The PPT explain about the NABL and accreditation process according to the ISO 17025. And how you will get benefited with the NABL/ISO 17025 accreditation for your Lab.
HPLC is a High Performance liquid Chromatography.
High Pressure Liquid Chromatography.
High Priced Liquid Chromatography.
It is column chromatography.
It is Liquid Chromatography.
It is modified from of gas chromatography, it is applicable for both Volatile as well as Non volatile compound.
It can mainly divided by two types 1. Normal phase HPLC 2. Reversed Phase HPLC.
It is having a high resolution and separation capacity.
GLP applies to nonclinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals).
GLP helps assure regulatory authorities that the data submitted are a true.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
What is NABL ?
The National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the guidance of the Dept. Of Science & Technology, Govt. of India.
HPLC is a High Performance liquid Chromatography.
High Pressure Liquid Chromatography.
High Priced Liquid Chromatography.
It is column chromatography.
It is Liquid Chromatography.
It is modified from of gas chromatography, it is applicable for both Volatile as well as Non volatile compound.
It can mainly divided by two types 1. Normal phase HPLC 2. Reversed Phase HPLC.
It is having a high resolution and separation capacity.
GLP applies to nonclinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals).
GLP helps assure regulatory authorities that the data submitted are a true.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
What is NABL ?
The National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the guidance of the Dept. Of Science & Technology, Govt. of India.
A NABL certified laboratory is one that has been accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL), which is the primary accreditation body for testing and calibration laboratories in India. NABL accreditation ensures that the laboratory meets international standards of quality and competence in testing, calibration, and measurement services. It signifies that the laboratory operates with accuracy, reliability, and impartiality, providing trustworthy results that are recognized both nationally and internationally.
The National accreditation Board for Testing and Calibration laboratories (NABL) is an independent organization operating under the supervision of the Department of Science and Technology, Government of India. Its primary objective is to provide certification to clinical labs in India for their testing and calibration activities.
National Accreditation Board for Testing and Calibration Laboratories (NABL) ...Megha865400
NABL is an accreditation body. Testing laboratories and Calibration laboratories in accordance with ISO/ IEC 17025. Medical testing laboratories in accordance with ISO 15189.Proficiency Testing Providers (PTP) and Reference material producers (RMP) in accordance with ISO/IEC 17043.
National Accreditation Board for testing and Calibration laboratory (NABL)harshadapadwal2
National Accreditation Board for testing and Calibration laboratory (NABL) is accreditation body for laboratories in India.
NABL is a constituent Board of Quality Council of India (QCI). QCI is a registered society under the Societies Registration Act, 1860. Department for Promotion of Industry and Internal Trade, Ministry of Commerce and Industry, Government of India is the nodal Department for QCI.
NABL has been established with the objective of providing Government, Industry Associations and Industry in general with a scheme of Conformity Assessment Body’s accreditation which involves third-party assessment of the technical competence of testing including medical and calibration laboratories, proficiency testing providers and reference material producers.
The laboratory accreditation services to testing and calibration laboratories are provided in accordance with ISO/ IEC 17025: 2005 or ISO/IEC 17025:2017 ‘General Requirements for the Competence of Testing and Calibration Laboratories’ and ISO 15189: 2012 ‘Medical laboratories -- Requirements for quality and competence’
The accreditation to Proficiency testing providers are based on ISO/IEC 17043 :2010 “Conformity assessment – General requirements for proficiency testing”
The accreditation to Reference Material Producers based on ISO 17034:2016 - General requirements for the competence of reference material producers ”
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO/IEC standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by ISO/IEC in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on somewhat more technical principles. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an accreditation body.
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO/IEC standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by ISO/IEC in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on somewhat more technical principles. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an accreditation body.
There have been three releases; in 1999, 2005 and 2017. The most significant changes between the 1999 and 2005 release were a greater emphasis on the responsibilities of senior management, explicit requirements for continual improvement of the management system itself, and communication with the customer. It also aligned more closely with the 2000 version of ISO 9001
1) GLP embodies a set of principles that provides a frame work within which laboratory studies are planned performed, monitored, and archived and reported.
