Contact person for Quality management: Jean Hanson, ILRI, Ethiopia
Contributors to this page: Bioversity International/ILRI, Ethiopia (Alexandra Jorge); CSL (David Galsworthy); CIP (Edwin Rojas).
This page provides the latest updates on Quality Management Systems (QMS) for genebanks.
There is increasing pressure to define and use criteria of quality for commercial as well as research processes and procedures. The underlying concepts have been applied in many areas of modern society to control risk and provide the mechanism for quality improvement. Manufacturing, food production, pharmaceutical industry, environmental controls and information technology are just some of the areas that rely on the application of quality standards and systems to support business. However, the biological/agricultural sciences have been slow to recognize the benefits of these systems and there have been limited Quality Management System (QMS) application in these fields.
A QMS can be defined as a set of policies, processes and procedures required to plan and execute the activities of any genebank. Implementing a QMS within any organization needs to be a top management decision.
An adequate and suitable QMS should have the capacity for improving the quality of operations by:
- Demonstrating control of critical risks.
- Improving control of proper functioning of equipment and quality of supplies.
- Improving quality control of processes.
- Formalizing training of staff and the demonstration of staff competence.
- Supporting best practice implementation.
- Compliance with any audit procedures.
The implementation of an appropriate QMS is particularly relevant for genebanks which are constantly striving for the highest standards in order to conserve and maintain crop genetic resources. Key genebanks have recently taken the lead in the implementation of QMS using the framework of the International Organization for Standardization (ISO) quality standards and have gained certification (ISO 9001) or accreditation (ISO 17025) of their operations. This has allowed an analysis of the possibility of using ISO quality standards more widely and broadly within its genebank community.
Options for QMS of genebanks
Options ranging from a minimum documentation for a quality system through to formal recognition through accreditation are all possible levels of implementation of a QMS suitable for genebank management:
1. Certification – Product certification refers to the processes intended to determine if a product meets minimum standards, similar to quality assurance, which is usually related to administrative operational procedures. The ISO 9001 is a generic management standard that can be applied to any business enterprise, public administration, government department or research institute. It has been successfully used in laboratories and genebanks. Certification to ISO 9001 standard does not guarantee the compliance (and therefore the quality) of any end product or service; rather, it certifies that consistent processes are used and the system of an organization is being applied to assure consistency. A pre-requisite for an organization to become certified is to have a documented quality management system that follows the content of ISO 9001. Examples of genebanks using certification are the Centre for Genetic Resources, the Netherlands and Institute of Plant Genetics and Crop Plant Research, Germany.
2. Accreditation – The accreditation process ensures that certification practices of competency, authority or credibility are acceptable, typically meaning that they are competent to test and certify third parties, behave ethically and employ suitable quality assurance. It is usually related to technical operational procedures. The ISO 17025 is aimed at improving an organization’s ability to consistently produce valid results and it has been successfully used for laboratories and also genebanks. ISO 17025 comprises both management and technical requirements. The management requirements are primarily related to the operation and effectiveness of the quality management system. The technical requirements address the competence of staff, validation of methodology and equipment control. Since this standard is about competence, accreditation is used for the formal recognition of that competence. In the same way as ISO 9001, a pre-requisite for an organization gaining accreditation is to have a documented quality management system that follows the requirements of ISO 17025 standard. This quality standard allows organizations to carry out procedures in their own way, but requires the demonstration of continuous improvement, by regular audit. An example of a genebank using accreditation is the International Potato Centre (CIP), Peru.
3. Documentation of Processes - Each genebank should define, document and adopt the processes employed to reach the appropriate minimum standard for routine procedures, taking into account specific risks and local conditions. Regular revisions and necessary updates may be necessary to this minimum specification. Documentation of processes is vital to enable the capture of knowledge accumulated by staff over many years. Lack of proper recording and documentation with limited accessibility to the information is a major issue. The completion of detailed documentation for genebank operations is seen as a minimum requirement for high quality genebank management and could eventually lead to full implementation and more formal verification of performance through certification and accreditation at a time when it is felt that the genebank is ready for moving to this level. Many genebanks are already using this approach.
