Sandeep Gadhwe

Asst. Professor, Sinhgad

College of Pharmacy,
Pune.

2/27/2022 Sandeep Gadhwe 1

 PART – II , ISO 17025 : 2005

 QCI  Our Scope

 NABL – General  Requirements
 Scope of NABL  Where we are
 Certification Vs  Training needs
Accreditation  Infrastructure needs
 Process of NABL  Documentation
Accreditation Requirements
 Benefit of  Action Plan
Accreditation

PART – III – Company (No a part of

PART – I , NABL this PPT )
2/27/2022 Sandeep Gadhwe 2
 QCI is governed by a Council of 38 members with equal
representations of government, industry and consumers.
 Chairman of QCI is appointed by the Prime Minister's office
on recommendation of the government and industry.
 Council is the apex level body responsible for formulating
the
 strategy,
 general policy,
 constitution and
 monitoring of various components of QCI
with objective to ensure transparent and credible
accreditation system.
 Each Board functions independently with its own
Chairperson appointed by the QCI Chairman and with the
members representing various stakeholders.
2/27/2022 Sandeep Gadhwe 3
 Prime minister

Pravin Mali
2/27/2022 Sandeep Gadhwe 4
  is an autonomous body
 registered under Societies Act in1992
 under the aegis of Department of
Science & Technology, Government of
India.

2/27/2022 Sandeep Gadhwe 5

6
ILAC : International Laboratory Accreditation Cooperation
IAF : International Accreditation Forum
APLAC : Asia Pacific Laboratory Accreditation Cooperation
SADCA : The Southern African Development Community
Cooperation in Accreditation
IAAC : The Inter American AccreditationCooperation
EA : The European cooperation forAccreditation
NATA : National Association of Testing Authorities, Australia
IANZ : International Accreditation New Zealand
HOKLAS : Hong Kong Accreditation Service
NABL : National accreditation board for testing and
calibration laboratories

2/27/2022 Sandeep Gadhwe 7

 NABL ,as an accreditation body, operates its
own system as per ISO/IEC 17011 .
 NABL is signatory to APLAC / ILAC Mutual
Recognition Arrangements (MRA) since 2000
after its first evaluation by APLAC .
 Second & Third evaluation by APLAC in 2004
& 2008 respectively.
 Fourth evaluation Completed in Sep. 2012

2/27/2022 Sandeep Gadhwe 8

 NABL Grants accreditation in almost all areas
of science, engineering and medical testing.
 The international standards followed are :
 ISO 15189:2007 (for Medical Testing) ,
 ISO/IEC 17025:2005 (for Testing, calibration)
 ISO 17043:2010 (for PT providers)

2/27/2022 Sandeep Gadhwe 9

 Testing Laboratories Calibration Laboratories Medical Laboratories

Biological, Electro-Technical Clinical Biochemistry

Chemical, Mechanical Clinical Pathology
Electrical, Radiological Genetics
Electronics, Fluid- Thermal Cytopathology
Flow, Mechanical, Optical Hematology & Immuno-
non-Destructive Fluid-Flow haematology
Testing, Histopathology
Optical& Microbiology& Serology
Photometry, Nuclear Medicine (only
Radiological, in-vitro tests)
Thermal, Forensic
2/27/2022 Sandeep Gadhwe 10
 Certification is a
comprehensive evaluation of  Accreditation is the formal
declaration by a neutral third
a process, system, product, party that the certification
event, or skill typically program is administered in a
measured against some way that meets the relevant
norms or standards of
existing norm or standard. certification program
 Certification does not make  Uses criteria specifically
any statement about the developed to determine
technical competence of the
technical competence of the laboratory.
laboratory.  This is an independent
 Example ISO 9001:2005 evaluation of laboratory’s
Certification technical competence
 Accreditation-Example ISO
17025

CERTIFICATION ACCREDITATION
2/27/2022 Sandeep Gadhwe 11
 Customer
Laboratory
Others

2/27/2022 Sandeep Gadhwe 12

 Customers can search laboratories
 Customers can search and identify the laboratories accredited by
NABL for their specific requirements from the NABL website or
Directory of accredited laboratories.
 Increased confidence in reports
 The labs are required to participate in proficiency testing which is
again demonstration of competence. So, there is increased
confidence in the reports released by the laboratory.
 The customers get services by credential staff.
 Savings in terms of time and money as it reduces or
eliminates the need of re-testing.

