Quality Management System in Forensic Laboratories

Quality Management
In context of Forensic and
analytical Laboratories
Tapeshwar Bhardwaj

Quality is
everywhere
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Quality is:
 The degree to which an item or process meets or
exceeds the customers requirements and
expectations
 The degree to which a set of inherent (existing)
characteristics fulfils requirements
 A satisfied customer
 Act as agreed
 Flexibility
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Good Quality System
Forensic Laboratory
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The Laboratory Process
Laboratory
Report
Sample
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ISO/IEC 17025:2005 scope
 General requirements for the
competence of testing and calibration
laboratories
 Accreditation: formal confirmation:
1 - working conform ISO 17025
2 – competence of laboratory
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ISO 17025 structure
1. Management requirements ->
working processes
2. Technical requirements -> competence
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Accreditation versus certification
Accreditation (ISO 17025)
1. Confirmity
2. Competence
Certification (i.e.ISO 9001)
1. Confirmity
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Focus ISO 9001
 Satisfied customer
 Continous improvement
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ISO17025:2005 Vs. ISO 9001
 ISO 17025: 2005 includes the principles of
ISO 9001 but follows not exactly all the
requirements of ISO 9001
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PDCA Cycle
DO
PLAN
ACT
CHECK
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PDCA Cycle
 PLAN: Design or revise business process
components to improve results
 DO: Implement the plan and measure its
performance
 CHECK: Assess the measurements and report
the results to decision makers
 ACT: Decide on changes needed to improve the
process or action, adaptation and correction
phase based on findings and decide to make
changes to a process, policy etc.
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Documentation of activities
 Act as described
 Describe the way you act
 Documentate procedures
 Follow the procedures and record relevant*
information and non-conformities
relevant* for the management and/or technical
requirements
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Q-Policy
statement
Q-manual
Instructions and forms
Procedures ( SOPS)
Documentation system
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Why Accreditation?
 The concept of Laboratory Accreditation was developed to provide a
means for third-party certification.
 Laboratory Accreditation provides formal recognition of competent
laboratories, thus,
 Providing a Laboratory Accreditation enhances customer confidence in
accepting testing / calibration reports issued.
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Benefits of Accreditation
 Formal recognition of competence of a laboratory by an
Accreditation body in accordance with
 Potential increase in business due to enhanced customer
confidence and satisfaction.
 Savings in terms of time and money due to reduction or
elimination of the need for re-testing.
 Better control of laboratory operations and feedback to
laboratories as to whether they have conformity to other labs.
 Increase of confidence in Testing / Calibration data and
personnel performing work.
 Customers can search and identify the laboratories accredited
by NABL for their specific requirements.
 Users of accredited laboratories will enjoy greater access for
their products, in both domestic and International avenues.
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Context: Forensic Laboratories
 Forensic testing is performed for a legal
purpose and may affect:
 Criminal trial (freedom/jail or death of
accused)
 Civil trial (denial of compensation/money)
 Loss of a job (if drug use proven)
 Loss of career (e.g. sports/athlete)
 Custody of children (if drug abuse proven)
 Testing must be ACCURATE!
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Laboratories in India
 Central (CFSLs, GEQDs, CFPB etc.)
 State (SFSLs, SFPB, SCC, )
 Police / Crime lab; Medical Examiner
 Regional (RFSLs)
 Police / Crime lab; Medical Examiner
 City (Mobile Forensic Labs)
 Private (Mainly specialised in QDs,
Insurance claims, Arson investigations and
Fingerprints and DNA Comparison etc.
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Courts in India: Adversarial
 In India, the court system is “adversarial”
 Prosecution and defense lawyers may each hire their
own forensic experts or laboratory of choice who may
give different opinions.
 Prosecution experts may perform testing and give an
interpretation (or opinion)
 Usually defense experts offer only an opinion and do
not have access to original evidences.
 The adversarial system should not affect the
science, but allows more than one scientific
opinion to be expressed in court.
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How does it makes a
difference?
 Prosecution laboratory results are more likely to
be challenged by defense
 Prosecution experts may be required to provide all
details of their analysis (chromatograms, methods,
chain of custody etc.)
 Many (good) forensic experts are available to review
analytical data for the defense and provide a second
opinion.
 Prosecution experts are more likely to have to defend
their analytical work in courts.
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Nobody is Perfect
 Everybody makes mistakes!!
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Quality Assurance Program
 Every forensic experts in a laboratory will
make a mistake. The problem is making sure
that the mistake is detected before a result is
reported.
 A good quality assurance program will help to
minimize errors and detect errors when they
occur.
 “Quality Assurance” covers every aspect of
laboratory work that can affect the quality of
the results reported.
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Example of a Preventable Error
 A person died in a psychiatric hospital
 Her medications were dispensed by hospital staff
 The pathologist determined death due to natural
causes, but toxicology testing indicated an
imipramine overdose!
 A public inquiry was held and data of the toxicologist
was reviewed – finding calculation error of 10-fold
 Public disclosure of the error was very embarrassing
for the toxicologist
 The error could have been discovered before public
embarrassment if the data had been properly peer
reviewed (i.e. by a colleague in the same laboratory).
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QA Includes
 Education and training
 Standard Operating Procedures (SOPs)
 Validation of methods; Criteria for evaluation of
calibrations, controls and case data
 Maintenance of equipment
 Review and reporting of results
 Verifying results of a colleague
 Someone else should check your transcriptions and calculations
 Proficiency testing
 Laboratory accreditation
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Organisations Involved in
Setting Guidelines
 ISO (International Organisation for
Standardization)
 IEC (International Electrotechnical
Commission)
 ILAQ (International Laboratory Accreditation
Cooperation)
 APLAC (Asia Pacific Laboratory Accreditation
Cooperation)
 NABL (National Accreditation Board for
Testing and Calibration Laboratories)
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ILAC MLA (Mutual Recognition Arrangement)
Peer Evaluation Process (ISO/IEC 17040)
Accreditation Body in country A
(ISO/IEC 17011)
Accreditation Body in country B
(ISO/IEC 17011)
Recognition
Laboratory in country A
(ISO/IEC 17025)
Test/Calibration Results
Recognition of
Equivalence
Laboratory in Country B
(ISO/IEC 17025)
Test /Calibration Results
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Recognition and Trade
It is generally agreed by the WTO that the
biggest obstacle to trade is Non Tariff
Technical Barriers.
It is in the interest of all to overcome these
and to develop a means of recognizing the
technical infrastructure and output from one
country in another country as being
equivalent.
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ISO
 The International Organization for
Standardization is an international standard-
setting body composed of representatives
from various national standards
organizations.
 Founded on 23 February 1947, the
organization promotes worldwide proprietary,
industrial and commercial standards. It is
headquartered in Geneva, Switzerland, and
works in 162 countries.
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Structure : ISO
 ISO is a voluntary organization whose members are
recognized authorities on standards, each one representing
one country.
 Members meet annually at a General Assembly to discuss
ISO's strategic objectives. The organization is coordinated by
a Central Secretariat based in Geneva.
 A Council with a rotating membership of 20 member bodies
provides guidance and governance, including setting the
Central Secretariat's annual budget.
 The Technical Management Board is responsible for over 250
technical committees, who develop the ISO standards.
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Membership
 ISO has 163 national members.
 ISO has three types of membership categories:
 Member bodies are national bodies considered the most
representative standards body in each country. These are the only
members of ISO that have voting rights.
 Correspondent members are countries that do not have their own
standards organization. These members are informed about ISO's
work, but do not participate in standards promulgation.
 Subscriber members are countries with small economies. They
pay reduced membership fees, but can follow the development of
standards.
 Participating members are called "P" members, as opposed to
observing members, who are called "O" members.
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ILAC
 The International Laboratory Accreditation Cooperation or
ILAC started as a conference in 1977 with the aim of
developing international cooperation for facilitating trade by
promotion of the acceptance of accredited test and calibration
results.
 In 1996, ILAC became a formal cooperation with a charter to
establish a network of mutual recognition agreements among
accreditation bodies that would fulfil this aim.
 The ultimate aim of the ILAC is increased use and acceptance
by industry as well as government of the results from
accredited laboratories, including results from laboratories in
other countries.
 In this way, the free-trade goal of a 'product tested once and
accepted everywhere' can be realised.
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Former APLAC: Now APAC
 The Asia Pacific Accreditation Cooperation
(APAC) was established on 1 January
2019 by the amalgamation of two former
regional accreditation cooperations – the
Asia Pacific Laboratory Accreditation
Cooperation (APLAC) and the Pacific
Accreditation Cooperation (PAC).
Tapeshwar Bhardwaj

