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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