2/27/2022 Sandeep Gadhwe 13

 Use of NABL symbol
 The accredited laboratories can issue test reports bearing the
accreditation body’s symbol or endorsement, as an indication of
accreditation.
 International Recognition
 Lab accreditation is highly regarded both nationally and
internationally as an indicator of technical competence
 Satisfaction of the staff
 The staff in an accredited laboratory is satisfied as it provides for
continuous learning ,good working environment, leadership.

2/27/2022 Sandeep Gadhwe 14

 Continuous improvement
 Accreditation to a laboratory stimulates continuous improvement .It
enables the laboratory in demonstrating commitment to quality test
reports.
 Systematic Control of lab work
 Better control of laboratory operations and feedback to laboratories
 Benchmark with best laboratories
 It also provides opportunity to the laboratory to benchmark with the
best
 Rise in business
 There is marked increase in the business of the labs as the
accredited status can be seen by the clients on NABL website.

2/27/2022 Sandeep Gadhwe 15

 It raises community confidence in the services provided by
the laboratory.
 Finally, Accreditation provides an objective system of
empanelment by insurance and other third parties.

2/27/2022 Sandeep Gadhwe 16

 Application for Accreditation
(by Laboratory)

Acknowledgement & Scrutiny of Application Feedback

(by NABL Secretariat) to
)
Laboratory
Adequacy of Quality Manual
(by Lead Assessor)
and
Pre-Assessment of Laboratory
(by Lead Assessor)
Necessary
Final Assessment of Laboratory
Corrective
(by Assessment Team)
Action
Scrutiny of Assessment Report
by
(by NABL Secretariat)
Laboratory
Recommendations for Accreditation
(by Accreditation Committee)

Approval forAccreditation
(( by Chairman NABL)

Issue of Accreditation Certificate

(by NABLSecretariat)
2/27/2022 Sandeep Gadhwe 17
 Testing
 Examination of a product design, product , service , process or
plant and determination of their conformity with specific
requirements or on the basis of professional judgment, general
requirements.
 Calibration
 Calibration is set of operations which under specified conditions,
establish the relationship between values indicated by measuring
system and the corresponding known values of a measured.
 It is essentially comparison with higher standard which is traceable
to national / international standard
 Management System
 Quality, Administrative and technical systems that governs the
operations of a laboratory.
 Accreditation
 Assurance of Competency to perform operations.

2/27/2022 Sandeep Gadhwe 18

 Quality
 Good quality does not necessarily mean high quality.
Instead it means a predicable degree of uniformity and
dependability at low cost with a quality suited to the
market (Deming)
 Degree to which a set of inherent characteristics fulfils
requirements(ISO 9001;2008)
 Quality Assurance
 “part of quality management focused on providing
. confidence that quality requirements will be fulfilled”
(ISO 9001:2008)

2/27/2022 Sandeep Gadhwe 19

 Should be a legal identity
 If Laboratory is part of a larger organization
having activities other than calibration or
testing, responsibilities of key laboratory
personnel shall be defined in order to
identify conflicts of interest.
 Can be operated from Permanent facilities,
at sites, or in associated temporary or mobile
facilities.

2/27/2022 Sandeep Gadhwe 20

 Laboratory shall have
 Managerial and technical personnel with authority and
resources
 Personnel free from pressures and influences.
 Policy & Procedure to Protect customer’s confidential
information including results.
 Policy & Procedure to safeguard competence, impartially,
operational integrity.
 Defined organization structure
 Adequate supervision
 Technical management – overall responsibility of technical
operations.
 Quality manager-responsibility of implementation of
management system.

