[ DEPARTMENT CIRCULAR NO. 06, S. 2018, March 08, 2018 ]
GENERAL GUIDELINES AND REQUIREMENTS FOR THE ACCREDITATION OF PRIVATE SEED TESTING LABORATORIES
Adopted: 08 January 2018
Date Filed: 08 March 2018
Date Filed: 08 March 2018
Pursuant to the provisions of Sections 11 & 12 of RA 7308 Seed Industry Development Act of 1992 creating the National Seed Quality Control Services and the need to accredit private seed testing laboratories to facilitate testing the quality of seeds, the following guidelines and requirements for the accreditation of private seed testing laboratories are hereby issued.
ARTICLE I
GENERAL PROVISIONS
GENERAL PROVISIONS
SECTION 1. Objective
This Circular aims to rationalize and enhance the requirements and procedures which shall be complied with by any private seed testing laboratory in order to obtain an accreditation from the Bureau of Plant Industry (BPI).
SECTION 2. Definition of Terms - for purposes of this Circular, the following terms shall mean:
2.1 Accreditation - The process in which an authoritative body formally recognizes the competence, impartiality and capability of an organization to carry out seed testing.SECTION 3. Scope - This Circular applies to the accreditation of any private seed testing laboratory by the BPI, specifically providing for the accreditation requirements and procedures, evaluation, approval and renewal of accreditation.
2.2 Accreditation Body - An authoritative body that performs accreditation and shall refer to herein as the Bureau of Plant Industry - through the National Seed Quality Control Services (BPI-NSQCS).
2.3 Audit - Periodic and systematic evaluation of all documents, procedures and technical competence of personnel involved in compliance to the requirements of BPI-NSQCS.
2.4 Auditors - Persons designated by the BPI Director to carry out audit and provide recommendation.
2.5 Certificate of Accreditation - An official document being issued by accreditation body to the accredited private seed testing laboratory.
2.6 Interlaboratory Comparison (ILC) - Organization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions.
2.7 ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories, specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling which was published in May 2005 by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.
2.8 ISTA - International Seed Testing Association, a leading international
organization for cooperation in building seed testing capacity in all regions of the world to develop, adopt and publish standard procedures for sampling and testing seeds, and to promote uniform application of these procedures for evaluation of seeds moving in international trade.
2.9 On site audit - Part of the audit conducted by the auditors to verify compliance of the applicant-laboratory with the accreditation requirements by the BPI-NSQCS which takes place in the premises of the laboratory.
2.10 Private Seed Testing Laboratory - Any non-government entity engaged in seed testing.
2.11 Proficiency Test - A process for checking actual laboratory testing performance, usually by means of inter-laboratory test data comparison.
2.12 Scope of Accreditation - Specifies requirement applicable to a particular test type such as moisture content, physical purity and germination for a specific crop group (ANNEX 1 BPI-NSQCS Crop Group Table) that the applicant-laboratory is applying for accreditation.
2.13 Seed Testing - the accurate and prompt analysis of a seed sample using various test types based on methodologies under the NSIC sanctioned BPI-NSQCS, or ISTA seed testing procedures.
2.14 Test type - Refers to different testing analysis for seed quality such as moisture content determination, physical purity and germination
ARTICLE II
REQUIREMENTS
REQUIREMENTS
SECTION 4. Documentary Requirements - The following documentary requirements shall be submitted to the BPI for laboratory accreditation:
4.1 Letter of Intent addressed to the BPI Director through the Chief of NSQCS;For documents requiring certified true copy, the applicant shall present the original copy for comparison with the scanned or photocopied documents. If the scanned or photocopied document is found to be a faithful reproduction, the same shall be stamped Verified from the Original.
4.2 Accomplished Application Form together with attached latest (within the last 6 months) 2 x 2 colored picture of the applicant or authorized representative;
4.3 Board Resolution or Special Power of Attorney, where appropriate, authorizing the applicant s representative to apply for accreditation;
4.4 Valid Business or Mayor's Permit (Certified True Copy); and
4.5 Certified true copy of the Certificate of Registration from the Department of Trade and Industry (DTI) for single proprietorship, Securities and Exchange Commission (SEC) for partnership and corporation, or Cooperative Development Authority (CDA) for cooperative, whichever is applicable.
