, impartiality and
consistent operation of laboratories.
• This document is applicable to all organizations
performing laboratory activities, regardless of the
number of personnel.
• Laboratory customers, regulatory authorities,
organizations and schemes using peer-assessment,
• accreditation bodies, and others use this document
in confirming or recognizing the competence of
laboratories..

About the Standard
2 Normative references
• ISO/IEC Guide 99, International vocabulary of
metrology — Basic and general concepts and
associated
• terms (VIM)1
• ISO/IEC 17000, Conformity assessment — Vocabulary
and general principles

About the Standard
3 Terms and definitions
For the purposes of this document, the relevant terms
and definitions given in ISO/IEC 17000 and following
apply.
• ISO and IEC maintain terminological databases for use
in standardization at the following addresses:
• ISO Online browsing platform: available at https://www.iso.org/obp
• IEC Electropedia: available at http://www.electropedia.org/

This document was prepared by the ISO Committee on Conformity
Assessment (CASCO) and circulated for voting to the national bodies
of both ISO and IEC, and was approved by both organizations.
This third edition cancels and replaces the second edition (ISO/IEC
17025:2005), which has been technically revised.
The main changes compared to the previous edition are as follows:
• the risk-based thinking applied in this edition has enabled some
reduction in prescriptive requirements and their replacement by
performance-based requirements;
• there is greater flexibility than in the previous edition in the
requirements for processes, procedures, documented information
and organizational responsibilities;
.
About the New Standard

About the Standard
1 Scope
2 Normative reference
3 Terms and definitions
4 General requirements
4.1 Impartiality
4.2 Confidentiality
5 Structural requirements
6 Resource requirements
7 Process requirements
8 Management system requirements

About the Standard
New Terms/Definitions:
• Laboratory
• Intralaboratory comparison
• Decision rule
• Impartiality
Obsolete Terms:
• Quality manager
• Technical manager
• Accommodation -> Facility
• Preventive actions -> risk and opportunities

About the Standard
• In this document, the following verbal forms
are used:
• — “shall” indicates a requirement;
• — “should” indicates a recommendation;
• — “may” indicates a permission;
• — “can” indicates a possibility or a capability.

4.1 Impartiality
Impartiality (also called evenhandedness or
fair-mindedness) is a principle of justice
holding that decisions should be based on
objective criteria, rather than on the basis of
bias, prejudice, or preferring the benefit to
one person over another for improper
reasons.

4.1 Impartiality
will be independent will not be affiliated
with the producer nor the user of the item
being tested
No commercial bias is present.
Impartial organization structure
shall not allow commercial, financial or
other pressures to compromise impartiality.

Example
• In house testing laboratory is free from any
kind of pressure from Production, stores or
sales or any other management people
• Test productivity is not linked with salary
• If laboratory is the part of a Product
manufacturing company, no false report to
certify the product
• If the laboratory is the part of Inspection
Agency

4.1 Impartiality
• Impartiality Risk : identification on going basis, risk
including from relationship of the personnel
• threats that arise from Analyst or Laboratory
management acting in their own interest
• competition threats : loosing contract or test

4.2 Confidentiality
• The laboratory shall be responsible, through legally
enforceable commitments,
• all other information is considered proprietary
information and shall be regarded as confidential.
• If Confidential information is shared for legal
purpose, client must be informed
• Customer information collected from outside source
is also confidential for customer
• All personnel including committee members,
contractual person will maintain confidentiality.

Legal Requirements
A laboratory must produce relevant evidence of legal
identification which can be any of the following:
• Registration under the Indian Companies Act, Limited
Liability Act, Partnership
• Act, Registration of Business as Sole Proprietor,
Indian Trust Act, Societies Registration Act,
• Any Government notification in support of
establishment of institution / laboratory or any
• approval from local or regulatory bodies. Laboratory
shall also comply with local / regional /national
requirements.
•

• The laboratory shall identify management that
has overall responsibility for the laboratory.
• The laboratory shall define and document the
range of laboratory activities for which it
conforms with this document.
• The laboratory shall meet customers
requirement, regulatory requirement and
other organization giving recognition .
• Same system with permanent and site

5.5 The laboratory shall:
a) Define the organization and management
structure of the laboratory, its place in any
parent organization, and the relationships
between management, technical operations and
support services;
b) specify the responsibility, authority and
interrelationship of all personnel who manage,
perform or verify work affecting the results of
laboratory activities;

RESPONSBILITY REQUIREMENT
Name Designation Responsibility Authority
Manage Perform Verify

Organization Structure

c) document its procedures to the extent
necessary to ensure the consistent application
of its laboratory activities and the validity of the
results.

5.6 Following responsibility must be addressed other
than regular responsibilities
a) implementation, maintenance and improvement of
the management system; (whatever designation like
QM)
b) identification of deviations from the management
system; (Non conformity)
c) initiation of actions to prevent or minimize such
deviations (Risk assessment)
d) Reporting for improvement and ensure effectiveness
(Audit and MR meeting)

5.7 Laboratory management shall ensure that:
a) Effective communication on effectiveness of
the management system and the importance of
meeting customers' and other requirements;
contract review, statuary and regulatory
requirement/circular mail on system need
b) the integrity of the management system is
maintained when changes to the management
system are planned and implemented.
(Organization structure/ system changes

DOCUMENTATION AND RECORD SUMMARY FOR
5 STRUCTURAL REQUIREMENTS CLAUSE OF ISO/IEC
17025
• Legal Identity
• Impartiality policy and risk identification
• Confidentiality agreement/arrangement with
laboratory staff
• Responsibility interrelationship matrix
• Evidence of communication with laboratory staff
• Circular mail as part of communication

6.1 General
The laboratory shall have available the personnel,
facilities, equipment, systems and support services
necessary to manage and perform its laboratory
activities.
Qualified technical person, required
accommodation, environment facility, calibrated
adequate equipment , quality reagent, CRM/
standard and other facility as required to perform
quality work

6.2 Personnel
6.2.1 All personnel of the laboratory, either internal
or external (including contract person/ sub contract
person/ part time person), that could influence the
laboratory activities shall act impartially, be
competent and work in accordance with the
laboratory's management system
Competence assessment as required

Competence Requirement :
6.2.2 The laboratory shall document the
competence requirements for each function
influencing the results of laboratory activities,
including requirements for education, qualification,
training, technical knowledge, skills and experience.
6.2.3 The laboratory shall ensure that the personnel
have the competence to perform laboratory
activities for which they are responsible and to
evaluate the significance of deviations.. (include
decision rule, non conformity, tolerance limit, LOD)

6.2.3 Personnel (contd)
Competence assessment
• Competence of each person to perform assigned
managerial or technical tasks according to
established criteria.
- Managerial task : duty roaster, lision with vendor
- Technical task : Testing of sample
• Reassessment shall take place at regular intervals.
• Retraining shall occur when necessary.

6.2.3 Personnel (contd)
Competence assessment
a) Direct observation of routine work processes and
procedures, including all applicable safety practices;
b)Direct observation on equip. maintenance and check
c) Monitoring the recording and reporting of
examination results;
d)Review of work records;
e) Assessment of problem solving skills;
f) Examination of specially provided samples, such as
previously examined samples, inter laboratory
comparison materials, or split samples.

6.2.4 The management of the laboratory shall
communicate to personnel their duties,
responsibilities and authorities.
Detailed job description with duties, responsibilities
and authorities
Communication evidence or signature of
acceptance may be required

6.2.5 The laboratory shall have procedure(s) and
retain records for:
a) determining the competence requirements;
(criteria against job)
b) selection of personnel; (selection record/
interview assessment/ joining details )
c) training of personnel; (training need and record)
d) supervision of personnel; (evidence of checking)
e) authorization of personnel; (evidence )
f) monitoring competence of personnel. ( periodical
competence assessment )

Training of Personnel
There shall be a system for imparting periodic, internal
and external training to the laboratory technical staff at
different levels wherever required before assigning any
analytical and testing work. Internal Training alone is
not considered adequate to make the staff
knowledgeable on the latest status of science and
technology. Evidence of effective training in specific
field should be available in terms of performance in
quality checks. All the technical staff working should be
sufficiently trained in all physical, chemical and
instrumental methods of analysis of the particular
product under concern.

6.2.6 The laboratory shall authorize personnel to
perform specific laboratory activities (authorization
records) , including but not limited to, the following:
a) development, modification, verification and
validation of methods; ( if followed non standard
method)
b) analysis of results, including statements of
conformity or opinions and interpretations; (decision
rule )
c) report, review and authorization of results.

Authorized Signatory for Mechanical

Authorized signatory for Electrical testing

6.3 Facilities and environmental condition

6.3.1 The facilities (it can be
vibration/sound/light/electromagnetic) and
environmental conditions shall be suitable for the
laboratory activities and shall not adversely affect
the validity of results.(following QC activities)
6.3.2 The requirements for facilities and
environmental conditions necessary for the
performance of the laboratory activities shall be
documented. Recording along with testing data.