2/27/2022 Sandeep Gadhwe 21

 Establish and maintain a management system appropriate
to the scope of its activities.
 Document its policies, system, programs procedures and
instructions to the extent necessary to assure the quality
of test / Calibration results.
 A Quality Policy statement and objectives shall be defined.
 Top management roles and responsibilities for meeting
system requirements including commitment to good
professional practices
 Quality System Documentation : Quality manual,
procedures, structure, roles and responsibility of technical
management and Quality manager

2/27/2022 Sandeep Gadhwe 22

 Establish and maintain Procedure to control all the
documents
 (Externally/internally generated).
Controls required are similar
Document approval and issu e
to ISO 9001
Document changes

 Additional requirements for Labs:

 Master list of documents (suggested)
 Document identification shall include
 date of issue and/or revision identification
 page numbering
 the total number of pages or a mark to signify the end of the
document,
 issuing authority.
2/27/2022 Sandeep Gadhwe 23
2/27/2022 Sandeep Gadhwe 24
 Procedures for
 Defining, documenting and understanding the testing requirements
including test methods
 Confirming that the Laboratory has the capability & resource to meet
the requirements
 Selection of Appropriate Test / Calibration method which is capable of
meeting Customer’s requirement.
 Any difference between request or tender and contracts
shall be resolved before start of work
 Records of review, including any significant changes shall
be maintained
 Review should also cover any work that is sub-contracted
 Customer shall be informed of any deviation from contract

2/27/2022 Sandeep Gadhwe 25

 Laboratory can subcontract work because of
 work load increase
 temporary in-capability,
 need for other expertise or
 continuing basis through permanent arrangements
 Work can only be subcontracted to competent laboratory
 Customer has to be informed regarding subcontracting
 The laboratory shall always remain responsible for
subcontractor’s work

2/27/2022 Sandeep Gadhwe 26

 Laboratory has to ensure that the quality of consumables
such as reagents that are used for testing / calibration are
of appropriate quality
 Laboratory can ensure the quality through
 Inspection of the consumables
 Other forms of verification
 Evaluating suppliers of consumables (mandatory for critical
consumables)
 The laboratory needs to maintain records of inspection,
verification, purchase orders describing specifications and
other quality requirements, and records of supplier
evaluations
2/27/2022 Sandeep Gadhwe 27
 Laboratory shall be willing to co-operate with the
customer in clarifying his request and in monitoring
laboratory's performance in relation to work performed.
 Laboratory shall obtain customer feedback, use and
analyze this feedback to improve management system and
customer service.

2/27/2022 Sandeep Gadhwe 28

  Laboratory shall have
Policy & Procedure for
resolution of complaints
received from customers
and other parties.
 Record shall be
maintained of all
complaints, investigations,

Pravin Mali
and corrective actions
taken

2/27/2022 Sandeep Gadhwe 29

 The Laboratory needs to have procedures to deal with
situations when any aspect of its work or test / calibration
results do not confirm to its own procedure or with
customer requirements
 The procedure needs to
 Define who will be responsible to handle the non conforming
work after it is detected
 Provide for an evaluation of significance of non-conforming work
– criticality analysis
 Provide for immediate Corrections to deal with the situation
 Provide for Informing customer if necessary and recall any
issued reports etc
 Evaluate need for Corrective actions if the non conformity is
estimated to recur frequently

2/27/2022 Sandeep Gadhwe 30

  Similar to ISO 9001, the
Laboratory’s Quality System
shall continually improve its
effectiveness through the
application of
 Quality Policy / Objective.
 Audit Results / Management Review
 Analysis of data ,
 corrective / preventive actions

2/27/2022 Sandeep Gadhwe 31

 The Laboratory needs to establish policy and procedure for
implementing corrective action when non-conforming work
has been identified or departure from policies and
procedure in management systems or technical operation
has been observed
 The requirements for taking Corrective and Preventive
actions are similar to ISO 9001. Steps include
 Root cause analysis
 Identification and selection of potential corrective actions for
elimination of problem and to prevent recurrence.
 Documenting and implementing any change resulting from
corrective action
 Monitoring of corrective actions
 Monitoring effectiveness.
 ISO 17025 recommends additional internal audits in case
identification of any non-conformance or departures casts
doubts on laboratories compliance with its own policies
and procedure

2/27/2022 Sandeep Gadhwe 32

 Laboratory shall identify the improvements needed and
the potential sources of non-conformance
 Develop action plans to reduce the likelihood of re
occurrence
 Application of controls to ensure that they are effective.

