SPORT MANAGEMENT ACCREDITATION COSMA ACCREDITATION PROCESS TRAINING.
GUIDELINES FOR ACCREDITATION OF CHEMICAL AND BIO...
Transcript of GUIDELINES FOR ACCREDITATION OF CHEMICAL AND BIO...
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Government of India
Ministry of Agriculture & Farmers Welfare
(Department of Agriculture, Cooperation & Farmers Welfare)
DIRECTORATE OF PLANT PROTECTION, QUARANTINE & STORAGE
NH IV, FARIDABAD – 121 001 (Haryana)
17025
GUIDELINES FOR ACCREDITATION OF CHEMICAL AND
BIO-PESTICIDE TESTING LABORATORIES AS PER ISO
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Necessity for accreditation
Accreditation is the formal recognition, authorization and registration of a laboratory that has
demonstrated its capability, competence and credibility to carry out the tasks it is claiming to be able to
do. It provides feedback to laboratories as to whether they are performing their work in accordance with
international criteria for technical competence.
As per National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation is
the third party attestation related to a conformity assessment body (Laboratory) conveying the formal
demonstration of its competence to carry out specific conformity assessment task.
In simple words, for Pesticides Testing Laboratories, accreditation is necessary to show their
competence in the work of analysis of pesticides. Laboratory accreditation is a mean to improve
Statkeholders confidence in the test reports issued by the laboratory, so that the stakeholders like
Pesticide manufacturers and their association may not doubt and shall accept the reports with
confidence.
Benefits of Accreditation
Formal recognition of competence of a laboratory by an Accreditation body in accordance with
international criteria has many advantages like:
1. Increased confidence of all stakeholders in Testing Reports issued by the laboratory.
2. Better control of laboratory operations and feedback to laboratories as to whether they have sound
Quality Assurance System and are technically competent
3. Savings in terms of time and money due to reduction or elimination of the need for re-testing of
products.
ISO 17025
ISO (International organisation for standardisation) is an independent, non-governmental organization
with a membership of 162 national standards bodies. Through its members, ISO brings together experts
to share knowledge and develop voluntary, consensus-based, market-relevant International Standards
that support innovation and provide solutions to global challenges.
ISO 17025, General requirements for the competence of testing and calibration laboratories, is the
international reference for testing and calibration laboratories wanting to demonstrate their capacity to
deliver reliable results.
ISO 17025 enables laboratories to demonstrate that they operate competently and generate valid results,
thereby promoting confidence in their work both nationally and around the world. It also helps facilitate
cooperation between laboratories and other bodies by generating wider acceptance of results between
countries. Test reports and certificates can be accepted from one country to another without the need for
further testing, which, in turn, improves international trade.
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Recognized Organization in India for providing accreditation as per ISO 17025
Although there are few autonomous bodies/ institutes which are providing accreditation as per ISO
17025. However, National Accreditation Board for Testing and Calibration Laboratories (NABL) which
is a constituent Board of Quality Council of India is an internationally recognized board for
accreditation, as per International standards. 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.
NABL maintains its linkages with the international bodies like International Laboratory Accreditation
Co-operation (ILAC) and Asia Pacific Laboratory Accreditation Co-operation (APLAC). NABL is a full
member of both and regularly takes part in the Technical Committee Meetings of both ILAC & APLAC,
engaged upon development and updating of guidelines connected with accreditation activities. In order
to achieve the objective of the acceptance of test/ calibration data across the national borders, NABL
operates and is committed to update its laboratory accreditation system as per international norms.
The laboratory accreditation services to testing and calibration laboratories are provided by NABL in
accordance with ISO 17025: 2017 ‘General Requirements for the Competence of Testing and
Calibration Laboratories
Requirements and procedure for getting accreditation from NABL
Getting ready for accreditation
It is very important for a laboratory to make a definite plan for obtaining accreditation and nominate a
responsible person as Quality Manager, who should be familiar with the laboratory’s existing quality
system to co-ordinate all activities related to seeking. The laboratory should carry out the
following important tasks towards getting ready for accreditation:.
1. Get fully acquainted with all relevant documents and understand the assessment Procedure and
methodology of making an application.
2. Depute technical officers for training on Quality Management System ISO 17025, Internal audit,
Measurement Uncertainty, Inter Laboratory Comparison ( ILCP) conducted by Bureau of Indian
Standard (BIS) at regular intervals at different places all over the country throughout the year.