6.3.3 The laboratory shall monitor, control and record
environmental conditions in accordance with relevant
specifications, methods or procedures or where they
influence the validity of the results.
The laboratory shall provide appropriate environmental
conditions and controls necessary for particular tests,
including temperature, humidity, freedom from
vibration, freedom from airborne and dust borne
microbiological contamination, special lighting adiation
screening. Critical environmental conditions should be
monitored.

6.3.4 Measures to control facilities shall be
implemented, monitored and periodically reviewed
and shall include, but not be limited to:
a) access to and use of areas affecting laboratory
activities;
b) prevention of contamination, interference or
adverse influences on laboratory activities;
c) effective separation between areas with
incompatible laboratory activities.

Example and recommendation
• Restrictions might be made because of security,
safety, or sensitivity to contamination. Typical
examples might be work involving explosives,
radioactive materials, carcinogens, toxic materials
and trace analysis. Where such restrictions are in
force, staff should be aware of:
• i. the intended use of a particular area;
• ii. the restrictions imposed on working within such
areas;
• iii. the reasons for imposing such restrictions

6.3.5 When the laboratory performs laboratory
activities at sites or facilities outside its permanent
control, it shall ensure that the requirements related
to facilities and environmental conditions of this
document are met.

Facilities and environmental condition

6.4 Equipment

6.4.1 The laboratory shall have access to equipment
(including, but not limited to, measuring instruments,
software, measurement standards, reference
materials, reference data, reagents, consumables or
auxiliary apparatus) that is required for the correct
performance of laboratory activities and that can
influence the results.

6.4.2 When the laboratory uses equipment outside
its permanent control, it shall ensure that the
requirements for equipment of this document are
met.
6.4.3 The laboratory shall 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.

Attention should be paid to the possibility of
contamination arising from the equipment or
cross-contamination from previous use. The
type used (glass, PTFE, etc), cleaning, storage,
and segregation of volumetric equipment is
critical, particularly for trace analyses when
leaching and adsorption can be significant.

6.4.4 The laboratory shall verify that equipment
conforms to specified requirements before being
placed or returned into service.
6.4.5 The equipment used for measurement shall be
capable of achieving the measurement accuracy
and/or measurement uncertainty required to provide
a valid result.

Equipment Validation Overview
[To establish] documented evidence which provides a high
degree of assurance that a specific process will consistently
produce a product meeting pre-determined specifications and
quality attributes.

Equipment qualification(EQ)/validation
• Design qualification (DQ)
• Installation qualification (IQ)
• Operational qualification (OQ)
• Performance qualification (PQ)

Design qualification
"Design qualification (DQ) defines the functional and operational
specifications of the instrument and details for the conscious
decisions in the selection
of the supplier".

Points to be considered for
inclusion in a DQ
• Description of the analysis problem
• Description of the intended use of the equipment
• Description of the intended environment
• Preliminary selection of the functional and performance
specifications (technical, environmental, safety)

Installation qualification
“Installation qualification establishes that the instrument is
received as designed and specified, that it is properly installed in
the selected environment, and that this environment is suitable
for the operation and use of the instrument.”

Operational qualification
"Operational qualification (OQ) is the process of demonstrating
that an instrument will function according to its operational
specification in the selected environment ."

The content of equipment qualification
• Application S.O.P’s
• Utilization List
• Process Description
• Test Instrument Utilized To Conduct Test
• Test Instrument Calibration
• Critical Parameters
• Test Function (List)
• Test Function Summaries

Performance qualification
"Performance Qualification (PQ) is the process of demonstrating
that an instrument consistently performs according to a
specification appropriate for its routine use "

6.4.6 Measuring equipment shall be calibrated
when:
— the measurement accuracy or measurement
uncertainty affects the validity of the reported
results, and/or
— calibration of the equipment is required to
establish the metrological traceability of the reported
results.

6.4.7 The laboratory shall establish a calibration
programme, which shall be reviewed and adjusted
as necessary in order to maintain confidence in the
status of calibration.
6.4.8 All equipment requiring calibration or which
has a defined period of validity shall be labeled,
coded or otherwise identified to allow the user of the
equipment to readily identify the status of calibration
or period of validity.

EQUIPMENT CALIBRATION INTERVALS (as per
NATA Document)
Laboratory equipment calibration and check programs
should cover:
a) commissioning of new equipment (including initial
calibration and checks after installation);
b) operational checking (checking during use with
reference standards or reference materials);
c) periodic checking (interim but more extensive
checking, possibly including partial calibration); d)
scheduled maintenance by in-house or specialist
contractors; e) complete recalibration.

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 requirements, shall be taken out of
service. It shall be isolated to prevent its use or
clearly labeled or marked as being out of service
until it has been verified to perform correctly. The
laboratory shall examine the effect of the defect or
deviation from specified requirements and shall
initiate the management of nonconforming work
procedure

6.4.10 When intermediate checks are necessary to
maintain confidence in the performance of the
equipment, these checks shall be carried out
according to a procedure.
6.4.11 When calibration and reference material data
include reference values or correction factors, the
laboratory shall ensure the reference values and
correction factors are updated and implemented, as
appropriate, to meet specified requirements.

6.4.12 The laboratory shall take practicable
measures to prevent unintended adjustments of
equipment from invalidating results.

6.4.13 Records shall be retained for equipment
which can influence laboratory activities. The
records shall 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; Contd.

6.4.13 Records shall be retained for equipment
which can influence laboratory activities. The
records shall include the following, where
applicable:
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. Contd.

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 The laboratory shall establish and maintain
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.

6.5.2 The laboratory shall ensure that measurement
results are traceable to the International System of
Units (SI) through:
a) calibration provided by a competent laboratory;
b) certified values of certified reference materials
provided by a competent producer with stated
metrological traceability to the SI;
c) direct realization of the SI units ensured by
comparison, directly or indirectly, with national or
international standards.

6.5.3 When metrological traceability to the SI units is
not technically possible, the laboratory shall
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.

Where a test is used to measure an empirical property
of a sample, such as flashpoint, equipment is often
defined in a national or international standard method
and traceable reference materials should be used for
calibration purposes where available. New or newly
acquired equipment should be checked by the
laboratory before use to ensure conformity with
specified design, performance and dimension
requirements.

6.6 Externally provided products and services

Purchase and Subcontract :
6.6.1 The laboratory shall ensure that only suitable
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, as received from the
external provider;
c) are used to support the operation of the laboratory.

6.6.2 The laboratory shall have a procedure and
retain 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; Contd.

c) ensuring that externally provided products and
services conform to the laboratory’s established
requirements, or when applicable, to the relevant
requirements of this document, before they are used
or directly provided to the customer;
d) taking any actions arising from evaluations,
monitoring of performance and re-evaluations of the
external providers.

6.6.3 The laboratory shall communicate its
requirements to external providers 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, or its customer,
intends to perform at the external provider's
premises.

DOCUMENTATION AND RECORD SUMMARY
FOR 6.6 CLAUSE OF ISO/IEC 17025
• Procedure for Purchase/subcontracting
/external service and supplies
• List of approved vendor/subcontractor
• Purchase indent
• Purchase order
• Vendor evaluation record
• Inspection plan for acceptance of laboratory
material and consumables and supplies

7.1 Review of requests, tenders and contracts

7.1.1 The laboratory shall have a procedure for the
review of requests, tenders and contracts. The
procedure shall ensure that:
a) the requirements are adequately defined,
documented and understood;
b) the laboratory has the capability and resources to
meet the requirements;
Contd.

c) where external providers are used, the
requirements of 6.6 are applied and the laboratory
advises the customer of the specific laboratory
activities to be performed by the external provider and
gains the customer's approval;
d) the appropriate methods or procedures are
selected and are capable of meeting the customers'
requirements.

7.1.2 The laboratory shall inform 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 shall be clearly defined. Unless
inherent in the requested specification or standard,
the decision rule selected shall be communicated to,
and agreed with, the customer.

7.1.4 Any differences between the request or tender
and the contract shall be resolved before laboratory
activities commence. Each contract shall be
acceptable both to the laboratory and the customer.
Deviations requested by the customer shall not
impact the integrity of the laboratory or the validity of
the results.
7.1.5 The customer shall be informed of any deviation
from the contract.

7.1.6 If a contract is amended after work has
commenced, the contract review shall be repeated
and any amendments shall be communicated to all
affected personnel.

7.1.7 The laboratory shall cooperate with customers
or their representatives in clarifying the customer's
request and in monitoring the laboratory’s
performance in relation to the work performed.
a) providing reasonable access to relevant areas of
the laboratory 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, shall be retained. Records shall also be
retained of pertinent discussions with a customer
relating to the customer's requirements or the results
of the laboratory activities.

7.2 Selection, verification and validation of
methods

7.2.1 Selection and verification of methods:
7.2.1.1 The laboratory shall use 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 the laboratory
activities, shall be kept up to date and shall be made
readily available to personnel (see 8.3).
7.2.1.3 The laboratory shall ensure that it uses the
latest valid version of a method unless it is not
appropriate or possible to do so. When necessary,
the application of the method shall be supplemented
with additional details to ensure consistent
application.