History: APLAC
 APLAC was initiated in 1992 as a forum for laboratory accreditation
bodies in the Asia Pacific region. The APLAC Memorandum of
Understanding (MOU), formally establishing APLAC, was signed in
April 1995 by the founding members.
 The inaugural signing of the APLAC Mutual Recognition
Arrangement (MRA) occurred on 19 November 1997, with 7
accreditation bodies signing the MRA for testing and calibration.
 The MRA was extended in November 2003 to include inspection,
and in April 2007 to refer specifically to ISO 15189 (the international
standard applied to medical laboratories) that had previously been
included under the “testing” scope of the MRA.
 The inaugural signing of the extended APLAC MRA to include
accreditation of reference material producers (RMPs) took place in
December 2007. The inaugural signing of the extended APLAC
MRA to include accreditation of proficiency testing providers (PTPs)
took place in June 2014.
 At the end of 2018, APLAC had 38 accreditation bodies that were
MRA signatories.
Tapeshwar Bhardwaj

History: PAC
 PAC was initiated in 1995, and approved the initial version of
its Multilateral Accreditation Arrangement (MLA) in 1997.
 In 1998 the first 5 accreditation bodies signed the MLA for the
scope of accredited quality management systems (QMS)
certification.
 Over the following years other scopes where added such as
other types of management system certification (e.g.
environmental management systems, food safety
management systems), product certification, person
certification and greenhouse gas validation and verification.
 At the end of 2018 PAC had 26 accreditation bodies that were
MLA signatories.
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Role of APAC
 APAC ‘s primary role is to manage and expand a mutual recognition
arrangement (MRA) among accreditation bodies in the Asia Pacific region.
 The MRA facilitates the acceptance of conformity assessment results (e.g.
test reports, test certificates, inspection reports, and certification) across the
region and with other regions around the world.
 Conformity assessment results that are produced by conformity assessment
bodies (CABs) that have been accredited by one APAC MRA signatory are
accepted by all the other APAC MRA signatories.
 This mutual recognition and acceptance of conformity assessment results
reduces the need to undertake duplicate testing, inspection or certification,
thus saving time and money, increasing economic efficiency and facilitating
international trade.
 APAC’s members include accreditation bodies, accreditation focal points
and other organisations that have an interest in accredited conformity
assessment results.
 APAC is recognized by the Asia Pacific Economic Cooperation (APEC) as
one of four APEC Specialist Regional Bodies (SRBs) that support the work
of the APEC Sub-Committee on Standards and Conformance.Tapeshwar Bhardwaj