2/27/2022 Sandeep Gadhwe 33

 Establish and maintain
Procedure to control records
 Controls required are similar
to ISO 9001
 ISO 17025 additionally requires
the following
 Procedures to protect and
back up electronically stored
records and prevent
unauthorized access
 All records to be held
securely and in confidence

2/27/2022 Sandeep Gadhwe 34

  Laboratory must retain the following
technical information:
 Records of original observations /derived
data,
 Calibration records
 Staff records
 Copy of each test / calibration reports
issued
 Uncertainty records
 Records of persons who carried out the test
 All recording to be done immediately
 Errors / mistakes shall not be erased /
replaced, but crossed out and new value
entered by the side

2/27/2022 Sandeep Gadhwe 35

 Document control Records.  Personnel Records.
 Contract Review Records.  Environmental Records.
 Subcontracting Records.  Calibration/ Test observations /
Raw Data/ int. check records.
 Purchasing Records.  Measurement Uncertainty Records.
 Customer feedback and  Computer /Software related
analysis Records. Records.
 Complaint Records.  Equipment Records/Traceability
Records
 Non-conforming work Records.
 Sampling Records
 Improvement records.

Pravin Mali
 Handling - receipt to dispatch-
 Corrective and preventive Records.
actions Record.  Quality Assurance Records.
 Internal Audit Records  Test reports/Calibration
 Management Review Records. Certificates.
 Retention Record for Documents
/Samples

Administrative and Quality System

Records. Technical System Records.
2/27/2022 Sandeep Gadhwe 36
 Internal Audit shall be conducted on predetermined
schedule to verify that its operations comply with
requirements of its Management system and all elements
of ISO 17025 requirements
 Quality manager is responsible for internal audits
 Audit shall be carried out by trained and qualified
personnel independent of activity to be audited.

Pravin Mali
 When audit findings cast doubt on effectiveness of
operations or on the correctness or validity of lab. results,
laboratory shall take timely corrective action.

2/27/2022 Sandeep Gadhwe 37

  Laboratory's Top Management shall periodically conduct a
review of lab’s management system
 Review Inputs are similar to ISO 9001, except the
following additional inputs:
 reports from managerial and supervisory personnel;
 assessments by external bodies
 the results of inter-laboratory comparisons or proficiency tests
 changes in the volume and type of the work

Pravin Mali
 quality control activities, resources and staff training.
 Findings from management reviews shall be recorded and
actions taken in agreed timescale

2/27/2022 Sandeep Gadhwe 38

2/27/2022 Sandeep Gadhwe 39
 The Laboratory must identify factors, which determine the
correctness and reliability of test and calibration results
and factors that contribute to uncertainty of
measurement.
 These factors must be accounted
 in developing test/calibration methods,
 during training and qualification of personnel, and
 in selection and calibration of equipment it uses.

Pravin Mali
2/27/2022 Sandeep Gadhwe 40
 Major Sources of
Uncertainties
I – Instrument ( 5.5)
1 – Instrumental Error
Acceptance Norm.
W – Work piece ( 5.7 , 5.8) 2– Uncertainty of calibration P – Person (5.2) / Procedure
1 – Non-homogeneity of test 3 – Instrumental Resolution. (5.4)
material 4 – Repeatability. ( Type A) 1 – Repeatability ( Type A)
2 – Instrumental Resolution (Skill of operator for positioning
(When instrument is under and measuring pressure etc.)
calibration) SWIPE

Pravin Mali
E – Environmental Factors (5.3)
S – Standard ( 5.5 & 5.6 ) Temperature control limits
1 – Un-compensated Dev. from Temperature variation.
nominal value.
Humidity.
2 – Uncertainty of calibration.
Cleanliness ( TypeA ).
3 – Non-homogeneity ( Type A).
Vibration ( Type A).