7.2.1.4 When the customer does not specify the
method to be used, the laboratory shall select an
appropriate method and inform the customer of the
method chosen. Methods published either in
international, regional or national 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
be used.

7.2.1.5 The laboratory shall verify that it can properly
perform methods (method verification) before
introducing them by ensuring that it can achieve the
required performance. Records of the verification
shall be retained. If the method is revised by the
issuing body, verification shall be repeated to the
extent necessary.

7.2.1.6 When method development is required, this
shall be a planned activity and shall be assigned to
competent personnel equipped with adequate
resources. As method development proceeds,
periodic review shall be carried out to confirm that the
needs of the customer are still being fulfilled. Any
modifications to the development plan shall be
approved and authorized.
7.2.1.7 Deviations from methods for all laboratory
activities shall occur only if the deviation has been
documented, technically justified, authorized, and
accepted by the customer

7.2.1.7 Deviations from methods for all laboratory
activities shall 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 The laboratory shall validate non-standard
methods, laboratory-developed methods and
standard methods used outside their intended scope
or otherwise modified. The validation shall be as
extensive as is necessary to meet the needs of the
given application or field of application.
a) calibration or evaluation of bias and precision
using reference standards or reference
materials;
Contd.

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 When changes are made to a validated
method, the influence of such changes shall be
determined and where they are found to affect the
original validation, a new method validation shall be
performed.
7.2.2.3 The performance characteristics of validated
methods, as assessed for the intended use, shall be
relevant to the customers' needs and consistent with
specified requirements.

Verification versus Validation

Verification
• Verification is the process by which the lab verifies that the
established performance claims of an test or product can be
replicated in the lab before sample testing
• Verification establishes that the laboratory performing the
test executes the test procedures correctly and ensures that
instrumentation and reagents work properly.
• Verification is acceptable in circumstances in which the test is
performed and used in the manner directed in the package
insert/Test SOP
• Any other off-label use would require validation by the
performing laboratory.

Validation
Validation is the process by which the laboratory measures the
testing efficacy of the test in question by determining its
performance characteristics when used as intended. When
you are following a non standard method at your defined
conditions.
• whenever using non-standard methods or a standard method
beyond the stated limits of operation is required to validate
such test methods

• Verification of performance specifications.
• (i) Demonstrate that it can obtain performance specifications
comparable to those established by the manufacturer for the
following performance characteristics:
• (A) Accuracy
(B) Precision
Verification

Verification
When standard methods are used, laboratories should
verify their own satisfactory performance against the
documented performance characteristics of the
method, before any samples are analyzed. Records of
the verification must be retained. For published test
methods that do not include precision data, the
laboratory must determine its own precision data
based on test data. All methods should include criteria
for rejecting suspect results.

Method selection
Where a test can be performed by more than
one method there must be documented criteria
for method selection. Where relevant the
degree of correlation between the methods
should be established and documented

Validation
Need to establish for each test system the performance
specifications for the following performance characteristics:
(i) Accuracy
(ii) Precision
(iii) Analytical sensitivity
(iv) Analytical specificity to include interfering substances
(v) Reportable range of test results for test system
(vi) Reference intervals (normal values)

Method Validation
Methods developed in-house must be validated and
authorized before use. Where they are available,
certified reference materials should be used to
determine any systematic bias, or where this is not
possible results compared with other technique(s),
preferably based on different principles of analysis.
• Where a change in method involves only minor
adjustments, such as sample size, different reagents,
the amended method should be validated

The Validation Process
Validation
Method
Validation
System
Suitability
Hardware
Software

The Validation Timeline
Vendor’s Site User’s Site User’s Site
Structural
and
Software
Qualification
Qualification
IQ
OQ
PQ
Calibration
and
Maintenance,
System
Suitability
Before Purchase Before Use After Use

The essential eight steps of Method Validation
• Precision
• Accuracy
• Limit of Detection (LOD)
• Limit of Quantification (LOQ)
• Specificity
• Linearity and Range
• Ruggedness
• Robustness

Accuracy
Is the measure of exactness of an analytical method, or the
closeness of agreement between the measured value and
the value or an accepted reference value.

Precision
Is the measure of the degree of repeatability of an analytical
method under normal operation and is normally expressed as
the percent relative standard deviation for a statistically
significant number of samples.

Accuracy and Precision
Precision
Accuracy
Precision
No Accuracy
No Precision
No Accuracy

Specificity
Is the ability to measure accurately and specifically the
analyte of interest in the presence of other components that
may be expected to be present in the sample matrix.
It is a measure of the degree of interference from such things
as other active ingredients, excipients, impurities, and
degradation products, ensuring that a peak response is due
only to a single component; that is, that no co-elutions exist.

Limit of Detection (LOD)
Is defined as the lowest concentration of an
analyte in a sample that can be detected,
though not necessarily quantitated.
It is a limit test that specifies whether or not an
analyte is above or below a certain value.

Limit of Quantification (LOQ)
Is defined as the lowest concentration of ana analyte in a
sample that can be determined with acceptable precision and
accuracy under the stated operational conditions of the
method.
LOQ is directly proportional to the precision.

LOD and LOQ
LOL
LOD
LOQ
Useful
Interval
LOD = Limit of Detection
LOQ =Limit of Quantification
LOL = Limit of Linearity
Concentration
Response of
the instrument
LOD = 3 S/N
LOQ = 10 S/N

Linearity and Range
Linearity
Is the ability of the method to elicit test
results that are directly proportional to
analyte concentration within a given range.
Range
Is the interval between the upper and lower levels of
analyte that have been demonstrated to be
determined with precision, accuracy, and linearity
using the method

Ruggedness
Ruggedness
`Is the degree of reproducibility of the results obtained
under a variety of conditions.
These conditions include differences in laboratories,
analysts, instruments, reagents, and experimental
periods.Robustness Is the capacity of a method to
remain unaffeccted by small deliberate variations in
method parameters.These deliberate variations are
change in the percent of organic solvent, pH, ionic
strength, or temperature, and detemining the effect
(if any) on the results of the method.

7.2.2.4 The laboratory shall retain the following
records of validation:
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 The laboratory shall have a sampling plan and
method when it carries out sampling of substances,
materials or products for subsequent testing or
calibration. The sampling method shall address the
factors to be controlled to ensure the validity of
subsequent testing or calibration results. The
sampling plan and method shall be available at the
site where sampling is undertaken. Sampling plans
shall, whenever reasonable, be based on appropriate
statistical methods.

7.3.2 The sampling method shall describe:
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 or calibration.

7.3.3 The laboratory shall retain records of sampling
data (sampling data sheet) that forms part of the
testing or calibration that is undertaken. These
records shall 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;
Contd.

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 or calibration items

7.4.1 The laboratory shall have a procedure for the
transportation, receipt, handling, protection, storage,
retention, and disposal or return of test or calibration
items, including all provisions (logistics and storage)
necessary to protect the integrity of the test or
calibration item, and to protect the interests of the
laboratory and the customer. Precautions shall be
taken to avoid deterioration, contamination, loss or
damage to the item during handling, transporting,
storing/waiting, and preparation for testing or
calibration. Handling instructions provided with the
item shall be followed.

7.4.2 The laboratory shall have a system for the
unambiguous identification of test or calibration items.
The identification shall be retained while the item is
under the responsibility of the laboratory. The system
shall ensure that items will not be confused physically
(Sample ID/ marking) or when referred to in records or
other documents. The system shall, if appropriate,
accommodate a sub-division of an item or groups of
items and the transfer of items.

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

Planning :
– Sample Acceptance and rejection criteria
– Sample acceptance and rejection record
– Customer communication log if sample is
compromised with deviation
– Disclaimer in the report
7.4.4 When items need to be stored or
conditioned under specified environmental
conditions, (Ex. Temp/humidity) these
conditions shall be maintained, monitored and
recorded.

7.5 Technical records.
7.5.1 The laboratory shall 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 (Type A and Type B factors) and
its associated measurement uncertainty and enable
the repetition of the laboratory activity under
conditions as close as possible to the original.
Contd.

7.5.1The technical records shall include the date and
the identity of personnel responsible for each
laboratory activity and for checking data and results.
Original observations (machine print out/ chemist
hand book), data and calculations shall be recorded at
the time they are made and shall be identifiable with
the specific task.

7.5.2 The laboratory shall ensure that amendments to
technical records can be tracked to previous versions
or to original observations. Both the original and
amended data and files shall be retained, 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 Laboratories shall identify the contributions to
measurement uncertainty. When evaluating
measurement uncertainty, all contributions that are of
significance, including those arising from sampling,
shall be taken into account using appropriate methods
of analysis.
7.6.2 A laboratory performing calibrations, including of
its own equipment, shall evaluate the measurement
uncertainty for all calibrations.