ASCLD
 The American Society of Crime Laboratory Directors
(ASCLD) is a nonprofit professional society of crime
laboratory directors and forensic science managers
dedicated to providing excellence in forensic science
through leadership and innovation.
 The purpose of the organization is:
 to foster professional interests,
 assist the development of laboratory management
principles and techniques;
 acquire, preserve and disseminate forensic based
information;
 maintain and improve communications among crime
laboratory directors;
 and to promote, encourage and maintain the highest
standards of practice in the field.
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BIS : Purpose
 BIS is the National Standard Body of India
established under the BIS Act 2016 for the
harmonious development of the activities of
 Standardization,
 Marking
 Quality certification of goods.
 BIS has been providing traceability and tangibility
benefits to the national economy in a number of
ways:
 providing safe reliable quality goods;
 minimizing health hazards to consumers;
 promoting exports and imports substitute;
 control over proliferation of varieties etc.
• More Info @ Click Here while holding the CTRL Key
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BIS Hallmarking
 The BIS hallmark is a hallmarking system for gold as well as
silver jewellery sold in India certifying to the purity of the
metal. It certifies that the piece of jewellery conforms to a set
of standards laid by the Bureau of Indian Standards, the
national standards organization of India.
 BIS hallmark for gold jewellery consists of several
components:
 A three digit no, indicating the purity of the gold in part-per-
thousand-format viz; 958, 916, 875, 833,792,750,708,667,
585, 375.
Thus a BIS 916 hallmark would certify to a purity of 916 per
1000, that is 91.6%, translating to a 22 carat purity of gold.
 Logo of the assaying center.
 A code denoting the year of hallmarking.
 Logo/code of the jeweller.
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NABL
 National Accreditation Board for Testing
and Calibration Laboratories (NABL) is
 An autonomous body
 Under the aegis of Department of Science &
Technology, Government of India.
 NABL is signatory body to APLAC MRA &
ILAC
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Process of Accreditation
1. Contact NABL Secretariat with a request for
procuring relevant NABL documents
2. Get fully acquainted with all relevant
documents and understand the assessment
Procedure and methodology of making an
application.
3. Train a person on Quality Management
System and Internal Audit (4-day residential
training courses conducted by NABL.
Contact NABL Secretariat for details).
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Process contd.
4. Prepare QUALITY MANUAL as per ISO/IEC
15189:2012 standards.
5. Prepare Standard Operating Procedure for
each investigation carried out in the
laboratory.
6. Ensure effective environmental conditions
(température, humidity, storage placement,
etc.).
7. Ensure calibration of instruments /
equipment.
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Process contd.
8. Impart training on the key elements of documentation, such
as:
 document format,
 authorization of document,
 issue and withdrawal procedures,
 document review and
 changes, etc.
Each document should have ID No., name of controlling authority,
period of retention, etc.
9. Remember Quality Manual is a policy document, which has to
be supplemented by a set of other next level documents.
Therefore ensure that these documents are well prepared.
10. Ensure proper implementation of all aspects that have been
documented in the Quality Manual and other documents
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Process contd.
11. Incorporate Internal Quality Control (IQC)
practice while samples are analysed.
12. Document IQC data as well as uncertainty of
measurements. Maintain Levy Jennings
charts.
13. Participate in External Quality Assessment
Schemes (EQAS).
14. If this is not available for certain analytes,
participate in inter-laboratory comparison
through exchange of samples with NABL
accredited laboratories.
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Process contd.
15. Document corrective actions on IQC /
EQA outliers.
16. Conduct Internal Audit and Management
Review.
17. Apply to NABL along with appropriate
fee.
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NABL operations
 Accreditation program in accordance with
requirements of ISO/IEC 17011: 2004.
 Testing and Calibration accredited by NABL,
complies with ISO/IEC 17025: 2005.
 Medical Laboratories accredited by NABL,
complies with ISO 15189: 20012.
 Proficiency Testing Provider accredited by
NABL, complies with ISO/IEC 17043: 2010.
 Reference Material Producers (RMP)
accreditation as per ISO Guide 34: 2009.
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Global Scenario
 Results issued by NABL Accredited Lab
are acceptable amongst 87 economies
(signatories to ILAC MRA).
 NABL Accredited Laboratories are
members of Global family of more than
40,000 accredited laboratories.
 NABL has emerged as the second largest
laboratory Accreditation Body (after
China).
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MRA Signatory Status
 Signatory to Mutual Recognition
Arrangement (MRA) since the year 2000: •
 Asia Pacific Laboratory Accreditation
Cooperation (APLAC)
 International Laboratory Accreditation
Cooperation (ILAC)
 Re–evaluated in 2004, 2008 and 2012,
2016 signatory status was re–affirmed.
 Next re-evaluation of NABL is due in 2020
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Acceptance of Results (issued by NABL
Accredited Labs) by Govt. & Regulators
 CGHS and Government Hospital
Laboratories
 Bureau of Energy Efficiency (BEE)
 Food Safety & Standards Authority of India
(FSSAI)
 State Electricity Boards (SEB’s)
 Agricultural & Processed Food Products
Export Dev. Authority
 Telecom Engineering Centre (TEC)
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 Central Pollution Control Boards (CPCB)
 Export Inspection Agency (EIA)
 Tea Board, Coffee Board, Spices Board etc.
 Judiciary relies on Accredited Forensic Labs
 Department of Weights & Measures (Legal
Metrology)
 Ministry of Drinking Water and Sanitation (MDWS)
 Insurance companies rely on reports of Medical
Labs
And many more………………
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Everything you need to know
about NABL
 Introduction and Objective of NABL: National Accreditation Board for Testing and
Calibration Laboratories (NABL) is an autonomous body under the aegis of Department of
Science & Technology, Government of India, and is registered under the Societies Act.
 NABL has been established with the objective to provide Government, Industry and
Society in general with a scheme for third-party assessment of the quality and technical
competence of testing and calibration laboratories.
 Government of India has authorized NABL as the sole accreditation body for Testing and
Calibration laboratories.
 In order to achieve this objective, NABL provides laboratory accreditation services to
laboratories that are performing tests / calibrations in accordance with NABL criteria
based on internationally accepted standard for laboratory accreditation ISO/IEC 17025.
 These services are offered in a non-discriminatory manner and are accessible to all
testing and calibration laboratories in India and abroad, regardless of their ownership,
legal status, size and degree of independence.
 NABL has established its Accreditation System in accordance with ISO/IEC 17011:2004,
which is followed internationally. NABL also compiles to the requirement of APAC MR001
for the fulfillment of APAC MRA and ILAC Arrangements. Location of NABL Office:
 NABL Secretariat is functioning from its office situated at 3rd Floor, NISCAIR, 14,
Satsang Vihar Marg, New Mehrauli Road – New Delhi 110067.
Tapeshwar Bhardwaj