4. Designer solution – A combination of QMS approaches can also be a practical solution for genebanks. ISO certification or accreditation can be used for particularly critical or high risk activities/procedures of the genebank together with documentation of processes for routine less risky operations. This compromise would guarantee a more controlled and reliable approach to key procedures and selected genebank activities. An example of a genebank using the designer approach is CIMMYT, where the genebank operations follow documented procedures but the seed health laboratory uses ISO standards.
Whichever option is selected the best value is obtained by balancing the use of resources on the one hand and perfection on the other. The objective of the quality system needs to be clearly defined so that the system can be effective. The design and implementation of a quality management system will vary depending on the type, size and products of the genebank. While there are many similarities between genebanks, allowing systems already created for some genebanks to be partially adapted/adopted by other similar genebanks, each genebank will have its own procedures depending on crop and management.
The comparison of options concluded that:
The highest level of quality assurance, as well as the most prestigious, is achieved with accreditation but this comes together with a higher financial cost and commitment.
An intermediate and possibly equally good option is the designer option, with careful choices of critical areas.
The least costly solution appears to be the Documented Procedures. This has the possibility to be upgraded into any of the other full certification and accreditation ISO solutions at a later stage, allowing for a gradual change.
Implementation of a QMS of genebanks
Steps in the selection and implementation process for a QMS are:
- Evaluate the external factors.
- Seek information regarding external policies and requirements that will impact on genebank procedures.
- Evaluate the internal factors.
- Assess the present system and resources available for implementation.
- Evaluate QMS model to apply.
- Gather information and determine the complexity and the amount of work required for different models and how this will be applied for the crop.
- Decide on QMS options.
- Based on the above information, determine which model best fits the needs.
- Formulate an implementation plan.
- The overall implementation plan should include: objectives, milestones and responsibilities for all the key areas of a QMS:
- Overall system design.
- Quality procedure production.
- Documentation of procedures and workflows (ideally this should be already in place in any genebank system).
- Introduce a record system to allow re-creation of all activities at a later stage.
- Internal audit training.
- Internal audit plan and implementation.
- Production of training records.
- Establish environmental controls as necessary.
- Validate methodology of processes.
- Produce equipment records and evidence of equipment control.
- Produce evidence of compliance.
- The overall implementation plan should include: objectives, milestones and responsibilities for all the key areas of a QMS:
- Implementation should be regularly monitored to ensure milestones are appropriate and met.
- Independent verification if desired/required
- This is only applicable for the certification to ISO 9001 or accreditation to ISO 17025. The normal process would involve the initial dialogue with the certification/accreditation body, pre-assessment visit, then assessment visit and finally the award of certification/accreditation.
- Ensure maintenance of the system
- The system needs to be regularly reviewed to ensure it is being adequately maintained. This includes regular surveillance visits in the case of certification or accreditation.
Recommended best practices for QMS of genebanks
The main recommendations for application of a QMS were:
- Any genebank should have a good a reliable QMS in place, properly documenting all the procedures, as a minimal baseline.
- Accreditation would be the best technical option to minimize the risk of loss of diversity in crop genebanks. If resources allow, the implementation of ISO 17025 is highly recommended but ISO 9001 is a good option.
- The designer solution provides flexibility using risk/vulnerability based choices to determine which areas require accreditation.
- Certification or Documented Procedures alone are not the best technical choices for genebanks with critical and risky areas.
Relevant adequate certification/accreditation bodies should be approached to consider a formal quality assurance ISO for genebanks.
Click on ISO for genebanks to read the full document about the feasibility study and major recommendations that were submitted to the SGRP in December 2008. Click also on the table of addressed changes to read about the major comments, suggestions and changes made.