SECTION 5. Technical Requirements - the applicant shall comply with the following technical requirements:
5.1 Profile of the Laboratory (name, address, organizational chart, contact person, contact number, function, and responsibilities);
5.2 Existing seed testing analysis which includes the following;
5.2.1 Scope of test type
5.2.2 Scope of crop group
5.3 Private seed testing laboratory that has been in operation for a minimum of one (1) year;
5.4 List of laboratory equipment and facilities with records of calibration and verification;
5.5 Lay-out of office/laboratory;
5.6 List of laboratory personnel involved in the test type being applied for including proof of relevant trainings and educational attainment;
5.7 Manual of Operations of the laboratory;
5.8 Copy of documents from international body (a) attesting that the applicant passed the Proficiency Test conducted by the said body and (b) demonstrating evaluation of laboratory performance in the scope applied for, if any. In the absence of these documents, the applicant shall participate in proficiency testing conducted by BPI NSQCS with satisfactory results; and
5.9 Copy of Certificate of Accreditation for ISO/IEC 17025, ISTA Accreditation,
or analogous accreditation, if any.
ARTICLE III
ACCREDITATION PROCEDURE
ACCREDITATION PROCEDURE
SECTION 6. Application Procedure
6.1 The applicant shall submit to the BPI Director through the Chief of the NSQCS a Letter of Intent including the documentary and technical requirements specified in Sections 4 & 5 hereof. All the documents submitted by the applicant shall be treated with utmost confidentiality.SECTION 7. Criteria for Evaluation of Application for Accreditation - The application for accreditation shall be evaluated based on the following:
6.2 Upon submission, the BPI-NSQCS designated staff shall immediately check the submitted documents for completeness of required documents. Applicants with complete documents shall be notified within three (3) working days upon submission of documents and must pay a non- refundable application fee. Applications with incomplete requirements shall be returned to the applicant stating the reason for denial and recommendations.
6.3 Within five (5) working days from payment of application fee, the applicant must attend a one (1) day orientation on the process of accreditation conducted by the BPI NSQCS.
7.1 Completeness of the required documents submitted;SECTION 8. Evaluation of Application for Accreditation
7.2 Legitimacy of the operation of the applicant's laboratory;
7.3 Methods used are in accordance with NSIC sanctioned, BPI-NSQCS, or
ISTA seed testing procedures;
7.4 As a measure of competency, applicants must pass the proficiency test;
and,
7.5 As a measure of competence of the analysts/staff, the applicant must pass the on-site audit
8.1 The process of accreditation shall take about 60 working days from the completion of orientation for accreditation conducted by BPI.SECTION 9. Certificate of Accreditation - The certificate of accreditation for private seed testing laboratory shall contain the following:
8.2 As part of the evaluation of application, the auditors shall make an on-site audit of the laboratory including interview of the head of the laboratory and its analysts, check documents like, but not limited to, standard operating procedures, work instructions manual, logbooks and calibration records.
8.3 During audit, the applicant shall be informed of any non-compliance and shall be given recommendations on corrective measures. The applicant shall submit to the BPI Director through the NSQCS a report of corrective actions within 30 working days after the audit. The auditors shall conduct further on-site audit to check if the corrective actions are complied with.
8.4 The BPI-NSQCS Chief shall endorse the result of evaluation to the BPI- Director for appropriate action. The Director shall approve or disapprove the application for accreditation based on the evaluation result and recommendation submitted.
8.5 The BPI Director through NSQCS shall issue the Certificate of Accreditation upon payment of the accreditation fee.
8.6 All application documents that are not favourably considered shall be returned to the applicant together with a letter stating the reason/s for denial.
9.1 Accreditation Code issued by BPI;SECTION 10. Authority to Conduct Seed Testing - Private seed testing laboratories accredited pursuant to this Circular shall be authorized to conduct seed testing in compliance with NSIC sanctioned, BPI-NSQCS, or ISTA seed testing procedures and shall be recognized as BPI-NSQCS seed testing laboratories.
9.2 Name of laboratory;
9.3 Address of the laboratory;
9.4 Scope of accreditation;
9.5 Name/s of authorized signatories and their specimen signatures;
9.6 Date of issuance and expiration;
9.7 Terms and conditions; and
9.8 Quick Response (QR) code.
SECTION 11. Validity of the Certificate of Accreditation - The certificate of accreditation shall be valid for a period of five (5) years from the date of issuance.
SECTION 12. Procedure for the Renewal of Accreditation - The procedure outlined in Sections 6 and 7 hereof shall be applied in the processing of applications for renewal of accreditation. Moreover, the following measures shall be complied with:
12.1 Accredited private seed testing laboratory may renew their accreditation within three (3) months before the expiry date. Failure to do so, the following procedures shall apply:SECTION 13. Extension of Scope of Accreditation - For an accredited laboratory that intends to extend the scope of accreditation to other test types and/or crop groups, the following requirements shall be submitted:
12.1.1 After the expiry date, the laboratory shall be removed from the list of accredited laboratories; and
12.1.2 In case the laboratory applies for re-accreditation after the expiry date or after delisting from the roll, the applicant shall be considered as a new applicant.
