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Inunalkmcl Journal for Quality tn Htallh Car*, VoL 9, No. 1, pp. 11-13,1997 Copyright O 1997 PnbEibed by Ebevier Scienoe Ltd. AD righu reserved Printed in Great Britain

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Accreditation and ISO: International Convergence On Health Care Standards ISQua Position Paper - October 1996
CHARLES D. SHAW
London, UK general guidance on the establishment of quality standards and external evaluation systems sensitive to health care, such as those offered by accreditation scientific evidence, just as clinical practice aims to converge and respond to evidence of biomedical research which is international, so should health care systems; standards for organization and delivery should have a common international basis challenge of ISO: the emergence by default of certification under ISO 9000 series for international recognition of health services poses a market challenge to national accrediting bodies, especially in the European Union but also in South Africa and Australia Reconciliation It would be neither practically nor politically feasible for ISO to replace existing accreditation systems, or vice versa, but there is room for convergence. Some of the main differences currently include: Terminology: Compliance with ISO may lead to certification which is verified by an accredited organisation or a certificated auditor. Health service accreditation is awarded by a body to a service provider. Neither should be confused with statutory licensing which is a legal requirement by the state as a minimum condition of service operation. Terminology is internationally consistent within ISO, but interpreted variously in different accreditation systems. Purpose: ISO certification is about designing a quality system for the manufacture of a product to the customer's specification. The emphasis is therefore on conformance to the processes that have been put in place by the supplier to design and manufacture the product Accreditation aims to improve the quality of care and service to the customer, both external (patients, populations) and internal (staff, providers); it therefore focuses also on the infrastructure to support service delivery and clinical practice.

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This paper was developed from a document discussed at the Accreditation Symposium held in association with the 13th Conference of the International Society for Quality in Health Care in Jerusalem in May 1996. The group did not have the advantage of representatives from the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), The Australian Council on Healthcare Standards (ACHS) or The New Zealand Council on Health Care Standards (NZCHS), but their informal positions were subsequently sought. Formal position papers on ISO and accreditation were addressed by the governing bodies of the JCAHO in Pecember 1995 and the ACHS in June 1996. In October 1996, this paper was endorsed by the Executive Board of the International Society for Quality in Health Care, Inc., (ISQua) as a formal position paper. Introduction As the demand for accountability for quality in health care develops globally, so does the demand for comparability of service standards. In some countries this demand is met by accreditation programmes set up by agencies internal to the health care system; others turn to international standards such as ISO 9002 and the associated industry-based models for certification. There is growing interest in the relationship between the two. The principal factors behind this are: multi-national demand. the mobility of international alliances of health service operators and of their clientele urges increased comparability between countries, including those where national accreditation systems already exist national developments: many nations are seeking

Mrs L Tregloan, Executive Officer, The Internationa] Society for Quality in Health Care, Inc., Lincoln House, 625 Swanston Street, Carlton, Victoria 3053, Australia. Tel: +61 3 9285 5368. Fax: +61 3 9285 5329. E-mail: l.tregloan@latrobe.cdu_iu

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12 Concept of improvement: ISO separates organizational development from the external assessment process. The assessors are not permitted to assist customers towards certification. Accreditation integrates these to support internal organizational development and the achievement of standards through quality management systems. . Frequency of assessment. Most accreditation systems require reassessment every one to three years and encourage continuing development through networking, educational programmes and bulletins. ISO requires six monthly reviews. Standards: ISO standards (e.g. the 9000 series) are general to service industries and focus on capability rather than results on quality of process rather than final product. ISO assesses the latter mainly through customer satisfaction; accreditation, while recognising the role of patient satisfaction, also takes into account its limitations and recognises a range of legitimate processes and outcomes in patients and in the population (including preventive intervention); it seeks to reconcile patients, populations and scientific evidence. ISO standards are divided into twenty categories and are largely process-orientated. Accreditation standards have less clearly defined categories and currently lack an explicit conceptual model. Some ISO standards, such as on "product identification and traceability", are fairly readily applied to services such as laboratory and radiology but require creative interpretation in application to direct patient care. Accreditation standards are considered relatively inadequate compared with those of ISO with respect to: purchasing, control and calibration of equipment, product identification and traceability, document control, design control (i.e. research and new products). Surveyors: Compliance with ISO standards is assessed by independent certificated auditors qualified by ISOrecognised training and ISO survey experience. Registration of training courses for ISO auditors is based on criteria including: application procedure, course content, duration and structure, tutors, assessment and examination, publicity, advertising and locations, suspension or withdrawals of registration. Compliance with accreditation standards is assessed by surveyors who are trained by the individual programme and who (except to an extent in the Joint Commission) generally work in a clinical or managerial environment similar to those which they assess. Breadth of survey: ISO assessments cover multiple separate elements of an organization; accreditation surveys cover entire hospitals and systems including community and primary care services. Costs: Apart from internal costs of preparation for external assessment, the cost for ISO certification