2) WHY WAS GLP CREATED? • In the early 70’s FDA became aware of cases of poor laboratory practice all over the United States. • They discovered a lot fraudulent activities and a lot of poor lab practices. • Examples of some of these poor lab practices found were 1. Equipment not been calibrated to standard form , therefore giving wrong measurements. 2. Incorrect/inaccurate accounts of the actual lab study. 3. Inadequate test systems.
3) Purpose of GLPs: • GLP is to certify that every step of the analysis is valid or Not. • Assure the quality & integrity of data submitted to FDA in support of the safety of regulated products. • GLPs have heavy emphasis on data recording, record & specimen retention.
4)GOOD LABORATORY PRACTICES PRINCIPLES. 1. Test Facility Organisation and Personnel. 2. Quality Assurance Programme(QAP). 3. Facilities. 4. Apparatus, Material and Reagents. 5. Test systems. 6. Test and Reference Substances. 7. Standard Operating Procedures(SOP). 8. Performance of The Study. 9. Reporting of Study Results. 10. Storage and Retention of Records and materials.
5) GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies.
6) "Good Laboratory Practice", or GLP for short, refers to a quality assurance system that is applied during the pre-clinical stage of research and development. Its aim is to test active ingredients under specific environmental conditions and over a defined period of time.
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Marvin neemt je in deze presentatie mee in de voordelen van non-endemic advertising op retail media netwerken. Hij brengt ook de uitdagingen in beeld die de markt op dit moment heeft op het gebied van retail media voor niet-leveranciers.
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Falcon stands out as a top-tier P2P Invoice Discounting platform in India, bridging esteemed blue-chip companies and eager investors. Our goal is to transform the investment landscape in India by establishing a comprehensive destination for borrowers and investors with diverse profiles and needs, all while minimizing risk. What sets Falcon apart is the elimination of intermediaries such as commercial banks and depository institutions, allowing investors to enjoy higher yields.
Implicitly or explicitly all competing businesses employ a strategy to select a mix
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Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
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Association Clause: It simply states that the subscribers wish to form a company and agree to become members of it, in accordance with the terms of the MOA.
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Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
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Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
2. PravinMali
PART – I , NABL
PART – III – Company (No a part of
this PPT )
QCI
NABL – General
Scope of NABL
Certification Vs
Accreditation
Process of NABL
Accreditation
Benefit of
Accreditation
Our Scope
Requirements
Where we are
Training needs
Infrastructure needs
Documentation
Requirements
Action Plan
PART – II , ISO 17025 : 2005
3. PravinMali
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.
5. PravinMali
is an autonomous body
registered under Societies Act in1992
under the aegis of Department of
Science & Technology, Government of
India.
7. PravinMali
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 Accreditation Cooperation
EA : The European cooperation for Accreditation
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
8. PravinMali
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
9. PravinMali
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)
11. PravinMali
CERTIFICATION ACCREDITATION
Certification is a
comprehensive evaluation of
a process, system, product,
event, or skill typically
measured against some
existing norm or standard.
Certification does not make
any statement about the
technical competence of the
laboratory.
Example ISO 9001:2005
Certification
Accreditation is the formal
declaration by a neutral third
party that the certification
program is administered in a
way that meets the relevant
norms or standards of
certification program
Uses criteria specifically
developed to determine
technical competence of the
laboratory.
This is an independent
evaluation of laboratory’s
technical competence
Accreditation-Example ISO
17025
13. PravinMali
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.
14. PravinMali
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.
15. PravinMali
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.
16. PravinMali
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.
