[ BPI ADMINISTRATIVE ORDER NO. 4, S. 2005, January 14, 2005 ]
GENERAL GUIDELINES AND REQUIREMENTS FOR ACCREDITATION OF PRIVATE AND OTHER SEED TESTING LABORATORIES
Pursuant to the implementation of Section 12 (g) of RA 7308 known as the Seed Act and the need to provide immediate and timely seed testing services for farming populace, the following requirements for accreditation of private and other seed testing laboratories are hereby promulgated based on ISO/IEC Guide 25: 1990 (E), General Requirements for the Competence of Calibration and Testing Laboratories, Bureau of Product Standard of the Department of Trade and Industry) and the International Seed Testing Association (ISTA), as follows:
I.
PURPOSE AND SCOPE:
This standard constitute the requirements which are to be fulfilled by any private and other seed testing laboratory in order to obtain an accreditation from the National Seed Quality Control Services (NSQCS), Bureau of Plant Industry.
Applicants will have to provide documentation for all points and must allow inspection of the premises by NSQCS assessors. Application forms are available from NSQCS Office, Visayas Avenue, Diliman, Quezon City.
Applicants pay for the services rendered during assessment, travel expenses, inspections and pay an annual fee for the privilege accreditation.
II
DEFINITION OF TERMS:
When used in this guidelines, the following terms shall mean as follows:
Accreditation Formal recognition of competence Accreditation Body National Seed Quality Control Services under BPI Assessors Persons appointed by the NSQCS, Bureau of Plant Industry to carry out audits and provide recommendation Audit Periodic and systematic assessment of all policies and procedures Certificate Document that presents test results and other information relevant to the test Seed Testing Lab. Laboratory that perform seed tests Pest Methods Defined technical procedure for performing a test ISO/IEC International Organization for Standardization, International Electrotechnical Commission ISO/IEC GUIDE Drawn up in response to IAC: (International Laboratory Accreditation Conference) request Documentation Written procedures or results Quality Manual Collection of documents, which describe quality policy, quality system and quality practices in the laboratory Reference Materials Materials, which provide essential traceability and are used to demonstrate the accuracy of results, calibrate equipment and methods, monitor performance and validate methods and enable comparison of methods by the set standards
III
REQUIREMENTS:
1. The Laboratory shall be legally identifiable.
The owner of the laboratory whether an individual, partnership or corporation must be registered with the Department of Trade and Industry (DTI) or the Securities and Exchange Commission (SEC).
2. The laboratory shall have a clear structure and responsibility.
It shall have:
2.1 Managerial staff with the authority and resources to discharge duties
2.2 Technical staff responsible for the "production" of results and all technical operations, i.e. laboratory seed analysis.
2.3 Quality control staff who has responsibility for the quality system of the laboratory and its implementation e.g. participating in referee testing.
3. The laboratory shall have a protocol - in terms of handling of results, audit and reviews, trained personnel, and adequate facilities, documentation such as:
3.1 Quality Manual - shall state the laboratory's policies and operational procedures and other related quality documentation such as:
a. Policy statement, including objectives and equipment
b. The organization and management structures of the laboratory, its place in any parent organization and relevant organizational chart.
c. Relations between management, technical operations, support services and quality system.
d. Procedures for control and maintenance of documentation
e. Job description of key staff and reference to job descriptions of other staff
f. Identification of the laboratory's signatories
g. Laboratory's testing methods and procedures including sampling which shall be preferably approved internationally, i.e. ISTA
h. Reference to major equipment and reference measurement standards (seed standards)
i. Reference to laboratory's scope and procedures of handling calibration, certification and maintenance of equipment.
j. Reference to verification practices including inter-laboratory comparisons, proficiency testing programmes, use of reference materials and internal quality control scheme.
k. Procedures to be followed for feedback and corrective action whenever testing discrepancies are detected or departures from documented policies and procedures
l. Procedures for dealing with complaints
m. Procedures for protecting confidentiality and proprietary rights
n. Procedures for audit and review
4. Personnel
4.1 The testing laboratory shall have sufficient personnel, having the appropriate education technical knowledge and experience for their assigned functions.
5. Equipment and Reference Materials
5.1 The laboratory shall be furnished with all items of equipment including reference materials required for the accurate performance of various seed quality test. These include germinator, over, dessicator, moisture tester, purity workboard, magnifier, microscope (special case) with corresponding supplies like filter paper, forceps, Petri dishes and the like
5.2 All equipment shall be properly labeled, maintained and calibrated; maintenance and calibration procedures shall be documented.
6. Training
6.1 The personnel shall have undergone training on the technical aspect of seed including operation and maintenance of the laboratory.
6.2 The laboratory shall ensure that training of personnel is kept up to date
IV
ASSESSMENT AUDITS
1. A pre and post - accreditation assessment is conducted by the BPI to determine if all the requirements for accreditation is met.
2. The laboratory shall afford representatives and assessors of the accreditation body access to the laboratory and to all documents needed for an assessment
V
MONITORING
1. Comprehensive and activities of laboratory staff is audited at least once a year as to the following elements:
1.a procedures and instructions in major analysis of sample, registration and processing of results
1.b knowledge and proficiency in analysis
2. Check analysis and compare results using the ISTA tolerance levels.
3. If there are non-conformities, corrective measures must be undertaken right away
VI
Schematic Diagram showing the procedure for the accreditation of private and other seed testing laboratories is attached.
VII
COMPLAINTS
The laboratory shall have documented policy and procedures for the resolution of complaints received from clients or other parties about the laboratory's activities. A record shall be maintained of all the complaints and of the actions taken by the laboratory.
VIII
VALIDITY
Accreditation shall be valid for a period of six (6) years.
The implementation of this order shall be spearheaded by the National Seed Quality Control services, Bureau of Plant Industry.
This order shall take effect immediately.
Adopted: 14 Jan. 2005
(SGD.) ARTHUR C. YAP
Secretary