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ACCREDITATION / Accreditation / Procedure
 
 
 
  Accreditation Procedure        
  Accreditation Procedure
 
ISTA Membership

Only ISTA member laboratories may apply for accreditation. Laboratories that are not ISTA members must apply for membership prior to accreditation. In general, membership in ISTA is open to all persons or laboratories supporting the Association's aims as laid down in the articles of the ISTA. Membership services include receipt of free copies of all new publications, participation in the inter-laboratory proficiency test programme and access to ISTA's international network of seed scientists and technologists. A directory of all ISTA members is published on the ISTA website.

Detailed information on membership and application forms are available from the ISTA Secretariat upon request.


Participation in the ISTA Inter-laboratory Proficiency Test Programme

Participation in the Proficiency Test Programme is obligatory for laboratories accredited by ISTA and a precondition for applying for accreditation. It is voluntary for non-accredited member laboratories who want to bench mark their performance with that of accredited laboratories and prepare themselves for accreditation some day.

Samples, prepared by the Proficiency Test Leader are distributed by the ISTA Accreditation Department on the beginning of February, June and October each year. A programme plan of proficiency tests is drawn up every three years and distributed to member laboratories. Laboratories accredited for the generic species group being tested in a particular test round are asked to carry out tests according to their preferred ISTA method and report the results on reporting sheets provided within a given deadline. The ISTA Accreditation Department collects and evaluates the proficiency test results after the deadline. Participating laboratories receive a graphical print out, showing their performance in comparison with the mean performance of all laboratories participating in the test.

Laboratories applying for accreditation can request a package of pre-accreditation proficiency test samples. Completing tests on these samples can minimise the time between application and completion of accreditation.

The document 'The ISTA Proficiency Test Programme' is published at the related documentation page .


Establishment of a Quality Management System

A laboratory applying for accreditation must establish a quality management system according the ISTA Laboratory Accreditation Standard. The quality management system shall be documented in a quality manual that also includes standard operating procedures (SOPs) and work instructions. The Secretariat compiled 'Guidelines for developing quality documentation' which may also be obtained free of charge upon request.


Application for Accreditation

Application for accreditation is made by submitting a completed Application Form for (Re‑)Accreditation. The laboratory is required to specify the scope of accreditation it claims competence for (i.e. methods and species tested). Authorisation for the issuance of ISTA Certificates can only be granted in accordance with a relevant scope of ISTA Accreditation.


Document Review

Laboratories audited for the first time will be requested to submit their quality documentation or parts of it to the Secretariat. These documents are subject to review by the ISTA Auditors to verify if the requirements concerning the documentation are appropriately addressed. In case of major non-conformities, the auditors may require corrective action to remove them prior to the on-site assessment. If the documents are considered appropriate for the purpose of an audit, the audit date is arranged. Accredited laboratories that are re-audited will be approached by the Secretariat well in advance to arrange the audit date and to ask for a completed Application Form for (Re-)Accreditation. They have to submit their quality documentation at least four weeks prior to the arranged audit date in two copies or electronically.

The documents must contain a general description of the laboratory, e.g. an organisational chart, and a description of the responsibilities of individual members of staff, e.g. management, administration, testing, reporting, etc. The laboratory's standard operating procedures (SOPs) and work instructions must also be provided. The appointed audit team will examine the documents and, if necessary, ask for more detailed documents and/or have corrective actions carried out prior to the audit. Where the language used in the laboratory is not English, ISTA requires a copy of the quality documents table of contents to be translated into English. The lead auditor will choose which parts of the quality documents have to be translated prior to the audit. Translation is the responsibility of the laboratory.


ISTA Audit

An ISTA audit is usually made by two auditors, the system auditor and the technical auditor. The system auditor is the lead auditor. As such he/she is responsible for all steps in the accreditation process. He or she examines the quality management system in general and whether it is applied in the every-day work. Technical auditors are seed experts and trained in assessing testing laboratories. He or she, on the other hand, examines the technical aspects of the laboratory (e.g. calibration procedures, application of testing procedures, performance of the laboratory in inter-laboratory comparative tests, etc.). The auditors verify the status of the laboratory concerning its involvement in other activities as well as the appropriateness of its scope of accreditation.

The appointment of auditors is the responsibility of the ISTA Accreditation Department and depends on the scope of accreditation and the availability and language knowledge of an auditor. The on-site assessment in the premises of the laboratory will be arranged in consultation with the laboratory by the ISTA Accreditation Department. The assessment usually starts with an opening meeting between the auditors, the head of the laboratory and the staff members involved. This meeting gives the auditors the chance to meet the laboratory staff and to explain the purpose of the audit and the process involved. After the opening meeting, the laboratory is inspected, documents are studied and staff members are interviewed. After that, the auditors will have a meeting to compile facts and data gathered during the inspection. In a final meeting the auditors present their overall results to the staff members.

Depending on the size of the laboratory, an on-site assessment takes between one to one and a half working days.

During the on-site assessment, audit findings are recorded in the Audit Detail Report, and signed by the respective auditor and the head of the laboratory. The overall result of the assessment will be reported in an Audit Report, which includes a Checklist of items covered during the audit. The Audit Report presented to the head of the laboratory after the audit contains at least the following: Name and address of the laboratory; names of the auditors; names and position of the staff present at the audit; scope of accreditation; summary of the laboratories performance in inter-laboratory comparative test results; summary of the audit findings; list of non-compliances that have to be removed; and deadline for removing substantial non-conformities.

A date by which the observed substantial non-conformity will be cleared will be negotiated with the laboratory. Substantial non-conformities have to be rectified before the auditors recommend accreditation. Non-substantial non-conformities have to be rectified before the next audit three years later.

Non-compliances with regard to the quality management system are recorded during the audit. There are two kinds of non-conformities:
Substantial non-conformities are non-conformities that have a significant influence on the quality of the work. This could be, e.g. a requirement given by the accreditation standard not implemented and described, or described but not yet implemented.
Non-substantial non-conformities are non-conformities that are not expected to have a significant influence on the quality of the laboratory's work.

Accreditation approval procedure: After having fulfilled the requirements of the ISTA Laboratory Accreditation Standard, the auditors will recommend the granting of accreditation to the laboratory. The ISTA Executive Committee is responsible for decisions regarding accreditation on the basis of the information gathered during the accreditation process and the recommendations of the auditors.

Documentation: When accreditation is approved, the laboratory receives a confirmation letter and the Certificate of Accreditation which states the audit date, the scope of accreditation and the period of validity. A list of methods covered by accreditation is appended to the Certificate of Accreditation. The Certificate is signed by the ISTA President and is validated by applying a dated identification sticker at the bottom of the certificate. This sticker is obtained when the ISTA Secretariat has received payment of the annual accreditation subscription fee.


Authorisation to issue ISTA Certificates

Once the accreditation process is completed, the laboratory obtains authorisation to issue ISTA Certificates in accordance with its scope of ISTA accreditation. Authorisation is granted with a validity of three years starting at the date of the on-site assessment.




 
Last updated: 24.05.2017 (BO)

 


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