Quality Assurance

• Quality Assurance (QA) is a management method that is defined as

“all those planned and systematic actions needed to provide
adequate confidence that a product, service or result will satisfy given
requirements for quality and be fit for use”

• As per ISO (1994): A Quality Assurance programme is defined as “the

sum total of the activities aimed at achieving that required standard”
• The assessment aims to produce information that is accurate, reliable
and adequate for the intended purpose.

• Quality Assurance extends to all aspects of data collection from

sanitary surveys to laboratory procedures.
Components of QA
• 3 levels:

1. organizational: dealing with the quality policy, objectives and

management and usually produced as the Quality Manual

2. functional: dealing with general practices such as training, facilities,

operation of QA

3. operational: dealing with the Standard Operating Procedures (SOPs)

worksheets and other aspects of day to day operations
Quality manual
Composed of the management documents needed to implement the QA
programme and includes:

• A quality policy statement, including objectives and commitments.

• The organization and management structure of the project, its place in

any parent organization and relevant organizational charts.

• The relationship between management, technical operations, support

services and the quality system.

• Procedures for control and maintenance of documentation

• Job descriptions for key staff and reference to the job descriptions of other staff.

• Identification of approved signatories.

• Procedures for ensuring traceability of all paperwork, data and reports.

• The laboratory's scope for calibrations and tests.

• Arrangements for ensuring that all new projects are reviewed to ensure that
there are adequate resources to manage them properly.

• Reference to the calibration, verification and testing procedures used.

• Procedures for handling calibration and test items.

• Reference to procedures for calibration, verification and maintenance of
equipment.

• Reference to verification practices including inter-laboratory comparisons,

proficiency testing programmes, use of reference materials and internal quality
control schemes.

• Procedures to be followed for feedback and corrective actions whenever

testing discrepancies or departure from documented procedures are detected
• Procedures to be followed for feedback and corrective actions whenever
testing discrepancies or departure from documented procedures are
detected.

• Complaints procedure.

• Procedures for protecting confidentiality and property rights.

• Procedures for audit and review.

SOPs (Standard Operating Procedures)
• documents detailing all specific operations and methods, including sampling,
transportation, analysis, use of and calibration of equipment, production of
reports and interpretation of data.

• The purpose of the SOP should be stated alongside the variables measured,
the expected range of values, the limitations of the method and the expected
precision and accuracy

• The storage, handling, recording and subsequent disposal of the sample

should also be covered in the SOP, including storage temperatures, sample
splitting, traceability, and any other issues
 Importance of Quality assurance
• Quality assurance is the basic maintenance of a specific level of Quality
within a working practice, designed to ensure attention to detail is achieved
and products are free of faults

• In the context of forensic labs, it guarantees a consistent set of standard and

integrity and the level of maintenance is achieved and sustained throughout
Forensic science establishments.

• It ensures reliable and accurate testing is undertaken at all times

• Forensic labs need to maintain the scientific quality standards

Accreditation
• It is a process through which an authorized independent agency
examines and certifies the competence and quality of a laboratory
based on particular predefined standards.

• It is the means of assessing the reliability and integrity of an

organization to ensure it meets the specific requirements in order to
reduce risks under the international accreditation standards

• Accreditation involves on-site and performance assessments as well

as ongoing proficiency testing. 
• Accreditation to ISO/IEC 17025 plays an important role in supporting the
provision of accurate and reliable results from laboratory testing, calibration,
sampling and measurement services across many sectors (quality
management for labs)

• By going through the accreditation process, a laboratory gains by necessarily

building a quality management system (based on principles listed later in this
article), which functions to reduce procedural errors and prevent errors from
“going out the door.”

• A “credential” that designates the laboratory as qualified and competent to

provide services in the field or fields in which it is accredited.
• A regular, objective “checkup” that helps a laboratory’s management
make continual improvements in its operation.

• In an increasing number of instances, entrée to a given market that

would otherwise be closed to the laboratory.
• Increased laboratory productivity, resulting from a decrease in the
number of clients who insist on having their own staff audit the
laboratory. More of these clients now base their confidence on a third-
party accreditation.

• International recognition of the accredited laboratory’s competence, if

the accreditation body is a signatory to the mutual recognition
arrangement of the International Laboratory Accreditation Cooperation
(ILAC).

• Accreditation assessments help the laboratory staff stay on the cutting

edge of technology developments in their field.
• Significant discounts in liability insurance premiums are not uncommon,
when the insurer appreciates the verification-of-competence that
accreditation represents.