7.6.3 A laboratory performing testing shall evaluate
measurement uncertainty. Where the test method
precludes rigorous evaluation of measurement
uncertainty, an estimation shall be made based on an
understanding of the theoretical principles or practical
experience of the performance of the method.

7.7 Ensuring the validity of results

7.7.1 The laboratory shall have a procedure for
monitoring the validity of results. The resulting data
shall be recorded in such a way that trends (control
chart/ linearity) are detectable and, where practicable,
statistical techniques (UCL &LCL, mean and
precision) shall be applied to review the results. This
monitoring shall be planned and reviewed and shall
include, where appropriate, but not be limited to:
a) use of reference materials(RM) or quality control
materials; (CRM/Standard etc)
Contd.

b) use of alternative instrumentation (method
comparability ) that has been calibrated to provide
traceable results;
c) functional check(s) of measuring and testing
equipment; ( other one point/two point etc check
d) use of check or working standards with control
charts, where applicable;
e) intermediate checks (in between calibration) on
measuring equipment;
f) replicate tests or calibrations using the same or
different methods;
Contd.

g) retesting or recalibration of retained items;
h) correlation of results for different characteristics of
an item; (ex. Carbon chemical with hardness)
i) review of reported results;
j) intralaboratory comparisons; (within internal
laboratories)
k) testing of blind sample(s). (sample not known)

7.7.2 The laboratory shall monitor its performance by
comparison with results of other laboratories, where
available and appropriate. This monitoring shall be
planned and reviewed and shall include, but not be
limited to, either or both of the following:
a) participation in proficiency testing;
b) participation in interlaboratory comparisons other
than proficiency testing.

7.7.3 Data from monitoring activities shall be
analyzed, used to control and, if applicable, improve
the laboratory's activities. If the results of the analysis
of data from monitoring activities are found to be
outside pre-defined criteria (acceptable limit),
appropriate action shall be taken to prevent incorrect
results from being reported.

7.8 Reporting of results

7.8.1 General
7.8.1.1 The results shall be reviewed and authorized
prior to release.
7.8.1.2 The results shall be provided accurately, clearly,
unambiguously and objectively, usually in a report (e.g.
a test report or a calibration certificate or report of
sampling), and shall 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 shall be retained as
technical records.

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

7.8.2 Common requirements for reports (test,
calibration or sampling)
7.8.2.1 Each report shall include at least 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”, “Calibration Certificate” or
“Report of Sampling”);
b) the name and address of the laboratory;
Contd.

c) the location of performance of the laboratory
activities, including when performed at a customer
facility or at sites away from the laboratory’s
permanent facilities, or in associated temporary or
mobile 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;
Contd.

g) a description, unambiguous identification, and,
when necessary, the condition of the item;
h) the date of receipt of the test or calibration item(s),
and the date of sampling, where this is critical to the
validity and application of the results;
i) the date(s) of performance of the laboratory
activity;
j) the 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 application of the
results;
Contd.

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

7.8.3 Specific requirements for test reports

7.8.3.1 In addition to the requirements listed in 7.8.2,
test reports shall, where necessary for the
interpretation of the test results, include the following:
a) information on specific test conditions, such as
environmental conditions;
b) where relevant, a statement of conformity with
requirements or specifications (see 7.8.6);
Contd.

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) where appropriate, opinions and interpretations
(see 7.8.7); Contd.

e) additional information that may be required by
specific methods, authorities, customers or groups of
customers.
7.8.3.2 Where the laboratory is responsible for the
sampling activity, test reports shall meet the
requirements listed in 7.8.5 where necessary for the
interpretation of test results.

DOCUMENTATION AND RECORD SUMMARY FOR 5.10
CLAUSE OF ISO/IEC 17025
• Test report format as per the requirement of
ISO/IEC 17025
• Copy of the test report
• Report correction record

7.8.4 Specific requirements for calibration
certificates

7.8.4.1 In addition to the requirements listed in 7.8.2,
calibration certificates shall include the following:
a) the measurement uncertainty of the measurement
result presented in the same unit as that of the
measured or in a term relative to the measured
(e.g. percent);
b) the conditions (e.g. environmental) under which
the calibrations were made that have an influence
on the measurement results;
c) a statement identifying how the measurements are
metrological traceable (see Annex A);

d) the results before and after any adjustment or
repair, if available;
e) where relevant, a statement of conformity with
requirements or specifications (see 7.8.6);
f) where appropriate, opinions and interpretations (see
7.8.7).
7.8.4.2 Where the laboratory is responsible for the
sampling activity, calibration certificates shall meet the
requirements listed in 7.8.5 where necessary for the
interpretation of calibration results.

7.8.4.3 A calibration certificate or calibration label
shall not contain any recommendation on the
calibration interval, except where this has been
agreed with the customer.

7.8.5 Reporting sampling – specific requirements

7.8.5 Reporting sampling – specific requirements
Where the laboratory is responsible for the sampling
activity, in addition to the requirements listed in 7.8.2,
reports shall 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);
Contd.

c) the location of sampling, including any diagrams,
sketches or photographs;
d) a reference to the sampling plan and sampling
method;
e) details of any environmental conditions during
sampling that affect the interpretation of the results;
f) information required to evaluate measurement
uncertainty for subsequent testing or calibration.

7.8.6 Reporting statements of conformity.

7.8.6.1 When a statement of conformity to a
specification or standard is provided, the laboratory
shall 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 The laboratory shall report on the statement of
conformity, such that the statement clearly identifies:
Contd.

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 interpretations are
expressed, the laboratory shall ensure that only
personnel authorized for the expression of opinions
and interpretations release the respective statement.
The laboratory shall document the basis upon which
the opinions and interpretations have been made.
7.8.7.2 The opinions and interpretations expressed in
reports shall be based on the results obtained from
the tested or calibrated item and shall be 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 shall be retained.

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
shall be clearly identified and, where appropriate, the
reason for the change included in the report.
7.8.8.2 Amendments to a report after issue shall be
made only in the form of a further document, or data
transfer, which includes the statement “Amendment to
Report, serial number... [or as otherwise identified]”, or
an equivalent form of wording.

Such amendments shall meet all the requirements of
this document.
7.8.8.3 When it is necessary to issue a complete new
report, this shall be uniquely identified and shall
contain a reference to the original that it replaces.

7.9 Complaints

7.9.1 The laboratory shall have a documented
process (flow chart or procedure) to receive, evaluate
and make decisions on complaints. (all staff/client and
others like statutory, legal)
7.9.2 A description of the handling process for
complaints ( how to raise a complaint ) shall be
available to any interested party on request. Upon
receipt of a complaint, the laboratory shall confirm
whether the complaint relates to laboratory activities
that it is responsible for and, if so, shall deal with it.
The laboratory shall be responsible for all decisions at
all levels of the handling process for complaints.

7.9.3 The process for handling complaints shall
include at least the following elements and methods:
a) description of the process (flow chart or process)
for receiving (acknowledgement), validating, (initial
confirmation) investigating the complaint (RCA), and
deciding what actions are to be taken in response to
it;
b) tracking and recording complaints, including actions
undertaken to resolve them; (correction and CA)
c) ensuring that any appropriate action(CA) is taken.

7.9.4 The laboratory receiving the complaint shall be
responsible for gathering and verifying all necessary
information to validate the complaint.(verification fact)
7.9.5 Whenever possible, the laboratory shall
acknowledge receipt of the complaint, and provide the
complainant with progress reports and the outcome.
7.9.6 The outcomes to be communicated to the
complainant shall be made by, or reviewed and
approved by, individual(s) not involved in the original
laboratory activities in question. (person involved in
the complaint will not investigate)

7.9.7 Whenever possible, the laboratory shall give
formal notice (Resolution letter) of the end of the
complaint handling to the complainant.

7.10 Nonconforming work.

Identification and
control of non-conformities
What is non conformities ?
In quality management, a nonconformity (also
known as a defect) is a deviation from a
specification, a standard, or an expectation.

Identification and
control of non-conformities
• What is non conformities ?
Ex. A sample is processed in less than 300 rpm
or required “g”
A sample requested for fungus culture in
incubated in normal incubate or rather BOD
incubator or incubated at less than temperature
required for test

Control of nonconforming testing and/or
calibration work
What is Non conformance ?
is non fulfillment of the specified requirement of
test
What is corrective action ?
Action taken to prevent reoccurrence

RISK ASSESSMENT

7.10.1 The laboratory shall have a procedure that
shall be implemented when any aspect of its
laboratory activities or results of this work do not
conform to its own procedures (MSP/WI/SOP) 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 shall ensure that:
a) the responsibilities and authorities for the
management of nonconforming work are defined;
Contd.

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 The laboratory shall retain records of
nonconforming work and actions as specified in
7.10.1, bullets b) to f).
7.10.3 Where the evaluation indicates that the
nonconforming work could recur, or that there is doubt
about the conformity of the laboratory's operations
with its own management system, (Deviation from
written down process/procedure) the laboratory
shall
implement corrective action.