2/27/2022 Sandeep Gadhwe 41

 A laboratory can use personnel either employed or under
contract
 However it must ensure that personnel are competent to
perform their respective task
 The laboratory is required to formulate goals with respect
to education, training and skills of personnel.
 The laboratory must have procedures for trainings. The

Pravin Mali
effectiveness of the training actions taken shall be
evaluated.
 Job descriptions are required to be maintained for all
laboratory persons.
 A formal system of authorization of personnel is required
for specific tasks such as performing tests, issue of
reports, giving opinions & interpretations
2/27/2022 Sandeep Gadhwe 42
 The laboratory needs to ensure that facilities and
environmental conditions do not adversely affect tests or
calibrations.
 Particular care is necessary for sampling and testing /
calibration at off-site locations
 Some tests / calibrations require specified environmental
conditions. The laboratory must monitor that these
conditions are met and not proceed if the conditions are

Pravin Mali
not met.
 In some types of tests, effective separation of Test /
calibration area may be required
 Access to areas affecting quality should be controlled.
 The laboratory should install measures for good house
keeping
2/27/2022 Sandeep Gadhwe 43
 The laboratory should normally carry out tests or calibrations
using ‘Standard methods’. These are methods published in
national / International standards, reputable technical
organizations, or in relevant scientific texts or journals, or as
specified by the manufacturer of the equipment
 Methods cover sampling, handling, transport, storage and
preparation of items to be tested and/or calibrated, and, where
appropriate, an estimation of the measurement uncertainty
 Laboratory can also use self developed methods for its own use
 Non-standard method, can be used for performing tests /

Pravin Mali
calibrations for customers but these need to be approved by him
 Laboratory developed methods and non standard methods require
validation
 Validation can be carried out through calibration with reference
materials, inter-lab comparisons, systematic evaluation of
influencing factors

2/27/2022 Sandeep Gadhwe 44

 Laboratory shall be furnished with all items for sampling, measurement,
and test equipment required for correct performance for
test/calibration. .
 Equipment
 shall be capable of achieving the accuracy required
 shall comply with specification relevant to tests / or calibrations concerned.
 shall be calibrated .
 Laboratory must allow use of equipment to authorized persons only
 The operating instrumentation shall be available
 There should be unique identification of each item of equipment.

Pravin Mali
 The Equipment History record must include
 Identification
 Manufacturer’s name, type identification, sr. No. Etc.
 Dates, results and copies of report and certificates of calibration, adjustment,
 Acceptance criteria, and due date of next calibration.
 Maintenance plan , date of maintenance.
 Details of any damage , malfunctioning or repairs

2/27/2022 Sandeep Gadhwe 45

 Other requirements with respect to equipment are:
 A procedure for safe handling / transportation /
storage /use and planned maintenance to prevent
deterioration.
 Removing from service, those equipments, which give,
suspected results or have been mishandled
 Examining the impact of defects and Non-conforming test/

Pravin Mali
calibration on previous results
 Identification of the Calibration status through labeling of
equipment
 Intermediate checks to maintain confidence in the
calibration status.
 Safeguarding from adjustments which would invalidate the
tests and/or calibration results.
2/27/2022 Sandeep Gadhwe 46
 All equipment used for tests / calibrations, having an effect on
validity of results shall be calibrated.
 Laboratory should have established program and procedures for
calibration Program for calibration shall be designed to ensure
that measurements are traceable to the international system of
units (SI) by reference to national measurement standards
 Calibration services from laboratories that can demonstrate
competence, measurement capability and traceability.
 When traceability is not possible, other methods permitted:
 Use of certified reference material provided by competent supplier &

Pravin Mali
specified methods.
 Use of specified methods and/or consensus standards
 Reference standards shall be calibrated, made traceable to SI
units,
 Reference material should be traceable to SI units or certified
reference material
 Intermediate checks for maintaining confidence in calibration
status of reference

2/27/2022 Sandeep Gadhwe 47

 The laboratory should have sampling plans & procedure
for sampling when it is responsible for carrying out
sampling
 The sampling process shall address the factors to be
controlled to ensure the validity of test and calibration
results
 Related data and operations related to sampling that
forms a part of testing and calibration should be
recorded properly.