• Improved performance by laboratory staff. Undergoing regular assessments

enhances staff discipline and sense of professionalism. Employees are more
likely to be committed to complying with the firm’s quality management
system and standards of performance.

• For calibration laboratories, accreditation by an internationally recognized

accreditation body validates their pivotal place in the unbroken chain of
traceability to national and international measurement standards.
The technical competence of a laboratory depends on a number of factors
including:

• The qualifications, training and experience of the staff

• The right equipment – properly calibrated and maintained
• Adequate quality assurance procedures
• Proper sampling practices
• Appropriate testing procedures
• Valid test methods
• Traceability of measurements to national standards
• Accurate recording and reporting procedures
• Suitable testing facilities
Need for accreditation of Forensic Labs
1. Perfection: raise the standards of practice and quality of
work performed in labs

2. Information exchange: standardization of procedure helps

to facilitate the exchange of information and technology
internationally
Elements for optimization

• Quality of organization

• Professionalism of employees

• Quality of the product

 Requirements for organization & employees
• Infrastructure and environmental conditions
• Procurement of supplies and services
• Well maintained and defined documentation
• Procedures established cases of mishaps or deviations from normal
• No association with commercial, financial or other pressures

• Confidentiality maintenance
• Understanding of questions or requests
• Timely delivery of reports
• Complaints and feedback
• Competence, behaviour & knowledge
 Requirements for examination methods &
techniques
• Appropriate sample preparation and sampling
• Validated methods
• Estimation of error rate
• Control data
• Procedure for handling deviations
• Functioning & maintained equipment
• Instructions for the equipments
Organizations for quality system
management
• NABL: National Accreditation Board for Testing and Calibration
Laboratories
• ISO: International Organization for Standardization
• ILAC: International Laboratory Accreditation Co-operation
• APLAC: Asia Pacific Laboratory Accreditation Co-operation
• ASCLD: American Society of Crime Laboratory Directors
• BIS: Bureau of Indian Standards
• SWG: Scientific Working Groups
 1. NABL
It is an accreditation body established in accordance with ISO/IEC 17011. It provides
accreditation to CABs (Conformity Assessment Bodies) i.e.:

• Testing laboratories in accordance with ISO/ IEC 17025 ‘General Requirements for the
Competence of Testing and Calibration Laboratories’ 
• Calibration laboratories in accordance with ISO/ IEC 17025 ‘General Requirements for
the Competence of Testing and Calibration Laboratories’ 
• Medical testing laboratories in accordance with ISO 15189 ‘Medical laboratories -
Requirements for quality and competence’ 
• Proficiency Testing Providers (PTP) in accordance with ISO/IEC 17043 “Conformity
assessment — General requirements for proficiency testing” and 
• Reference material producers (RMP) in accordance with ISO 17034 “General
requirements for the competence of reference material producers”. 
Testing laboratories

NABL approval is required for laboratories that test different products and
equipment. Such laboratories will include:

• Chemical
• Biological
• Radiology
• Forensic
• Food Processing
• Fluid / Mechanical
• Thermal
Calibration Laboratories

Calibration laboratories will also require NABL approval. The

following laboratories would require NABL approval:

• Radiological
• Mechanical/ Fluid-Flow
• Thermal Optical
• Electronic
 Medical Laboratories
All forms of pharmaceutical and medical companies would require NABL approval to test
different medications. This approval is crucial for the medical industry. The following
laboratories require this approval:

• Serology
• Microbiology
• Bacteriology
• Nuclear Medication
• Genetics
• Pathology
• Biogenetics
• Haematology
Proficiency Laboratories

Different laboratories that test the proficiency of products will require

this form of approval. The following proficiency laboratories will
require this approval:

• Medical
• Inspection
• Calibration
Reference Material Laboratories

Laboratories that analyze different materials' reactions would also

require approval from the NABL. The following reference material
laboratories require this approval:

• Biological processes
• Engineering Processes
• Genetics Industry
• Pharmaceutical Industries.
• It is an autonomous body which is a part of the Quality Council of India

• aim of this institution is to provide an impartial assessment of the quality

standards for institutions, government bodies, and primary institutions

• NABL is Mutual Recognition Arrangements (MRA) signatory to ILAC

as well as APAC for the accreditation of Testing and Calibration
Laboratories (ISO/IEC 17025), Medical Testing Laboratories (ISO
15189), Proficiency Testing Providers (PTP) (ISO/IEC 17043) and
Reference materials producers (RMP).
• NABL 113: specific guidelines for accreditation of forensic science
laboratories
• The sole purpose of the NABL-ISO 17025 is to provide third-
party assessment to ensure excellent quality and technical
competence of testing and calibration laboratories, which
enables the government and the industry to streamline and
maintain the standardized quality environment
 NABL-ISO 17025 Implementation
Requirements
• Define Roles and Responsibility for Lab Operation and management.