7.11 Control of data and information management
7.11.1 The laboratory shall have access to the data
and information needed to perform laboratory
activities.

7.11.2 The laboratory information management system(s)
(LIMS) used for the collection, processing, recording,
reporting, storage or retrieval of data shall be validated
for functionality (beta testing), including the proper
functioning of interfaces (with uni direction and bi
direction) within the laboratory information management
system(s) by the laboratory before introduction.
Whenever there are any changes, including laboratory
software configuration or modifications to commercial
off-the-shelf software, they shall be authorized,
documented and validated before implementation.

Computerized based analytical system
Such systems will normally be validated by checking for
satisfactory operation (including performance under
extreme circumstances) and establishing the reliability
of the system before it is allowed to run unattended.
An assessment should be made of the likely causes of
system malfunction. Where possible the controlling
software should be tailored to identify and highlight
any such malfunctions and tag associated data.

7.11.3 The laboratory information management
system(s) shall:
a) be protected from unauthorized access;
b) be safeguarded against tampering and loss;
c) be operated in an environment that complies with
provider or laboratory specifications or, in the case of
non-computerized systems, provides conditions which
safeguard the accuracy of manual recording and
transcription;
Contd.

d) be 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 When a laboratory information management
system is managed and maintained off-site or through
an external provider, the laboratory shall ensure that
the provider or operator of the system complies with
all applicable requirements of this document.

7.11.5 The laboratory shall ensure that instructions,
manuals and reference data relevant to the laboratory
information management system(s) are made readily
available to personnel.
7.11.6 Calculations and data transfers shall be
checked in an appropriate and systematic manner.
Electronic transfer of data should be checked to
ensure that no corruption has occurred during
transmission. This can be achieved on the computer
by the use of `verification files’ but wherever practical
the transmission should be backed up by a hard copy
of the data.

8.1 Options
8.1.1 General.
The laboratory shall 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 the laboratory results.

8.1.1 General. (Cont.……..)
In addition to meeting the requirements of
Clauses 4 to 7, the laboratory shall implement a
management system in accordance with Option A or
Option B.

8.1.2 Option A
• As a minimum, the management system of the
laboratory shall address the following:
• management system documentation (8.2)
• control of management system documents (8.3)
• control of records (8.4)

• actions to address risks and opportunities (8.5)
• improvement (8.6)
• corrective actions (8.7)
• internal audits (8.8)
• management reviews (8.9).

8.1.3 Option B
• A laboratory that has established and maintains
a management system, in accordance with the
requirements of ISO 9001, and that is capable of
supporting and demonstrating the consistent
fulfilment of the requirements of Clauses 4 to 7,
also fulfils at least the intent of the management
system requirements specified in 8.2 to 8.9.

8.2 Management system documentation(Option A )
• 8.2.1 Laboratory management shall establish,
document, and maintain policies and objectives
for the fulfilment of the purposes of this
document and shall ensure that the policies and
objectives are acknowledged and implemented at
all levels of the laboratory organization.

8.2.2 The policies and objectives shall address the
competence, impartiality and consistent operation
of the laboratory.
8.2.3 Laboratory management shall provide
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 fulfilment of the
requirements of this document shall be included
in, referenced from, or linked to the management
system. (documentation linkage with reference)
8.2.5 All personnel involved in laboratory activities
shall 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)

Document control terminology
• List of document/register of document/master list
• Master document
• Controled copy
• Uncontroled copy
• Obsolete copy
• Issue and revision
• Document preparation, approval and issue
• Document review
• Document change
• Document Amendment

List of Documents-Master list
Sl
no
Name of
document
Document
no
Copy
No
Issue
no
Issue date Last
revision
Holder
01 Quality
Manual
IAQM/Q
M/01
01 01 01-12-
2012
05-10-2011 Quality
Manager

Document Review
Sl no Name of
document
Document
no
Section Page no Review
findings
Holder

List of Documents
Sl
no
Name of
document
Document
no
Copy
No
Issue
no
Issue date Last
revision
Holder
01 Quality
Manual
IAQM/Q
M/01
01 01 01-05-
2012
05-10-2012 Quality
Manager

8.3 Control of management system documents
(Option A)
8.3.1 The laboratory shall control the documents
(internal and external) that relate to the fulfilment
of this document.
8.3.2 The laboratory shall ensure that:
a) documents are approved for adequacy prior to
issue by authorized personnel;

8.3.2 (Cont.….)
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;

8.3.2 (Cont.….)
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.

8.4 Control of records (Option A)

8.4 Control of records (Option A)
8.4.1 The laboratory shall establish and retain
legible records to demonstrate fulfilment of the
requirements in this document.

8.4 Control of records (Cont.….)
8.4.2 The laboratory shall implement the controls
needed for the identification, storage, protection,
back-up, archive, retrieval, retention time, and
disposal of its records. The laboratory shall retain
records for a period consistent with its contractual
obligations. Access to these records shall be
consistent with the confidentiality commitments,
and records shall be readily available.

8.5 Actions to address risks and opportunities
(Option A)

8.5.1 The laboratory shall consider the risks and
opportunities associated with the 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 The laboratory shall plan:
a) actions to address these risks and
opportunities;
b) how to:
• integrate and implement these actions into its
management system;
• evaluate the effectiveness of these actions.

8.5.3 Actions taken to address risks and
opportunities shall be proportional to the
potential impact on the validity of laboratory
results.

What is Risk ?
• A random event that has negative impact
• Risk has two components
- Probability of occurrence
- Severity
• DIMENSIONS-Harm-physical injury or damage
-Hazard-source of harm
-Severity-measure of consequences

What is Risk Assessment
Risk Assessment is a systematic approach to
identify hazards, evaluate risk and incorporate
appropriate measures to manage and mitigate
risk for any work process or activity.

Risk Concepts
Risk management also includes control and monitoring of risks, as well as
communicating these risks
How likely is it? What are the Impacts
Risk Level
MANAGE RISK
What can go Wrong

Risk Assessment Team
QUALITIES
• Knowledge of the device, method, technology
• Neutral
• Careful
• Creative thinkers
• Confident
• Thick skinned
• Communicators
• Curious
• Finishers
• Cynical – Always questioning, don't accept everything on face value
• Social – Team players

Risk management Plan
• An organized approach to assessing and managing
risk
• Establishes scope & requirements
• Assigns responsibilities
• Sets criteria for acceptability
• Establishes verification activities & feedback
mechanisms
• Provides the roadmap
• Encourages objectivity
• Prevents essential elements being forgotten

Risk management Process
1. Selection of Risk method
2. Information review
3. Process mapping
4. Risk analysis- identify hazards
5. Risk estimation for each hazard
6. Determine acceptability of risks.
7. Evaluation based on acceptance criteria

8. Risk reduction/control/mitigation
9. Evaluate residual risk
10. Periodic review for effectiveness
Risk management process - contd

RISK ASSESSMENT METHOD
– HORIZONTAL RISK ASSESSMENT
– VERTICAL RISK ASSESSMENT
HORIZONTAL RISK ASSESSMENT : Department
or any functional activities,
example : Reception/machine shop area,
mechanical/ chemical test area
VERTICAL RISK ASSESSMENT : Test parameter
wise
• Ex. Vertical risk analysis of Water BOD test
parameter, pre analytic phase, analytic phase and
post analytic phase

RISK ASSESEMENT STEP
Step 1. Selection of risk method :
a) It may be advisable to start with Horizontal risk assessment and
then completing with vertical risk
b) Vertical risk will take more time to complete the work
c) While doing vertical risk many of the horizontal risk may be ignored

• Step 2. Information review. –
All the information on the test.
• pre analytical procedure
• instrument manuals,
• package inserts,
• technical bulletins,
• Regulatory / accrediting organization
requirements,
• QC and PT records,

• Step 2. Information review. – contd…….
• Training procedures,
• Prior failure investigation records,
• Any institutional guidance on the test or
analyte.
Caution - do not rely on memory

Step 3. Process mapping :-
• staff who run the test method,
• the test results,
it’s important to understand what really occurs, not
just what is supposed to occur.

RISK ASSESEMENT STEP contd-----
Step 4. Risk Analysis - Identification of hazards.
“What can go wrong” during routine
operations ?
What hazards are present. ?
Categorize the hazard.
Operator,
Environment,
System (Instrument),
Reagents, or Specimen.
Transcriptional
AIM
Controls necessary to reduce unwanted risk.

RISK ASSESEMENT STEP contd……………
Step 5. Risk estimation
Evaluate the risk for each hazard:
How likely it is that a failure will occur ?
How likely it is that it will lead to harming a
test results issued to customer ?
How severe that harm could be ?
ATTRIBUTES
Subjective
Discussion
customer to understand decision rules

RISK ASSESEMENT STEP contd……
• Step 6. Determine acceptability of risks.
• Severity and probability of harm to determine
whether the risks are acceptable.
• Each lab to determine where to draw the line
between acceptable and unacceptable.
• The team to determine whether a given risk is
acceptable or not.