Concept of Laboratory
Accreditation
 The concept of Laboratory Accreditation was developed to
provide a means for third-party certification of the competence
of laboratories to perform specific type(s) of testing and
calibration.
 Laboratory Accreditation provides formal recognition of
competent laboratories, thus providing a ready means for
customers to find reliable testing and calibration services in
order to meet their demands.
 Laboratory Accreditation enhances customer confidence in
accepting testing / calibration reports issued by accredited
laboratories.
 The globalization of Indian economy and the liberalization
policies initiated by the Government in reducing trade barriers
and providing greater thrust to exports makes it imperative for
Accredited Laboratories to be at international level of
competence.
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Types of Laboratory can seek
Accreditation
The laboratories should be legally identifiable &
appropriately registered. They can be a part of a big
organization or an
 Independent entity.
 NABL can provide accreditation to:
 Laboratories undertaking any sort of testing or
calibration in the specified fields.
 Private or government laboratories.
 Small operations to large multi-field laboratories.
 Site facilities, temporary field operations and
mobile laboratories.
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Fields of Testing and Calibration
Covered by NABL
Testing Laboratories Calibration Laboratories Medical Laboratories
• Biological
• Chemical
• Electrical
• Electronics
• Fluid Flow
• Mechanical
• Non-destructive
• Photometry
• Radiological
• Thermal
• Electro-Technical
• Mechanical
• Fluid Flow
• Thermal and Optical
• Radiological
• Clinical Biochemistry
• Clinical Pathology
• Hematology and
Immunohematology
• Microbiology
• Serology
• Histopathology
• Cytopathology
• Genetics
• Nuclear Medicine (in-
vitro only)
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Preparations Required by
Laboratory for Accreditation
1. Laboratory management should first decide about getting accreditation for its
laboratory from NABL.
2. It is important for a laboratory to make a definite plan of action for obtaining
accreditation and nominate a responsible person to coordinate all activities related
to seeking accreditation. The person nominated should be familiar with laboratory's
existing Quality System. S/he should be formally designated as the Quality
Manager.
3. Procure all relevant NABL documents from NABL Secretariat and get fully
acquainted with each of these.
4. Laboratory needs to ascertain the status of its existing Quality System and
Technical Competence with regards to requirements for NABL Accreditation. Is the
system documented and effective or does it need modification. Does it need to
build the Quality System of the laboratory from scratch?
5. It must be remembered that Quality Manual is a policy document, which has to be
supplemented by a set of other documents like Procedural Manuals, Work
Instructions etc. to align the Quality System in accordance with NABL Criteria. The
laboratory must ensure that the procedures described in the Quality Manual and
other documents are being implemented. For preparing Quality Manual or verifying
its contents, the laboratory may take help of “Guide for Preparing Quality Manual"
(NABL 160). The laboratory may also get its personnel trained in NABL's training
programme on Laboratory Quality System, Management and Internal Audit.
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6. Relevant requirements for NABL accreditation should be discussed
amongst concerned staff of the laboratory. This will enable them to
understand their weaknesses and strengths.
7. Quality Manager must conduct an Internal Audit and take corrective
actions before applying for accreditation.
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Process of Accreditation
Stage I (Filling of Application)
 Prepare your laboratory's application for NABL accreditation, giving all desired information
and enlisting the test(s) / calibration(s) along with range and measurement uncertainty for
which the laboratory has the competence to perform. Laboratory can apply either for all or
part of their testing / calibration facilities. Formats NABL 151, NABL 152 & NABL 153 are to
be used by Testing, Calibration and Medical Laboratories respectively for applying to NABL
for accreditation.
 Laboratory has to take special care in filling the scope of accreditation for which the
laboratory wishes to apply. In case, the laboratory finds any clause (in part or full) not
applicable to the laboratory, it shall furnish the reasons.
 Laboratories are required to submit five sets of duly filled in application forms for each field
of testing / calibration along with five sets of Quality Manual and Application Fees.
 NABL Secretariat on receipt of application will issue acknowledgement to the laboratory.
After scrutiny of application for it being complete in all respects, a unique Customer
Registration Number will be allocated to laboratory for further processing of application.
 NABL Secretariat shall then nominate a Lead Assessor for giving Adequacy Report on the
Quality Manual / Application submitted by the laboratory. A copy of Adequacy Report by
Lead Assessor will be provided to Laboratory for taking necessary corrective action, if any.
The laboratory shall submit Corrective Action Report.
After satisfactory corrective action by the laboratory, a Pre-Assessment audit of the laboratory
will be organised by NABL. Laboratories must ensure their preparedness by carrying out its
internal audit before Pre-Assessment.
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Stage II (Pre-Assessment audit)
 NABL Secretariat shall organise the Pre-Assessment audit, which
shall normally be carried by Lead Assessor at the laboratory sites.
 The pre-assessment helps the laboratory to be better prepared for
the Final Assessment. It also helps the Lead Assessor to assess the
preparedness of the laboratory to undergo Final Assessment apart
from Technical Assessor(s) and Total Assessment Man-days
required vis-à-vis the scope of accreditation as per application
submitted by the laboratory.
 A copy of Pre-Assessment Report will be provided to Laboratory for
taking necessary corrective action on the concerns raised during
audit, if any.
 The laboratory shall submit Corrective Action Report to NABL
Secretariat.
 After laboratory confirms the completion of corrective actions, Final
Assessment of the laboratory shall be organized by NABL.
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Stage III (Final Assessment)
 NABL Secretariat shall organize the Final Assessment at the
laboratory site(s) for its compliance to NABL Criteria and for that
purpose appoint an assessment team.
 The Assessment Team shall comprise of a Lead Assessor and
other Technical Assessor(s) in the relevant fields depending
upon the scope to be assessed.
 Assessors shall raise the Non-Conformance(s), if any, and
provide it to the laboratory in prescribed format so that it gets
the opportunity to close as many Non-Conformance(s) as they
can before closing meeting of the Assessment.
 The Lead Assessor will provide a copy of consolidated report of
the assessment to the laboratory and send the original copy to
NABL Secretariat.
Laboratory shall take necessary corrective action on the remaining
Non-Conformance(s) / other concerns and shall submit a report to
NABL within a maximum period of 2 months.
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Stage IV (Corrective
Reassessment)
 After satisfactory corrective action by the laboratory, the Accreditation
Committee examines the findings of the Assessment Team and
recommends additional corrective action, if any, by the laboratory.
 Accreditation Committee determines whether the recommendations in the
assessment report is consistent with NABL requirements as well as
commensurate with the claims made by the laboratory in its application.
 Laboratory shall have to take corrective action on any concerns raised by
the Accreditation Committee.
 Accreditation Committee shall make the appropriate recommendations
regarding accreditation of a laboratory to NABL Secretariat.
 Laboratories are free to appeal against the findings of assessment or
decision on accreditation by writing to the Director, NABL.
 Whenever possible NABL will depute its own technical personnel to be
present at the time of assessment as Coordinator and NABL Observer.
Sometimes, NABL may at its own cost depute a newly trained Technical
Assessor as "Observer" subject to convenience of the laboratory to be
accessed.
Tapeshwar Bhardwaj