Training of the personals on ISO 17025:2017 will provide the knowledge regarding following
general requirements for a testing laboratory:-
1. General requirements
(a) Impartiality
(b) confidentiality
2. Structural requirements
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(a) Legal
(b) Management
2. Resource requirements
(a) Manpower
(b) Facilities and Environmental conditions
(c) Equipment
(d) Traceability ( Certified Reference Material and Calibration of Equipment)
(e) Product and services
3. Process requirements
(a) Review of request, tenders and contracts
(b) Selection, verification and validation of methods
(c) Sampling
(d) Handling of test items
(e) Technical records
(f) Evaluation of measurement of uncertainty
(g) Validity of results
(h) Reporting of results
(i) Complaints
(j) Non conforming work
(k) Control of Data and Information management
4. Management system requirements
(a) Management system documentation
(b) Control of management system documents
(c) Control of records
(d) Action to address risks and opportunities
(e) Improvement
(f) Corrective actions
(g) Internal audits
(h) Management reviews
3. Based on the requirement of ISO 17025, make following document:
1. Quality manual – as per the guidance available in NABL document No-160 which includes:
(a) Quality policy
(b) Quality objectives
(c) Structural requirements
Legal Documents (evidence of legality)
Scope of work (scope of accreditation)
Organizational chart
Authorizations
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Control of records
2. ISO 17025 Technical/ Resource Requirements
1. Personnel Procedure
Trainings
Training calendar
Training report
Technical training effectiveness evaluation
Skill Matrix
Authorization/ Appointment Letter
Responsibilities List
Job description List
Qualifications List
List of Competence requirements
Equipment Procedure
Traceability information (Metrological Traceability)
Equipment Master list and their location having history and unique identification
number
Details and calibration status of equipment form
Preventive Maintenance Plan
Corrective Action
Calibration Schedule
Statistical techniques Report
Control chart
Facilities and Environmental Conditions Monitoring Procedure
Environmental conditions monitoring form
Security Procedure
Cleaning and safety procedure
Housekeeping Checklist/record
2. Process Requirements
Externally provided products and services procedure
List of approved suppliers
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Supplier Evaluation Form
Supplier Re-Evaluation Form
Purchase Request/Indent Form
Inspection form for Incoming Critical Supplies/Equipment
Material Acceptance/rejection form
Review of requests, tenders and contracts Procedure
Customer Service Request Form
Handling, transport and storage procedure
Equipment Tag
Procedure for receiving samples
Procedure for transportation of chemical/ consumable materials
Procedure for storage of sample/ chemical as well as for leftover/ remnant chemicals
Authorization from state pollution control board for receiving, storage, trans-
boundary movement and safe disposal
Procedure for disposal and record of disposal of pesticides/chemicals
Receiving and releasing procedure
Incoming and Outgoing register
Receiving Record
Releasing Record
Equipment Control Tag
Certificate Receive form
Technical records
Accomplished Measurement Data Sheets
Calibration Certificates
Measurement Uncertainty calculation ( CRM & Equipment)
Intermediate check records
Preventive Maintenance Records
Corrective Action record
Validation Records
Repeat analysis record
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Records of Inter Laboratory Comparison Program
Records of blind analysis
Selection and Verification of Methods Procedure
Verification and Validation Form
Calibration Procedure List
Technical worksheets (Measurement Data Record Sheet)
Operating instructions/work instructions list
International / National Standards List
Validation of Methods Procedure
Validation Check form
Validation Report and Approval Form
Evaluation of Measurement Uncertainty Procedure
Measurement uncertainty budget and calculator
Ensuring the validity of results
Intermediate check procedure
Intermediate check Form
Preventive maintenance procedure
Preventive maintenance plan
Equipment History Card
PT/ILC results
PT/ILC Plan
PT/ILC Analysis report
Functionality check form
Control Charts –see under Equipment
Replicate Test Results
Repeatability and Reproducibility Results
Reporting of Results – requirements for certificates
Calibration results (Measurement Data Sheet)
Calibration certificate format which includes:
Reporting statements of conformity guide
Reporting opinions and interpretations guide
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Amendments procedure
Other Records and Forms which are used depending on the Laboratory Design
Complaints Procedure
Complaints Record Form
Procedure for handling of complaints
Corrective and preventive action form
Control of data and information management Procedure
Customer feedback procedure, SOP and forms& format
3. Management System Requirements
Impartiality and confidentiality Procedure
Confidentiality Acceptance form
Impartiality policy
Risk to impartiality monitoring sheet
Risk Assessment records
Management system documentation
(a) Documents control procedure
Change request form/Amendment form
Document for archive or disposal form
Master list and distribution list of documents
(b) Records Control Procedure
List of records
Locations and retention period record
(c) Internal Audit Procedure
Internal Audit report
Internal Audit non-conformity report
Corrective and preventive action form
Audit plan
Management Review Meeting Procedure
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Management Review meeting form (agenda with attendance)
Minutes of meeting
Corrective Action Procedure
Corrective action form
Root cause analysis procedure, SOP and Forms & Formats
Actions to Address risks and Opportunities Procedure
Risk assessment database file
Risk and Opportunity for Improvement Form
Improvement Procedure
Improvement monitoring sheet
Control of Non-conforming Procedure
Hold and release tag
Service Report Form
Customer Complaints Procedure
Complaints and feedback form
4. Prepare Quality Manual (QM) of the laboratory, as per the guidance provided in NABL document
No-160, which gives an insight of the process for preparing Quality manual and Structure and
format of quality manual.
