ISO accreditation a world-first for CIP genebank

the formal ISO Certificate of Accreditation

In what is a world first, the CGIAR International Potato Center (CIP) in Lima, Peru, was awarded International Organization for Standardization (ISO) Accreditation for its germplasm acquisition, management and distribution operations. This is the first time that a genebank has gained accreditation anywhere in the world.

This means that in vitro material distributed from CIP will bear ISO accreditation that it is free from viruses, pathogens and diseases. As well as the confidence this will inspire in CIP’s partners, it is evidence that the biodiversity the Center holds in trust is being safely conserved for the future.
 
With the collaboration of a quality systems expert from the Central Science Laboratory in the UK, Dr. David Galsworthy, CIP has successfully implemented a quality system covering the complete distribution process of in vitro germplasm. “CIP is the first CG genebank to implement a quality system in a genebank,” said David Galsworthy, “and the first genebank in the world to gain accreditation to ISO 17025.”

“The accreditation is a milestone event in many ways for CIP and was only possible through the hard work and dedication of the CIP staff,” said Dr. Pamela Anderson, the Director General of CIP. “This demonstrates how seriously we take our obligations to distribute disease-free germplasm. I am very proud that CIP’s genebank is the first in the world to gain ISO accreditation.”

The movement of planting material globally provides a potential pathway for the spread of many pests and diseases. CIP, as custodian of the world’s largest collection of potato and sweetpotato germplasm, has always taken its obligations to maintain and distribute this material extremely seriously. In early 2007, CIP’s senior management took the forward-looking decision to formalize and modernize the systems of ensuring the distribution of clean germplasm within a Quality System and obtain external third party verification of their effectiveness through accreditation.

Implementing a Quality System involves identifying, characterizing and controlling key operational processes and demonstrating their effectiveness through validation and quality control. CIP was extremely keen to use a Quality System to demonstrate the highest level of technical expertise and competence. In doing so, the Center chose to model its system on the   ISO/IEC 17025 Quality  Standard  for  the Competence of Testing Laboratories. This is recognized as the highest and most demanding Standard for Quality Systems. The Center sought accreditation against this Standard from the highly respected United Kingdom Accreditation Service (UKAS).

The work of introducing the Quality System built on the considerable investment CIP has made over a number of years, with workflows formalized and a barcode records system introduced to track the movement of germplasm.  During 2007, with the help of David Galsworthy, the vision of a fully integrated Quality System became a reality. All aspects of the acquisition, management and distribution of germplasm were brought into the system, with participation from staff of the genebank, pathogen testing, distribution, administration and research informatics.

The operational documentation was organized using an innovative Wiki-based web solution to link well over 500 sources of information. This has resulted in a highly flexible, paperless system that can be easily updated to reflect changes in the organization of the work. “Working through a website with the capability to manage contributions from all the staff involved turned out to be extremely efficient,” said David Galsworthy. “This approach has a very wide-ranging potential for its application and it is a model I will be taking back to the UK and implementing it in my own Institute.” This approach will also allow the remote assessment of the system by the UKAS assessment team, saving airfares and costs for the Center.

Validation data were also generated to clearly establish and quantify the risks associated with potential failure of the germplasm-pathogen screening process. The results of this validation clearly demonstrated the high level of confidence that CIP can place in these detection systems. CIP staff received training in internal auditing, to monitor effectiveness as well as promoting quality improvement and efficiency gains.

Implementation finished in December 2007. Assessment Manager Dr. Sally Higgins and Dr. Colin Jeffries of the Scottish Agricultural Science Agency (SASA) made the UKAS initial assessment against ISO/IEC 17025 in January 2008. Dr. Jeffries is also one of the editors of the FAO/IPGRI Technical Guidelines for the Safe Movement of Potato Germplasm and acted as the assessment technical expert.

The UKAS assessment team was very positive and complementary about the systems that had been introduced as well as the extremely high level of competence of all the staff involved. “CIP has demonstrated through this Initial Assessment, good compliance with the requirements of ISO 17025,” wrote Colin Jefferies in his report. “The personnel interviewed and witnessed were enthusiastic, knowledgeable and competent in the procedures examined.”

The issues raised at the assessment visit were dealt with and Accreditation was granted by UKAS on the 22 February 2008.  The Quality System will be continue to be monitored by UKAS during the annual surveillance visits and has the potential to help drive even higher the gold standard for genebank management that has now been set at CIP. “The genebank is a long-term responsibility for CIP and we have made a long-term commitment to this process,” said Dr. Charles Crissman, Deputy Director General for Research.
 
“This is a significant step forward for the organization,” said David Galsworthy. “CIP’s commitment to this process is to be commended.” The realization of an accredited system supporting healthy germplasm distribution at CIP could provide a model for other genebanks within the CGIAR and the rest of the world.  This would contribute significantly to the speed and trust with which germplasm can be shared among countries for breeding purposes and the future delivery of better varieties that afford developing countries greater food security.