C. D.Shaw depends on the number of days (at commercial consulting rates) required for external assessment until success is achieved. Costs for accreditation are determined by the frequency and scope of the surveys; surveyors are generally charged out at marginal costs. Accreditation surveys are thus cheaper than ISO assessments. Recognition of recognition: Organisations competent to certificate under ISO may be "accredited" by national registrars using international criteria. Similarly, individual assessors may be recognised by the International Register of Certificated Auditors (IRCA). There is currently no equivalent in health service accreditation. In short, ISO offers a framework for denning and assessing compliance with service standards which are recognized internationally but are not sensitive to population health care needs. Accreditation is founded on the latter but standards, assessors and awards are not recognized or readily adaptable internationally. Ingredients for convergence In order to align ISO to accreditation (or vice versa) and to assist countries considering setting up new programmes, core international frameworks are required towards: a conceptual framework which is consistent with the goals of health care organizations, reflects their resulting management targets and is oriented to organizational development common language (e.g. to differentiate accreditation from licensing) standards for assessment of health care providers for accreditation which are sensitive to patient expectations, evidence-based practice and clinical outcomes; these should incorporate the standards development process, content and interpretation. There is a precedent for industry-specific standards displacing the generic ISO 9000 series and subsequently being recognised by ISO: General Motors, Chrysler and Ford collaborated to develop for the motor industry "QS 9000" which has now been adopted internationally. training and recognition of accreditation surveyors operation of certificated accreditation programmes, including common information for benchmarking of health care providers and to demonstrate performance and impact of accreditation systems; a framework, using a range of international yardsticks, was developed and applied to the New Zealand programme in 1996. There is interest in the International Society for Quality Health Care being the umbrella organisation to set up a mechanism for further development. Readers of the Journal are encouraged to send comments on this paper in the form of "Letters to the Editor" to the

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International Convergence On Health Care Standards

13 analyse external peer review techniques (ExPeRT) has been funded for three years from August 1996 by the BIOMED 2 research programme of the European Union. This project may include countries which have reciprocal research agreements with the EU; these include Australia, Canada, Israel, South Africa and USA. ExPeRT will begin to address some of the above issues about accreditation in a European context, but is neither funded nor mandated to work outside those boundaries. Any such development would rely on the consent and commitment of existing accrediting organisations, an agreed costed programme of action and funding. . Reciprocal review program. As was developed and applied to the New Zealand program in 1996, a performance review program has been established between the Canadian Council on Health Services Accreditation, Australian Council on Healthcare Standards, New Zealand Council on Healthcare Standards and the Kings Fund in the United Kingdom.

Editor-in-Chief. Please see the "Instructionsfor Authors", page ii, in the endpages of the Journal. Those readers interested in receiving information on further developments in this area should register their interest and send contact details to: Mrs. Lee Tregloan, Executive Officer, The International Society for Quality in Health Care, Inc., Lincoln House, 625 Swanston Street, Carlton, Victoria 3053, Australia. Tel: +61.3 9285 5368. Fax: +61.3 9285 5329 or +61.3 9347 4851, E-mail: ISQUA@latrobe.edu.au

APPENDIX
Existing international linkages The following links may be regarded as complementary to ISQua's interest. ExPeRT. A three year project in Europe to catalogue and

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