18. PravinMali
Application for Accreditation
(by Laboratory)
Acknowledgement & Scrutiny of Application
(by NABL Secretariat)
)
Adequacy of Quality Manual
(by Lead Assessor)
Pre-Assessment of Laboratory
(by Lead Assessor)
Final Assessment of Laboratory
(by Assessment Team)
Scrutiny of Assessment Report
(by NABL Secretariat)
Recommendations for Accreditation
(by Accreditation Committee)
Approval for Accreditation
(( by Chairman NABL)
Issue of Accreditation Certificate
(by NABL Secretariat)
Feedback
to
Laboratory
and
Necessary
Corrective
Action
by
Laboratory
20. PravinMali
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.
21. PravinMali
.
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)
22. PravinMali
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.
23. PravinMali
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.
24. PravinMali
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
25. PravinMali
Establish and maintain Procedure to control all the
documents
(Externally/internally generated).
Document approval and issue
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.
Controls required are similar
to ISO 9001
27. PravinMali
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
28. PravinMali
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
29. PravinMali
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
30. PravinMali
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.
31. PravinMali
Laboratory shall have
Policy & Procedure for
resolution of complaints
received from customers
and other parties.
Record shall be
maintained of all
complaints, investigations,
and corrective actions
taken
32. PravinMali
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
33. PravinMali
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
34. PravinMali
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
35. PravinMali
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.
36. PravinMali
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
37. PravinMali
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
38. PravinMali
Administrative and Quality System
Records. Technical System Records.
Document control Records.
Contract Review Records.
Subcontracting Records.
Purchasing Records.
Customer feedback and
analysis Records.
Complaint Records.
Non-conforming work Records.
Improvement records.
Corrective and preventive
actions Record.
Internal Audit Records
Management Review Records.
Personnel Records.
Environmental Records.
Calibration/ Test observations /
Raw Data/ int. check records.
Measurement Uncertainty Records.
Computer /Software related
Records.
Equipment Records/Traceability
Records
Sampling Records
Handling - receipt to dispatch-
Records.
Quality Assurance Records.
Test reports/Calibration
Certificates.
Retention Record for Documents
/Samples
39. PravinMali
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.
When audit findings cast doubt on effectiveness of
operations or on the correctness or validity of lab. results,
laboratory shall take timely corrective action.
40. PravinMali
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
quality control activities, resources and staff training.
Findings from management reviews shall be recorded and
actions taken in agreed timescale
42. PravinMali
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.
43. PravinMali
Major Sources of
Uncertainties
I – Instrument ( 5.5)
1 – Instrumental Error
Acceptance Norm.
2 – Uncertainty of calibration
3 – Instrumental Resolution.
4 – Repeatability. ( Type A )
W – Work piece ( 5.7 , 5.8)
1 – Non-homogeneity of test
material
2 –Instrumental Resolution
(When instrument is under
calibration)
P – Person (5.2) / Procedure
(5.4)
1 – Repeatability ( Type A )
(Skill of operator for positioning
and measuring pressure etc.)
S – Standard ( 5.5 & 5.6 )
1 – Un-compensated Dev. from
nominal value.
2 – Uncertainty of calibration.
3 – Non-homogeneity ( Type A ).
E – Environmental Factors (5.3)
Temperature control limits
Temperature variation.
Humidity.
Cleanliness ( Type A ).
Vibration ( Type A ).
S W I P E
44. PravinMali
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
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
45. PravinMali
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
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
46. PravinMali
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 /
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
47. PravinMali
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.
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
48. PravinMali
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/
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.
49. PravinMali
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 &
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
50. PravinMali
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.
51. PravinMali
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
52. PravinMali
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
programme
Replicate testing
Retesting of returned items
Correlation of item using different characteristics of the item
53. PravinMali
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,
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
54. PravinMali
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
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.
55. PravinMali
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.
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 system records.
56. PravinMali
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
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.
57. PravinMali
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/
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.
58. PravinMali
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
Laboratories
NABL 103-Specific Guidelines for Chemical Testing
Laboratories
NABL 114-Guidelines for Food Testing Laboratories
documents given by NABL and must posses the
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 Accreditation Cooperation
EA : The European cooperation for Accreditation
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