5. Prepare quality system procedure (QSP) which define the management, quality system forms and
formats (QSF&F), Standard Operation Procedure (SOP) and Work Instructions
6. Prepare Standard Operating Procedure and Work Instructions for each and every test of pesticide,
which a laboratory like to include in the scope of accreditation.
7. Ensure effective environmental condition in the laboratory like temperature, humidity, storage and
house keeping etc.
8. Ensure the calibration of equipment and glassware from an accredited institute for calibration and
maintain their chain of traceability with preventive maintenance.
9. Purchase certified reference material for the pesticides under scope of accreditation and maintain
their traceability record.
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10. Calculate the measurement of uncertainty for every procedure/equipment as per MU given by
certificate of calibration.
11. Ensure proper implementation of all aspects that have been documented in the Quality Manual and
other documents. The laboratory must ensure that the procedures described in the Quality Manual
and other documents are being implemented and evaluated timely.
12. The Laboratory must have participated satisfactorily in an inter-laboratory comparison with
adequate number of accredited laboratories. The minimum stipulated participation for laboratories
is one parameter/ type of test/ calibration per discipline, prior to grant of accreditation and an on-
going program as per NABL 163. The satisfactory performance shall be defined in term of z-score
or any other acceptable internationally accepted method. For unsatisfactory performance, the
laboratory is to take corrective actions.
13. Conduct at least one internal audit for Quality management and Technical Aspect in accordance
with ISO and Management review Meeting (MRM) followed by Management Review Committee
Meeting (MRCM) of the laboratory before applying for accreditation.
14. Laboratory has to maintain records of Internal audit as well as training documents of IA in
respective form and files
Accreditation Process
An applicant laboratory will apply on the website of NABL for submission of application and the
concerned fee. The Legal identity of laboratory, Authorised signatory and quality manual prepared by
the laboratory will be submitted online. For different discipline the laboratory has to apply separately.
The Quality Manual will be forwarded by NABL to a Lead Assessor to judge the adequacy of the
Quality Manual as to whether it is in compliance with ISO 17025 standards.
Thereafter the Lead Assessor will conduct a Pre-Assessment of the laboratory for one day. Based on the
Pre-Assessment report the laboratory may have to take certain corrective actions, so as to be fully
prepared for the final assessment.
Finally, when the laboratory is ready, the Lead Assessor and a team of technical assessors will conduct
the final assessment. The number of technical assessors will depend on the number of disciplines
applied for. The accreditation process involves a thorough assessment of all the elements of the
laboratory that contribute to the production of accurate and reliable test data. These elements include
staffing, training, supervision, quality control, equipment, recording and reporting of test results and the
environment in which the laboratory operates. The laboratory may have to take certain corrective
actions, after the final assessment.
After satisfactory corrective actions are taken by the laboratory (within a period of one month), the
Accreditation Committee will examine the report and if satisfied recommend accreditation. The time
required for the process of accreditation will depend upon the preparedness of the laboratory and its
response to the non - conformances raised during the pre-assessment and final assessment. The total
duration ranges between 6 and 8 months.
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Surveillance and Re-Assessment
Accreditation to a laboratory shall be valid for a period of two years.. The laboratories may enhance or
reduce the scope of accreditation during surveillance. After every year, Lab has to apply for the desktop
surveillance audit which is conducted in NABL office itself for the work done by the Laboratory to
check the technical competence to comply ISO 17025 standard.
The laboratories need to apply for renewal of accreditation, at least six months before the expiry of
validity of accreditation for which a re-assessment shall be conducted.
The information on fees of accreditation and its further maintenance may be gathered from NABL
document No 100.
References:-
1. ISO/IEC 17025:2017 , General requirements for the competence of testing and calibration
laboratories. International Organization for Standardization by ISO Central Secretariat Ch. de
Blandonnet, 8 Case Postale, 401 CH – 1214 Vernier, Geneva, Switzerland
2. Laboratory accreditation-Procedural guidelines, A.S .Kanagasabapathy and Pragna Rao
Kamineni Hospitals Ltd., L.B. Nagar, Hyderabad - 500 068, Indian Journal of Clinical
Biochemistry,2005, 20 (2) 186-188
3. www.nabl-india.org
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Important documents related to accreditation available on the website of NABL
S. No. Name of the document Document No 1. General Information Brochure 100
2. Terms & Conditions for Obtaining and
Maintaining NABL Accreditation
131
3. Application Form for Testing Laboratories 151
4. NABL’s Policies for Accreditation
(as per ISO/IEC 17025:2017
165
5. Guide for Preparing Quality Manual 160
6. Guidelines for Estimation and Expression of
Uncertainty of Measurement
141
7. Policy on Calibration and Traceability of Measurements
142
8. Policies and Procedures for inter-laboratory
comparisons and / or Proficiency Testing
163
9. Pre-assessment Guidelines and Forms
209
10. Policy and Procedures for assessment,
Surveillance & Re-assessment of laboratories
214
11. Policies & Procedures for dealing with
Adverse Decisions
216
12. Master list of NABL documents NABL 200 13. Document Review Checklist (as per ISO/IEC 17025:
2017)
220
14. Desktop surveillance 218