12.2 The BPI Director through the NSQCS shall issue a certificate of accreditation.
12.3 At any time, the BPI Director may authorize the conduct of on-site audit and monitoring of the accredited laboratory.
13.1 Written Procedure;The BPI-NSQCS may conduct on site audit, if necessary.
13.2 Proficiency test for the specific test type or crop group being applied for;
13.3 List of personnel authorized to conduct the test; and
13.4 Proof of training.
ARTICLE IV
AUDIT
AUDIT
SECTION 14. Scope of Audit - The audit shall cover the test types for particular crop group applied for by the applicant as shown in ANNEX 1 BPI-NSQCS Crop Group Table.
SECTION 15. Monitoring Period - Regular monitoring shall be conducted by designated BPI-NSQCS staff at least three (3) times within the validity period of accreditation. The accredited laboratory must also participate in inter-laboratory comparison organized by BPI-NSQCS once a year.
SECTION 16. Audit Procedure - The procedure for the conduct of audit are as follows:
16.1 A notice of audit shall be forwarded to the accredited laboratory at least one (1) week before the scheduled audit. The notice includes the following:
16.1.1 Date of audit;
16.1.2 Scope of audit; and
16.1.3 Names of at least three (3) auditors who will conduct the audit.
16.2 The applicant, all authorized signatories and all concerned analysts of the applicant must be present during the conduct of audit.
16.3 After the audit proper, the audit team leader shall present and discuss the findings with the applicant and all concerned.
16.4 If there are non-compliance, the applicant shall submit to the BPI Director, through the NSQCS, a report of corrective and preventive actions on all findings within 30 working days from receipt of the said report.
16.5 The BPI-NSQCS shall evaluate the submitted report of corrective and preventive actions and prepare the results of evaluation.
16.6 The BPI-NSQCS Chief shall endorse the results of evaluation to the BPI Director for the issuance of a certificate of compliance to audit.
ARTICLE V
FEES
SECTION 17. Fees - The following fees shall be collected:
Application fee: - P 1,000.00
Accreditation fee:
New - P 4,000.00
Extension - P 1,500.00
Renewal - P 1,500.00
ARTICLE VI
SANCTIONS AND PENALTIES
SECTION 18. Sanctions and Penalties - The following are grounds for the suspension or cancellation of accreditation:
18.1 Suspension of Accreditation
18.1.1 When an audit reveals that an accredited laboratory has failed to comply with the requirements for accreditation and corrective action cannot be taken/submitted within the specified time as directed by the BPI-Director.18.2 Cancellation of Accreditation
18.1.2 When the accredited laboratory has two (2) consecutive unsatisfactory proficiency test results due to ineffective corrective actions on the affected scope.
18.2.1 Misdeclaration, misrepresentation, false statements, dishonesty and fraud in the application for accreditation, renewal of accreditation or in seed testing documents.An accredited laboratory whose accreditation is cancelled shall return to BPI- NSQCS the original certificate of accreditation.
18.2.2 If the laboratory fails to achieve full compliance, declines to take appropriate corrective action within three (3) months from the date of suspension.
18.2.3 If the laboratory does not intend to renew its accreditation at the end of the accreditation period and voluntarily declares non- interest in accreditation within the accreditation period.
Reactivation of suspended accreditation shall be done only after a full assessment is conducted and the laboratory is found to comply with the accreditation requirements. The laboratory shall reapply and pay all the required fees and other costs that may be incurred during the assessment.
ARTICLE VII
MISCELLANEOUS PROVISIONS
MISCELLANEOUS PROVISIONS
SECTION 19. Repealing Clause - Administrative Order No. 4 Series of 2005, or the General Guidelines and Requirements for Accreditation of Private and Other Seed Testing Laboratories, is hereby repealed. All existing administrative orders, memoranda, circulars, rules and regulations or parts thereof, which are inconsistent with the provisions, of this Circular are hereby repealed or modified accordingly.
SECTION 20. Separability Clause - If any portion of this Circular is declared unconstitutional or invalid, other portions thereof which are not affected shall continue to be in full force and effect.
SECTION 21. Effectivity - This Circular shall take effect fifteen (15) days upon publication in the official gazette or in two (2) newspapers of general circulation and its filing with the National Administrative Register, U.P. Law Center.
(SGD) EMMANUEL F. PINOL
Secretary, Department of Agriculture and Chairman,
National Seed Industry Council
Secretary, Department of Agriculture and Chairman,
National Seed Industry Council