RISK ASSESEMENT STEP contd……………
• Step 7. Risk reduction/control/mitigation.
• Identify ways to reduce the probability of harm,
using prevention and detection methods,
• Revised operator training, Posted warnings,
• More robust QC rules,
• Greater surveillance of the process, or even repeat
testing
• In cases where the test manufacturer indicates that
certain aspects of the test are monitored through
built-in controls, the lab may wish to conduct a study
to verify the effectiveness of the control before
including it as a control measure.

RISK ASSESEMENT STEP contd…………….
• Step 8. Evaluate residual risk.
• Once controls are assigned, the team
then reviews the risks again and re-
determines the risk level. Any risk not
prevented or detected 100% of the time
is considered residual risk.

• Step 9 Periodic review of Risk:
Once risk assessment, risk control procedure
is adopted , periodic review of the same is
required to understand the effectiveness of
risk

Possible responses to risk analysis
findings
• Accept the risk – do nothing
• Reallocate resources
• Get more information
• Eliminate the risk entirely
• Mitigate the risk
• Have a contingency plan
• Transfer the risk

Risk Assessment
Flowchart
Manage Risk
7. Hazard Control 8. Additional control measures
(Responsible person, timeline)
Review, Approval,
Communicate
Record Keeping and
Document Control
Assess
5. Existing Control Measures 6. Evaluate Risk (Severity, Probability)
Identify
1. Selecting Experiments
2. Break Down into
Successive Tasks
3. Potential Hazards 4. Potential Harm (Ill
health condition)

Risk Evaluation
Risk matrix to determine risk level
Likelihood
Severity
Remote (1) Occasional (2) Frequent (3)
Minor (1) 1 2 3
Moderate (2) 2 4 6
Major (3) 3 6 9

8.6 Improvement (Option A)

8.6 Improvement (Option A)
• 8.6.1 The laboratory shall identify (Quality
Indicator/ compalint/ Non conformance/ IQA
Risk and select opportunities for improvement
and implement any necessary actions.
• 8.6.2 The laboratory shall seek feedback, both
positive and negative, from its customers. The
feedback shall be analyzed and used to improve
the management system, laboratory activities
and customer service.

Tools used for continuous improvement
2. Run Chart
Performance
Time

8.7 Corrective actions (Option A)

8.7 Corrective actions (Option A)
8.7.1 When a nonconformity occurs, the
laboratory shall:
a) react to the nonconformity and, as applicable:
–take action to control and correct it;
–address the consequences;

8.7 Corrective actions (Option A) (Cont.…..)
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
(RCA) ;
• determining if similar nonconformities exist, or
could potentially occur

8.7 Corrective actions (Option A) (Cont.…..)
• 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 shall be appropriate to the
effects of the nonconformities encountered.

Fishbone diagram analysis
Makes
customer
wait
Absent receiving
party
Working system of
operators
Customer Operator
Absent
Out of office
Not at desk
Lunchtime
Too many phone
calls
Absent
Not giving
receiving party’s
coordinates
Complaining
Leaving a
message
Lengthy talk
Does not know
organization well
Takes too much time
to explain
Does not
understand
customer

FOR 8.7 CLAUSE OF ISO/IEC 17025
• Corrective action Procedure
• Corrective action record

8.7.3 The laboratory shall retain records as
evidence of:
a) the nature of the nonconformities, cause(s) and
any subsequent actions taken;
b) the results of any corrective action.

8.8 Internal audits (Option A)

8.8 Internal audits (Option A)
8.8.1 The laboratory shall 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 the laboratory activities;
• the requirements of this document;
b) is effectively implemented and maintained.

8.8 Internal audits (Option A) (Cont.…..)
8.8.2 The laboratory shall:
a) plan, establish, implement and maintain an
audit programme including the frequency,
methods, responsibilities, planning requirements
and reporting, which shall take into consideration
the importance of the laboratory activities
concerned, changes affecting the laboratory, and
the results of previous audits

8.8 Internal audits (Option A) (Cont.…..)
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.

FOR 8.8 Internal audits CLAUSE OF ISO/IEC
17025
• Internal audit procedure
• List of Internal Auditors
• Internal Audit Plan
• Internal Audit Schedule
• Internal audit checklist
• Internal audit observation/ record
• Internal audit nonconformance
• Internal audit summary record

8.9 Management reviews (Option A)

8.9 Management reviews (Option A)
8.9.1 The laboratory management shall review 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 shall be
recorded and shall include information related to
the following:
a) changes in internal and external issues that are
relevant to the laboratory;
b) fulfilment of objectives;
c) suitability of policies and procedures;
d) status of actions from previous management
reviews;

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

Minimum Management review agenda (cont.…)
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
shall record all decisions 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 fulfillment of the requirements of this
document
c) provision of required resources;
d) any need for change.

8.9 Management reviews (Option A) (Cont.….)
8.9.2 The inputs to management review shall be
recorded and shall include information related to
the following:

FOR 8.9 Management reviews CLAUSE OF
ISO/IEC 17025
• Management Review Procedure
• Management Review meeting Notice/Agenda
• Minutes of Management review and follow up
action record

I
INTENRAL QUALITYAUDIT PRACTICES
PRESENTED BY
Dr S Chakraborty
www.sambhuchakraborty.com

web: www.quality-pathshala.com
 Formal training for conducting laboratory Internal
Audit to comply with requirement of ISO/IEC 17025 :
2017 standard
 Assist in implementing laboratory accreditation
system as per requirement of accreditation body
 To Qualify as Internal Auditor for doing laboratory
Audit Internally
 Can help in carrying out second Party audit
COURSE OBJECTIVES

Principles of Auditing
Audit Planning and execution
NC Reporting and system effectiveness
Checklist preparation
Close examination of requirements in
laboratory accreditation
Case Studies
COURSE OUTLINE

GENERAL PRINCIPLES OF AUDITING
AUDIT OF laboratory
QUALITY MANAGEMENT SYSTEM

DEFINITION
Quality Management system audit is-----------
Systematic and Independent Examination of
activities to.
Verify compliance.
Judge Effectiveness-of quality management
system

A FORMAL activity carried out against policy,
quality manual and procedures to INDEPENDENTLY
examine OBJECTIVE EVIDENCE and verify
compliance or otherwise with SPECIFIED
REQUIREMENT and also judge EFFECTIVENESS
FORMAL DEFINATION

INTERNAL VERSUS EXTERNAL AUDIT
External auditor
- has to stick to the norm
- will almost exclusively report on non-
conformities
- examines a limited scope of services

INTERNAL VERSUS EXTERNAL AUDIT
Internal auditor
has to detect non-conformities,
but can also report on other issues
covers the complete scope
is unrelated to the audited section of the
organization,
knows the inner workings of the
organization

THE INTERNAL AUDIT PROCESS
• Scheduled Audits
programme managed by Quality Assurance Officer
examine documents, results, processes
identify problems
improve
• Unscheduled Audits
investigate problem
improve

WHY INTERNAL AUDITING ?
Self evaluation for Adequacy &
compliance
Assessing Effectiveness of Management
System (Specially under changing
scenario)
Evaluation of Vendors for Acceptance as
supplier
Evaluation of supplier competence

• Demonstration of Quality competence (As per
Designed Assessment Type)
• Requirements of Applicable Standards (eg. ISO
9001; ISO/IEC 17025
• Ascertain Effectiveness of Corrective Actions
• Looking for Areas of Improvement
WHY INTERNAL AUDITING ?

AUDIT STAGES
STAGE-I : ADEQUACY/INTENT
• Is the system defined ?
• Is the system documented as per standard
• Quality Manual versus ISO/IEC 17025 :
2017 requirement

AUDIT STAGES
STAGE-II : COMPLIANCE/IMPLEMENTATION
• Is the documented system Implemented ?
• Is the specified requirement is full fill
• Objective evidence of activities versus the
manual/procedures

AUDIT STAGES
STAGE- III : EFFECTIVENESS
• Is the implemented system effective ?
• Is the desired Output/objective Achieved
• Objective evidence of the effectiveness of the
quality system

REQUIREMENTS OF ISO/IEC 17025
• Need to demonstrate compliance as per clause 8.8.1
The laboratory shall 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 the laboratory activities;
• the requirements of this document;
b) is effectively implemented and maintained.

REQUIREMENTS OF ISO/IEC 17025
8.8.2 The laboratory shall:
a)plan, establish, implement and maintain an audit programme
including the frequency, methods, responsibilities, planning
requirements and reporting, which shall take into consideration
the importance of the laboratory 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.