Stage V (Granting of Accreditation)
 Accreditation to a laboratory shall be valid
for a period of 3 years and NABL shall
conduct periodical Surveillance of the
laboratory at intervals of one year.
 Laboratory shall apply for Renewal of
accreditation to it at least 6 months before
the expiry of the validity of accreditation.
Tapeshwar Bhardwaj

NABL Certification Differ from
ISO 9000 Certification
 ISO 9000 Certification is on Quality System Management only whereas the NABL
Accreditation provides formal recognition of technical competence of the laboratories,
thus providing a ready means for customers to find reliable testing and calibration
services in order to meet their demands as well as the Quality system. Accreditation is a
higher level activity than system certification.
 Laboratories can be checked and certified for their compliance to international
management system standards such as ISO 9000. This involves the auditing of an
organization’s quality management system. Although this will give you confidence of the
laboratory’s quality system, it tells you nothing about its technical competence or its
ability to provide reliable and accurate test data that will be accepted by your customers
and trading partners.
 Proper technical evaluation requires the use of technical experts who can assess the
laboratory against internationally accepted criteria. These criteria are embraced globally
in a document called ISO/IEC 17025. Accreditation bodies may also apply additional
technical requirements for evaluating a laboratory, as per requirements of different
technical fields.
 Laboratory accreditation against the standard ISO/IEC 17025 does, however also covers
the quality management elements of ISO 9000. So laboratory accreditation, which is
based on ISO/IEC 17025 is a measure of both technical competence and quality
management and is the most appropriate process rather than quality ISO-9000
certification.
Tapeshwar Bhardwaj

Proficiency Testing Programmes
Organized by NABL
 All NABL accredited testing and calibration laboratories are required to participate in
Proficiency Testing Programmes conducted by NABL or the nodal organizations
appointed by NABL. Accredited and applicant laboratories are required to approach
NABL Co-coordinator for Proficiency Testing programs or the nodal laboratories
appointed by NABL whenever a PT programme for a specific testing / calibration is
organized by NABL. For calibration laboratories, NPL, Delhi is the main nodal laboratory.
 Laboratories are also expected to participate (as far as available and practicable) in
international Inter- Laboratory Comparison / Proficiency Programmes conducted by
APAC, EA or equivalent organizations. NABL keeps the accredited laboratories informed
about all such international programmes through NABL newsletter / APAC newsletter.
 It is essential for all its accredited laboratories to participate in International / Regional
Proficiency Testing Programmes including APAC in a manner so that all major areas of
scope of accreditation are covered in a cycle of 4 years. This of course applies to those
special areas where Inter-Laboratory Proficiency Testing Programmes are not available.
 All applicant laboratories are required to successfully participate in at least one Inter -
Laboratory Proficiency Testing in accordance with ISO/IEC Guide-43. For this purpose all
alternative techniques covered in ISO/IEC Guide-43 will be acceptable.
Tapeshwar Bhardwaj

Criteria for using NABL Symbol
 All NABL accredited laboratories are expected to use NABL symbol on their
letterhead, test / calibration reports and any other relevant documents. NABL
symbol shall be used for the purpose of identifying correctly and unambiguously the
test / calibration services accredited by NABL.
 While using the symbol it shall be ensured by the laboratory that design and its
manifestations are not distorted, it can be reproduced in any single color (preferably
black) and any size.
 It shall be responsibility of the accredited laboratory that the use of symbol does not
misrepresent the scope of accredited testing / calibration services. In case where
the accreditation sought and granted do not cover all the activities of the
laboratory's services care should be exercised to restrict the use of symbol only to
those accredited activities. The letterheads and publicity materials, brochures, test /
calibration reports of the accredited laboratory bearing the NABL symbol shall cover
only the test results under accredited category. For non-accredited category the
laboratory shall use a letterhead without NABL symbol or specially identify those
tests/ measurements which are not covered by accreditation.
 Accredited laboratories shall not authorize the use of symbol for tests / calibration
services sub-contracted to other laboratories, which are not accredited by NABL.
 In case of complaints in this regard from users and other laboratories, NABL shall
get the same examined by a committee and take appropriate action.
Tapeshwar Bhardwaj

ISO/IEC 17025
ISO/IEC 17025 is the basis for competency of
testing and calibration laboratories.
Accreditation to ISO/IEC 17025 requires that:
 The laboratory has a quality system meeting
requirements of ISO 9001.
 The lab facility has adequate equipment to
perform its testing or calibration tasks.
 The lab facility has adequate laboratory
personnel with the competence to perform the
calibration and testing.
 In addition most accreditation schemes in the
U.S. require proficiency testing amongst the
laboratories.
Tapeshwar Bhardwaj

