A healthy approach

Globally, quality improvement has become one of the key issues within management and provision of services in healthcare, argues Anne Cunningham, the international programme manager of global health audit group CHKS. Over the years a growing number of healthcare organizations have pursued different external awards to demonstrate that they provide a quality service.

The standards

Sometimes external audit is voluntary and the organization undertakes the audit to demonstrate to clients, commissioners and the public that they provide a quality service. Other services, such as radiotherapy, are required to have a formal system of quality assurance.

The best approach to auditing certification against ISO 9001 has been to translate the ISO clauses into the terminology of health care. The ISO clauses are integrated within the accreditation standards framework, thus taking out the hard work of trying to interpret the meaning of the generic ISO standard into a health care setting. To further consolidate interpretation into a health care system the standards have been mapped and implemented against CEN/TS 15224.

The standards framework places great emphasis on working with the standards within the context of the particular organization and the health system of the individual country.

Clients working with the ISO certification programme follow the format of ‘assess current practice, action plan and service development, internal survey then further action plan and service development before the external audit’. To make the process meaningful and relevant it is stressed that processes need to be implemented and evidence of change and improvement demonstrated. All too often, processes are documented to meet the requirement of the clauses, but there is little evidence of the system working effectively.

"It's essential to collect and digest information on the healthcare organizations from reputable sources such as the WHO publications and copies of legislation"

The audit process

Using auditors who are senior healthcare professionals with experience of the specific healthcare services relevant to those being audited will generally make the process easier. In CHKS, for example, auditors undergo a two-day training programme which covers evidence gathering, interviewing, audit trailing and report writing. By using senior healthcare professionals the evidence gathered through documentation and review of clinical practice is undertaken from a relevant knowledge base.

Any external audits should be led by staff who are trained as lead auditors and oversee the work of the other auditors, and this acts as an internal quality assurance mechanism.

Working internationally

The biggest stumbling block to working internationally is knowledge of the host country’s healthcare system. It’s essential, therefore, to collect and digest information on the healthcare organizations from reputable sources such as the WHO publications and copies of legislation. Documents such as these provide background information on the healthcare system. With this type of information it is possible to adapt the standards framework to reflect the host country’s legal, technical and cultural approach to the management of healthcare. It is worth investing time working with clients to ensure the standards are interpreted and audited within a culturally relevant framework.

Language is a potential barrier and extra time for translation needs to be considered when undertaking audit interviews. For instance, in some countries such as Portugal, CHKS has trained local healthcare professionals to be auditors and they take on dual roles of being auditors and providing translation services for UK auditors. They are also able to guide the auditors on whether the evidence submitted is appropriate in the national context whilst applying international quality management standards.  

Respecting and acknowledging cultural differences is important and the use of local healthcare professionals to advise and guide is essential. However, the auditor has to be mindful that the principles of ISO 9001:200 are not being undermined and the clause needs to be considered in a local context.

In conclusion, working internationally is a balancing act; the auditor has to be aware of the local context of the country and adapt to make the audit meaningful, but at the same time, be rigorous enough to ensure that there is a robust quality improvement system.  

About the author:

Anne Cunningham is the international programme manager with CHKS, which provides comparative information and quality improvement services for healthcare professionals in many countries across Europe, as well as working in Australia, New Zealand and South Africa.

The CHKS Healthcare Accreditation and Quality Unit (HAQU) provides certification against ISO 9001:2000 and accreditation services to healthcare organisations in both the UK and internationally.HAQU has 10 years' experience as a certificating body having previously been known as the Health Quality Service before it was acquired by CHKS Ltd in 2005. It is the longest established healthcare accreditation programme in Europe and is one of only two able to award both healthcare accreditation against internationally recognised standards and ISO certification 9001. HAQU also provides consultancy support for developing healthcare quality.

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