QUALITY AUDIT TYPES
 1st Party - WE auditing our own system
(Internal)
 2nd Party - WE auditing our subcontractor
(External)- vendor laboratory, suppliers
3rd Party - We being audited by an
Certification Body-laboratory

AUDIT SCHEDULE
Annual
Address all elements of the quality system
- not all departments
Frequency ?
-critical areas

DOCUMENTS USED IN
INTERNAL AUDITING
Checklists
Non conformance & Corrective action
request forms
Audit report forms

DOCUMENTING THE AUDIT PROGRAM
• Internal audit procedure (s)
– selection and training of auditors
– scheduling audits
– responsibilities of auditors
– preparation, conducting and reporting on
audits
– identifying, resolving and following up
corrective actions
– reporting audit results to management

EFFECTIVE AUDITING
Gather evidence about compliance with
quality management system or standard

EFFECTIVE AUDITING
Gather information about:
– organization structures , job description,
various process and sub process of the
department, internal customer or
interrelationship matrix, laboratory
management system, MIS, Departmental
standard operating procedures,

SPECIFIED REQUIREMENTS FOR QUALITY MANAGEMENT
SYSTEM AUDIT:
Can be stated as follows :
 Customer requirements
 Quality System requirements
- Quality manual
- SOPs/Procedures/Work instructions
- ISO/IEC 17025 : 2005 Standard requirement
 Legal requirements-statutory, regulatory or industry body
 Regulation of certification body
AUDIT TERMINOLOGY AND USES

OBJECTIVE EVIDENCE :
Evidence which exists
Uninfluenced by emotion or prejudice
Can be stated
Can be documented
Is about quality
Can be quantitative (countable)
Can be qualitative (measured by degree)
Can be verified

OBJECTIVE EVIDENCE (SOURCE):
• Available from
– Quality Manual and other documents
– Quality records
– Statement of Auditee
• Objective evidence need to be
– Verifiable
– Traceable

AUDIT SAMPLE :
Need to representative from
People
Work station stages/Process
client records
Documents
General Records

• NON CONFORMANCE :
This is a judgmental term, in that we are stating
that the quality system, or part of it, does not
comply with requirements. Action is required!
Noncompliance must be substantiated with
observations or findings, and backed by objective
evidence.

NONCONFORMITY :
• Non fulfillment of a specified requirement
• Condition averse to quality
• Specified requirements:
– Conditions of contract
– ISO/IEC 17025 : 2005 standard
– Quality manual
– Procedures
– Legal requirements
– Specified opinion by auditee

JUDGING SYSTEM EFFECTIVENESS :
Based on conclusions from audit findings

1.Intent: “Have you said what you do?”
Do the defined or documented processes
adequately express your approach?
2.Implementation: “Have you done what you said?”
Do the observed and recorded practices show
compliance with the stated intent?
3.Effectiveness: “Have you done it well?”
Do the results of the process indicate the desired
outcomes have been achieved?

REPEATED NON CONFORMANCE :
This may also be an example that
corrective action is not effective
Effectiveness of system

DEFINITIONS
Auditor
Person with the competence to conduct
and audit
Auditor Qualification
The combination of minimum Educational
qualification, Training, developed audit skill &
personal attributes demonstrating competency

AUDITORS CRITERIA
Knowledge of specified requirement:
 Collecting objective evidence for compliance
or otherwise
 Drawing representative sample
 Asking right questions.

AUDIT EXECUTION
ASKING RIGHT QUESTION :
Do not ask close ended question, ask open ended
question
Close ended question : where your are directly asking
for objective evidences, where you are not getting
scope for verifying the scope
Close ended question : give me your adverse event
record, where is your maintenance record, show me
your purchase register etc

AUDIT EXECUTION
√ Open ended question : where question
creates opportunity for further opening of the
question to verify the system and
methodologies
√ Open ended question : what is your Quality
control policy, how do you transport sample in
the laboratory from site

AUDIT EXECUTION
• ASKING RIGHT QUESTION/OPEN QUESTION
There are 7 Friends
 Who (does it)
 What (is done)
 Where (is it done)
 Why (is it done)
 When (does it get done)
 How (is it done; often is it done)
 Show me

AUDIT EXECUTION
7 Friends in other way
(6 W and 1 H) - Who - What - Where - When –
Which - Why - How

AUDITORS CRITERIA (GENERAL)
 Following Audit Trails
 Recognizing non conformances
 Judging effectiveness
 Audit Frequency

Knowledge of specified requirement :
 Knowledge on ISO/IEC 17025 : 2005
standard,
 Knowledge on local govt. statutory &
regulatory body such as pollution control
board, various Licensing department for
operation of Laboratory

Collecting objective evidence:
 Collect objective evidence against each audit
sample
 Objective evidences may be any quality
system document reference
 Objective evidence may be any client record,
general record, any data, equipment label,
physical observation etc.

Auditor should know the characteristics of
representative sample, so that audit finding lead to
the fact of the system.
Auditor will do the audit by asking open ended
question.
Drawing representative sample :
Asking right questions :

• Following AUDIT TRAIL :
AUDIT TRAIL : A record of transactions in an
information system that provides verification of
the activity of the system. The simplest audit trail
is the transaction itself. If any adverse event is
happened, when it is happened, who reported,
what happened

Recognizing non conformances :
To know the condition of non conformances and reporting non
conformance
Judging effectiveness :
Auditor shall determine and judge the effectiveness of the quality
system

Audit Frequency :
Auditor should determine from the audit findings the
frequency of audit

THE AUDIT LIFE CYCLE
The audit life cycle is often referred to as
P.E.R.C
 Planning
 Execution and Preparation
 Reporting/Recording
 Close out :Follow up/closing of Non
conformance/confirmation of corrective action

1. Audit Plan
2. Develop Checklists
3. Opening Meeting
4. Gather Evidence
5. Record Result
6. Closing Meeting
7. Audit Report

AUDIT PREPARATION
AUDIT PLANNING
&
PREPARATION FOR THE AUDIT

AUDIT PLANNING
CHECKLIST
BENEFITS:
• Keeps audit objectives clear
• Evidence of audit planning
• Maintains audit pace and continuity
• Reduces auditor bias
• Reduces workload during audit
DRAWBACKS :
• Checklists tend to lose value if they are:
• Tick lists
• Questionnaire
• Prepare them as aides-memoir

AUDIT PLANNING
CHECKLIST PREPARATION
1. Convert clauses of the standard into questions
2. Using these questions and the quality manual
• Plan what to look at and why i.e. look for
• Consider sample sizes

AUDIT SKILLS
AUDITING SKILLS :
 It is fact finding technique
 Not fault finding
- ASK
- VERIFY
- OBSERVE

AUDIT SKILL
• Horizontal audit :This examines one element
in a process on more than one item. It is a
detailed check of a particular aspect of the
documentation and implementation of the
quality management system or examination
processes.
• Vertical audit :
– This examines more than one element in a
process, on one item.

AUDIT SAMPLE AT CUSTOMER CELL
Horizontal Sample Vertical sample Location What to check
Reception, contract review,
laboratory information,
sample storage
Space adequacy in
laboratory area
Store Ergonomics , availability
and use
reagent, receiving and
dispatch from store
Chemical Sample ID No Laboratory receiving
chemical reporting section
Collection time, receiving
time, processing, CRM, QC
identification of sample
Mechanical Sample ID No Laboratory receiving ,
Mechanical and reporting
Receiving time, method,
storage, Reference standard
QC

REPORTING
Taking Notes
Recording audit sample examined for Dept. audited
Person contacted –laboratory clauses involved
Area seen - Process stage involved
Documents examined- Records verified
Audit trails identified/followed
Compliance/Non compliance
Reference of non compliance

REPORTING
NOTE TAKING
• Notes could be used as reference for:
- Immediate investigation
- Investigation later
- Use by a colleague
- Subsequent audits
• Notes must therefore be :
- Legible
- Retrievable
- Positive reporting helps to determine depth in Auditing, Basis for
- selecting samples and judging system effectiveness.

REPORTING
• Recording of Non Compliance/Non conformance Report
• Aspect to be considered
• Exact observation of the facts
• Where was it found ?
• What was found ?
• Why it is a non-compliance?
• Who was there ?
• Use local terminology
• Make it retrievable
• Make it helpful : Why?
• Non conformance shall be neatly worded and should not be subjected
to interpretation

 Informed judgments of Assessors (conclusions to
be drawn from all positive and negative findings)
 Major/Minor nonconformities
 System intent
 System implementation
 System effectiveness
 Strength and weakness of departments
 Strength and weakness of quality system
 Any failure internal and external
 Audit results, Trends, corrective and preventive
action
SYSTEM EFFECTIVENESS

Audit checklist Format
Clause
No
Requirements of
ISO/IEC 17025 :
Yes/No N/A Comments
•Checklist always should be tailor made based
laboratory facility and scope
•Find out the application area of each standard
•Find out the scope of horizontal and vertical
audit
•Prepare checklist in detailed, preferable
mentioned reference of objective evidence

HOW TO PREPARE CHECKLIST FOR DEPARTMENT
• 1ST Find out the scope of service of the department
• Find out the application of various clauses of ISO/IEC
17025 : 2005 requirement
• This application of chapter Horizontally and Vertically
• Find out the applicable standard and as well as
objective elements

Audit Checklist
5.2.4 Staff facilities
• Does the laboratory have adequate access to washrooms, supply
of drinking water and facilities for storage of personal protective
equipment and clothing?
5.2.5 Customer sample collection facilities
• Do the Customer sample collection facilities have separate
reception/ waiting and collection areas?
• Are appropriate first aid materials available and maintained for
both Customer and staff at sample collection facilities?