ISO/IEC 17025
1. These are the base requirements necessary for a
laboratory to be able to implement and operate to
demonstrate it is competence
 They are not “super” requirements
 Cost (of compliance and/or Accreditation) is cost of achieving consistently
good results
 Cost of not having consistently good results could be much higher
2. 17025 focus is on:
 Management requirements and Technical requirements
 Annex A Cross reference to ISO 9001
 Annex B Guidelines for establishing application for sector fields
Tapeshwar Bhardwaj

MANGEMENT REQUIREMENTS
Clause 4 (ISO/IEC 17025:2005)
 Organization and management
 Quality management system
 Document control
 Review of contracts
 Examination by referral laboratories
 External services and supplies
 Advisory services
 Resolution of complaints
 Identification and control of nonconformities
 Corrective actions
 Preventive actions
 Continual improvement
 Quality and technical records
 Internal audits
 Management review
Tapeshwar Bhardwaj

Management Requirements
4.1 Organisation and Management
 Legal entity
 Conflict of interest defined and relationship documented (Part of
larger org.)
 Impartiality (4.1.5 b) and freedom from commercial/financial
pressures which might influence judgement for 3rd party activities
(Note 2)
 Have policies in place to avoid involvement in activities that would
negatively effect confidence in its competence, impartiality,
judgement or operational integrity.
 Have Management and Technical staff (sufficient) and with
adequate authority.
Tapeshwar Bhardwaj

4.2 Quality Management System
 Must have implemented a QMS appropriate for its scope and activities (documented
to extent necessary to assure quality of result)
Understood by all in org. and communicated to all (4.2.2 d)
 System must be documented (4.2.2)
 Top management must demonstrate commitment
4.3 Document control
 Approval and issue – Reviewed and approved (uniquely identified)
 Document changes – by original function. Altered text highlighted
Management Requirements (Contd.)
Tapeshwar Bhardwaj

4.4 Review of requests, tenders and contracts
 Have procedures in place for this (Records of review must be available)
 Have necessary resources
 Differences resolved before acceptance
 Can be oral or documented (contract) (Note)
 For review of simple or routine results (date and initials of person doing test
sufficient) – Note in (4.2.2)
 Repetitive tests – Review at initial stage only as long as unchanged
4.5 Subcontracting
 Use of a competent subcontractor (could be one that complies with ISO/IEC 17025)
 Advise customer and obtain approval (in writing)
 Maintain a register or subcontractors
Tapeshwar Bhardwaj

4.7 Customer service
 The laboratory shall obtain feedback from customers and analyze for possible
improvement.
4.8 Complaints
4.9 Control of nonconforming testing/calibration work
 Policies – procedures implemented shall include
 Responsibilities and authority
 Evaluation
 Correction taken “immediately”
 Responsibility for authorizing resumption of work is defined
Tapeshwar Bhardwaj

4.10 Improvement
 Shall continually improve effectiveness of MS through analysis
4.11 Corrective action
 Shall designate and give authority for implementing Corrective Action
 Shall start with a cause analysis (analysis of all potential causes)
 Identify all potential corrective actions (select and implement)
 Shall monitor corrective actions effectiveness
4.12 Preventative Actions
 Needed improvements and potential sources of NC shall be identified
 Action plans developed when identified
Tapeshwar Bhardwaj

4.13 Control of Records
 Readily retrievable
 Protect and back up needed
4.14 Internal audits
 Done periodical – All elements of system
 Done by trained and qualified staff where ever permitted by persons independent
of activities to be audited
4.15 Management Review
 Identifies what should be considered
 Period (12 months – note)
Tapeshwar Bhardwaj

TECHNICAL REQUIREMENTS
Clause 5 (ISO/IEC 17025:2005)
 Personnel
 Accommodation & environmental conditions
 Laboratory equipment
 Pre-examination procedures
 Examination procedures
 Assuring quality of examination procedures
 Post-examination procedure
Tapeshwar Bhardwaj

Technical Requirements
 5.1 General
 5.1.1 Many factors determine the correctness and reliability of the tests
and/or calibrations performed by a laboratory. These factors include
contributions from:
• human factors (5.2);
• accommodation and environmental conditions (5.3);
• test and calibration methods and method validation (5.4);
• equipment (5.5);
• measurement traceability (5.6);
• sampling (5.7);
• The handling of test and calibration items (5.8).
 5.1.2 The extent to which the factors contribute to the total uncertainty
of measurement differs considerably between (types of) tests and
between (types of) calibrations. The laboratory shall take account of
these factors in developing test and calibration methods and
procedures, in the training and qualification of personnel, and in the
selection and calibration of the equipment it uses.
Tapeshwar Bhardwaj

Technical Requirements (CONTD.)
5.2 Personnel
 Competent qualified appropriately on basis of education, training, experience and
demonstrated skills
 Persons who give opinions and interpretations of test results should have additional
qualifications
 Policy to identify training needs
 Effectiveness of training shall be calculated
 Authorize specific staff for specific work
5.3 Accommodation and Environment
 Appropriate and Adequate
 effects tests must be documented (conditions)
 Prevent cross contamination
 Access controlled
Tapeshwar Bhardwaj

5.4 Test and calibration methods and validation
 Instructions on use of all equipment and handling of items
 Deviation from methods documented and justified authorized and
accepted by customer
 Standards do not need to be supplemented/ rewritten
 Selection of method – meets customer needs and appropriate
 Can use international, regional, national or published by reportable
technical organizations/journal or specified by manufacturer
 Laboratory developed methods
- when necessary, approved by customer and validated
 Non standard test methods validated
Tapeshwar Bhardwaj

5.4 Test and calibration methods and validation (continued)
 Validation of Methods
Defines validation as “Particular requirements for a specific intended
use are fulfilled”
 Laboratories validate non standard methods, laboratories developed,
standard methods used outside intended scope.
- Record validation
 Estimation of Uncertainty
- Procedure to estimate UOM
- Where methods includes and defines UOM then it is established
(ISO 5725 Guide to expression of UOM)
 Control of data
- Adequate checks
- Software documented and validated
Tapeshwar Bhardwaj

