[ 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

Pursuant to the provisions of Sections 11 & 12 of RA 7308 œSeed 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


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.

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
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.

ARTICLE II
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;

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.
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.

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


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.

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.
SECTION  7. Criteria  for Evaluation  of Application  for Accreditation  - The application for accreditation shall be evaluated based on the following:
7.1     Completeness of the required documents submitted;

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
SECTION 8. Evaluation of Application for Accreditation
8.1 The process of accreditation shall take about 60 working days from the completion of orientation for accreditation conducted by BPI.

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.
SECTION  9. Certificate  of Accreditation  - The certificate  of accreditation  for private seed testing laboratory shall contain the following:
9.1     Accreditation Code issued by BPI;
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 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.

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:
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.
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:
13.1   Written Procedure;
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.
The BPI-NSQCS may conduct on site audit, if necessary.

ARTICLE IV
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.

18.1.2  When  the  accredited  laboratory  has  two  (2)  consecutive unsatisfactory proficiency test results due to ineffective corrective actions on the affected scope.
18.2   Cancellation of Accreditation
18.2.1   Misdeclaration,   misrepresentation,   false  statements,  dishonesty and  fraud  in the  application  for  accreditation,  renewal  of accreditation or in seed testing documents.

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.
An accredited laboratory whose accreditation is cancelled shall return to BPI- NSQCS the original certificate of accreditation.

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


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