Pravin Mali
2/27/2022 Sandeep Gadhwe 48
  The laboratory should have a procedure for transportation
/ handling / storage / disposal of test / calibration items
 In case any abnormalities / departures from normal
functioning or normal conditions are observed these shall
be recorded.
 There should be a Procedure for avoiding deterioration,
loss or damage to Test / calibration item while it is in the
custody of the laboratory

Pravin Mali
2/27/2022 Sandeep Gadhwe 49
 The laboratory must have an internal quality control
procedure for monitoring the validity of calibrations
undertaken.
 Results data shall be recorded in such a way that trends
are detectable: where practicable statistical techniques
shall be applied.
 Monitoring methods used:
 Internal quality control using secondary reference materials
 Participation in inter-laboratory comparison or proficiency testing

Pravin Mali
programme
 Replicate testing
 Retesting of returned items
 Correlation of item using different characteristics of the item

2/27/2022 Sandeep Gadhwe 50

 Test report / calibration certificate should be reporting the
results accurately and clearly.
 The report must contain
 Title of the report
 Name and address of laboratory,
 Report I.D. on each page
 Name and address of client
 Identification of method used,

Pravin Mali
 Unique item identification, description and condition
 Dates of item receipt, test or calibration conducted
 Sampling plan and procedures used,
 The test or calibration results
 Identification of person(s) authorizing the test report or calibration
certificate
 Details of environmental conditions during test / calibration
 Uncertainty in case of calibration reports
2/27/2022 Sandeep Gadhwe 51
 Opinions and interpretations can be given but shall
document the basis up on which the opinions and
interpretations have made.
 Results of test performed by subcontractor shall be clearly
identified.
 Electronic transmission of results can be done but
requirements of this standard shall be met

Pravin Mali
 The format for report and certificate shall be designed to
accommodate each type of test and calibration
 Amendment to the test and calibration certificate
 Can be issued as a supplement to test / calibration report
 Complete issue shall be uniquely identified and shall contain reference
to the original that it replaces.

2/27/2022 Sandeep Gadhwe 52

 Implementation, maintenance of Management system
complying to ISO/IEC 17025.
 Maintenance of Impartiality, integrity, confidentiality and
customer’s proprietary rights in lab operations.
 Ensure control for all documents internally generated as
well as externally generated.

Pravin Mali
 Review of customer requests, tenders & Contracts.

 Evaluation, selection of Suppliers.

 Effective resolution of Customer complaints.

 Organizing Internal audit as per scheduled plan.

 Initiating corrective actions against every non-compliance

identified in external and internal audit and maintenance
of all management systemSandeep
2/27/2022 records.
Gadhwe 53
 Selection, documentation and approval of test/ calibration
methods
 Periodic Updation of test results / calibration activities ,
as and when changed.
 Ensure Traceability of all the lab equipment and reference
standards and their fitness for subsequent use.
 Management and training of staff

Pravin Mali
 Evaluate and ensure staff competency
 Design and implementation of the QC program
 Stopping work when QC criteria are violated
 Attention to matters relating to impartiality and
confidentiality.
 Ensure technical validity of the results
 Liaison with the quality manager in matters of common
concern, affecting testing or calibration.
2/27/2022 Sandeep Gadhwe 54
 The testing laboratory is obligated to
 fulfil the requirements of ISO/IEC 17025 and to have
approved authorized signatory who bears the full
responsibility for proper execution of the test or
calibration and correctness of the data in the test report/

Pravin Mali
Calibration Certificates .
 Lab has to have at least one approved authorized signatory
for each specific discipline.
 Authorized signatories should Carry out regular measures
to assure the quality of test results are maintained.

2/27/2022 Sandeep Gadhwe 55

 The authorized signatory should be qualified, experienced
in the relevant discipline as per the specific criteria
demonstrating skill for the Job assigned i.e. testing or
calibration. E.g.
 NABL 102 - Specific Criteria for Biological Testing

Pravin Mali
Laboratories
 NABL 103-Specific Guidelines for Chemical Testing
Laboratories
 NABL 114-Guidelines for Food Testing Laboratories
 documents given by NABL and must posses the

2/27/2022 Sandeep Gadhwe 56

2/27/2022 Sandeep Gadhwe 57
2/27/2022 Sandeep Gadhwe 58