5.5 Equipment
 Needs all equipment for tests. Allows use of outside equipment
 Calibration schedules
 Operated by authorized persons
 Maintenance and storage
 Equipment labelled
 Safeguarded from adjustments which could invalidate it
5.6 Measurement traceability
 Calibrated before use
 Calibration traceable to SI System
 Calibration laboratories unbroken link to Primary Standards/Secondary Standards
Tapeshwar Bhardwaj

5.7 Measurement traceability
 “A calibration certificate bearing an accreditation body logo from a calibration
laboratory accredited to this International Standard, for the calibration concerned is
sufficient evidence of traceability of the calibration data reported.”
 Testing laboratories
 Reference Standards and Reference Materials
Calibration of Ref. Standards – traceability (only used for this purpose)
Ref. Materials traceable to SI Units if possible or CRM
Intermediate checks
 Sampling
Sampling plan and procedures when it carries out sampling at location where
done.
Based on statistical methods (where available)
Tapeshwar Bhardwaj

5.8 Handling of test and calibration items
 Procedures for transport, receipt, handling
 Protection, storage, Disposal
 Identifying test items
5.9 Assuring the quality of test and calibration results procedures for monitoring
the validity of tests and calibrations
5.10 Reporting of results
 Accurately and clearly unambiguously and objectively
 Usually in a report and all information in it necessary for interpretation
 Allows of simplified reporting (information still needs to be available)
Tapeshwar Bhardwaj

Test reports and calibration certificates
 Identifies all information needed
 Where applicable UOM for best reports
 UOM for calibration certificates
 Evidence that measurements are traceable (calibration)
 When statement of compliances is made UOM shall be
taken into account (Calibration)
 No recommendation on calibration internal
Tapeshwar Bhardwaj

Opinions and Interpretation
 Document basis upon which interpretation is used
 Clearly marked as such
 Not confused with inspections and Product certification
 Subcontracted results clearly identified
 Calibration Certification issued to the contracting
laboratory
Tapeshwar Bhardwaj

Next Step
Now obtain application form from :
The Director NABL
Fill it out carefully annex all details and
submit along with the prescribed fee
Tapeshwar Bhardwaj

Three stages of
NABL Accreditation Process
Stage 1 Quality System Manual adequacy
study by NABL lead Assessor
Stage II Pre-assessment visit by the Lead
Assessor (One day)
Stage III Final Assessment by the NABL
team (two days or more)
Tapeshwar Bhardwaj

After final assessment
 Report will reach NABL with total knowledge
of the laboratory
 NABL technical committee will review the
report and recommendations
 Will communicate to the laboratory about
the accreditation status
 Accredited labs need to go in for periodic
surveillance with annual fee
Tapeshwar Bhardwaj

NABL 210 (Assessor’s Guide)
 The assessment is carried out by a team of Assessors, led by
a Lead Assessor, empanelled by NABL.
 The assessment is carried out systematically on all aspects of
technical competence and of CAB’s management system.
The objective evidence so collected forms the basis:
 for arriving at a judgement for recommendation of the team
 to specify the competence of CAB in terms of its capability to
perform the activities for which it is seeking accreditation or
holds accreditation.
 The objective of the assessment, however, is not to compile
non-conformities as an evidence to justify denial of
accreditation.
Tapeshwar Bhardwaj

 Irrespective of Laboratory size, Quality needs to be validated by Third
Party
 Documentation is easy under ISO 17025
 NABL guide lines provide local/ regional requirements
 Laboratory can be accredited by any authorized Third Party
 Quality Control and PT requirements are the integral components of
accreditation
 Focus should be continual improvement
Tapeshwar Bhardwaj

Assessor’s Role
 To obtain evidence on compliance with respect to
the ISO/IEC 17025:2005 ‘General Requirements for
the Competence of Testing and Calibration
Laboratories’
 The CAB meets other requirements of NABL
including the NABL’s Specific Criteria for the
relevant field and / or discipline and has
competence to perform the specific test(s)/
calibration(s)
 Should pay attention to the specific announcements
on web-site pertaining to policy decisions
 to exercise his scientific & technical judgement and
form his opinion regarding extent of conformity with
respect to accreditation criteria.
Tapeshwar Bhardwaj

 To maintain the confidentiality on the matters / subjects
related to CAB
In case the assessment team members observe gross non-
conformities in the documents and their implementation, the lead
assessor shall consult with NABL Secretariat for abandoning the
assessment process.
 The role of Lead Assessor, Technical Assessor, Technical
Expert and Technical Observer during assessment of testing
and calibration laboratories is addressed in NABL 215; for
medical laboratories it is addressed in NABL 217; for
Proficiency Testing Provider (PTP) it is addressed in NABL
183; and for Reference Material Producers (RMP) it is
addressed in NABL 193.
Tapeshwar Bhardwaj

Assignment Procedure
 If the application form and/ or associated documents received from
CAB are acceptable to NABL, it shall appoint Assessment Team
and inform the laboratory. NABL Secretariat, in consultation with
Lead Assessor, will constitute the composition of team. CABs have
the right to object to the appointment of a particular Lead Assessor/
Assessor, and in such cases, NABL may offer an alternative to the
extent possible, if the reasons given by the CAB are acceptable to
NABL.
 Assessors are chosen to the extent possible from the empanelled
list of Assessors maintained by NABL based on individual’s
technical expertise vis-à-vis a CAB’s requested scope of
accreditation. The number of Assessors in the team shall depend on
the range and volume of scope involved. For multi-disciplinary CAB,
Assessors shall be selected in such a manner so as to cover each
discipline and its range/ scope of operation.
Tapeshwar Bhardwaj

 Lead Assessor/ Assessor(s) are informed
subsequently after the CAB has agreed on
the membership of the team.
Tapeshwar Bhardwaj