LABORATORY ACCREDITATION PROCESS
PRESENTED BY
DR. S Chakraborty

ASSESSMENT CRITERIA
• ASSESSMENT
STANDARDS
– ISO/IEC 17025:2017
QUALITY SYSTEM
STANDARD
– TECHNICAL CRITERIA
OR TECHNICAL
CRITERIA PRESCRIBED
BY ACCREDITATION
BODY

How to Prepare for Accreditation
• STAGE I
– DEFINITE PLAN OF ACTION FOR OBTAINING
ACCREDITATION
– APPOINT A PERSON AS MR/QUALITY MANAGER
WHO WILL LOOK AFTER QUALITY SYSTEM AND
SHALL COORDINATE ALL ACTIVITIES RELATED TO
ACCREDITATION AND

• STAGE II
– SECURE ALL RELEVANT RECOMMENDED
DOCUMENT FROM ACCREDITATION BODY
WEBSITE AND ISO/IEC 17025:2017 STANDARD ISO
STORE
– PREPARE QUALITY MANUAL AND OTHER
RELEVANT QUALITY SYSTEM DOCUMENT
– IMPLEMENT THE SYSTEM AS DOCUMENTED

• STAGE III
– CONDUCTING
INTERNAL QUALITY
AUDIT AND ASCERTAIN
TECHNICAL
COMPETENCE ON
QUALITY SYSTEM

• STAGE IV
– PREPARE THE ACCREDITATION APPLICATION ENLISTING
THE TESTS WITH RANGES AND ACCURACY (USE FORMAT
151,152 as applicable for NABL For CAMS-D-05/ D-06 04)
– SUBMIT FIVE SETS OF APPLICATION ALONG WITH TWO
COPIES OF THE QUALITY MANUAL FOR NABL (As per 2005
standard)
– For CAMS TWO COPIES APPLICATION ALONG WITH SELF
ASSESSMENT TOOLKIT

ACCREDITATION FLOW CHART
Adequacy audit on lab
documentation
Compliance assessment
Assessment report review by
CAMS
Verification –
Documentary/onsite, if
necessary
Re-assessment – 3 months before expiry date
Continuation of Accreditation intimation
Desktop surveillance assessment – 10 months after date of award
Accreditation awarded for 2 years
Presentation to the accreditation committee for Accreditation.
Additional Inputs/ Clarification
Submit application along with self-assessment toolkit other documents and fees.
Potential applicant obtains information and documents from CAMS website/office

CAMS/D-01
C o n f o r m i t y A c c r e d i t a t i o n M a n a g e m e n t S y s t e m (CAMS)
QUALITY HOUSE
386/1 D. H .Road, Kolkata 700063
Website: www.cams.org
Issue No. 01 Issue Date: 20.03.2018 Amend No: 00 Amend Date: -- Page 2 of 2
Fees Structure
Sl. No Activities Amount (Rs.)
A Processing Fees for Each Field
1. New Application 30,000
2. Application for Extension of scope within the same field/ new field
Extension of scope within the same field 10,000
New field 30,000
3. Assessment Fees ( per Assessment Visit) 10,000
4. Assessor charge
Lead Assessor ( Per Day) 8000
Technical Assessor ( Per Assessor /Per day ) 6000
5. Additional/Special Assessment Fees as per requirement, per assessment visit including
assessor fee.
12000
6. Assessor travel & allied expenditure ( lodging and boarding, local transport )
Actual charges, cost of to & fro journeys ( flights Economy class or by 2nd AC Class train or AC Bus and decent
accommodation to be arranged/borne by CAB. No cash transaction be effected
B Annual Renewal Fees
7. For each Field 15000
C. Renewal Application
As in “A” and “B” above
All payments shall be made by at par cheque / Demand draft / NEFT payable in favour of CAMS at Kolkata. In addition to the
above mentioned fee, GST @ 18.0 % (Existing) or as applicable to be paid along with said charges / fees.
Corporate/ Govt. Laboratory may request to submit the quotation.
No of Auditors deployment and day(s) of assessment will depend on the location and scope of
Accreditation involved.
Conformity Accreditation Management
System
Document Ref:
Title : General Information Brochure

ACCREDITTION PROCESS

ACCREDIATTION BY CAMS
• NO PREASSESSMENT
• ASSESSOR FROM LOCAL REGION
• IF ASESSOR FROM OTHER REGION IF NOT
AVAILABLE WITH MINIMUM TRAVEL COST
• NO ADDITONAL TRAVEL COST IF AUDITOR
CANCEL THE TRAVEL PLAN
• MINIMUM BUDGET FOR ACCREDITATION

Acknowledgement and Registration of Application
• AB Secretariat on receipt of application form, the quality
manual and the fees issues an
• acknowledgement to the CAB. After scrutiny of application for
its completeness in all
• respects, a unique ID number is allocated to the CAB, which is
used for correspondence with
• the CAB. NABL/CAM Secretariat may ask for additional
information/ clarification(s) at this stage, if found necessary.

Lead Assessor appointment and Document Adequacy
• Appointment of Lead Assessor
• AB secretariat appoints a Lead assessor from the list of
empanelled assessors. The lead
• assessor evaluates the adequacy of the quality manual on
behalf of AB and submits the
• report to AB secretariat.
• Adequacy of Quality Manual
• The preliminary review for the adequacy of the application
and quality manual submitted by
• the CAB is carried out by AB Secretariat whereas the detailed
review is carried out by
• Lead Assessor.

Pre Assessment
The pre-assessment by NABL of the CAB is conducted to:
a. evaluate non-conformities (if any) in the implementation of
the quality system.
b. assess the degree of preparedness of the CAB for the
assessment
c. determine the number of assessors required in various fields
based on the scope of accreditation, number of key location
to be visited etc.
The lead assessor submits a pre-assessment report to AB
Secretariat with a copy to the CAB. The CAB takes corrective
actions on the non-conformities raised on the documented
management system and its implementation and submits a
report to AB Secretariat.

ASSESSMENT
• After the CAB has taken corrective actions, AB proposes
constitution of an assessment
• team. The team includes the lead assessor (generally same
who is already appointed for
• pre-assessment), the technical assessor(s)/ expert(s) in order
to cover various fields within the scope of accreditation
sought.
• After the constitution of assessment team is finalized, AB fixes
dates for on-site
• assessment in consultation with the CAB, the lead assessor
and technical assessor(s)/ expert(s).

ASSESSMENT
• The assessment team reviews the CAB ‟s
documented management system and verifies its
• compliance with the requirements ISO/IEC
17025:2005
• specific criteria and other AB policies. The
documented Management system, SOPs, work
instructions, test methods etc. are assessed for their
implementation and effectiveness. The CAB‟s
technical competence to perform specific tasks is
also evaluated.

Scrutiny of Assessment Report
• The assessment report is examined by AB
Secretariat and follow up action as required is
• initiated. CAB has to take necessary corrective
action on non - conformities/ concerns and
• submit a report to AB Secretariat within 60
days. AB monitors the progress of closing of
• non -conformities.

Accreditation Committee
• After satisfactory corrective action by the CAB, the
Accreditation Committee examines the assessment report,
additional information received from the CAB and the
consequent verification, if any.
• In case the Accreditation Committee finds deficiencies in the
assessment report, the AB Secretariat obtains clarification
from the Lead Assessor/ Assessor/ CAB concerned. In case
everything is in order, the Accreditation Committee makes
appropriate recommendations regarding accreditation of the
CAB to the AB.

Grant of Accreditation and Surveillance
Grant of Accreditation
• When the recommendation results in the grant of
accreditation, AB issues an accreditation certificate which has
an unique number and AB hologram / Unique Code,
discipline, date of validity along with the scope of
accreditation.
On-Site Surveillance
• For the newly accredited CABs, in the first cycle of
Accreditation, AB conducts an on-site surveillance within 12
months from the date of accreditation. The first surveillance is
similar to initial assessment and covers entire extension to the
scope, (if any).

Desktop Surveillance
• The desktop surveillance consists of calling of records from
the CAB to ascertain that the CAB continues to maintain the
requirements of ISO/IEC 17025 : 2017 and relevant AB
specific criteria. From the second cycle onwards the CAB is
subjected to desktop surveillance within 12 months of each
re-accreditation.
Reassessment
• The accredited CAB is subjected to re-assessment every 2
years. The CAB has to apply 6 months before the expiry of
accreditation to allow AB to organise assessment of the CAB,
so that the continuity of the accreditation status is
maintained.

Thank you
Dr. S. Chakraborty
Institute of Applied Quality Management, Kolkata
Phone: 9830051583

17025 - 2017 Training Manual for the Laboratory

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