• Testing to be performed as per  Defined standard

• Essential documents development and maintenance for quality assurance.

• All the samples must be organized and documented.

• Written procedures must be followed for all the tasks.

• The quality of the results should be checked and monitored frequently.

• Test reports should be created for test results and the estimation of the
measurements.

• Data integrity must be ensured and maintained.

• Analytical processes must be validated for sampling and testing.

• Results that are non-conforming must be documented, analyzed and controlled.

• Employees must be qualified for their assigned jobs.

• Environmental conditions must be taken into account and monitored

throughout.

• All the inquiries and complaints from clients should be formally addressed.
 Internal Advantages
• Increased confidence in the testing and calibration reports due
to increased accuracy, validation, and right documentation.

• Improved control over lab operations due to detailed

documentation, ISO 17025 standard regulations, and other
effective guidelines.

• Improved testing competency & quality of testing competencies

& results.
• Improved feedback from clients for the improved accuracy.

• Acquired measurable growth in business as a result of the

improvement in processes and results as well as improved
efficiency.

• Streamlined internal management and consistency in operations

and hence, efficiency in the internal operations.

• Improved performance of the employees due to increased

motivation.
 External Advantages
• Recognition nationally & internationally due to exceptional performance.

• Enhanced customer trust and confidence because of accurate test

reports and results.

• Reduction in multiple assessments hence increased client trust and saved

time.

• Recognition in the industry for extraordinary performance.

• Cost and time saving as a result of increased efficiency.

 2. ISO
• Independent, non-govt, non-profitable, worldwide organization
which develops and publishes international standards.

• Founded in 1947 with 167 member countries

• Applicable for products and services

• a set of internationally recognized guidelines

• ISO 17025: accreditation that is recognized in the EU and USA,
which is used in the forensic laboratory system because of its
effectiveness for identifying issues and errors whilst cutting
wastage and facilitating mass processes

• ISO 17020:  inspection body accreditation. It includes all

activities performed by an inspection body, including examining
products and equipment, processes, procedures, services, and
determines their overall conformity and accurate reporting of
results
• It is a global standard for the technical competence of
calibration and testing laboratories

• Supports use of robust systems and procedures and

practices for storage, processing and evidence analysis

• Important for expert evidence as provides scientific

basis.

• assure its customers of precision, accuracy and repeatability of

results.
ISO/IEC 17020: 2012
5.2.1 ISO/IEC-17025: Personnel
• Personnel performing specific tasks shall be qualified on the basis of
appropriate education, training, experience and/or demonstrated skills,
as required
• Wherever required, they should hold personnel certification
• If responsible for forming opinion or interpretation included in test
reports, should possess
 relevant knowledge of technology used for manufacturing of things
used
 knowledge of general requirements expressed in legislation and
standards
5.10.5 ISO/IEC-17025
Opinions & interpretations
• When opinions and interpretations are included, the lab should
document the basis upon which the they have been made.

• Opinions and interpretations should be clearly marked as such in test

report
• Should include but not be limited to
 opinion on the statement of compliance or non-compliance of
results with requirements
 recommendations on how to use the results
 Report basics

It should include:

• Samples tested

• Attribute studied

• Analytical method used

• Result

• Interpretation
• Connectel-India's first established Forensic Science Laboratory in Private
Sector with International Accreditation of ISO/IEC 17025:2017 Standards
in Forensic Testing

• The report from this lab is acceptable in 107 countries in the world under
its accreditation.

Connectel deals with Digital Forensics, Questioned Documents, Finger

Print and Signature examination, Handwriting and other physical
documents, Audio and Video Examination, along with Crime Scene
Investigation, which includes forensic photography
• Alibi Global Private Ltd, a startup registered under the Kerala
Startup Mission (KSUM), has received accreditation from the
National Accreditation Board for Testing & Calibration
Laboratories (NABL).
• domain of cyber forensics, providing training and support to the
law enforcement agencies, including Kerala police, Tamil Nadu
police, National Crime Records Bureau, Indian Computer
Emergency Response Team, Andaman & Nicobar police, Centre
for Development of Advanced Computing and also to private
clients
Requirements of ISO / IEC 17025 NABL Accreditation

• In two sections:

1. Management requirements

2. Technical requirements
ILAC g 19