Procedure for Assessment
 NABL shall first appoint the Lead Assessor and send
CAB’s Quality Manual and application to the Lead
Assessor.
 The Lead Assessor shall examine the Quality Manual
and shall submit Adequacy Report to NABL within 30
days.
A non-conformity can be identified and can be one or
more of the following:
 related to the management system
 related to technical activities
 failure to fulfill the required objectives
 difference between work practices and documented
instructions
Tapeshwar Bhardwaj

 A non-conformity can be classified as
Major or Minor. A major non-conformity is:
 absence of a procedure required by
standard
 significant failure to implement a
procedure
 direct-effect on quality of results
All other non-conformities are minor.
Tapeshwar Bhardwaj

Pre-Assessment Visit
 Objective
 to have a better understanding of the documentation;
 to familiarize with the facilities, sites/ location,
circumstances and to have better knowledge of
operations;
 to make the methodology to be adopted for the
assessment;
 to check the preparedness of the CAB to undergo
assessment;
 to review the scope of accreditation and to ascertain the
requirement of the number of assessors/ experts and the
duration of assessment. The Lead Assessor must take into
consideration the travelling distance and time required for
visit to different sites and also for witnessing site activities.
Tapeshwar Bhardwaj

Visit
 Explaining the purpose of the assessment
 Explaining the obligations on the part of the
CAB to confirm by demonstration
 Reviewing the management system
documents
 Reviewing the scope of the accreditation
 Giving an overview of the accreditation
process
 Obtain signatures on NABL 131 (Terms and
Conditions for maintaining Accreditation)
Tapeshwar Bhardwaj

On-site Assessment
 Opening Meeting
 The team and the CAB personnel will introduce each
other.
 The Lead Assessor should make it clear in his opening
remarks that the object of the assessment is to assess the
work of laboratory according to ISO/IEC 17025:2005.
 He / she explains the objective and scope of assessment
and what is expected from the CAB during the
assessment.
 The Lead Assessor shall present the assessment plan
(NAF (XX) 1) to CAB representatives. The CAB will be
requested to assign guide/ co-coordinator to accompany
each Assessor.
 Lead assessor shall obtain signatures of all participants of
opening meeting
Tapeshwar Bhardwaj

 On-site Assessment Procedure
 Refer Assessor’s Guide for complete step-by- step
procedure.
 Closing Meeting
 The Lead Assessor shall summarize the findings of
the Assessment Team and present it to the CAB
representatives.
 During the closing meeting, the management
representative present shall be asked to suggest a
date for completion of corrective action of all non-
conformity.
 The closing meeting is to end with thanks giving for
the co-operation and assistance given by CAB .
Tapeshwar Bhardwaj

 Post Assessment
 Lead Assessor shall send the assessment report
along with recommendation to NABL secretariat
at the earliest (within ten days of assessment)
and in confidence by speed post or by courier
service mail.
 Assessor shall provide comments / recommend
for closure of NC(s) raised once CAB have taken
satisfactory corrective actions and submit
satisfactory documentary evidence.
 When a further visit is required / clarifications
required, the Assessors shall be contacted by
NABL secretariat.
Tapeshwar Bhardwaj

GUIDE TO FORMULATE
RECOMMENDATIONS FOR NABL
 The Lead Assessor shall take into account the number and
type of non-conformities found during assessment.
 Where no non-conformities are found, the Lead Assessor
shall recommend accreditation of the CAB
 When non-conformities are found, the Lead Assessor cannot
recommend accreditation.
 In such cases, the recommendation shall be such that
accreditation may be granted subject to the satisfactory
discharge of all non-conformities. Where in one area of
testing or calibration or RMP or PTP, major non-
conformities have been identified/ recorded, but overall
there are no major system failures, the Lead Assessor
may recommend accreditation for all areas except for the
non-complying area.
Tapeshwar Bhardwaj

 The CAB management shall be asked to specify
the period required to complete the corrective
action for non-conformities in line with NABL
norms.
 Where the number and seriousness of non-
conformities found is such that the whole of the
CAB’s management system and organization is
demonstrably inadequate, the Lead Assessor’s
recommendations shall be such that accreditation
is refused. In such cases, the CAB may write to
NABL about the dissatisfaction / disagreement.
Tapeshwar Bhardwaj

PROCEDURE FOR CONDUCTING
CLOSING MEETING
 Purpose:
 to enable the team to present the CAB
management with a summary of the findings
of the assessment.
 to inform the management of the
recommendations that the team will make to
the NABL secretariat.
Tapeshwar Bhardwaj

 The concluding report (NAF (XX)-6) shall be based on the
summary report including (NAF (XX)-4 and NAF (XX)-5)
prepared by Assessment Team.
 Final meeting shall be chaired by the Lead Assessor, who
should:
 Thank the CAB for its assistance and cooperation. He
shall also refer to individuals as may be appropriate.
 Explain the significance of the type of non-conformities.
 Ask for questions to be deferred until the findings have
been presented, although points of clarification should not
be refused.
 Invite each Assessor to summarize his or her findings
based on the report, but it should not be discussed in
detail. He should present his/ her findings as individual
Assessor.
Tapeshwar Bhardwaj

 Invite the CAB to specify the date by which any required corrective actions will be
implemented. It should be in line with NABL norms.
 Provide the CAB with an opportunity to discuss the assessment and answer any
questions.
 Apprise CAB with the requirements of NABL 133.
 During the closing meeting, the Assessment Team
should not enter into debating the validity of their
conclusions or recommendations.
 If these are questioned, the Assessor may, however, enumerate individual non-
conformities, which justify the recommendations in question and point out the
combined effect of the observations of the assessment. If the CAB is still
unwilling to implement the recommendations, the Lead Assessor should advise
them to take up the matter with NABL.
 Lead assessor shall obtain signature of those who attend
the closing meeting in NAF (XX)-1A.
Tapeshwar Bhardwaj

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