You can also check the latest updates from AEGIS regarding regional network approaches.
References and further reading
A European Genebank Integrated System. [online] Available from: http://www.ecpgr.cgiar.org/AEGIS/AEGIS_home.htm/. Date accessed: 08 April 2010.
ACI Global. 2010. Overview of ISO 9001:2008. ACI Global Pty Ltd. [online] Available from: http://www.aciglobal.com.au/ISO9001_Overview.html. Date accessed: 08 April 2010.
American Association for Laboratory Accreditation. [online] Available from: http://www.a2la.org/. Date accessed: 08 April 2010.
American Society for Quality. [online] Available from: http://www.asq.org/. Date accessed: 08 April 2010.
Anon. 2002. Feedback on ISO 9001:2000. ISO Management Systems, Special Report. pp 19-29 [online] Available from: http://www.bin.co.uk/info/9k2kfeedback.pdf. Date accessed: 08 April 2010.
Anon. 2002. Reactions to ISO secretary-general’s ‘police yourselves’ call to ISO 9000 community. ISO Management Systems, Debate pp 55-61. [online] Available from: http://www.bin.co.uk/info/Reactions_IMS.pdf. Date accessed: 08 April 2010.
Centro de estudos da Macaronésia (CEM). O Centro: ISOPlexis. [online] Available in Portuguese from: http://www.uma.pt/Investigacao/Ccbg/swebs/germoplasma/index.html. Date accessed: 26 March 2010.
CGN quality management system. [online]. Center for Genetic Resources, the Netherlands. Available from: http://www.cgn.wur.nl/UK/CGN+General+Information/Quality+manual/ Date accessed: 10 February 2011.
Chartered Quality Institute (CQI) . [online] Available from URL: http://www.thecqi.org/ Date accessed: 08 April 2010.
Engels J, Maggioni M. 2008. Quality Management System for AEGIS. A European Genebank Integrated System. Meeting in Poland. Bioversity International, Rome, Italy. [online] Available from: http://www.ecpgr.cgiar.org/AEGIS/Meeting_Poland0708/QMS_draft.pdf. Date accessed: 08 April 2010.
European cooperation for Accreditation (EA). [online] Available from: http://www.european-accreditation.org/default_flash.htm. Date accessed: 08 April 2010.
Honsa and McIntyre. 2003. ISO 17025: Practical benefits of implementing a quality system.
International Food Safety & Quality Network. Food Safety Standards Directory. [online] Available from: http://ifsqn.com/links.php. Date accessed: 08 April 2010.
International Organization for Standardization (ISO). 2010. ISO forms, model agendas, standard letters. [online] Available from: http://www.iso.org/forms. Date accessed: 08 APril 2010.
International Organization for Standardization (ISO). 2010. ISO/IEC directives and ISO supplement. [online] Available from: http://www.iso.org/directives. Date accessed: 08 April 2010.
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Quality Network. 2006. ISO 17025 Competence of Testing and Calibration Laboratories. [online] Available from: http://www.quality.co.uk/custpage.htm. Date accessed: 08 April 2010.
Rtech Laboratories. 2003. ISO 17025: Practical Benefits of Implementing a Quality System. Journal of AOAC International. [online], 86 (5), pp.1038-1044. Available from: http://www.atypon-link.com/AOAC/doi/abs/10.5555/jaoi.2003.86.5.1038?journalCode=jaoi. Date accessed: 08 April 2010.
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Wade J. 2002. Is ISO 9000 really a standard? ISO Management Systems, Viewpoint. pp.17-20. [online] Available from: http://www.bin.co.uk/info/IMS_May_2002.pdf. Date accessed: 08 April 2010.
Wikipedia. 2010. List of ISO standards. Wikimedia Foundation, Inc. [online] Available from: http://en.wikipedia.org/wiki/List_of_ISO_standards. Date accessed: 08 April 2010.