Many prosthetic and orthotic service providers in the industrialized world have realized the benefits of achieving ISO 9001:2000 accreditation. Until now, this has not been replicated in the developing world.
When Carson Harte, the international director of the Cambodia Trust (CT) told me at the end of 2000 that he was considering working towards ISO accreditation, I had to ask myself if the expense is worthwhile for an organization which provides free limbs and orthotic devices to the people of Cambodia, one of the poorest countries in the world. CT's production costs for a transfemoral prosthesis are typically less than $100. Also, the service will be eventually transferred to the Cambodian government, which has little money to provide any service at all and will certainly not want to fund the extra expense of maintaining an international quality standard.
My own experience with ISO in both the O&P and aircraft industries convinced me that the improvements that an organization undergoes with ISO implementation should not be ignored. The creation of a quality management system (QMS) would benefit the service provided in rehabilitation centers and could easily be upgraded to ISO 9001 later. The drawback of a "standalone" QMS is that the standard is to an extent defined by the experiences of those implementing it.
ISO 9000 series quality standards are a set of rules defining practices that are internationally recognized. They were originally a replica of British Quality Standards BS5750, which were adopted from standards and practices used in the defense and arms industries. Since their 1987 founding, ISO 9000 series have themselves undergone significant changes. The current standard, ISO 9001:2000, focuses on setting quality objectives which encourage continuous improvement and ultimately, customer satisfaction.
One prerequisite clearly stated in the quality standard is senior management commitment. Without it, any attempt at implementation would wither and die. The ISO QMS also focuses on "consensus management," which is widely understood to mean that ideas and changes are agreed to by employees as well as management. People welcome responsibility and like to use their creativity to solve problems. When management truly believes and encourages this philosophy, it leads to better cooperation and morale within the organization.
ISO: Aiding 'Cambodianization'
The government of New Zealand agreed to fund a project to develop the capacity within the Cambodian Trust of staff members who are Cambodian nationals, with a view to localization of the Cambodian operations by 2005.
ISO 9001:2000 accreditation is an integral part of this project, which has directly led to the whole of the Cambodia Trust rehabilitation service being managed and operated solely by Cambodian nationals. The Cambodian School of Prosthetics and Orthotics (CSPO) will follow when staff members become more experienced.
Like many small nongovernmental organizations (NGOs), the Cambodia Trust began by trying to fulfill a desperate need in a war-ravaged country, initially with only a couple of expatriates and a few local staff. Practices and procedures tended to be committed to memory. Very little was ever written down. Policies and procedures frequently changed with the arrival of new management. In the meantime the organization grew to provide services in three clinics, operate an International Society for Prosthetics and Orthotics (ISPO) Level II prosthetic and orthotic school and employ almost 100 staff members.
The first and probably the biggest hurdle for the implementation process was to get the staff to take ownership of the project. Developing trust and allowing staff members to speak openly were facilitated with the formation of small meeting groups. Khmer staff members were encouraged to chair and take minutes for their own meetings.[Editor's note: The Khmer people comprise about 90 percent of Cambodia's population, and the Khmer language is spoken by about 95 percent of the people. Thus, the Cambodian people and language are often referred to as "Khmer."] Monthly appraisal meetings began to be held to promote two-way communication between staff and supervisors. Khmer staff members were trained to be quality managers and auditors. Being given this responsibility helped to involve their hearts and minds in the project and in their work.
A necessary part of the implementation process was staff training. All staff members now have a job description written in their native tongue and can explain how their job contributes to the quality of service to the patient.
The Khmer staff members were highly enthusiastic and keen to prove that they could achieve international standards and be judged by them, which is why I feel that implementation of ISO 9001:2000 is better than adopting a homemade quality system.
In late August 2001, ISO auditors from BM Trada, a certifying organization, swooped in from Thailand, armed with clipboards and wearing no-nonsense expressions, for a pre-audit check. Despite the best preparations, some serious nonconformities were highlighted. After a further three months of work, the implementation team felt that more work was still required to meet the standard. The final audit was rescheduled from mid-December 2001 to March 2002.
The focus on continuous improvement provided some positive results early on in the implementation process. For example, spoilage of polypropylene when draping dropped to almost nil in provincial clinics. Even in the Phnom Penh clinic, where third-year students from CSPO conduct their internships, the technical supervision of students improved and the number of aborted drapes decreased to only one per month per student. These statistics are collected by the workshop staff themselves and a month-to-month running total is displayed on a whiteboard. This visible example of continuous improvement provides staff with motivation because they can see that the quality system is showing results.
Building Confidence, Saving Money
Increasing efficiency and cost effectiveness of the organization is essential. The terrorist attacks of September 11, 2001, have diverted attentionand funding from countries which have become very reliant on donors in affluent countries. This factor, combined with recent corruption scandals in Cambodian managed projects, has made the situation more acute. Donors now demand value for money, so it is necessary for organizations to be transparent and accountable. The ISO quality system provides a convenient vehicle for this openness. The aim to reduce costs and increase efficiency must be realized by all staffinstead of being just a slogan liberally bandied by managers worried about budgets. With a funding shortfall of US $250,000 this year at the Cambodia Trust, real strain is put on people's jobs. If any kind of service is to survive once it is in the hands of the government, operating costs must be reduced much further.
The road to implementation of ISO 9001:2000 in any country, developed or developing, is not quick, easy, or stress-free. The system can be intensely paperwork-heavy. The Cambodia Trust is one of the first organizations in the not-for-profit sector to achieve this accreditation. Where most organizations use the system to make money, CT is hoping that it will help make the little they have last longer and instill confidence in potential donors. With a moderate financial investment combined with hard work, total commitment, and self-belief, the CT has found its Cambodianization objectives about 18 months further along than originally expected. Staff members at all levels are much more motivated, aware, and interested in how the organization works. There is a collective sense of achievement. All of these, I imagine, are bonuses far exceeding the expected reward seen in Carson's initial vision of gaining accreditation.
The Next Challenge
The next big challenge to the staff is to maintain their quality system. According to Rob Kantner, author of the ISO Answer Book, this is more difficult and stressful than achieving it. The staff must now live by those quality objectives written months before and show evidence of continuous improvement when the auditors come calling again.
A question remains to be answered: What about the financial sustainability of an ISO QMS in the developing world? In Cambodiaa country with perhaps the highest percentage of disabled people in the worldthis is about more than money.
For more information about ISO international quality standards, visit www.iso.ch